# K052294: Shoulder Nail Plate

- Pathway: 510(k) (Traditional)
- Applicant: Hand Innovations, LLC
- Decided: Oct 21, 2005 after 59 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K962616 (1996). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051728: Modification to Shoulder Fixation System, Hand Innovations, LLC (2005) Summary page 1.
- K023007: Distal Radius Fracture Repair System, Hand Innovations, Inc. (2002) Summary page 1.
- K043404: Modification to T2 Proximal Humeral Nail, Howmedica Osteonics Corp. (2004) Summary page 1.

## Indications for use
The Shoulder Nail Plate of the Shoulder Fixation System is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal Humerus.

Source page: https://510kreport.com/device/K052294
Methodology: https://510kreport.com/methodology