# K061949: Doubleplay Suture Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Biocomposites, Ltd.
- Decided: Sep 25, 2006 after 77 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- 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 K003227 (2001). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043337: Arthrex Bio-Corkscrew FT Suture Anchor, Arthrex, Inc. (2004) Summary page 1.
- K041698: Axya Medical, Inc. Model 5000 Axyaloop Bio-Absorbable Bone Anchor, Axya Medical, Inc. (2004) Summary page 1.

## Indications for use
The Doubleplay TM Suture Anchor is intended for fixation of suture to bone in orthopaedic procedures in the shoulder, foot/ankle, knee, hand/wrist, elbow and pelvis.

Source page: https://510kreport.com/device/K061949
Methodology: https://510kreport.com/methodology