# K013534: Self-Countersinking Bone Screw

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Orthopedics, Inc.
- Decided: Dec 17, 2001 after 55 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: 1 generation back to K922322 (1992). 4 ancestors in all.
241 later devices descend from it; 3 cite it directly.
0 of 246 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962823: Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer, Synthes (Usa) (1996) Summary page 1.
- K963192: Synthes Sterile 3.5 MM and 4.0 MM Cannulated Screws, Synthes (Usa) (1996) Summary page 1.
- K923256: Alphatec 2.7 MM Cannulated Cortical Lag Screw, Alphatec Mfg., Inc. (1992) Summary page 1.
- K922322: Alphatec 3.5MM  Znnulated Cortical Lag Screw, Alphatec Mfg., Inc. (1992). Our OCR of the scanned summary read K922332, FDA’s number for Bartels Epstein-Barr Virus Igg Eia (Baxter Diagnostics, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Alphatec 3.5mm Cortical Lag Screw”.
- (no number) DePuy-Ace 4.0mm Cannulated Cancellous Screw: named in the summary without a submission number
- (no number) Alphatec 4.0mm Cortical Lag Screw: named in the summary without a submission number

## Most influential descendants
- K024086: Propeller Head Small Cannulated Screw System (2003), 171 descendants of its own
- K082874: Biodrive Cannulated Screw System (2009), 168 descendants of its own
- K093629: Solitaire and Solitaire Peek Anterior Spinal System (2010), 143 descendants of its own
- K113796: Solitaire-C Cervical Spacer System (2012), 142 descendants of its own
- K132029: Vault-C Intervertebral Body Fusion Device (2013), 108 descendants of its own

## Indications for use
The Self-Countersinking Bone Screw is indicated for the following conditions: Fixation of fractures in long bones such as the fibula, tibia, humerus, radius and ulna as well as fractures in the patella Fixation of small bones such as those in the foot, ankle, wrist, and elbow Ligament reconstruction Arthrodesis of the foot, ankle, wrist, and elbow Small bone osteotomies Osteochondritis dissecans

Source page: https://510kreport.com/device/K013534
Methodology: https://510kreport.com/methodology