# K112672: Headless Compression Screw

- Pathway: 510(k) (Traditional)
- Applicant: Skeletal Dynamics, LLC
- Decided: Dec 13, 2011 after 90 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 K030302 (2003). 1 ancestor in all.
10 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030302: HBS Headless Bone Screw, Schoening & Assoc., Inc. (2003) Summary page 1.

## Most influential descendants
- K143624: Headless Compression Screw System (2015), 7 descendants of its own
- K132910: Depuy Synthes Spine Dens Access System (2013), 4 descendants of its own
- K142707: AIS Odontoid Fracture Fixation System (2014), 3 descendants of its own
- K201662: REDUCT® Headless Compression Screw System (2020), 2 descendants of its own
- K192744: CORRIDOR Fixation System (2019), 2 descendants of its own

## Indications for use
The Skeletal Dynamics Headless Compression Screw System is intended for fixation of osseous fragments or fractures, arthrodesis of small joints, and osteotomies, with the appropriately sized screw. Examples include: Scaphoid fractures, lunate fractures, capitate fractures, trapezial fractures, metacarpal and metatarsal fractures, phalangeal fractures, radial head fractures, ulnar styloid fractures, ostec-chondral fractures, small joint fusions, carpal fractures and non-unions, capitellum fractures, distal radius fractures, humeral head fractures, glenoid fractures, intercarpal fusions, interphalangeal fractures, metatarsal osteotomies, tarsal fusions, malleolar fractures, patellar fractures, odontoid fractures, and mandibular fractures.

Source page: https://510kreport.com/device/K112672
Methodology: https://510kreport.com/methodology