Data / Medical devices / United States / Highridge Medical, LLC
Highridge Medical, LLC: FDA-registered device maker in Westminster, CO, United States, 260 510(k) clearances and 10 PMA approvals
Highridge Medical, LLC is registered with the FDA (registration 3012447612) in Westminster, CO, United States. It lists 112 device types. The FDA files 260 510(k) clearances and 10 PMA approvals under its listings, the newest dated May 21, 2025. 18 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3012447612
- Address
- 10225 Westmoor Dr, Westminster, CO, United States, 80021
- Owner or operator
- Highridge Medical, LLC (9061535)
- Roles
- Manufacturer, Specification developer
- First device listed
- February 27, 2004
- Registered through
- 2027
- Brand names listed
- Chisel, Clamp, FlareHawk, FlareHawk Interbody Fusion System, FlareHawk11/TiHawk11, HD Lumbar Interbody System, Hive Stand-alone Anterior Lumbar Interbody System, Integrity Implants Navigated Instruments and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 260.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 21, 2025 | K243116 | FlareHawk Interbody Fusion System | MAX | Substantially Equivalent | Integrity Implants Inc. Dba Accelus | accessdata.fda.gov |
| April 4, 2025 | K250332 | Virage® OCT Spinal Fixation System | NKG | Substantially Equivalent | Highridge Medical, LLC | accessdata.fda.gov |
| April 5, 2024 | K240647 | Virage® Navigation System | OLO | Substantially Equivalent | Zimvie Spine (Zimmer Biomet Spine, Inc.) | accessdata.fda.gov |
| March 15, 2024 | K240539 | Vital Spinal Fixation System | NKB | Substantially Equivalent | Zimvie Spine (Zimmer Biomet Spine, Inc.) | accessdata.fda.gov |
| November 16, 2023 | K233443 | Vital Navigation System | OLO | Substantially Equivalent | Zimvie Spine (Zimmer Biomet Spine, Inc.) | accessdata.fda.gov |
| October 11, 2023 | K230116 | Vital Spinal Fixation System | NKB | Substantially Equivalent | Zimvie Spine (Zimmer Biomet Spine, Inc.) | accessdata.fda.gov |
| August 7, 2023 | K231098 | LineSider® Spinal System | NKB | Substantially Equivalent | Integrity Implants, Inc. | accessdata.fda.gov |
| July 13, 2023 | K231769 | activL® Next Generation Instrumentation | QLQ | Substantially Equivalent | Aesculap Implants Systems, LLC | accessdata.fda.gov |
| March 25, 2022 | K213355 | Toro-L Interbody Fusion System | MAX | Substantially Equivalent | Integrity Implants, Inc. | accessdata.fda.gov |
| March 24, 2022 | K220453 | FlareHawk Interbody Fusion System | MAX | Substantially Equivalent | Integrity Implants, Inc. | accessdata.fda.gov |
| January 7, 2022 | K213720 | Vital Navigation System | OLO | Substantially Equivalent | Zimvie (Zimmer Biomet Spine, Inc.) | accessdata.fda.gov |
| December 23, 2021 | K212088 | Integrity Implants Navigated Instruments | OLO | Substantially Equivalent | Integrity Implants, Inc. | accessdata.fda.gov |
| August 27, 2021 | K212023 | Virage Navigation System | OLO | Substantially Equivalent | Zimmer Biomet Spine, Inc. | accessdata.fda.gov |
| April 2, 2021 | K210275 | Polaris Spinal System | NKB | Substantially Equivalent | Zimmer Biomet Spine, Inc. | accessdata.fda.gov |
| March 26, 2021 | K203038 | Toro-L Interbody Fusion System | MAX | Substantially Equivalent | Integrity Implants, Inc. | accessdata.fda.gov |
| January 28, 2021 | K203507 | Vitality® Spinal Fixation System | NKB | Substantially Equivalent | Zimmer Biomet Spine, Inc. | accessdata.fda.gov |
| December 3, 2020 | K203367 | LineSider Spinal System | NKB | Substantially Equivalent | Integrity Implants, Inc. | accessdata.fda.gov |
| November 3, 2020 | K202198 | FlareHawk Interbody Fusion System | MAX | Substantially Equivalent | Integrity Implants, Inc. | accessdata.fda.gov |
| October 8, 2020 | K202309 | Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, Concero Facet Screw System, Alpine XC Adjustable Fusion System, Aspen MIS Fusion System, L-Plate MIS Fusion System | KWQ | Substantially Equivalent | Zimmer Biomet Spine, Inc. | accessdata.fda.gov |
| September 23, 2020 | K201367 | FlareHawk TiHawk9 Interbody Fusion System | MAX | Substantially Equivalent | Integrity Implants, Inc. | accessdata.fda.gov |
| April 28, 2020 | K200541 | Hive Stand-alone Anterior Lumbar Interbody System | OVD | Substantially Equivalent | Hd Lifesciences, LLC | accessdata.fda.gov |
| December 2, 2019 | K191722 | Vital Navigation System | OLO | Substantially Equivalent | Zimmer Biomet Spine, Inc. | accessdata.fda.gov |
| October 24, 2019 | K190556 | Zimmer Biomet Universal Navigation System | OLO | Substantially Equivalent | Zimmer Biomet Spine, Inc. | accessdata.fda.gov |
| June 21, 2019 | K190360 | LineSider Spinal System | NKB | Substantially Equivalent | Integrity Implants, Inc. | accessdata.fda.gov |
| April 8, 2019 | K183550 | Vitality® Spinal Fixation System | NKB | Substantially Equivalent | Zimmer Biomet Spine, Inc. | accessdata.fda.gov |
| April 3, 2019 | K183184 | FlareHawk Interbody Fusion System | MAX | Substantially Equivalent | Integrity Implants, Inc. | accessdata.fda.gov |
| January 7, 2019 | K182114 | FlareHawk Interbody Fusion System | MAX | Substantially Equivalent | Integrity Implants, Inc. | accessdata.fda.gov |
| March 15, 2018 | K180227 | Polaris Spinal Growth System | PGM | Substantially Equivalent | Zimmer Biomet Spine, Inc. | accessdata.fda.gov |
| February 12, 2018 | K171495 | Zyston Strut Open Titanium Spacer System | MAX | Substantially Equivalent | Zimmer Biomet Spine, Inc. | accessdata.fda.gov |
| September 27, 2017 | K172275 | Vitality® Spinal Fixation System, Vitality®+ Power Instrument System | NKB | Substantially Equivalent | Zimmer Biomet Spine, Inc. | accessdata.fda.gov |
| July 14, 2017 | K171907 | Vitality® Spinal Fixation System | NKB | Substantially Equivalent | Zimmer Biomet Spine, Inc. | accessdata.fda.gov |
| July 13, 2017 | K170676 | HD Lumbar Interbody System | MAX | Substantially Equivalent | Hd Lifesciences, LLC | accessdata.fda.gov |
| May 16, 2017 | K162133 | VerteFIT Corpectomy Cage System | MQP | Substantially Equivalent | Ldr Spine USA, Inc. | accessdata.fda.gov |
| February 28, 2017 | K163543 | Biomet Fusion System | OVD | Substantially Equivalent | Zimmer Biomet Spine, Inc. | accessdata.fda.gov |
| October 13, 2016 | K160076 | XCage Interbody Fusion System | MAX | Substantially Equivalent | Ouroboros Medical, Inc. | accessdata.fda.gov |
| September 28, 2016 | K161173 | Avenue® T TLIF Cage | OVD | Substantially Equivalent | Ldr Spine USA, Inc. | accessdata.fda.gov |
| August 4, 2016 | K161798 | FacetBRIDGE® System | MRW | Substantially Equivalent | Ldr Spine USA, Inc. | accessdata.fda.gov |
| March 31, 2016 | K153495 | Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant System | MAX | Substantially Equivalent | Ldr Spine USA | accessdata.fda.gov |
| February 16, 2016 | K153631 | Zimmer Virage OCT Spinal Fixation System | NKG | Substantially Equivalent | Zimmer Spine, Inc. | accessdata.fda.gov |
| January 25, 2016 | K152137 | FacetBRIDGE System | MRW | Substantially Equivalent | Ldr Spine USA | accessdata.fda.gov |
| January 21, 2016 | K153695 | Biomet Spine Fusion System | MAX | Substantially Equivalent | Biomet Spine, LLC | accessdata.fda.gov |
| December 7, 2015 | K151934 | ROI-C Titanium-Coated Implant System | OVE | Substantially Equivalent | Ldr Spine USA | accessdata.fda.gov |
| November 13, 2015 | K151974 | Polaris Spinal System | NKB | Substantially Equivalent | Biomet Spine | accessdata.fda.gov |
| September 17, 2015 | K150765 | LDR Spine ROI-C Cervical Cage System | OVE | Substantially Equivalent | Ldr Spine USA | accessdata.fda.gov |
| August 31, 2015 | K150896 | Vitality Spinal Fixation System | NKB | Substantially Equivalent | Zimmer Spine, Inc. | accessdata.fda.gov |
| June 30, 2015 | K151224 | Lineum OCT Spine System | NKG | Substantially Equivalent | Biomet Spine | accessdata.fda.gov |
| June 24, 2015 | K151031 | Virage OCT Spinal Fixation System | NKG | Substantially Equivalent | Zimmer Spine, Inc. | accessdata.fda.gov |
| June 18, 2015 | K142752 | Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System, Nex-Link OCT Cervical Plating System, Sequoia Pedicle Screw System including SpeedLink II, ST360º Spinal Fixatoin System, Title 2 Polyaxial Spinal System | NKB | Substantially Equivalent | Zimmer Spine, Inc. | accessdata.fda.gov |
| March 20, 2015 | K143626 | inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating System, SC-AcuFix Slimline Anterior Cervical Plate System, SC-AcuFix Thinline Anterior Cervical Plate System, Trinica Anterior Lumbar Plate System, Trinica and Trinica Select Anterior Cervical Plate System, V2F Anterior Fixation System | KWQ | Substantially Equivalent | Zimmer Spine, Inc. | accessdata.fda.gov |
| February 12, 2015 | K143297 | Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody Fusion System, InFix Anterior Lumbar System, TraXis Vertebral Body Replacement (Ti and VUE) | MAX | Substantially Equivalent | Zimmer Spine, Inc. | accessdata.fda.gov |
| December 15, 2014 | K140734 | NEXTGEN ALTIUS OCT SYSTEM | KWP | Substantially Equivalent | Ebi, LLC | accessdata.fda.gov |
| November 5, 2014 | K133518 | MAXAN ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | Biomet Spine (Aka Ebi, LLC) | accessdata.fda.gov |
| October 29, 2014 | K142053 | UNIVERSAL CLAMP SPINAL FIXATION SYSTEM | OWI | Substantially Equivalent | Zimmer Spine, Inc. | accessdata.fda.gov |
| October 9, 2014 | K141791 | BIOMET FUSION SYSTEM | OVD | Substantially Equivalent | Biomet Spine | accessdata.fda.gov |
| September 25, 2014 | K141804 | POLARIS SPINAL SYSTEM - HA COATED | NKB | Substantially Equivalent | Biomet Spine, LLC | accessdata.fda.gov |
| September 23, 2014 | K141500 | OPTIO-C ANTERIOR CERVICAL SYSTEM | KWQ | Substantially Equivalent | Zimmer Spine, Inc. | accessdata.fda.gov |
| July 7, 2014 | K133784 | VISTA-S DEVICE, ASSOCIATED INSTRUMENTATION | ODP | Substantially Equivalent | Zimmer Trabecular Metal Technology | accessdata.fda.gov |
| June 2, 2014 | K133556 | VIRAGE OCT SPINAL FIXATION SYSTEM | KWP | Substantially Equivalent | Zimmer Spine, Inc. | accessdata.fda.gov |
| May 21, 2014 | K140611 | TRINICA ANTERIOR LUMBAR PLATE SYSTEM | KWQ | Substantially Equivalent | Zimmer Spine, Inc. | accessdata.fda.gov |
| May 1, 2014 | K133514 | XCAGE INTERBODY FUSION SYSTEM | MAX | Substantially Equivalent | Ouroboros Medical | accessdata.fda.gov |
| April 24, 2014 | K140123 | POLARIS SPINAL SYSTEM -TRANSLATION SCREW | NKB | Substantially Equivalent | Ebi, LLC | accessdata.fda.gov |
| March 12, 2014 | K133746 | POLARIS SPINAL SYSTEM | NKB | Substantially Equivalent | Biomet Spine (Aka Ebi, LLC) | accessdata.fda.gov |
| March 7, 2014 | K133363 | INTERBRIDGE INTERSPINOUS POSTERIOR FIXATION SYSTEM | PEK | Substantially Equivalent | Ldr Spine USA, Inc. | accessdata.fda.gov |
| January 30, 2014 | K133184 | ARDIS INTERBODY SYSTEM | MAX | Substantially Equivalent | Zimmer Spine, Inc. | accessdata.fda.gov |
| January 16, 2014 | K132894 | OPTIO-C ANTERIOR CERVICAL SYSTEM | OVE | Substantially Equivalent | Zimmer Spine, Inc. | accessdata.fda.gov |
| December 20, 2013 | K132790 | INFIX ANTERIOR LUMBAR SYSTEM | MAX | Substantially Equivalent | Zimmer Spine, Inc. | accessdata.fda.gov |
| December 17, 2013 | K133291 | ST360 DEGREES SPINAL FIXATION SYSTEM | NKB | Substantially Equivalent | Zimmer Spine, Inc. | accessdata.fda.gov |
| November 27, 2013 | K133086 | TITLE 2 POLYAXIAL SPINAL SYSTEM | NKB | Substantially Equivalent | Zimmer Spine, Inc. | accessdata.fda.gov |
| November 25, 2013 | K132884 | PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM | NKB | Substantially Equivalent | Zimmer Spine, Inc. | accessdata.fda.gov |
| September 4, 2013 | K131980 | SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM | NKB | Substantially Equivalent | Zimmer Spine, Inc. | accessdata.fda.gov |
| September 4, 2013 | K131615 | POLARIS SPINAL SYSTEM | OSH | Substantially Equivalent | Biomet Spine (Aka Ebi, LLC) | accessdata.fda.gov |
| September 3, 2013 | K131242 | ARDIS INTERBODY SYSTEM | MAX | Substantially Equivalent | Zimmer Spine, Inc. | accessdata.fda.gov |
| August 29, 2013 | K132012 | TRINICA(R) ANTERIOR CERVICAL PLATE SYSTEM, TRINICA(R) SELECT ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | Zimmer Spine, Inc. | accessdata.fda.gov |
| July 12, 2013 | K131547 | LANX FUSION SYSTEM | OVD | Substantially Equivalent | Lanx, Inc. | accessdata.fda.gov |
| May 24, 2013 | K131156 | LANX SPINAL FIXATION SYSTEM | KWP | Substantially Equivalent | Lanx, Inc. | accessdata.fda.gov |
| March 18, 2013 | K123767 | LANX FUSION SYSTEM- SA | OVD | Substantially Equivalent | Lanx, Inc. | accessdata.fda.gov |
| March 1, 2013 | K123602 | TM ARDIS INTERBODY SYSTEM INSERTER | MAX | Substantially Equivalent | Zimmer Trabecular Metal Technology | accessdata.fda.gov |
| February 25, 2013 | K123549 | POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW PLACEMENT SYSTEM | NKB | Substantially Equivalent | Biomet Spine (Aka Ebi, LLC) | accessdata.fda.gov |
| February 1, 2013 | K123134 | EASYSPINE SYSTEM | NKB | Substantially Equivalent | Ldr Spine USA, Inc. | accessdata.fda.gov |
| December 7, 2012 | K122733 | V2F ANTERIOR FIXATION SYSTEM | KWQ | Substantially Equivalent | Zimmer Spine, Inc. | accessdata.fda.gov |
| December 3, 2012 | K123451 | POLARIS SPINAL SYSTEM - BALLISTA II RODS | NKB | Substantially Equivalent | Biomet Spine (Aka Ebi, LLC) | accessdata.fda.gov |
| September 20, 2012 | K122378 | NEXTGEN ALTIUS OCT SYSTEM | KWP | Substantially Equivalent | Biomet Spine (Aka Ebi, LLC) | accessdata.fda.gov |
| September 10, 2012 | K121316 | LANX SPINAL FIZATION SYSTEM | NKB | Substantially Equivalent | Lanx, Inc. | accessdata.fda.gov |
| August 24, 2012 | K121103 | LDR SPINE USA SPINE TUNE, TL SPINAL SYSTEM, LDR SPINE USA EASYSPINE, POSTERIOR SPINAL SYSTEM, LDR SPINE USA MC IMPLANT S | NKB | Substantially Equivalent | Ldr Spine USA, Inc. | accessdata.fda.gov |
| August 17, 2012 | K122145 | LANX SPINAL FIXATION SYSTEM | NKB | Substantially Equivalent | Lanx, Inc. | accessdata.fda.gov |
| August 2, 2012 | K121940 | LANX SPINAL FIXATION SYSTEM | NKB | Substantially Equivalent | Lanx, Inc. | accessdata.fda.gov |
| July 26, 2012 | K113285 | LDR SPINE USA AVENUE L INTERBODY FUSION | OVD | Substantially Equivalent | Ldr Spine USA, Inc. | accessdata.fda.gov |
| July 18, 2012 | K121671 | PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM | NKB | Substantially Equivalent | Zimmer Spine, Inc. | accessdata.fda.gov |
| June 27, 2012 | K120760 | LDR SPINE SPINETUNE TL SPINAL SYSTEM | MNH | Substantially Equivalent | Ldr Spine USA, Inc. | accessdata.fda.gov |
| June 15, 2012 | K121130 | POLARIS SPINAL SYSTEM-BALLISTA SPINAL RODS | NKB | Substantially Equivalent | Biomet Spine | accessdata.fda.gov |
| June 15, 2012 | K120203 | TM-400 DEVICE | MAX | Substantially Equivalent | Zimmer Trabecular Metal Technology, Inc. | accessdata.fda.gov |
| May 29, 2012 | K113561 | TM ARDIS INTERBODY SYSTEM TM ARDIS INTERBODY SYSTEM INSTRUMENATION | MAX | Substantially Equivalent | Zimmer Trabecular Metal Technology | accessdata.fda.gov |
| April 26, 2012 | K113796 | SOLITAIRE-C CERVICAL SPACER SYSTEM | OVE | Substantially Equivalent | Ebi, LLC | accessdata.fda.gov |
| April 17, 2012 | K113593 | NEXTGEN ALTIUS OCT SYSTEM | KWP | Substantially Equivalent | Biomet Spine (Aka Ebi, LLC) | accessdata.fda.gov |
| March 9, 2012 | K120399 | LANX SPINAL FIXATION SYSTEM | NKB | Substantially Equivalent | Lanx, LLC | accessdata.fda.gov |
| December 29, 2011 | K113559 | LDR SPINE CERVICAL INTERBODY FUSION SYSTME-ROI-C LORDOTIC IMPLANTS | ODP | Substantially Equivalent | Ldr Spine USA, Inc. | accessdata.fda.gov |
| December 19, 2011 | K113434 | LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS) | NKB | Substantially Equivalent | Lanx, Inc. | accessdata.fda.gov |
| December 16, 2011 | K112388 | LANX CERVICAL SA | OVE | Substantially Equivalent | Lanx, Inc. | accessdata.fda.gov |
| November 23, 2011 | K111119 | TRABECULAR METAL (TM) FUSION DEVICE | ODP | Substantially Equivalent | Zimmer Spine, Inc. | accessdata.fda.gov |
| November 18, 2011 | K111983 | VISTA-S DEVICE MODEL 08/06-401-XXXXX, 08/06-402-XXXXXX | ODP | Substantially Equivalent | Zimmer Trabecular Metal Technology | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| June 11, 2015 | P120024 | ACTIVL ARTIFICIAL DISC | MJO | 12 | January 29, 2026 | accessdata.fda.gov |
| August 23, 2013 | P110009 | MOBI-C CERVICAL DISC PROSTHESIS (TWO-LEVEL INDICATION) | MJO | 34 | September 16, 2026 | accessdata.fda.gov |
| August 7, 2013 | P110002 | MOBI-C CERVICAL DISC PROSTHESIS (ONE-LEVEL INDICATION) | MJO | 34 | September 16, 2026 | accessdata.fda.gov |
| April 20, 2001 | P980048 | BAK/CERVICAL (BAK/C) INTERBODY FUSION SYSTEM | MAX | 3 | October 6, 2004 | accessdata.fda.gov |
| September 20, 1996 | P950002 | BAK INTERBODY FUSION SYSTEM | MAX | 13 | July 1, 2004 | accessdata.fda.gov |
| October 29, 1992 | P860005 | PRO OSTEON IMPLANT 500 HYDROXYAPATITE BONE VOID FILLER | OIS | 11 | May 31, 2002 | accessdata.fda.gov |
| April 30, 1987 | P850035 | SpF® Implantable Spinal Fusion Stimulator | LOE | 51 | September 20, 2024 | accessdata.fda.gov |
| February 18, 1986 | P850022 | Biomet® OrthoPak® Non-invasive Bone Growth Stimulator System; Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator Sy | LOF | 31 | February 29, 2024 | accessdata.fda.gov |
| January 25, 1980 | P790005 | OsteoGenTM Implantable Bone Growth Stimulators | LOE | 58 | November 23, 2022 | accessdata.fda.gov |
| November 6, 1979 | P790002 | Biomet(R) EBI BONE Healing System | LOF | 35 | October 26, 2023 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 16, 2023 | 93650 | Class II | Ongoing | Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System | Spinal fixation system 7.5mmx 50mm screws are packaged with the correct labeling, but the screws themselves were laser marked with an incorrect size description of 7.5 x 40; use of incorrect screws could lead to screw perforation and indention of vascular or other structures. | accessdata.fda.gov |
| July 30, 2018 | 82076 | Class II | Terminated | Vitality Spinal Fixation System. Thoracolumbosacral pedicle screw system (non-sterile). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients. For use in Orthopedic medical specia | The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vitality screws, hooks and connectors due to a manufacturing issue.These devices are indicated as an adjunct to fusion for various indications | accessdata.fda.gov |
| May 10, 2017 | 77251 | Class II | Terminated | Vitality Spinal Fixation System, Vitality T27 Final Drivers and Vitality Torque Limiting Handle 90 in-lbs Model Number(s): 07.02066.001, 07.02053.001, 730M0017 | Zimmer Biomet is conducting a medical device recall for Vitality T27 Final Drivers and Vitality Torque Limiting Handle 90 in-lbs because when applying torque to tighten the closure top the driver has the potential to create a torsional spring which can cause damage and the potential for the values of torque to go out of specification. | accessdata.fda.gov |
| March 16, 2017 | 76610 | Class II | Terminated | Altius M-INI OCT Posterior Spinal Fixation System, Model Number 1200-9216 The AltiusTM OCT and AltiusTM M-INITM OCT Systems when intended to promote fusion of the cervical spine and occipitocervico-thoracic junction (Occ | Zimmer Biomet is recalling the Altius M-INI OCT Posterior Spinal Fixation System because the driver is unable to mate with the screw head tulip. | accessdata.fda.gov |
| June 30, 2016 | 74687 | Class II | Terminated | Zyston Transform Instrument Case. Model Number PCR8200-2101. Device labeled sterile. | Zimmer Bioment Spine, Inc. announces a voluntary field action for the Zyston Transform Instrument Case and Zyston Transform Implant Kit because the locking mechanism on the implant is not functioning as intended. | accessdata.fda.gov |
| February 12, 2016 | 73402 | Class II | Terminated | 10mm X 12o Solitaire Ti Medium Spacer Solitaire Anterior Spinal System, Model Number 1400-1230. Product Usage: The SOLITAIRETM SPINAL SYSTEM is designed for use with autograft and is indicated for stand-alone interverteb | Zimmer Biomet Spine initiated a recall of certain Solitaire Ti Spacers because they may have a mislabeled lordotic angle of 12degrees when the angle is actually 6 degrees. | accessdata.fda.gov |
| September 29, 2015 | 72312 | Class II | Terminated | MaxAn 4.0mm and 4.5mm fixed screws, used in the MaxAn Anterior Cervical Plate System. The MaxAn Anterior Cervical Plate System is a decompression-based technique for cervical spine stabilization. | The packaging of 4.5 mm diameter MaxAn screws identifies/labels the screws as 4.0 mm diameter screws. | accessdata.fda.gov |
| August 5, 2015 | 71940 | Class II | Terminated | Biomet Parsippany, NJ. 4 0 MM X 14 MM Variable Screw C-Tek Maxan Anterior Cervical Plate System. Lot 375440. | Some of P/N 14-521614B Lot 375440 was mislabeled as P/N 14-521614 Lot 375440. | accessdata.fda.gov |
| July 22, 2015 | 71877 | Class II | Terminated | Biomet Spine Lineum OCC Starter Flexible and Lineum Flexible Inner Shaft, Model Numbers 14-525050 and 14-525057, reusable devices distributed with bubble wrap inside a plastic pouch. The Lineum system is designed to faci | Biomet has initiated a recall on Biomet Spine Lineum OCC Starter Flexible and its inner shaft instrumentsafter identifying that these instruments were distributed prior to completion of all design control activities. | accessdata.fda.gov |
| March 12, 2015 | 70832 | Class II | Terminated | Lineum HF Torque Handle Limit (Lineum) Model Number 14-525035 P_roduct Usage: Designed to facilitate reconstruction of the cervical and upper thoracic spine using bones screws, locking plugs, and various types of rods, h | Biomet is recalling the Lineum HF Torque Handle Limit (Lineum) and Torque Limiting Handle (Aspen/ Alpine) due to the supplier withdrawing it from the market for component updates or reconfiguration. | accessdata.fda.gov |
| November 4, 2013 | 66836 | Class II | Terminated | LANX Timberline MPF Lateral Modular Plate Fixation System Straight Split Tip Driver - Short ("Driver"). Model Number 8630-0107. The Timberline MPF device is an intervertebral body fusion device consisting of a PEEK inter | Lanx, Inc. is recalling various lots of Timberline MPF Straight Split Tip Driver - Short ("Driver") because the width of the most distal end from the Driver handle (the tip of the hex portion of the Driver) is oversized. | accessdata.fda.gov |
| August 22, 2013 | 70070 | Class II | Terminated | Timberline Anchored Lateral Fixed Retractable Sleeve Model No. 8630-0205. Timberline Anchored Lateral Fixed Retractable Sleeves are used with the Timberline MPF System to help establish access into the vertebrae for the | The inner diameter of the Sleeve shaft is undersized, resulting in interference fit when inserting the Anchored Lateral Straight Retractable Awl or the Anchored Lateral Straight Retractable Drill into the Sleeve. | accessdata.fda.gov |
| August 22, 2013 | 70060 | Class II | Terminated | Timberline Anchored Lateral Variable Retractable Sleeve LITPCR8600-2101-07, Model No. 86300204 Timberline Anchored Lateral Variable Retractable Sleeves (the Sleeves) are used with the Timberline MPF System to help establ | The inner diameter of the Sleeve shaft is undersized, resulting in interference fit when inserting the Anchored Lateral Straight Retractable Awl or the Anchored Lateral Straight Retractable Drill into the Sleeve shaft. | accessdata.fda.gov |
| August 22, 2013 | 70056 | Class II | Terminated | Anchored Lateral Retractable Drill, Timberline IPF IFU IFU8621-0113, Model 8630-0102. Timberline Anchored Lateral Retractable Drills are used with the Timberline MPF System to establish access into the vertebrae for the | The outer diameter of the Drill shaft is oversized; thereby, resulting in interference fit when inserting the Drill into the Fixed or Variable Sleeve Assembly. | accessdata.fda.gov |
| November 30, 2012 | 70383 | Class II | Terminated | Set Screw 5.5 mm Rod - Model #7703-1600. Product Usage: The titanium alloy set screw is used to seat a 5.5 mm titanium alloy, commercially pure titanium or cobalt chrome rod into a pedicle screw tulip in order to create | Biomet Spine LLC is recalling the Set Screw 5.5 mm Rod due to the set screw being out of specification | accessdata.fda.gov |
| February 22, 2012 | 70381 | Class II | Terminated | Timberline Cranial Caudal and Posterior Blades, 40 - 180mm Model # 8734-2XXX, 8734-5XXX is a reusable device provided within an aluminum sterilization tray along with other instruments for use in a Timberline procedure T | Biomet Spine, LLC is recalling the Timberline Cranial Caudal and Posterior Blades, 40-180mm due to oversize of the set screw hex feature. | accessdata.fda.gov |
| December 19, 2011 | 70376 | Class II | Terminated | Telluride Percutaneous Rod Inserter Long, Model #7706-1904. The Inserter is a reusable device provided within an aluminum sterilization case along with other orthopedic manual surgical instruments. The case consists of t | The Telluride Percutaneous Rod Inserter Long does not contain a feature that locks the Rod in place during use. There is a potential for the Rod to disengage from the Inserter during insertion, and could lead to harm to the patient. | accessdata.fda.gov |
| March 9, 2011 | 69615 | Class II | Terminated | LANX, REF, PCR8XXX-XXX, LOT, RXONLY. Packaged within aluminum sterilization case. Product Usage: The Durango implant is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature pat | Biomet Spine, LLC. announces voluntary recall of Durango Anchored ALIF Plate due to the set screw component potentially becoming dislodged from the plate assembly. | accessdata.fda.gov |
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Updated January 29, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.