# K220765: HS Fiber Cerclage

- Pathway: 510(k) (Traditional)
- Applicant: Riverpoint Medical, LLC
- Decided: Jul 26, 2023 after 497 days
- Product code: JDQ (Cerclage, Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K920201 (1992). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170206: Arthrex FiberTape Cerclage, Arthrex, Inc. (2017) Summary page 4.

## Indications for use
HS Fiber Cerclage sutures are indicated for use in general soft tissue approximation and/or ligation. These sutures may be used in cardiovascular surgeries, and orthopedic surgeries using allograft or autograft tissue. When used as a bone fixation cerclage, the sutures are intended for: * Trauma surgery indications including olecranon, ankle, patella, and some shoulder rewiring. * Repair of long bone fracture due to trauma or reconstruction.

Source page: https://510kreport.com/device/K220765
Methodology: https://510kreport.com/methodology