# K033355: Lactoscrew Screw Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Orthopedics, Inc.
- Decided: Jun 30, 2004 after 254 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: 2 generations back to K943806 (1995). 6 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012872: Resorbable Screw Anchor, Arthrotek, Inc. (2001) Summary page 1.

## Most influential descendants
- K061389: Allthread Lactosorb Suture Anchor (2006), 7 descendants of its own
- K080088: Biomet Sports Medicine Anchor Devices and Ziploop Constructs (2008), 6 descendants of its own
- K110473: Nanotack Suture Anchor 1.4MM (2011), 2 descendants of its own
- K193402: ALLthread PEEK Suture Anchor (2020), 0 descendants of its own
- K192942: ALLthread Titanium Suture Anchor (2020), 0 descendants of its own

## Indications for use
Indications for the LactoScrew TM 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 tendodesis, 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/K033355
Methodology: https://510kreport.com/methodology