# K033233: Lactosorb Tibial L-15 Screw and Washer

- Pathway: 510(k) (Special)
- Applicant: Biomet, Inc.
- Decided: Nov 5, 2003 after 30 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: 4 generations back to K911837 (1991). 10 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021832: Arthrotek Resorbable NO-Profile Lactosorb L-15 Screw & Washer, Biomet, Inc. (2002) Summary page 1.

## Most influential descendants
- K130731: Stabiliz Fixation System - SPL Locking Screw (2013), 0 descendants of its own
- K051069: Nonresorbable Centraloc Tibial Screw & Washer (2005), 0 descendants of its own

## Indications for use
The LactoSorb Tibial L-15 Screw and Washer is indicated for the following procedures: 1. ACL and PCL reconstruction 2. Medial collateral ligament repair 3. Lateral collateral ligament repair 4. Posterior oblique ligament repair 5. iliotibial band tenodesis reconstruction 6. Patellar ligament and tendon repair This device is also intended to be used as back-up fixation in ACL reconstruction in conjunction with other marketed devices in order to provide additional fixation strength in instances of questionable bone quality.

Source page: https://510kreport.com/device/K033233
Methodology: https://510kreport.com/methodology