WishBone K-Wire System
FDA 510(k) K173013 · Wishbone Medical, Inc.
510(k) numberK173013
Submission
- Device name
- WishBone K-Wire System
- Applicant
- Wishbone Medical, Inc.
Warsaw, IN, US - Received
- September 27, 2017
- Decision date
- December 14, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HTY – Pin, Fixation, Smooth
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code HTY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262722 | Primal K-Wire (P99-193-1410)HTY · Special | Paragon 28, Inc. | 08/28/2026SE |
| K253325 | ZipToe Hammertoe Fusion SystemHTY · Traditional | Toetal Solutions | 12/29/2025SE |
| K252657 | Impact PEEK Union Nail SystemHTY · Special | Nvision Biomedical Technologies, Inc. | 09/19/2025SE |
| K250315 | Ronavis FX (FX-001)HTY · Traditional | AIRS, Inc. | 08/01/2025SE |
| K251362 | PediFlex Flexible Nail SystemHTY · Traditional | OrthoPediatrics Corp. | 06/24/2025SE |
| K250646 | Impact PEEK Union Nail SystemHTY · Traditional | Nvision Biomedical Technologies | 06/11/2025SE |
| K241014 | Biomet Kirschner Wires (K-Wires)HTY · Traditional | Biomet, Inc. | 05/22/2024SE |
| K231272 | OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…HTY · Traditional | OSSIO , Ltd. | 12/01/2023SE |
| K231147 | Hammerdesis Interphalangeal Fusion SystemHTY · Traditional | Intelivation | 09/14/2023SE |
| K230750 | OSSIOfiber® Cannulated Trimmable Fixation NailHTY · Traditional | OSSIO , Ltd. | 09/13/2023SE |
More from OSSIO , Ltd.
| 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 |
| K203467 | WishBone Medical Plate and Screw SystemHWC · Special | 12/23/2020SE |
| 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 |
Questions and answers
When was WishBone K-Wire System cleared by the FDA?
WishBone K-Wire System (K173013) received a 510(k) decision of Substantially Equivalent on December 14, 2017, 78 days after the submission was received.
What is the product code of K173013?
The FDA product code is HTY – Pin, Fixation, Smooth, a Class II (moderate risk) device regulated under 21 CFR 888.3040.