# K012872: Resorbable Screw Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Arthrotek, Inc.
- Decided: Nov 20, 2001 after 85 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: 1 generation back to K943806 (1995). 5 ancestors in all.
30 later devices descend from it; 4 cite it directly.
0 of 36 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) Summary page 1.
- K973775: Harpoon Suture Anchors, Biomet, Inc. (1998) Summary page 1.
- K954443: Lactosorb Suture Anchor, Poly-Medics,Inc. (1996) Summary page 1.
- K003273: Lactosorb Screw Anchor, Biomet, Inc. (2001)
- K011522: Resorbable Bone Pins, Biomet, Inc. (2001) Summary page 1.

## Most influential descendants
- K041274: Resorbable Interference Screw (2004), 26 descendants of its own
- K070389: Peek Knotless Anchors (2007), 9 descendants of its own
- K033355: Lactoscrew Screw Anchor (2004), 8 descendants of its own
- K110230: Rog Knotless Suture Anchor (2011), 7 descendants of its own
- K061801: 2.8 & 3.5MM Lactoscrew Suture Anchors (2006), 7 descendants of its own

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

Source page: https://510kreport.com/device/K012872
Methodology: https://510kreport.com/methodology