# FDA device clearances in Tennessee: 109 since Nov 2024

Updated October 30, 2026.

FDA made 109 device decisions for applicants in Tennessee from November 20, 2024 to October 30, 2026: 79 510(k) clearances and De Novo grants and 30 PMA approvals and supplements, for 36 applicants. The newest, DEN250054 on October 30, 2026, is Virtuoso Endoscopy System from Virtuoso Surgical, Inc..

## The full list

FDA device clearances for applicants in Tennessee: 109 rows for $5.45, FDA 510(k) and PMA decisions dated November 11, 2024 to October 30, 2026. Columns: Number, Pathway, Device name, Applicant, Applicant address, Contact, Decision, Decision date, Decision type, Date received, Product code, Device type, Device class, Panel, Applicant state, Applicant country, Supplement reason, Read on, Source. The new rows each week by email, about 7 rows a month: $19 a month. Pay by card with no account. Prices exclude VAT. CSV and Excel files with the columns this page does not show (contact, pathway, device name, applicant address, date received, device type and 5 more), which open on your screen as soon as the payment clears and come by email. The rows on this page are a sample.

Buy: https://specstream.ai/data/fda-clearances/state/tennessee

SpecStream is the live web data engine for teams and agents. It reads every new FDA device clearance and approval as openFDA publishes it, and this page is that reading. Ask for the specialties, product codes or states you follow and each new decision arrives in your sheet, CRM, Slack or agent with the applicant and its address.

- Decisions: 109
- 510(k) and De Novo: 79
- PMA: 30
- Latest decision: October 30, 2026

## Newest decisions

The newest 100 of 109, each linked to its FDA record. The full list adds the applicant's address, the 510(k) contact as FDA prints it, the device class and the date received.

| Decision date | Number | Device | Applicant | Location | Decision | Type | Product code | Source |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| October 30, 2026 | DEN250054 | Virtuoso Endoscopy System | Virtuoso Surgical, Inc. | Tennessee | Unknown | De Novo | SJS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN250054) |
| October 29, 2026 | K262572 | Symmetrix™ PX Spinal System | Medtronic Sofamor Danek USA, Inc. | Tennessee | Substantially Equivalent | 510(k) traditional | MAX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262572) |
| October 21, 2026 | K263352 | TeKBrace Knotless Anchor | TheraMicro | Tennessee | Substantially Equivalent | 510(k) special | MBI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K263352) |
| October 1, 2026 | K262473 | NEXUS® Hip Stem | Microport Orthopedics, Inc. | Tennessee | Substantially Equivalent | 510(k) special | LZO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262473) |
| September 25, 2026 | K260055 | syngo.CT Brain Quantification | Siemens Medical Solutions USA, Inc. | Tennessee | Substantially Equivalent | 510(k) traditional | QIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260055) |
| September 23, 2026 | K260597 | VIRTUE QA | ProNova Solutions | Tennessee | Substantially Equivalent | 510(k) traditional | LHN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260597) |
| September 8, 2026 | K261462 | LANDMARK Total Knee System | Smith & Nephew, Inc. | Tennessee | Substantially Equivalent | 510(k) traditional | MBH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261462) |
| September 5, 2026 | K261684 | FreezeSpray TA | Cryosurgery, Inc. | Tennessee | Substantially Equivalent | 510(k) traditional | MLY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261684) |
| August 26, 2026 | P050053/S066 | INFUSE BONE GRAFT | Medtronic, Inc. | Tennessee | Approved | PMA 180-day supplement | NPZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P050053S066) |
| August 26, 2026 | P000058/S095 | INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE | Medtronic Sofamor Danek USA, Inc. | Tennessee | Approved | PMA 180-day supplement | NEK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P000058S095) |
| August 26, 2026 | P000054/S075 | INFUSE BONE GRAFT | Medtronic Sofamor Danek USA, Inc. | Tennessee | Approved | PMA 180-day supplement | MPW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P000054S075) |
| August 26, 2026 | K260811 | Heartvue.Proton | Heartvue.ai, Inc. | Tennessee | Substantially Equivalent | 510(k) traditional | QIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260811) |
| August 21, 2026 | K253728 | EVOLUTION® AM BIOFOAM® Tibial System | Microport Orthopedics, Inc. | Tennessee | Substantially Equivalent | 510(k) traditional | MBH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253728) |
| August 18, 2026 | K262729 | TeKBrace Solo Soft Tissue Reinforcement Device | Theramicro | Tennessee | Substantially Equivalent | 510(k) special | QUW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262729) |
| August 18, 2026 | K260266 | Tympendi™ (810) | Grace Medical, Inc. | Tennessee | Substantially Equivalent | 510(k) traditional | KHJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260266) |
| August 4, 2026 | K260572 | Marrow Marxman | Medimetrix, LLC | Tennessee | Substantially Equivalent | 510(k) traditional | KNW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260572) |
| August 3, 2026 | P040013/S033 | GEM21S® Growth Factor Enhanced Matrix Implementation of Restricted Access Barrier System (RABS) at Pyramid | Lynch Biologics, LLC | Tennessee | Approved | PMA 135-day supplement | NPZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P040013S033) |
| July 28, 2026 | P050053/S069 | Infuse™ Bone Graft | Medtronic, Inc. | Tennessee | Approved | PMA 180-day supplement | NPZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P050053S069) |
| July 28, 2026 | P000058/S099 | Infuse TM Bone Graft/Medtronic lnterbody Fusion Device | Medtronic Sofamor Danek USA, Inc. | Tennessee | Approved | PMA 180-day supplement | NEK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P000058S099) |
| July 28, 2026 | P000054/S078 | Infuse™ Bone Graft | Medtronic Sofamor Danek USA, Inc. | Tennessee | Approved | PMA 180-day supplement | MPW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P000054S078) |
| July 24, 2026 | K262290 | REMEDY POLY+PLUS SNAP FIT Acetabular Cup | Osteoremedies, LLC | Tennessee | Substantially Equivalent | 510(k) special | KWL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262290) |
| July 17, 2026 | K253011 | Catalyft PL Expandable Interbody System | Medtronic Sofamor Danek USA, Inc. | Tennessee | Substantially Equivalent | 510(k) traditional | MAX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253011) |
| July 14, 2026 | K261020 | Symmetrix™ L Spinal System | Medtronic Sofamor Danek USA, Inc. | Tennessee | Substantially Equivalent | 510(k) traditional | MAX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261020) |
| July 1, 2026 | K261021 | EasyWhip Family | Winter Innovations, Inc. | Tennessee | Substantially Equivalent | 510(k) traditional | GAT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261021) |
| June 25, 2026 | K253786 | syngo.CT Coronary Cockpit | Siemens Medical Solutions USA, Inc. | Tennessee | Substantially Equivalent | 510(k) traditional | QIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253786) |
| June 18, 2026 | K261099 | Blood Volume Analyzer (200) | Daxor Corporation | Tennessee | Substantially Equivalent | 510(k) special | JWO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261099) |
| June 16, 2026 | K253159 | Prophecy Incompass Surgical Planning System | Wright Medical Technology, Inc. (Stryker) | Tennessee | Substantially Equivalent | 510(k) traditional | HSN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253159) |
| June 9, 2026 | K261621 | TekBrace Solo Soft Tissue Reinforcement Device | Theramicro | Tennessee | Substantially Equivalent | 510(k) special | QUW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261621) |
| June 5, 2026 | P230038 | AbsorbaSeal 5.6.7F Vascular Closure Device | Cyndrx, LLC | Tennessee | Approved | PMA original approval | MGB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230038) |
| June 5, 2026 | K253656 | OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System | Medtronic Sofamor Danek USA, Inc. | Tennessee | Substantially Equivalent | 510(k) traditional | GEI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253656) |
| May 30, 2026 | K261154 | CoLink® & CoLag® Non-Sterile Screws | In2Bones USA, LLC | Tennessee | Substantially Equivalent | 510(k) special | HWC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261154) |
| May 21, 2026 | K261315 | Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia... | Siemens Medical Solutions USA, Inc. | Tennessee | Substantially Equivalent | 510(k) special | KPS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261315) |
| April 24, 2026 | P110015/S012 | 13C-Spirulina Gastric Emptying Breath Test (GEBT) | Advanced Breath Diagnostics | Tennessee | Approved | PMA 180-day supplement | PGE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P110015S012) |
| April 21, 2026 | K260216 | CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal System | Medtronic Sofamor Danek USA, Inc. | Tennessee | Substantially Equivalent | 510(k) traditional | NKB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260216) |
| April 17, 2026 | K260900 | DYNEX® External Fixation Systems | Vilex, LLC | Tennessee | Substantially Equivalent | 510(k) special | KTT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260900) |
| April 6, 2026 | K254084 | AETOS Shoulder System - CONCELOC Glenoids | Smith & Nephew, Inc. | Tennessee | Substantially Equivalent | 510(k) traditional | KWS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254084) |
| March 27, 2026 | K252081 | SportLinc Syndesmosis Device | Lincotek Medical | Tennessee | Substantially Equivalent | 510(k) traditional | HTN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252081) |
| March 20, 2026 | K253574 | SOMATOM X.cite; SOMATOM X.ceed | Siemens Medical Solutions USA, Inc. | Tennessee | Substantially Equivalent | 510(k) traditional | JAK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253574) |
| March 19, 2026 | P050053/S068 | INFUSE® Bone Graft | Medtronic, Inc. | Tennessee | 30-day notice accepted | PMA 30-day notice | NPZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P050053S068) |
| March 19, 2026 | P000058/S098 | INFUSE® Bone Graft/LT-Cage Lumbar Tapered Fusion Device | Medtronic Sofamor Danek USA, Inc. | Tennessee | 30-day notice accepted | PMA 30-day notice | NEK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P000058S098) |
| March 19, 2026 | P000054/S077 | INFUSE® Bone Graft | Medtronic Sofamor Danek USA, Inc. | Tennessee | 30-day notice accepted | PMA 30-day notice | MPW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P000054S077) |
| March 6, 2026 | K253538 | TeKBrace Knotless Anchor | Theramicro | Tennessee | Substantially Equivalent | 510(k) traditional | MBI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253538) |
| February 24, 2026 | P050053/S067 | INFUSE Bone Graft | Medtronic, Inc. | Tennessee | 30-day notice accepted | PMA 30-day notice | NPZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P050053S067) |
| February 24, 2026 | P000058/S097 | INFUSE Bone Graft/Medtronic Interbody Fusion Device | Medtronic Sofamor Danek USA, Inc. | Tennessee | 30-day notice accepted | PMA 30-day notice | NEK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P000058S097) |
| February 24, 2026 | P000054/S076 | INFUSE Bone Graft | Medtronic Sofamor Danek USA, Inc. | Tennessee | 30-day notice accepted | PMA 30-day notice | MPW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P000054S076) |
| February 13, 2026 | P000058/S096 | Infuse Bone Graft | Medtronic Sofamor Danek USA, Inc. | Tennessee | Approved | PMA panel track supplement | NEK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P000058S096) |
| January 21, 2026 | K254165 | Infinity™ OCT System | Medtronic Sofamor Danek USA, Inc. | Tennessee | Substantially Equivalent | 510(k) special | NKG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254165) |
| January 7, 2026 | K253941 | CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly) | Medtronic Sofamor Danek USA, Inc. | Tennessee | Substantially Equivalent | 510(k) special | NKB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253941) |
| January 6, 2026 | K253178 | TRILEAP Plating System | Crossroads Extremity Systems | Tennessee | Substantially Equivalent | 510(k) traditional | HRS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253178) |
| December 31, 2025 | P000057/S013 | Ascension MCP | Smith & Nephew, Inc. | Tennessee | Approved | PMA 135-day supplement | NEG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P000057S013) |
| December 23, 2025 | K253675 | OsteoRemedies Hip Spacer System | Osteoremedies, LLC | Tennessee | Substantially Equivalent | 510(k) special | KWL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253675) |
| December 15, 2025 | K251770 | SleepRes PAP System | Sleepres, Inc. | Tennessee | Substantially Equivalent | 510(k) traditional | BZD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251770) |
| December 5, 2025 | K250764 | SpineLinc Anterior Cervical Implant System | Lincotek Medical | Tennessee | Substantially Equivalent | 510(k) traditional | ODP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250764) |
| November 21, 2025 | K250586 | Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory | Deroyal Industries, Inc. | Tennessee | Substantially Equivalent | 510(k) traditional | OMP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250586) |
| October 29, 2025 | K252416 | AETOS Shoulder System Meta Humeral Prosthesis Size 0 | Smith & Nephew, Inc. | Tennessee | Substantially Equivalent | 510(k) traditional | KWS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252416) |
| October 29, 2025 | K251643 | Synchfix EVT | Wright Medical Technology, Inc. (Stryker Corporation) | Tennessee | Substantially Equivalent | 510(k) traditional | HTN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251643) |
| October 24, 2025 | K253335 | CD Horizon™ Spinal System | Medtronic Sofamor Danek USA, Inc. | Tennessee | Substantially Equivalent | 510(k) special | NKB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253335) |
| October 24, 2025 | K253129 | Infinity™ OCT System | Medtronic Sofamor Danek USA, Inc. | Tennessee | Substantially Equivalent | 510(k) special | NKG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253129) |
| October 16, 2025 | K253000 | CryoFreeze Wart and Skin Tag Remover | Cryosurgery, Inc. | Tennessee | Substantially Equivalent | 510(k) special | GEH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253000) |
| October 15, 2025 | K251805 | syngo.CT Dual Energy | Siemens Medical Solutions USA, Inc. | Tennessee | Substantially Equivalent | 510(k) traditional | JAK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251805) |
| October 10, 2025 | K252903 | Verruca-Freeze H Plus | Cryosurgery, Inc. | Tennessee | Substantially Equivalent | 510(k) special | GEH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252903) |
| September 30, 2025 | K252085 | Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom) | Wright Medical Technology, Inc. (Stryker Corporation) | Tennessee | Substantially Equivalent | 510(k) traditional | MQV | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252085) |
| September 4, 2025 | K251444 | Endoskeleton™ Interbody Systems | Medtronic Sofamor Danek USA, Inc. | Tennessee | Substantially Equivalent | 510(k) traditional | MAX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251444) |
| August 27, 2025 | K251382 | Phoenix Sinus Tarsi Stent System | Astra Orthomed, Inc. | Tennessee | Substantially Equivalent | 510(k) traditional | HWC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251382) |
| August 8, 2025 | K250472 | SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) | Amdt Holdings, Inc. | Tennessee | Substantially Equivalent | 510(k) traditional | KTT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250472) |
| August 5, 2025 | P000057/S014 | ASCENSION MCP | Smith & Nephew, Inc. | Tennessee | 30-day notice accepted | PMA 30-day notice | NEG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P000057S014) |
| August 4, 2025 | K251087 | Blood Volume Analyzer (200) | Daxor Corporation | Tennessee | Substantially Equivalent | 510(k) traditional | JWO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251087) |
| July 31, 2025 | K251561 | Biograph Trinion | Siemens Medical Solutions USA, Inc. | Tennessee | Substantially Equivalent | 510(k) special | KPS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251561) |
| July 28, 2025 | K251061 | NAEOTOM Alpha.Peak/NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime | Siemens Medical Solutions USA, Inc. | Tennessee | Substantially Equivalent | 510(k) traditional | JAK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251061) |
| July 21, 2025 | P110015/S011 | 13C-Gastric Emptying Breath Test (GEBT), 13C-Spirulina Gastric Emptying Breath Test (GEBT), 13C-GEBT | Advanced Breath Diagnostics | Tennessee | Approved | PMA 180-day supplement | PGE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P110015S011) |
| July 3, 2025 | K250822 | SOMATOM go.Now; SOMATOM go.Up; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM... | Siemens Medical Solutions USA, Inc. | Tennessee | Substantially Equivalent | 510(k) traditional | JAK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250822) |
| June 26, 2025 | K251395 | The Rialto™ SI Fusion System | Medtronic Sofamor Danek USA, Inc. | Tennessee | Substantially Equivalent | 510(k) traditional | OUR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251395) |
| June 20, 2025 | K250037 | Incompass Total Ankle System | Wright Medical Technology, Inc. (Stryker) | Tennessee | Substantially Equivalent | 510(k) traditional | HSN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250037) |
| June 12, 2025 | K251193 | Grafton™ DBM; Grafton Plus™ DBM Paste; Magnifuse™ Bone Graft | Medtronic Sofamor Danek, Inc. | Tennessee | Substantially Equivalent | 510(k) traditional | MQV | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251193) |
| June 12, 2025 | K243608 | TRIGEN Stable Lock Nut & Washer | Smith & Nephew, Inc. | Tennessee | Substantially Equivalent | 510(k) traditional | JDS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243608) |
| May 30, 2025 | K251063 | TekBrace Solo Soft Tissue Reinforcement Device | Theramicro | Tennessee | Substantially Equivalent | 510(k) traditional | QUW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251063) |
| May 16, 2025 | K250141 | Synthecure Synthetic Calcium Sulfate | Austin Medical Ventures, Inc. | Tennessee | Substantially Equivalent | 510(k) traditional | MQV | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250141) |
| May 15, 2025 | K250444 | NEXUS® Hip Stem | Microport Orthopedics, Inc. | Tennessee | Substantially Equivalent | 510(k) traditional | LZO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250444) |
| April 22, 2025 | K250669 | Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology | Medtronic Sofamor Danek USA, Inc. | Tennessee | Substantially Equivalent | 510(k) traditional | MAX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250669) |
| April 17, 2025 | P150030/S049 | R3™ Delta Ceramic Acetabular System | Smith & Nephew, Inc. | Tennessee | 30-day notice accepted | PMA 30-day notice | MRA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P150030S049) |
| April 10, 2025 | K243145 | syngo.CT LVO Detection | Siemens Medical Solutions USA, Inc. | Tennessee | Substantially Equivalent | 510(k) traditional | QAS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243145) |
| April 2, 2025 | K250760 | SPECTRUM GV Bone Cement | Osteoremedies, LLC | Tennessee | Substantially Equivalent | 510(k) special | LOD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250760) |
| April 2, 2025 | K250677 | LEGION Total Knee System | Smith & Nephew, Inc. | Tennessee | Substantially Equivalent | 510(k) special | JWH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250677) |
| March 28, 2025 | K250571 | CATALYSTEM Femoral Stems | Smith & Nephew, Inc. | Tennessee | Substantially Equivalent | 510(k) special | LZO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250571) |
| March 19, 2025 | P130001/S009 | ColoHealth | New Day Diagnostics, LLC | Tennessee | Approved | PMA 180-day supplement | PHP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P130001S009) |
| March 19, 2025 | P050053/S065 | INFUSE® Bone Graft | Medtronic, Inc. | Tennessee | 30-day notice accepted | PMA 30-day notice | NPZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P050053S065) |
| March 19, 2025 | P000058/S094 | INFUSE® Bone Graft/LT-Cage Lumbar Tapered Fusion Device | Medtronic Sofamor Danek USA, Inc. | Tennessee | 30-day notice accepted | PMA 30-day notice | NEK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P000058S094) |
| March 19, 2025 | P000054/S074 | INFUSE® Bone Graft | Medtronic Sofamor Danek USA, Inc. | Tennessee | 30-day notice accepted | PMA 30-day notice | MPW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P000054S074) |
| March 17, 2025 | K250514 | UPT Series Medical RO Water Treatment System | Specialty Water Technologies, Inc. | Tennessee | Substantially Equivalent | 510(k) special | FIP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250514) |
| March 13, 2025 | K243487 | CryoFreeze Wart and Skin Tag Remover | Cryosurgery, Inc. | Tennessee | Substantially Equivalent | 510(k) traditional | GEH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243487) |
| March 7, 2025 | K243801 | FRONT-LINE Field Sterilizer (FL135) | Fort Defiance Industries, LLC | Tennessee | Substantially Equivalent | 510(k) special | FLE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243801) |
| March 5, 2025 | K250304 | TITANEX Screw Systems | Vilex, LLC | Tennessee | Substantially Equivalent | 510(k) special | HWC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250304) |
| March 3, 2025 | P150030/S048 | R3 DELTA CERAMIC HIP SYSTEM | Smith & Nephew, Inc. | Tennessee | 30-day notice accepted | PMA 30-day notice | MRA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P150030S048) |
| February 28, 2025 | P150030/S045 | R3 Delta Ceramic Hip System | Smith & Nephew, Inc. | Tennessee | Approved | PMA 180-day supplement | MRA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P150030S045) |
| February 21, 2025 | P150030/S047 | R3™ Delta Ceramic Acetabular System | Smith & Nephew, Inc. | Tennessee | 30-day notice accepted | PMA 30-day notice | MRA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P150030S047) |
| February 19, 2025 | K241666 | EVOS Pelvic and Acetabular System | Smith & Nephew | Tennessee | Substantially Equivalent | 510(k) traditional | HRS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241666) |
| February 18, 2025 | K243574 | Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique | Microport Orthopedics, Inc. | Tennessee | Substantially Equivalent | 510(k) traditional | JWH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243574) |
| February 12, 2025 | K243523 | NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime | Siemens Medical Solutions USA, Inc. | Tennessee | Substantially Equivalent | 510(k) traditional | JAK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243523) |
| January 17, 2025 | K243706 | Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft Granules | Medtronic Sofamor Danek, Inc. | Tennessee | Substantially Equivalent | 510(k) traditional | MQV | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243706) |
| January 16, 2025 | P150030/S046 | R3™ Delta Ceramic Acetabular System | Smith & Nephew, Inc. | Tennessee | 30-day notice accepted | PMA 30-day notice | MRA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P150030S046) |

## Applicants with the most decisions

| Applicant | Decisions | Latest |
| --- | --- | --- |
| Medtronic Sofamor Danek USA, Inc. | 23 | October 29, 2026 |
| Smith & Nephew, Inc. | 16 | September 8, 2026 |
| Siemens Medical Solutions USA, Inc. | 11 | September 25, 2026 |
| Cryosurgery, Inc. | 5 | September 5, 2026 |
| Medtronic, Inc. | 5 | August 26, 2026 |
| Microport Orthopedics, Inc. | 4 | October 1, 2026 |
| Theramicro | 4 | August 18, 2026 |
| Vilex, LLC | 4 | April 17, 2026 |
| Osteoremedies, LLC | 3 | July 24, 2026 |
| Lynch Biologics, LLC | 2 | August 3, 2026 |
| Daxor Corporation | 2 | June 18, 2026 |
| Wright Medical Technology, Inc. (Stryker) | 2 | June 16, 2026 |
| Advanced Breath Diagnostics | 2 | April 24, 2026 |
| Lincotek Medical | 2 | March 27, 2026 |
| Wright Medical Technology, Inc. (Stryker Corporation) | 2 | October 29, 2025 |
| Medtronic Sofamor Danek, Inc. | 2 | June 12, 2025 |
| Virtuoso Surgical, Inc. | 1 | October 30, 2026 |
| TheraMicro | 1 | October 21, 2026 |
| ProNova Solutions | 1 | September 23, 2026 |
| Heartvue.ai, Inc. | 1 | August 26, 2026 |

## By panel

| Panel | Decisions | Latest |
| --- | --- | --- |
| [Orthopedic](https://specstream.ai/data/fda-clearances/panel/orthopedic) | 65 | October 29, 2026 |
| [Radiology](https://specstream.ai/data/fda-clearances/panel/radiology) | 14 | September 25, 2026 |
| [General, Plastic Surgery](https://specstream.ai/data/fda-clearances/panel/general-plastic-surgery) | 10 | August 18, 2026 |
| [Dental](https://specstream.ai/data/fda-clearances/panel/dental) | 7 | August 26, 2026 |
| Unknown | 2 | October 30, 2026 |
| [Gastroenterology, Urology](https://specstream.ai/data/fda-clearances/panel/gastroenterology-urology) | 2 | August 4, 2026 |
| [Hematology](https://specstream.ai/data/fda-clearances/panel/hematology) | 2 | June 18, 2026 |
| [Clinical Chemistry](https://specstream.ai/data/fda-clearances/panel/clinical-chemistry) | 2 | April 24, 2026 |
| [Ear, Nose, Throat](https://specstream.ai/data/fda-clearances/panel/ear-nose-throat) | 1 | August 18, 2026 |
| [Cardiovascular](https://specstream.ai/data/fda-clearances/panel/cardiovascular) | 1 | June 5, 2026 |
| [Anesthesiology](https://specstream.ai/data/fda-clearances/panel/anesthesiology) | 1 | December 15, 2025 |
| [Pathology](https://specstream.ai/data/fda-clearances/panel/pathology) | 1 | March 19, 2025 |
| [General Hospital](https://specstream.ai/data/fda-clearances/panel/general-hospital) | 1 | March 7, 2025 |

## By decision type

| Decision type | Decisions | Latest |
| --- | --- | --- |
| [510(k) traditional](https://specstream.ai/data/fda-clearances/decision/510k-traditional) | 53 | October 29, 2026 |
| [510(k) special](https://specstream.ai/data/fda-clearances/decision/510k-special) | 25 | October 21, 2026 |
| [PMA 30-day notice](https://specstream.ai/data/fda-clearances/decision/pma-30-day-notice) | 16 | March 19, 2026 |
| [PMA 180-day supplement](https://specstream.ai/data/fda-clearances/decision/pma-180-day-supplement) | 10 | August 26, 2026 |
| [PMA 135-day supplement](https://specstream.ai/data/fda-clearances/decision/pma-135-day-supplement) | 2 | August 3, 2026 |
| [De Novo](https://specstream.ai/data/fda-clearances/decision/de-novo) | 1 | October 30, 2026 |
| [PMA original approval](https://specstream.ai/data/fda-clearances/decision/pma-original-approval) | 1 | June 5, 2026 |
| [PMA panel track supplement](https://specstream.ai/data/fda-clearances/decision/pma-panel-track-supplement) | 1 | February 13, 2026 |

## Where FDA publishes these decisions

- [FDA 510(k) database](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm)
- [FDA PMA database](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm)
- [openFDA device API](https://open.fda.gov/apis/device/)

Source: [openFDA device 510(k) and PMA (U.S. Food and Drug Administration)](https://open.fda.gov/apis/device/). CC0 1.0 (openFDA). Decisions are as FDA publishes them in its 510(k) and PMA databases, read through openFDA. A PMA row is the original approval or one supplement. The panel is the FDA advisory committee that reviewed the device. FDA adds decisions to openFDA some weeks after their date, so the newest weeks fill in later. The 510(k) contact is in the full list only, as FDA prints it for the submission.

Free to reuse with credit to SpecStream under [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/).