# K143331: Zimmer Plates and Screws System (ZPS) - Non-sterile ZPS

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Mar 4, 2015 after 104 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: 6 generations back to K000684 (2000). 18 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140508: Zimmer Plates and Screws System (ZPS)- Non-Sterile Plates and Screws, Zimmer, Inc. (2014) Summary page 4.
- K143066: Zimmer Plates and Screws (ZPS) - Non Sterile Plate Line Extensions, Sterile/Non-Sterile ZPS / Screws and Washers, Zimmer, Inc. (2014). Cleared while this submission was under review Summary page 4.
- K142836: Zimmer Plates and Screws (ZPS), Forte Screws, Zimmer, Inc. (2014) Summary page 4.

## Most influential descendants
- K171320: ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS Humerus and Olecranon Plates & MBOSS/FIXION Screws, ARMAR / ARTIS Tibia and Buttress Plates & MBOSS/FIXION Screws, ARMAR / ARTIS 2.4mm Plates & MBOSS/FIXION Screws, ARMAR/ ARTISClavical Hook Plate & MBOSS/FIXION Screws, ARMAR/ ARTIS Metaphyseal Plate & MBOSS/FIXION Screws, ARMAR / ARTISCalcaneal Plate & MBOSS/FIXION Screws (2018), 2 descendants of its own
- K241599: Signature Osteosynthesis Plate System (2025), 0 descendants of its own
- K200701: Skeletal Dynamics Midshaft Humerus Plating System (2020), 0 descendants of its own
- K152841: Zimmer Plates and Screws System (ZPS) Sterile 2.7mm Cortical Screws (2015), 0 descendants of its own

## Indications for use
ZPS One-Third Tubular Plates, T-Plates, Semi-Tubular Plates, Symphyseal Bridge Plates, Reconstruction Plates, Contourable Dual Compression Plates, Cloverleaf and Spoon Plates are indicated for temporary internal fixation and stabilization of osteotomies and fractures, such as: • comminuted fractures • supracondylar fractures • extra-articular fractures • fractures in osteopenic bone • nonunions • malunions 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 and Forte Screws are temporary internal fixation devices designed to stabilize fractures during the normal healing process.

Source page: https://510kreport.com/device/K143331
Methodology: https://510kreport.com/methodology