Talus of Vilex (Tov)
FDA 510(k) K041289 · Vilex, Inc.
510(k) numberK041289
Submission
- Device name
- Talus of Vilex (Tov)
- Applicant
- Vilex, Inc.
Pleasant Hills, PA, US - Received
- May 13, 2004
- Decision date
- August 5, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HWC – Screw, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code HWC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261057 | ActivaScrew Cannulated COMHWC · Traditional | Bioretec, Ltd. | 09/04/2026SE |
| K260106 | OsteoCoil GT Active Compression SystemHWC · Traditional | Flower Orthopedics Corporation DBA Conventus… | 08/24/2026SE |
| K262344 | Large Compression ScrewsHWC · Special | TriMed, Inc. | 08/12/2026SE |
| K253858 | GFS - Sterile Screws and Top HatHWC · Special | T.A.G. Medical Products Corporation, Ltd. | 08/05/2026SE |
| K262075 | Lapidus Screw KitHWC · Special | Relja Innovations, LLC | 07/22/2026SE |
| K260809 | Arthrex Sterile VAL and VAL KreuLock Compression Screw SystemHWC · Traditional | Arthrex, Inc. | 06/25/2026SE |
| K253108 | VEOFIX Snap Off ScrewHWC · Traditional | Steps Ortho | 06/05/2026SE |
| K261154 | CoLink® & CoLag® Non-Sterile ScrewsHWC · Special | In2Bones USA, LLC | 05/30/2026SE |
| K261241 | TriMed Compression ScrewsHWC · Special | TriMed, Inc. | 05/14/2026SE |
| K254215 | Arthrex Beaming SystemHWC · Traditional | Arthrex, Inc. | 05/08/2026SE |
More from Arthrex, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K260900 | DYNEX® External Fixation SystemsKTT · Special | 04/17/2026SE |
| K250304 | TITANEX Screw SystemsHWC · Special | 03/05/2025SE |
| K240475 | Hintermann Series H2 Total Ankle SystemHSN · Traditional | 12/02/2024SE |
| K243408 | TACTIX Vector Syndesmosis SystemHTN · Special | 11/27/2024SE |
| K233816 | REDEMPTION Charcot Plating SystemHRS · Traditional | 08/28/2024SE |
| K240035 | TACTIX Vector Syndesmosis SystemHTN · Traditional | 08/01/2024SE |
| K231343 | Redemption Duo Hindfoot Nail SystemHSB · Traditional | 01/30/2024SE |
| K231504 | TITANEX MICROBEAM Screw System, TITANEX ARTEMIS Screw SystemHWC · Traditional | 09/11/2023SE |
| K231493 | NITINEX Memory Compression StapleJDR · Traditional | 08/11/2023SE |
| K230462 | OPTIX H2 Patient Specific Instrument SystemHSN · Traditional | 07/17/2023SE |
Questions and answers
When was Talus of Vilex (Tov) cleared by the FDA?
Talus of Vilex (Tov) (K041289) received a 510(k) decision of Substantially Equivalent on August 5, 2004, 84 days after the submission was received.
What is the product code of K041289?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.