# K082078: Zimmer Periarticular Locking Plate System: Distal Humeral and Proximal Ulna Plates

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Nov 3, 2008 after 103 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K962616 (1996). 11 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070906: Modificaton to: Zimmer Periarticular Locking Plates and Screws, Zimmer, Inc. (2007) Summary page 1.

## Most influential descendants
- K130008: Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol), 3.0 Cancellous Locking Screw, 3.0 Cortical Locking (2013), 1 descendant of its own
- K260958: I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular Stability; I.T.S. Humeral Head Plate with Angular Stability; I.T.S. FR.O.H. Calcaneus Repair System; I.T.S. Pilonplate with Angular Stability; I.T.S. Olecranonplate with Angular Stability; I.T.S. Straight Plate with Angular Stability; I.T.S. Screw System; I.T.S. PRS Sacral Rod System; I.T.S. Fibula Plate PROlock with Angular Stability; I.T.S. Distal Humeral Plates with Angular Stability; I.T.S. LRS (L (2026), 0 descendants of its own
- K201229: Intai Anatomic Locking Plate and Screw System (2022), 0 descendants of its own
- K141734: Zimmer Periarticular Locking System (2014), 0 descendants of its own

## Recalls of this device
- Oct 10, 2019 · Class II · Z-0317-2020: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
- Nov 5, 2013 · Class II · Z-0591-2014: Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product from this faci
- Nov 5, 2013 · Class II · Z-0587-2014: Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product from this faci
- Nov 5, 2013 · Class II · Z-0585-2014: Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product from this faci
- Nov 5, 2013 · Class II · Z-0588-2014: Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product from this faci
- Nov 5, 2013 · Class II · Z-0589-2014: Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product from this faci
- Jul 30, 2013 · Class II · Z-2101-2013: Zimmer is initiating a lot specific voluntary recall of the Distal Medial Humeral Locking Plate, Short due to the incorrect information printed on the Chinese label. The original label indicates that 

## Indications for use
The 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/K082078
Methodology: https://510kreport.com/methodology