# K243905: Stitch Cerclage – Suture Tapes

- Pathway: 510(k) (Traditional)
- Applicant: GM Dos Reis Industria e Comercio Ltda.
- Decided: Aug 14, 2025 after 238 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: 10 generations back to K792022 (1979). 71 ancestors in all.
No later device cites it as a predicate yet.
0 of 72 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221485: Arthrex FiberTape and TigerTape Cerclage Sutures, Arthrex, Inc. (2022) Summary page 5.

## Indications for use
Stitch Cerclage - Suture Tapes are indicated in orthopedic surgeries as bone fixation cerclage, specifically: » Sternotomy indications including the "rewiring" of osteomized sternums; » Repair of long bone fractures due to trauma or reconstruction.

Source page: https://510kreport.com/device/K243905
Methodology: https://510kreport.com/methodology