# K234059: Forma Medical Optimal Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Forma Medical, Inc.
- Decided: Jun 26, 2024 after 187 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: 15 generations back to K962616 (1996). 288 ancestors in all.
No later device cites it as a predicate yet.
0 of 289 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180554: ANTHEM Fracture System, Globus Medical, Inc. (2018) Summary page 4.

## Indications for use
The Forma Medical Optimal Plating System is intended for fixation of fractures, osteotomies, arthrodeses, and bone reconstructions in adult patients with normal or osteopenic bone. Indications include flat (scapula), long (clavicle, upper and lower extremities including metacarpals, metatarsals, and phalanges), irregular (pelvis, hand, foot) bones and joints (wrist, ankle). The Forma Medical Optimal Plating System is not indicated for ribs, sternum, spine, or the skull.

Source page: https://510kreport.com/device/K234059
Methodology: https://510kreport.com/methodology