BC Reflex Uni Knee System
FDA 510(k) K212307 · Bodycad Laboratories, Inc.
510(k) numberK212307
Submission
- Device name
- BC Reflex Uni Knee System
- Applicant
- Bodycad Laboratories, Inc.
Quebec City, CA - Received
- July 23, 2021
- Decision date
- October 12, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HSX – Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3520
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code HSX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261609 | Freedom Partial Knee SystemHSX · Traditional | Maxx Orthopedics, Inc. | 08/04/2026SE |
| K260796 | Tahoe Unicondylar Knee System with TiNbN OvercoatHSX · Special | Shalby Advanced Technologies, Inc. Dba Consensus… | 04/02/2026SE |
| K251771 | Cambridge Partial KneeHSX · Traditional | Signature Orthopaedics Pty, Ltd. | 12/16/2025SE |
| K251834 | Persona Partial KneeHSX · Traditional | Zimmer Biomet | 08/15/2025SE |
| K251618 | MOTO Partial Knee System ExtensionHSX · Traditional | Medacta International S.A. | 07/24/2025SE |
| K251453 | Arthrex iBalance Partial Knee SystemHSX · Traditional | Arthrex, Inc. | 07/01/2025SE |
| K241260 | ACTIFY Unicondylar Knee SystemHSX · Traditional | Globus Medical, Inc. | 12/06/2024SE |
| K242711 | JOURNEY II Unicompartmental Knee System (JOURNEY II UK)HSX · Traditional | Smith & Nephew, Inc. | 10/30/2024SE |
| K242746 | OvertureTi Knee Resurfacing SystemTMHSX · Special | Overture Orthopaedics | 10/07/2024SE |
| K232114 | TRIBRID® Unicompartmental Knee SystemHSX · Traditional | Kyocera Medical Technologies, Inc. | 04/04/2024SE |
More from Kyocera Medical Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K253300 | Fine OsteotomyHRS · Special | 10/28/2025SE |
| K250394 | Fine TTOPBF · Traditional | 10/21/2025SE |
| K250923 | Fine OsteotomyHRS · Traditional | 08/21/2025SE |
| K241356 | Fine OsteotomyHRS · Traditional | 09/05/2024SE |
| K240703 | Fine OsteotomyHRS · Special | 04/12/2024SE |
| K240066 | Fine OsteotomyPBF · Special | 02/09/2024SE |
| K231314 | Fine OsteotomyPBF · Special | 06/02/2023SE |
| K211895 | BC Reflex Uni Knee SystemHSX · Traditional | 08/20/2021SE |
| K211646 | FINE OsteotomyHRS · Traditional | 07/28/2021SE |
| K203697 | BC Reflex Uni Knee SystemHSX · Special | 03/12/2021SE |
Questions and answers
When was BC Reflex Uni Knee System cleared by the FDA?
BC Reflex Uni Knee System (K212307) received a 510(k) decision of Substantially Equivalent on October 12, 2021, 81 days after the submission was received.
What is the product code of K212307?
The FDA product code is HSX – Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3520.