# K091493: Ortho Select Bone Plates and Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Select Implant Technology Gesellschaft
- Decided: Feb 5, 2010 after 261 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: 1 generation back to K993106 (1999). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993106: Smith & Nephew Bone Plate System (Bone Plates, Bone Screws and Accessories), Smith & Nephew, Inc. (1999) Summary page 1.
- K001941: Synthes Modular Foot System, Synthes (Usa) (2000) Summary page 1.
- (no number) Synthes Bone Plates and Screws for Standard Osteosynthesis (Preamendment): named in the summary without a submission number

## Indications for use
The ORTHO SELECT Bone Plates and Screw System is used for adult or pediatric patients as indicated for pelvic, small, and long bone fracture fixation. Indications for use include fractures of the tibia, fibula, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, middle hand and middle foot bones; treatment of the calcaneal; and hip arthrodesis. In pediatric patients, the ORTHO SELECT Bone Plates and Screw System is intended for use on mature bone only. It is not intended for placement across the growth plate.

Source page: https://510kreport.com/device/K091493
Methodology: https://510kreport.com/methodology