# K160304: OsteoBullet Compression Screw

- Pathway: 510(k) (Traditional)
- Applicant: Phalanx Innovations
- Decided: Apr 29, 2016 after 85 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: 6 generations back to K792022 (1979). 21 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060026: Koby Surgical Internal Fixation System, Koby Surgical (2006) Summary page 4.
- K123672: Inion Freedomscrew (Alternative Marketing Name: Inion Otps Freedomscrew), Inion OY (2013) Summary page 4.

## Most influential descendants
- K180257: InCore® Lapidus System (2018), 3 descendants of its own
- K200291: CREED™ Cannulated Screws (2020), 2 descendants of its own
- K192578: InCore TMT System (2019), 1 descendant of its own
- K252657: Impact PEEK Union Nail System (2025), 0 descendants of its own
- K223847: CREED™ Cannulated Screws (2023), 0 descendants of its own

## Indications for use
OsteoBullet Compression Screw is intended to maintain alignment and fixation of bone fractures, non-unions, osteotomies, or arthrodeses of small bones in the hand and foot.

Source page: https://510kreport.com/device/K160304
Methodology: https://510kreport.com/methodology