# K243344: Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Feb 20, 2025 after 118 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: 11 generations back to K792022 (1979). 79 ancestors in all.
No later device cites it as a predicate yet.
0 of 80 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181749: SuperCable® Iso-Elastic™ Cerclage System, Kinamed, Incorporated (2018) Summary page 5.
- K232755: Arthrex FiberTape and TigerTape Cerclage Sutures, Arthrex, Inc. (2023) Summary page 5.

## Indications for use
Arthrex FiberTape and Tiger Tape Cerclage sutures and Arthrex Radiopaque FiberTape 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 * Provide fixation during the healing process following syndesmotic trauma, such as fixation of acromioclavicular separation due to coracoclavicular ligament * Spinal applications including sublaminar and intrafacet wiring of the spinal column

Source page: https://510kreport.com/device/K243344
Methodology: https://510kreport.com/methodology