# K122437: NO-Profile Screws NO-Profile Washer NO-Profile Screws Washerloc Washers

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Sports Medicine
- Decided: Oct 18, 2013 after 434 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: 2 generations back to K871037 (1987). 3 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981967: Washerloc Screw System, Ligament Screw System, NO-Profile BI-Cortical Screw System, Channel Ligament Clamp, Heckman Scre, Arthrotek/Biomet, Inc. (1998) Summary page 1.
- K871037: Cancellous Fixation Screw & Washer for Use W/Screw, Concept, Inc. (1987) Summary page 1.

## Most influential descendants
- K193214: WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System, Biomet Headless Compression and Twist-Off Screws (2020), 3 descendants of its own
- K211290: Cannulated Fasteners and Nuts (2021), 2 descendants of its own
- K242691: OsteoCentric Technologies Cannulated Fasteners and Nuts (2024), 0 descendants of its own
- K230226: Integrity-SI® Fusion System (2023), 0 descendants of its own

## Indications for use
Soft tissue fixation to bone, specifically during ligament reconstructive procedures.

Source page: https://510kreport.com/device/K122437
Methodology: https://510kreport.com/methodology