WishBone Medical Plate and Screw System
FDA 510(k) K203467 · Wishbone Medical, Inc.
510(k) numberK203467
Submission
- Device name
- WishBone Medical Plate and Screw System
- Applicant
- Wishbone Medical, Inc.
Warsaw, IN, US - Received
- November 25, 2020
- Decision date
- December 23, 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
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 |
|---|---|---|
| K231461 | Smart Correction System (HA Half Pins)KTT · Special | 06/16/2023SE |
| K230527 | WishBone Medical Plate and Screw SystemHRS · Special | 03/29/2023SE |
| K221366 | Smart Correction System Rings and Compatible HA-Coated Half PinsKTT · Special | 06/06/2022SE |
| K213489 | Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula PlateHRS · Traditional | 01/27/2022SE |
| K193368 | Smart Correction SystemKTT · Traditional | 09/18/2020SE |
| K182704 | WishBone Guided Growth SystemOBT · Traditional | 06/25/2019SE |
| K180736 | WishBone Medical Plate and Screw SystemHRS · Traditional | 10/04/2018SE |
| K173013 | WishBone K-Wire SystemHTY · Traditional | 12/14/2017SE |
Questions and answers
When was WishBone Medical Plate and Screw System cleared by the FDA?
WishBone Medical Plate and Screw System (K203467) received a 510(k) decision of Substantially Equivalent on December 23, 2020, 28 days after the submission was received.
What is the product code of K203467?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.