# K221485: Arthrex FiberTape and TigerTape Cerclage Sutures

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Aug 22, 2022 after 91 days
- Product code: HTN (Washer, Bolt Nut)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K792022 (1979). 70 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 76 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183232: Double ENDOBUTTON Fixation Device, Smith and Nephew, Inc. (2019) Summary page 4.

## Most influential descendants
- K232755: Arthrex FiberTape and TigerTape Cerclage Sutures (2023), 2 descendants of its own
- K230976: Arthrex Radiopaque FiberTape Cerclage sutures (2023), 1 descendant of its own
- K243905: Stitch Cerclage – Suture Tapes (2025), 0 descendants of its own
- K243344: Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures (2025), 0 descendants of its own
- K243742: Arthrex DynaNite Nitinol Staples (2025), 0 descendants of its own

## Indications for use
Arthrex FiberTape and TigerTape cerclage sutures are intended for use in soft tissue approximation and or ligation. These sutures may be incorporated, as components, into surgeries where constructs including those with allograft or autograft tissues are used for repair. When used as bone fixation cerclage the sutures are intended for: * Trochanteric reattachment after trochanteric osteotomy following total hip arthroplasty * Sternotomy indications including the "rewiring" of osteomized sternums * Trauma surgery indications including olecranon, ankle, patella and some shoulder fracture rewiring - Treatment of anterior glenoid bone loss using the Latarjet or bone block procedure (allograft or autograft) *Repair of long bone fractures due to trauma or reconstruction

Source page: https://510kreport.com/device/K221485
Methodology: https://510kreport.com/methodology