# K183104: Mini Cannulated Headed and Headless Screw Set

- Pathway: 510(k) (Traditional)
- Applicant: Stryker GmbH
- Decided: Jun 10, 2019 after 214 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: 7 generations back to K962823 (1996). 38 ancestors in all.
No later device cites it as a predicate yet.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120493: Mini Cannulated Headed and Headless Screw Set, Instratek, Inc. (2012) Summary page 5.

## Indications for use
The Stryker Cannulated Titanium (Ti6AL4V) Headed & Headless Mini 2.5 mm, 3.0 mm, and 4.0 mm bone screws are indicated for use in the treatment of bone fractures, osteotomies, arthrodesis, osteochondritis, and tendon reattachment in small bones and interfragmentary indications including specific long bone indications. The device is intended for, but not limited to, hand surgery, orthopedic surgery, plastic surgery, and podiatric surgery. These devices are not intended for use in the spine. The Stryker Cannulated Titanium Headed & Headless Mini Screw Set is intended for the following surgical indications: - Scaphoid fractures - Lunate fractures - Capitate fractures - Trapezial fractures - Metacarpal fractures - Metatarsal fractures - Phalangeal fractures - Radial head fractures - Ulnar styloid fractures - Small joint fusion - Osteochondral fractures - Humeral head fractures - Glenoid fractures - Carpometacarpal joint fractures - Interphalangeal joint fractures - Tarsal fusions - Malleolar fractures - Patellar fractures - Metaphyseal fractures - Interfragmentary radius fractures - Interfragmentary ulnar fractures - Small hand and wrist bone fractures - Distal metatarsal osteotomies - Forefoot interfragmentary fractures - Midfoot interfragmentary fractures

Source page: https://510kreport.com/device/K183104
Methodology: https://510kreport.com/methodology