HS Fiber Cerclage
FDA 510(k) K220765 · Riverpoint Medical, LLC
510(k) numberK220765
Submission
- Device name
- HS Fiber Cerclage
- Applicant
- Riverpoint Medical, LLC
Portland, OR, US - Received
- March 16, 2022
- Decision date
- July 26, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JDQ – Cerclage, Fixation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3010
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code JDQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261271 | Cable-Ready® Cable Grip SystemJDQ · Traditional | Pioneer Surgical Technology, Inc. | 07/16/2026SE |
| K243905 | Stitch Cerclage Suture TapesJDQ · Traditional | GM Dos Reis Industria e Comercio Ltda. | 08/14/2025SE |
| K243344 | Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage…JDQ · Traditional | Arthrex, Inc. | 02/20/2025SE |
| K232733 | Mbrace CableJDQ · Traditional | Medacta International S.A. | 05/03/2024SE |
| K233949 | ACCORD Cable SystemJDQ · Traditional | Smith & Nephew, Inc. | 03/13/2024SE |
| K232986 | VariTrax Sternal CircumFixation SystemJDQ · Traditional | Circumfix Solutions, Inc. | 01/30/2024SE |
| K230976 | Arthrex Radiopaque FiberTape Cerclage suturesJDQ · Traditional | Arthrex, Inc. | 08/24/2023SE |
| K231333 | STRETTO Cable SystemJDQ · Traditional | Globus Medical, Inc. | 08/04/2023SE |
| K221795 | STERN FIX Sternal Stabilization SystemJDQ · Traditional | Neos Surgery S.L | 10/19/2022SE |
| K211613 | Stern Fix Sternal Stabilization SystemJDQ · Traditional | Neos Surgery S.L | 01/19/2022SE |
More from Neos Surgery S.L
| 510(k) | Device | Decision |
|---|---|---|
| K262677 | Iconix Knotless TMBI · Special | 08/27/2026SE |
| K253693 | Strut Suture; No-Tie ButtonMBI · Traditional | 03/11/2026SE |
| K253695 | LigaMendMBI · Traditional | 02/27/2026SE |
| K253024 | ProZip Knotless ImplantGAT · Special | 10/16/2025SE |
| K252201 | HS FiberGAT · Special | 08/13/2025SE |
| K252144 | Iconix Speed Anchor; Iconix Speed HA+ AnchorMBI · Special | 07/30/2025SE |
| K243988 | RootMend MRRMBI · Traditional | 03/20/2025SE |
| K242494 | OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel ConstructMBI · Traditional | 11/26/2024SE |
| K243323 | Iconix Knotless AnchorMBI · Special | 11/19/2024SE |
| K243203 | OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft AnchorMBI · Special | 10/29/2024SE |
Questions and answers
When was HS Fiber Cerclage cleared by the FDA?
HS Fiber Cerclage (K220765) received a 510(k) decision of Substantially Equivalent on July 26, 2023, 497 days after the submission was received.
What is the product code of K220765?
The FDA product code is JDQ – Cerclage, Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3010.