Tigon Medical Fractures, Instability, and Reconstruction (FIRE)
FDA 510(k) K240175 · Tigon Medical
510(k) numberK240175
Submission
- Device name
- Tigon Medical Fractures, Instability, and Reconstruction (FIRE)
- Applicant
- Tigon Medical
Millersville, MD, US - Received
- January 23, 2024
- Decision date
- October 29, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|
| K260921 | Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor LineMBI · Special | 04/21/2026SE |
| K252596 | Tigon Medical Knotless and Dual Javelin All-Suture AnchorsMBI · Traditional | 12/04/2025SE |
| K242529 | Tigon Medical All-Suture Anchors (ASA)MBI · Traditional | 12/20/2024SE |
| K220464 | Tigon Medical Gryphon Anchor LineMBI · Traditional | 03/22/2023SE |
| K211049 | Tigon Medical Button SystemMBI · Traditional | 08/04/2021SE |
| K182507 | Tigon Medical Tissue AnchorsMBI · Traditional | 01/21/2019SE |
Questions and answers
When was Tigon Medical Fractures, Instability, and Reconstruction (FIRE) cleared by the FDA?
Tigon Medical Fractures, Instability, and Reconstruction (FIRE) (K240175) received a 510(k) decision of Substantially Equivalent on October 29, 2024, 280 days after the submission was received.
What is the product code of K240175?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.