# K170206: Arthrex FiberTape Cerclage

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Nov 15, 2017 after 295 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: 2 generations back to K920201 (1992). 3 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143716: DSM Biomedical DPR Cable, Dsm Biomedical (2015) Summary page 4.
- K102834: Iso-Elastic Cerclage System (1MM and 2MM Cable Diameter), Kinamed, Incorporated (2011) Summary page 4.

## Most influential descendants
- K232755: Arthrex FiberTape and TigerTape Cerclage Sutures (2023), 2 descendants of its own
- K260018: Arthrex FiberButton (2026), 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
- K220765: HS Fiber Cerclage (2023), 0 descendants of its own

## Indications for use
The Arthrex FiberTape Cerclage suture is 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 a bone fixation cerclage the suture is 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. • Repair of long bone fractures due to trauma or reconstruction.

Source page: https://510kreport.com/device/K170206
Methodology: https://510kreport.com/methodology