# K012503: Metal Screw Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing, Inc.
- Decided: Oct 22, 2001 after 80 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- 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: 1 generation back to K943806 (1995). 2 ancestors in all.
17 later devices descend from it; 4 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943806: Harpoon Suture Anchors, Biomet, Inc. (1995). Our OCR of the scanned summary read K943808, FDA’s number for Rionet HM-02 (Rockwin Corp.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Harpoon Suture Anchor (Biomet, Inc.)”.
- K973775: Harpoon Suture Anchors, Biomet, Inc. (1998) Summary page 1.

## Most influential descendants
- K071520: Renovo Suture Anchors, Models 100-2001 Thru 100-5502X (2007), 7 descendants of its own
- K042460: TI - Screw Anchor SP (2004), 7 descendants of its own
- K080088: Biomet Sports Medicine Anchor Devices and Ziploop Constructs (2008), 6 descendants of its own
- K101126: Pontis Sutures and Suture Anchors with Optional Crimps (2010), 3 descendants of its own
- K110473: Nanotack Suture Anchor 1.4MM (2011), 2 descendants of its own

## Indications for use
Indications for the Metal Screw Anchor include use in soft tissue reattachment procedures in the shoulder, wrist, elbow, and knee. Specific indications are as follows: Shoulder Indications — Bankart repair, SLAP lesion repair, acromioclavicular separation, rotator cuff repair, capsule repair, or capsulolabral reconstruction, biceps tenodesis, and deltoid repair. Wrist/Hand Indications — Scapholunate ligament reconstruction, and ulnar/radial collateral ligament reconstruction. Ankle/Foot Indications — Lateral stabilization, medial stabilization, Achilles tendon repair/reconstruction, hallux valgus reconstruction, mid- and forefoot reconstruction. Elbow Indications — Ulnar or radial collateral ligament reconstruction, and biceps tendon reconstruction. Knee Indications — Medial collateral ligament repair, lateral collateral ligament repair, posterior aoblique ligament repair, joint capsule closure, lliotibial band tenodesis, and patellar ligament/tendon repair.

Source page: https://510kreport.com/device/K012503
Methodology: https://510kreport.com/methodology