# K051069: Nonresorbable Centraloc Tibial Screw & Washer

- Pathway: 510(k) (Traditional)
- Applicant: Arthrotek, Inc.
- Decided: Jun 29, 2005 after 64 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- 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: 5 generations back to K911837 (1991). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033233: Lactosorb Tibial L-15 Screw and Washer, Biomet, Inc. (2003) Summary page 1.
- K021832: Arthrotek Resorbable NO-Profile Lactosorb L-15 Screw & Washer, Biomet, Inc. (2002) Summary page 1.
- K041617: Stalif TT, Surgicraft, Ltd. (2004) Summary page 1.

## Indications for use
1. Anterior cruciate ligament (ACL) and posterior cruciate ligament (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/K051069
Methodology: https://510kreport.com/methodology