Intraosseous Fixation System
FDA 510(k) K201556 · Extremity Medical, LLC
510(k) numberK201556
Submission
- Device name
- Intraosseous Fixation System
- Applicant
- Extremity Medical, LLC
Parsippany, NJ, US - Received
- June 10, 2020
- Decision date
- July 8, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K250536 | MetaFore Small Screw SystemHWC · Traditional | 10/08/2025SE |
| K251128 | Extremity Medical External Fixation SystemKTT · Special | 05/07/2025SE |
| K241563 | Extremity Medical External Fixation SystemKTT · Traditional | 02/21/2025SE |
| K212297 | Omni Foot and Ankle Plating SystemHRS · Special | 08/20/2021SE |
| K211261 | Axis Charcot Fixation SystemHWC · Special | 05/28/2021SE |
| K191525 | KinematX Total Wrist Arthroplasty SystemJWJ · Traditional | 03/04/2020SE |
| K192592 | Axis Plating SystemHRS · Traditional | 11/21/2019SE |
| K181067 | AlignX Ankle Fusion SystemHRS · Special | 05/23/2018SE |
| K180808 | Omni Foot Plating SystemHRS · Traditional | 05/22/2018SE |
| K172260 | Omni Foot Plating SystemHRS · Traditional | 11/06/2017SE |
Questions and answers
When was Intraosseous Fixation System cleared by the FDA?
Intraosseous Fixation System (K201556) received a 510(k) decision of Substantially Equivalent on July 8, 2020, 28 days after the submission was received.
What is the product code of K201556?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.