Data / Medical devices / United States / Trilliant Surgical LLC
Trilliant Surgical LLC: FDA-registered device maker in Houston, TX, United States, 10 510(k) clearances and 1 PMA approval
Trilliant Surgical LLC is registered with the FDA (registration 3007420745) in Houston, TX, United States. It lists 41 device types. The FDA files 10 510(k) clearances and 1 PMA approval under its listings, the newest dated February 23, 2022. 14 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3007420745
- Address
- 727 N. Shepherd Dr STE 100, Houston, TX, United States, 77007
- Owner or operator
- Trilliant Surgical (10027494)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- November 12, 2008
- Registered through
- 2027
- Brand names listed
- 3S Hemi, 3S Hemi Implant, Arsenal, Arsenal Ankle Plating System, Awl, Bender, Broach, Clamp 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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 23, 2022 | K212378 | Arsenal Ankle Plating System | HRS | Substantially Equivalent | Trilliant Surgical | accessdata.fda.gov |
| August 12, 2019 | K191009 | Arsenal Plating System | HRS | Substantially Equivalent | Trilliant Surgical | accessdata.fda.gov |
| October 26, 2018 | K181898 | Two-Step Implant System | HWC | Substantially Equivalent | Trilliant Surgical | accessdata.fda.gov |
| November 16, 2017 | K172178 | Minimally Invasive Bunion Plating System | HRS | Substantially Equivalent | Trilliant Surgical, Ltd. | accessdata.fda.gov |
| January 14, 2016 | K153338 | Tiger Cannulated Screw System | HWC | Substantially Equivalent | Trilliant Surgical, Ltd. | accessdata.fda.gov |
| November 7, 2012 | K122959 | HAMMER TOE IMPLANT | HWC | Substantially Equivalent | Trilliant Surgical, Ltd. | accessdata.fda.gov |
| June 4, 2012 | K121008 | TRILLIANT SURGICAL K-WIRES | HTY | Substantially Equivalent | Trilliant Surgical, Ltd. | accessdata.fda.gov |
| October 20, 2011 | K112737 | TIGER HEADLESS CANNULATED SCREWS | HWC | Substantially Equivalent | Trilliant Surgical, Ltd. | accessdata.fda.gov |
| August 4, 2008 | K081510 | TIGER CANNULATED SCREW SYSTEM | HWC | Substantially Equivalent | Trilliant Surgical, Ltd. | accessdata.fda.gov |
| November 28, 2007 | K072922 | 3S HEMI TOE | KWD | Substantially Equivalent | Trilliant Surgical, Ltd. | 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 |
|---|---|---|---|---|---|---|
| May 27, 2009 | P050050 | SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (S.T.A.R.ANKLE) | NTG | 23 | March 13, 2024 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| November 4, 2019 | 84987 | Class II | Terminated | 8mm HTR Sterile Hammer Toe Reaming Kit, Material: Stainless Steel, Sterile: R, PX only, UDI: (01)00812926022345(17)231225 (10)TSL007202 | The firm has identified that parts from the kit, lot: TSL007202, have the potential to contain the incorrect contents of the 8mm HTR Sterile Hammer Toe Reaming Kit. The kit should contain (2) reamers total, (1) Concave Reamer and (1) Convex Reamer; there is the potential that kits from the identified lot may have (2) of the same reamer type as opposed to one | accessdata.fda.gov |
| October 10, 2019 | 85374 | Class II | Terminated | 3.5mm Aresenal Screw Drill Bit, Ref: 330-35-001, Qty. 70, Rx Only, Non-Sterile, UDI: (01)00812926029696 - Product Usage: A drill bit facilitates implant insertion | Labeling Error; specifically, drill bits from lots # TSL008495A are marked with the lot # of TSL008495. This could lead to parts being misidentified and impact device traceability. | accessdata.fda.gov |
| March 14, 2019 | 84350 | Class II | Terminated | Gridlock Ankle Screw Driver Bit REF 320-35-003 - Product Usage: A screwdriver facilitates implant insertion and removal. | A screwdriver used to facilitate implant insertion and removal was found to be out of specification for the minor diameter of the drive feature causing the driver to be unable to retain screws as intended. | accessdata.fda.gov |
| July 19, 2018 | 84977 | Class II | Terminated | Instructions for Use and Surgical Cleaning and Sterilization Protocol for: (1) Trilliant Surgical Tiger Cannulated Screw System, Model 210-00-001; and (2) Combination Tiger/Tiger Headless Cannulated Screw System, Model 2 | Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018. | accessdata.fda.gov |
| March 27, 2018 | 80195 | Class II | Terminated | Cannulated Driver Handle, Catalog #: 210-00-003, Rx Only, Non Sterile | Firm is voluntarily recalling cannulated driver handles (210-00-003 and 210-00-004) that may demonstrate a degradation of function with the adapter collar sticking, and/or not retaining the mating adapter male shaft. | accessdata.fda.gov |
| December 8, 2016 | 76029 | Class II | Terminated | Tiger Screw Sterilization Tray Base Assembly Model 210-00-001 Revision N, O The product is a component of a system indicated for the fixation of fractures, non-unions, arthrodeses, and osteotomies of bones appropriate fo | Four lots of Tiger Screw Sterilization Tray Base Assemblies were released to the field with a printing error where k-wire description markings indicate diameters of 0.45 and 0.35 instead of 0.045" and 0.035", respectively. | accessdata.fda.gov |
| September 2, 2016 | 75187 | Class II | Terminated | Model 208-70-110, Long Thread Tiger Large Cannulated Headless Screw, 7 x 110 mm labeled as "7.0 x 110mm LTTHCS REF 208-70-110 QTY 30 LOT TSL003721 2016-03-29 Trilliant Surgical, LTD" | Screws were identified as having the incorrect part number and lot number marked upon them. The part number incorrectly indicated a length of 115 mm rather than 110 mm. The lot number incorrectly indicated lot number of TSL003765 rather than TSL003721. | accessdata.fda.gov |
| August 6, 2015 | 71967 | Class II | Terminated | 7 Hole VL Gridlock Fibula Plate, Part # 300-60-001 NON-STERILE SINGLE USE ONLY; 9 Hole VL Gridlock Fibula Plate, Part # 300-60-002 NON-STERILE SINGLE USE ONLY; 11 Hole VL Gridlock Fibula Plate, Part # 300-60-003 NON-STER | The affected parts subject to the recall are out of specification, resulting in in the loss of the optimal locking screw functionality of the plates. The thread depth of the screw holes is insufficient, potentially limiting the ability to engage and lock with associated mating locking screws. | accessdata.fda.gov |
| July 31, 2015 | 71936 | Class II | Terminated | 2.4, 3.0, and 4.0 mm Gridlock Screw Driver Bit, Model Number 310-30-003, Lot Number TSL002605, NON-STERILE. For use with the Gridlock Plating System for trauma and reconstructive procedures of small bones. | Gridlock screw driver bits for the Gridlock Plating System were identified to be out of specification and have the potential for shallow engagement between the driver and the screw, resulting in an increased likelihood of stripping screw heads intraoperatively. Specifically, the minor diameter of the drive feature is above the specification, potentially redu | accessdata.fda.gov |
| July 20, 2015 | 71815 | Class II | Terminated | Concave Reamer Head, 16 mm; Concave Reamer Head, 18 mm; Concave Reamer Head, 20 mm; Concave Reamer Head 22 mm; Convex Reamer Head, 16 mm; Convex Reamer Head, 18 mm; Convex Reamer Head 20 mm; Convex Reamer Head 22 mm, use | The cannulation of the Concave and Convex Reamer Heads may be too small to allow the Guide Pin to freely pass through. | accessdata.fda.gov |
| July 20, 2015 | 71813 | Class II | Terminated | Tiger Cannulated Tray Lid Part # 210-00-001-1 NON-STERILE; Combined Tiger/Headless Screw Part # 210-99-101 NON-STERILE; These are components of the Tiger Cannulated Screw System and the Tiger Headless Cannulated Screw Sy | Sterilization tray lids for the Tiger and Tiger Headless Cannulated Screw Systems were reported to occasionally be difficult to remove from the sterilization tray. | accessdata.fda.gov |
| July 20, 2015 | 71812 | Class II | Terminated | 3.0/4.0 Cannulated Drill Bit; a component of the Tiger Cannulated Screw System The Tiger Cannulated Screw Fixation System implants are intended for fixation of fractures, non-unions, arthrodesis and osteotomies of the sm | The cannulation of the 3.0/4.0 Cannulated Drill Bit inner diamter is too small to allow for the guide wire to pass completely through. | accessdata.fda.gov |
| July 20, 2015 | 71783 | Class II | Terminated | 2.0/2.4 Cannulated Screw Countersink Part # 210-24-002 NON-STERILE and 3.0/4.0 Cannulated Screw Countersink Part # 210-40-002 NON-STERILE Product Usage: The Tiger Cannulated Screw Fixation System implants are intended fo | The cutting efficiency of the Countersinks was out of specification. | accessdata.fda.gov |
| April 14, 2009 | 55180 | Not yet classified | Terminated | 2.0/2.4 Cannulated Screw Driver Bit, part #210-24-003 | Firm received several complaints of field failures, e.g., "broke during surgery" and the firm initiated a design change. A communication to sales staff 04/14/2009 instructed them to recover and reconcile these products from user physicians. | accessdata.fda.gov |
Compare with other makers
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- All makers of Shoulder Prosthesis, Reverse Configuration
Updated March 13, 2024. 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.