# K101030: Modification to HBS Headless Bone Screw

- Pathway: 510(k) (Special)
- Applicant: Biopro, Inc.
- Decided: Jun 3, 2010 after 51 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K792022 (1979). 5 ancestors in all.
40 later devices descend from it; 1 cites it directly.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020791: HBS Headless Bone Screw, Millennium Medical Technologies, Inc. (2002) Summary page 1.
- K991197: Vilex/Duval/Orthex Cannulated Bone Screw, Models P222-XX, S25-XX, P227-XX, S30-XX, P235-XX, S35-XX, P240-XX, S40-XX, P24, Vilex, Inc. (1999) Summary page 1.
- K010783: 2.0/2.4 Cannulated Screw System, Osteomed Corp. (2001) Summary page 3.

## Most influential descendants
- K120493: Mini Cannulated Headed and Headless Screw Set (2012), 39 descendants of its own
- K123890: Acumed Cannulated Screw System (2013), 36 descendants of its own
- K190586: Monster® Screw System (2019), 21 descendants of its own
- K200398: AxSOS 3 AF System and AxSOS 3 Ti System (2020), 9 descendants of its own
- K150693: PHIN-FX Cannulated Lag Screw System (2015), 9 descendants of its own

## Recalls of this device
- Jun 25, 2019 · Class II · Z-2259-2019: Manufacturing flaw in the sterile barrier system
- Jun 25, 2019 · Class II · Z-2239-2019: Manufacturing flaw in the sterile barrier system

## Indications for use
HBS-Mini (2.5mm) — HIBS Standard (3.0mm) Scaphoid fractures — Scaphoid fractures Lunate fractures — Carpal fractures and non-unions Capitate — Capitellum fractures Trapezial fractures — Metacarpal fractures Metacarpal and metatarsal fractures — Phalangeal fractures Phalangeal fractures — Distal radial fractures Radial head fractures — Radial head fractures Ulnar styloid fractures — Ulnar styloid fractures Osteo-chondral — Small joint fusions Small joint fustions — Humeral head fractures — Glenoid fractures — Intercarpal fusions — Interphalangeal fractures — Metatarsal osteotomies — Tarsal fusions — Malleolar fractures — Patellar fractures — Osteo-chondral fractures

Source page: https://510kreport.com/device/K101030
Methodology: https://510kreport.com/methodology