# K141517: Zimmer Plates and Screws (ZPS)-Non-Sterile Plates

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Aug 13, 2014 after 65 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 K921458 (1992). 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)
- K921458: TMP Microplating System, Techmedica, Inc. (1992) Summary page 4.
- K020401: Synthes Calcaneal Plate, Synthes (Usa) (2002) Summary page 4.

## Indications for use
ZPS Plates are indicated for temporary internal fixation and stabilization of osteotomies and fractures. Smaller-sized ZPS plates are used for small bones and small fragments of the hands and feet. ZPS Calcaneal plates are indicated for temporary internal fixation and stabilization of osteotomies and fractures of the calcaneus. ZPS Screws are temporary internal fixation devices designed to stabilize fractures during the normal healing process.

Source page: https://510kreport.com/device/K141517
Methodology: https://510kreport.com/methodology