# K040593: Periarticular Locking Plates and Screws, 2358, 2359 Series

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Apr 12, 2004 after 35 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K962616 (1996). 4 ancestors in all.
162 later devices descend from it; 14 cite it directly.
0 of 167 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012114: Synthes Locking Distal Radius Plating System, Synthes (Usa) (2001) Summary page 1.
- K982732: Synthes (Usa) Distal Radius Plate System (DRPS), Synthes (1998) Summary page 1.
- (no number) Zimmer ECT® Internal Fracture Fixation System: named in the summary without a submission number

## Most influential descendants
- K100271: Vari AX Distal Radius Line Extensions of XXL Plates (2010), 80 descendants of its own
- K112455: Aiming Blocks for Variax Distal Radius Plates (2011), 56 descendants of its own
- K113760: Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks & Joystick (2012), 40 descendants of its own
- K042598: Periarticular Locking Plates and Screws, 2357 and 2359 Series (2004), 31 descendants of its own
- K050121: Zimmer Periarticular Locking Plate System, Model 2357 & 2359 (2005), 27 descendants of its own

## Recalls of this device
- Dec 9, 2015 · Class II · Z-0646-2016: Product on the package label did not match what was inside the package. The label was for part number 00-2359-058-35 (Zimmer Periarticular Locking Plate System 3.5mm Locking Screw 58mm Length) lot num
- Jun 10, 2014 · Class II · Z-2131-2014: A complaint was received in which it was reported that an 8-hole plate from lot 62276042 had an enlarged hole that is unable to lock the screw, which resulted in the screw head pulling through plate h

## 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/K040593
Methodology: https://510kreport.com/methodology