# K030302: HBS Headless Bone Screw

- Pathway: 510(k) (Traditional)
- Applicant: Schoening & Assoc., Inc.
- Decided: Aug 8, 2003 after 191 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
No predicates in its family tree.
12 later devices descend from it; 2 cite 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K112672: Headless Compression Screw (2011), 10 descendants of its own
- 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

## Indications for use
Headless bone screw system for the fixation of osseous fragments or fractures including: HBS - MINI Scaphoid fractures Lunate fractures Capitate Trapezial fractures Metacarpal and metatarsal fractures Phalangeal fractures Radial head fractures Ulnar styloid fractures Osteo-chrondral Small joint fusions HBS - STANDARD Scaphoid fractures Carpal fractures & non-unions Capitellum fractures Metacarpal fractures Phalangeal fractures Distal radial fractures Radial head fractures Ulnar styloid fractures Small joint fusions Humeral head fractures Glenoid fractures Intercarpal fusions Interphalangeal fractures Metatarsal osteotomies Tarsal fusions Malleolar fractures Patellar fractures Osteo-chrondral fractures Odontoid fractures Mandibular fractures

Source page: https://510kreport.com/device/K030302
Methodology: https://510kreport.com/methodology