# K031666: Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DS

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Nov 18, 2003 after 173 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K904436 (1990). 24 ancestors in all.
161 later devices descend from it; 5 cite it directly.
0 of 186 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010673: Arthrex Fiberwire, Model Spu-02NB-3800, Arthrex, Inc. (2001) Summary page 1.
- K012923: Arthrex Fiberwire, Usp Size 5, Model AR-7201, Arthrex, Inc. (2001)
- K021434: Arthrex Fiberwire in Usp Sizes, Arthrex, Inc. (2002) Summary page 1.
- K980155: Endobutton Continuous Loop, Smith & Nephew, Inc. (1998) Summary page 1.
- K022853: Endotack, KARL STORZ Endoscopy-America, Inc. (2002) Summary page 1.
- K990120: Modification of Depuy Ace Timax Medial Pilon Plate, Depuy Ace Medical Co. (1999) Summary page 1.
- K982347: Depuy Ace Timax Pilon Plate, Depuy Ace Medical Co. (1998) Summary page 1.
- K990156: Multitak SS Buttons, Bonutti Research (1999) Summary page 1.

## Most influential descendants
- K062747: Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MM (2006), 143 descendants of its own
- K100652: Acl Tightrope (2010), 65 descendants of its own
- K123341: Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button, Arthrex Proximal Biceps Button (2012), 52 descendants of its own
- K112990: Acl Tightrope,Acl Tightrope Duuble Bundle (2011), 49 descendants of its own
- K150768: JuggerKnot Soft Anchors (2015), 40 descendants of its own

## Recalls of this device
- Jan 11, 2016 · Class II · Z-1360-2016: Potential for a component contained in the Implant System to be non-sterile.

## Indications for use
The Arthrex ACL RetroConstructionTMButton Kit for fixation of bone to bone or soft tissue to bone is intended as a fixation post, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair utilizing titanium buttons and recommending use of size 2 or size 5 FiberWireTMor equivalent. Specifically, Arthrex will be offering this for ACL repair.

Source page: https://510kreport.com/device/K031666
Methodology: https://510kreport.com/methodology