# K031609: Swiss Orthopedic Solutions, Inc., Small Fragment Locking Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Swiss Orthopedic Solutions, Inc.
- Decided: Jun 9, 2003 after 18 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
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 (USA) Dynamic Locking Compression (DCL) System, also known as the Locking Compression Plate Set: named in the summary without a submission number

## Indications for use
The Swiss Orthopedic Solutions Inc., Small Fragment Locking Plate Set is a plate and screw system, intended to treat fractures osteotomies and non-unions of various bones, including but not limited to, the radius, ulna, proximal and distal tibia, pelvis, clavicle, fibula, humerus and scapula particularly in osteopenic bone.

Source page: https://510kreport.com/device/K031609
Methodology: https://510kreport.com/methodology