Company · US
Vilex, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 1998 to 2026. Name variants (Inc, Corp, punctuation) are merged.
30510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HWC | Screw, Fixation, Bone | 9 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 5 |
| HRS | Plate, Fixation, Bone | 4 |
| KWD | Prosthesis, Toe, Hemi-, Phalangeal | 3 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 2 |
| HSN | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | 2 |
| HTN | Washer, Bolt Nut | 2 |
| JDR | Staple, Fixation, Bone | 2 |
| JDW | Pin, Fixation, Threaded | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 17, 2026 | K260900 | DYNEX® External Fixation Systems Vilex, LLC | KTT |
| Mar 5, 2025 | K250304 | TITANEX Screw Systems Vilex, LLC | HWC |
| Dec 2, 2024 | K240475 | Hintermann Series H2 Total Ankle System Vilex, LLC | HSN |
| Nov 27, 2024 | K243408 | TACTIX Vector Syndesmosis System Vilex, LLC | HTN |
| Aug 28, 2024 | K233816 | REDEMPTION Charcot Plating System Vilex, LLC | HRS |
| Aug 1, 2024 | K240035 | TACTIX Vector Syndesmosis System Vilex, LLC | HTN |
| Jan 30, 2024 | K231343 | Redemption Duo Hindfoot Nail System Vilex, LLC | HSB |
| Sep 11, 2023 | K231504 | TITANEX MICROBEAM Screw System, TITANEX ARTEMIS Screw System Vilex, LLC | HWC |
| Aug 11, 2023 | K231493 | NITINEX Memory Compression Staple Vilex, LLC | JDR |
| Jul 17, 2023 | K230462 | OPTIX H2 Patient Specific Instrument System Vilex, LLC | HSN |
| Apr 25, 2023 | K230204 | ALPHALOK Plating System Vilex, LLC | HRS |
| Dec 13, 2022 | K221342 | REDEMPTION Beaming System Vilex, LLC | HWC |
| Nov 15, 2022 | K221558 | ALPHALOK Plating System Vilex, LLC | HRS |
| May 2, 2022 | K212348 | ALPHALOK Plating System Vilex, LLC | HRS |
| Oct 12, 2021 | K212552 | Correx Software Vilex, LLC | KTT |
| Sep 11, 2020 | K202143 | Dynex Micro Vilex, LLC | KTT |
| Aug 24, 2020 | K202054 | Dynex Ring Fixation System, Diametrix Ring Fixation System Vilex, LLC | KTT |
| Jul 23, 2014 | K132820 | VILEX ULTIMA EXTERNAL FIXATION SYSTEM WITH HA COATED PINS AND WIRES Vilex, Inc. | JDW |
| Oct 9, 2012 | K112837 | VILEX EZ-STAPLE (MEMORY BONE FIXATION STAPLE) Vilex, Inc. | JDR |
| Nov 14, 2011 | K102413 | FUZE: INTRAMEDULLARY INTERNAL FIXATION NAIL Vilex, Inc. | HSB |
| Jul 20, 2011 | K102401 | HEMI IMPLANT; MINI HEMI IMPLANT Vilex, Inc. | KWD |
| Mar 28, 2007 | K070052 | MET-HEAD MODEL# MHDD-XX:CC DIAMETER, CC CANNULATION Vilex, Inc. | KWD |
| Nov 22, 2005 | K052196 | VILEX X-FIX Vilex, Inc. | KTT |
| Aug 5, 2004 | K041289 | TALUS OF VILEX (TOV) Vilex, Inc. | HWC |
| Aug 5, 2004 | K041287 | VILEX BONE PLATE SYSTEM Vilex, Inc. | HWC |
| Mar 1, 2004 | K023684 | CANNULATED METALLIC HEMI TOE IMPLANT, MODELS MPJ241975, MPJ221775, MPJ211675, MPJ191565, MPJ171365 Vilex, Inc. | KWD |
| Mar 18, 2002 | K014154 | VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW DB1 THREAD, MODEL F25-XX-09; VILEX SOLID BONE SCREWS DB1 THREAD,MODEL F20-XX-00 Vilex, Inc. | HWC |
| Apr 26, 1999 | K991197 | VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW, MODELS P222-XX, S25-XX, P227-XX, S30-XX, P235-XX, S35-XX, P240-XX, S40-XX, P24 Vilex, Inc. | HWC |
| Apr 26, 1999 | K991151 | VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREW, ORTHEX CANNULATED BONE SCREW Vilex, Inc. | HWC |
| Jan 16, 1998 | K973309 | VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREW Vilex, Inc. | HWC |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||