# K012572: Soft Tissue Screw and Washer

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Dec 3, 2001 after 116 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 K931519 (1994). 4 ancestors in all.
47 later devices descend from it; 7 cite it directly.
0 of 52 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.
- K931519: Acufex Suretac, Acufex Microsurgical, Inc. (1994) Summary page 1.
- K011522: Resorbable Bone Pins, Biomet, Inc. (2001)
- K953877: Mitek Gii Anchor, Mitek Surgical Products, Inc. (1995) Summary page 1.
- (no number) Quick Anchor Plus: named in the summary without a submission number

## Most influential descendants
- K041274: Resorbable Interference Screw (2004), 26 descendants of its own
- K032894: Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T, 239025T, 239030T, 231020T, 231025T, (2004), 15 descendants of its own
- K052080: Matryx Interference Screw (2005), 13 descendants of its own
- K070389: Peek Knotless Anchors (2007), 9 descendants of its own
- K061657: Hitch Lactosorb Suture Anchor (2006), 8 descendants of its own

## Indications for use
Indications for Screw and Washer: Shoulder Indications: Bankart repair, SLAP lesion repair, acromioclavicular separation repair, rotator cuff repair, capsule repair and capsulolabral reconstruction, biceps tenodesis, deltoid repair. Wrist Indications: Scapholunate ligament reconstruction. Elbow Indications: Tennis elbow repair, biceps tendon reattachment, medial and lateral repairs, ulnar or radial collateral ligament reconstruction. Knee Indications: Extra-capsular repair. Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis reconstruction, patellar ligament/tendon repair, vastus medialis obliquus (VMO) muscle advancement. The Soft Tissue Screw and Washer is preloaded with suture for use at the discretion of the physician.

Source page: https://510kreport.com/device/K012572
Methodology: https://510kreport.com/methodology