# K081172: Composite Hitch Suture Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing Corp
- Decided: Jul 17, 2008 after 84 days
- Product code: JDR (Staple, Fixation, Bone)
- 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: 5 generations back to K002639 (2001). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061657: Hitch Lactosorb Suture Anchor, Arthrotek, Inc. (2006) Summary page 1.
- K012572: Soft Tissue Screw and Washer, Biomet, Inc. (2001) Summary page 1.
- K070925: Modification to: Bioknotless BR Anchor / Lupine BR Anchor, Depuy Mitek, A Johnson & Johnson Company (2007) Summary page 1.

## Indications for use
Indications for the Composite HitchTM Suture Anchor include use in soft tissue reattachment procedures in the shoulder, wrist/hand, elbow, and knee. Specific indications are as follows: Shoulder: Bankart repair, SLAP lesion repair, acromioclavicular separation repair, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair. Wrist/Hand: Scapholunate ligament reconstruction Elbow: Tennis elbow repair, Biceps tendon reconstruction, medial and lateral repairs, ulnar or radial collateral ligament reconstruction. Knee: Extracapsular repair: Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis, patellar ligament/tendon repair, vastus medialis obliquus (VMO) muscle advancement.

Source page: https://510kreport.com/device/K081172
Methodology: https://510kreport.com/methodology