# K071816: Harpoon Suture Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Sports Medicine, Inc.
- Decided: Sep 20, 2007 after 80 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: 3 generations back to K961555 (1996). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973775: Harpoon Suture Anchors, Biomet, Inc. (1998) Summary page 1.
- K053344: Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture Anchor, Smith & Nephew, Inc. (2006) Summary page 1.
- K012503: Metal Screw Anchor, Biomet Manufacturing, Inc. (2001) Summary page 1.

## Indications for use
Harpoon® and Mini-Harpoon® Suture Anchors are indicated for use in soft tissue reattachment procedures. Specific Indications are: Shoulder - Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair, and anterior shoulder instability repair Wrist - Scapholunate ligament reconstruction Elbow - Biceps tendon reattachment, Ulnar or radial collateral ligament reconstruction, and lateral epicondylitis repair Knee - Extracapsular Repair (Medial collateral ligament repair, lateral collateral ligament repair, and posterior oblique ligament repair), joint capsule closure, iliotibial band tenodesis reconstruction, patellar realignment and tendon repair, and vastus medialis obliquus (VMO) muscle advancement Foot and Ankle - Hallux valgus repairs, medial or lateral instability repair/reconstruction, Achilles tendon repair/reconstruction, midfoot reconstruction, and metatarsal ligament/tendon repair/reconstruction Hip - Capsular Repair (acetabular labral repair)

Source page: https://510kreport.com/device/K071816
Methodology: https://510kreport.com/methodology