Trilliant Surgical LLC
Houston, TX, US
Trilliant Surgical LLC appears in FDA device records in Houston, TX. FDA records list 18 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 24 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 18 510(k) clearances for Trilliant Surgical LLC between 2007 and 2022. The busiest year on record is 2011, with 3. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2007 | 1 |
| 2008 | 1 |
| 2011 | 3 |
| 2012 | 3 |
| 2013 | 2 |
| 2016 | 2 |
| 2017 | 3 |
| 2018 | 1 |
| 2019 | 1 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K212378 | Arsenal Ankle Plating System | HRS | Substantially Equivalent | |
| K191009 | Arsenal Plating System | HRS | Substantially Equivalent | |
| K181898 | Two-Step Implant System | HWC | Substantially Equivalent | |
| K172405 | SNIPER STAPLE SYSTEM, NON-STERILE | JDR | Substantially Equivalent | |
| K172178 | Minimally Invasive Bunion Plating System | HRS | Substantially Equivalent | |
| K162354 | Sniper Staple System | JDR | Substantially Equivalent | |
| K160177 | Gridlock Ankle Plating System | HRS | Substantially Equivalent | |
| K153338 | Tiger Cannulated Screw System | HWC | Substantially Equivalent | |
| K130964 | GRIDLOCK PLATING SYSTEM | HRS | Substantially Equivalent | |
| K123525 | GRIDLOCK PLATING SYSTEM | HRS | Substantially Equivalent | |
| K122959 | HAMMER TOE IMPLANT | HWC | Substantially Equivalent | |
| K121452 | GRIDLOCK PLATING SYSTEM | HRS | Substantially Equivalent | |
| K121008 | TRILLIANT SURGICAL K-WIRES | HTY | Substantially Equivalent | |
| K111834 | DISCO SUBTALAR IMPLANT | HWC | Substantially Equivalent | |
| K112737 | TIGER HEADLESS CANNULATED SCREWS | HWC | Substantially Equivalent | |
| K103183 | TRILLIANT SURGICAL SUBTALAR IMPLANT | HWC | Substantially Equivalent | |
| K081510 | TIGER CANNULATED SCREW SYSTEM | HWC | Substantially Equivalent | |
| K072922 | 3S HEMI TOE | KWD | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007420745 | 3007420745 | Trilliant Surgical LLC | 727 N. Shepherd Dr, Houston, TX 77007 US | 2026 | and 31 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- HWJAwl
- HXWBender
- HTWBit, Drill
- HTQBroach
- HXDClamp
- HWWCountersink
- HTEElevator
- HWBExtractor
- MBIFastener, Fixation, Nondegradable, Soft Tissue
- HTDForceps
- HTJGauge, Depth
- FZXGuide, Surgical, Instrument
- OQGHip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
- HWAImpactor
- MDMInstrument, Manual, Surgical, General Use
- KDDKit, Surgical Instrument, Disposable
- JDSNail, Fixation, Bone
- LXHOrthopedic Manual Surgical Instrument
- HTYPin, Fixation, Smooth
- HRSPlate, Fixation, Bone
- NTGProsthesis, Ankle, Uncemented, Non-Constrained
- LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- KWDProsthesis, Toe, Hemi-, Phalangeal
- LRYPunch, Surgical
- HTOReamer
- GADRetractor
- HSBRod, Fixation, Intramedullary And Accessories
- HWCScrew, Fixation, Bone
- HXXScrewdriver
- PHXShoulder Prosthesis, Reverse Configuration
- JDRStaple, Fixation, Bone
- GATSuture, Nonabsorbable, Synthetic, Polyethylene
- HWTTemplate
- LRPTray, Surgical
- FSMTray, Surgical, Instrument
- HTNWasher, Bolt Nut
- NDGWasher, Bolt, Nut, Non-Spinal, Metallic
- HXCWrench
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1635-2020 | 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 (1) of each type. | Class II | Terminated | |
| Z-1892-2020 | 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. | Class II | Terminated | |
| Z-0799-2020 | 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. | Class II | Terminated | |
| Z-1614-2020 | Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Small Joint Reaming System, Model 311-00-001. The firm name on the label is Trilliant Surgical Ltd, Houston, TX. | Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018. | Class II | Terminated | |
| Z-1613-2020 | Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Gridlock Ankle Plating System, Model 320-01-100. The firm name on the label is Trilliant Surgical Ltd, Houston, TX. | Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018. | Class II | Terminated | |
| Z-1612-2020 | Instructions for Use and Surgical Cleaning and Sterilization Protocol for: (1) Trilliant Surgical Ltd Tiger Large Cannulated Screw System, Model 215-00-001; and (2) Trilliant Surgical Ltd Large Cannulated Headless Screw System, Model 215-00-001. The firm name on the label is Trilliant Surgical Ltd., Houston, TX. | Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018. | Class II | Terminated | |
| Z-1611-2020 | Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd 3S Hemi Toe Implant System, Model 111-00-001. The firm name on the label is Trilliant Surgical Ltd, Houston, TX. | Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018. | Class II | Terminated | |
| Z-1610-2020 | Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Two-Step Hammertoe Implant System, Model 214-00-001. The firm name on the label is Trilliant Surgical Ltd, Houston, TX. | Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018. | Class II | Terminated | |
| Z-1609-2020 | Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Gridlock Plating System, Model 310-01-100. The firm name on the label is Trilliant Surgical Ltd, Houston, TX. | Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018. | Class II | Terminated | |
| Z-1608-2020 | Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Disco Subtalar Implant System, Model 112-00-001. The firm name on the label is Trilliant Surgical, Ltd, Houston, TX. | Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018. | Class II | Terminated | |
| Z-1607-2020 | Instructions for Use and Surgical Cleaning Sterilization Protocol for Trilliant Surgical Ltd Twist Sublatar Implant System, Model 112-00-001. The firm name on the label is Trilliant Surgical, Ltd, Houston, TX. | Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018. | Class II | Terminated | |
| Z-1606-2020 | Instructions for Use and Surgical Cleaning and Sterilization Protocol for: (1) Trilliant Surgical Ltd Tiger Headless Cannulated Screw System, Model 212-00-001; and (2) Combination Tiger Cannulated/Tiger Headless Cannulated Screw System, Model 210-00-101. The firm name on the label is Trilliant Surgical Ltd, Houston, TX. | Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018. | Class II | Terminated | |
| Z-1605-2020 | 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 210-00-101. The firm name on the label is Trilliant Surgical, Houston, TX. | Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018. | Class II | Terminated | |
| Z-2339-2018 | Ratcheting Cannulated Driver Handle, Catalog #: 210-00-004, 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. | Class II | Terminated | |
| Z-2338-2018 | 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. | Class II | Terminated | |
| Z-0960-2017 | 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 for the size of the device. | 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. | Class II | Terminated | |
| Z-0609-2017 | 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. | Class II | Terminated | |
| Z-2490-2015 | 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-STERILE SINGLE USE ONLY. For use in trauma and reconstructive procedures in small bones. | 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. | Class II | Terminated | |
| Z-2738-2015 | 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 reducing the engagement between the driver and the screw head. | Class II | Terminated | |
| Z-2456-2015 | 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, used with Gridlock Plating system, for use in trauma and reconstructive procedures in small bones. | The cannulation of the Concave and Convex Reamer Heads may be too small to allow the Guide Pin to freely pass through. | Class II | Terminated | |
| Z-2464-2015 | 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 System The Tiger Cannulated Screw Fixation System and the Tiger Headless Cannulated Screw Fixation System implants are intended for fixation of fractures, non-unions, arthrodesis and osteotomies of the small bones in the hand and foot. The implants and guide wires are intended for single use only. | Sterilization tray lids for the Tiger and Tiger Headless Cannulated Screw Systems were reported to occasionally be difficult to remove from the sterilization tray. | Class II | Terminated | |
| Z-2452-2015 | 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 small bones in the hand and foot. The implants and guide wires are intended for single use only. | 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. | Class II | Terminated | |
| Z-2421-2015 | 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 for fixation of fractures, non-unions, arthrodesis, and osteotomies of the small bones in the hand and foot. The implants and guide wires are intended for single use only. | The cutting efficiency of the Countersinks was out of specification. | Class II | Terminated | |
| Z-1438-2010 | 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. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain