# K032072: Lactosorb L15 Screw Anchor with Lactocarbonate Suture

- Pathway: 510(k) (Traditional)
- Applicant: Arthrotek, Inc.
- Decided: Oct 1, 2003 after 90 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). 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)
- K012872: Resorbable Screw Anchor, Arthrotek, Inc. (2001) Summary page 1.
- K970896: Mitek 3.5 MM Panalok Wedge Absorbable Suture Anchor System, ETHICON, Inc. (1997). Our reading of the summary gave K970396, FDA’s number for Human Chorionic Gonadotropin Calibrator (Dade Chemistry Systems, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Ethicon Mitek Panalok Suture Anchor System”.
- K003273: Lactosorb Screw Anchor, Biomet, Inc. (2001) Summary page 1.

## Indications for use
Indications for the Lactosorb Screw Anchor with Lactocarbonate Suture includes the 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 repair, joint capsule closure, iliotibial band tenodesis, and patellar ligament/tendon repair.

Source page: https://510kreport.com/device/K032072
Methodology: https://510kreport.com/methodology