# K232755: Arthrex FiberTape and TigerTape Cerclage Sutures

- Pathway: 510(k) (Special)
- Applicant: Arthrex, Inc.
- Decided: Oct 6, 2023 after 28 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: 10 generations back to K792022 (1979). 76 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 79 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220947: Arthrex Knotless AC Repair Devices, Arthrex, Inc. (2022) Summary page 4.
- K221485: Arthrex FiberTape and TigerTape Cerclage Sutures, Arthrex, Inc. (2022) Summary page 4.
- K170206: Arthrex FiberTape Cerclage, Arthrex, Inc. (2017) Summary page 4.

## Most influential descendants
- 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 * To provide fixation during the healing process following syndesmotic trauma, such as fixation of acromioclavicular separation due to coracoclavicular ligament disruption.

Source page: https://510kreport.com/device/K232755
Methodology: https://510kreport.com/methodology