# K141734: Zimmer Periarticular Locking System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Aug 13, 2014 after 47 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K962616 (1996). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042598: Periarticular Locking Plates and Screws, 2357 and 2359 Series, Zimmer, Inc. (2004) Summary page 4.
- K082078: Zimmer Periarticular Locking Plate System: Distal Humeral and Proximal Ulna Plates, Zimmer, Inc. (2008) Summary page 4.
- K111039: Zimmer Periarticular Locking Plate System, Zimmer, Inc. (2011) Summary page 4.

## Recalls of this device
- Jun 27, 2023 · Class II · Z-2254-2023: Thread form issue of the locking holes in that the locking screws would not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not
- Oct 10, 2019 · Class II · Z-0310-2020: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
- Oct 10, 2019 · Class II · Z-0317-2020: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

## Indications for use
The Zimmer Periarticular Locking Plate System is 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 - Malunions

Source page: https://510kreport.com/device/K141734
Methodology: https://510kreport.com/methodology