# K150121: Zimmer Periarticular Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Feb 23, 2015 after 34 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K000684 (2000). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 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) Summary page 4.
- K063303: Universal Locking System, 2.7MM Plates & Screws, Zimmer, Inc. (2006) Summary page 4.

## Recalls of this device
- Oct 10, 2019 · Class II · Z-0313-2020: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
- Oct 10, 2019 · Class II · Z-0314-2020: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
- Oct 10, 2019 · Class II · Z-0305-2020: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
- Oct 10, 2019 · Class II · Z-0307-2020: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
- Oct 10, 2019 · Class II · Z-0308-2020: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
- Oct 10, 2019 · Class II · Z-0315-2020: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
- Jan 11, 2016 · Class II · Z-1122-2016: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
- Jan 11, 2016 · Class II · Z-1156-2016: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
- Jan 11, 2016 · Class II · Z-1125-2016: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

## Indications for use
Periarticular Plating System plates are indicated for temporary internal fixation and stabilization of osteotomies and fractures, including: comminuted fractures, supracondylar fractures, intra-articular and extra-articular condylar fractures, fractures in osteopenic bone, nonunions, and malunions. Periarticular Plating System Small Distal Volar Radial Radius and Small Distal Volar Ulnar Radius plates are indicated for temporary internal fixation and stabilization of fractures and osteotomies of the volar aspect of the distal radius, including associated carpal fusions. Periarticular Plating System Calcaneal plates are indicated for complex extra-articular and intra-articular fractures and osteotomies of the calcaneus. Periarticular Plating System screws are temporary internal fixation devices designed to stabilize fractures during the normal healing process.

Source page: https://510kreport.com/device/K150121
Methodology: https://510kreport.com/methodology