# K012469: Resorbable NO Profile Screw and Washer

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing, Inc.
- Decided: Dec 3, 2001 after 123 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 K911837 (1991). 8 ancestors in all.
4 later devices descend from it; 1 cites 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)
- K982497: Arthrotek Interference Screw, Biomet, Inc. (1998) Summary page 1.
- K943806: Harpoon Suture Anchors, Biomet, Inc. (1995) Summary page 1.
- K973775: Harpoon Suture Anchors, Biomet, Inc. (1998) Summary page 1.
- K984490: Sutureless Anchor, Innovasive Devices, Inc. (1999) Summary page 1.
- K993339: Endopearl with Threader, Linvatec Corp. (1999) Summary page 1.

## Most influential descendants
- K021832: Arthrotek Resorbable NO-Profile Lactosorb L-15 Screw & Washer (2002), 3 descendants of its own
- K033233: Lactosorb Tibial L-15 Screw and Washer (2003), 2 descendants of its own
- 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 Resorbable No Profile Screw and Washer is indicated for the following procedures: ACL and PCL reconstruction Medial collateral ligament repair Lateral collateral ligament repair Posterior oblique ligament repair lliotibial band tenodesis reconstruction 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/K012469
Methodology: https://510kreport.com/methodology