# K081608: Proximal Humerus Scaffold Fixation System (Phsfs)

- Pathway: 510(k) (Traditional)
- Applicant: Toby Orthopaedics, LLC
- Decided: Dec 19, 2008 after 193 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Synthes LCP Proximal Humerus Plate: named in the summary without a submission number

## Recalls of this device
- Jun 5, 2013 · Class II · Z-0599-2020: Potential suture clip breaking during a humerus fixation surgery.

## Indications for use
The Proximal Humerus Scaffold Fixation System (PHSFS) is indicated for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus.

Source page: https://510kreport.com/device/K081608
Methodology: https://510kreport.com/methodology