# K171628: HBS2 Headless Bone Screw

- Pathway: 510(k) (Traditional)
- Applicant: Stuckenbrock Medizintechnik GmbH
- Decided: Jan 12, 2018 after 224 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 K021556 (2002). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 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 8.
- K021556: Synthes 2.4 MM Cannulated Compression Screw, Synthes (Usa) (2002) Summary page 8.
- K050636: Synthes 3.0MM Headless Compression Screws, Synthes (Usa) (2005) Summary page 8.

## Indications for use
HBS2 Headless Bone Screw is used for the treatment of intraarticular and extraarticular fractures and pseudoarthroses of smaller bones and bone fragments as well as for arthrodeses on small joints, especially in the scope of: HBS2 MIDI: Scaphoid fractures, Scaphoid pseudoarthroses, Proximal pole fractures of the scaphoid, DIP arthrodeses, Metacarpal fractures, Metatarsal fractures, Fractures of the processus styloideus ulnae, Proximal radial head fractures HBS2 MINI: Scaphoid fractures, Scaphoid pseudoarthroses, Proximal pole fractures of the scaphoid, DIP arthrodeses, Metacarpal fractures, Fractures of the processus styloideus ulnae, Proximal radial head fractures, Fractures of the processus styloideus radii

Source page: https://510kreport.com/device/K171628
Methodology: https://510kreport.com/methodology