# K060969: Polyax Locked Plating System

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: May 12, 2006 after 35 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K962616 (1996). 6 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003235: PE.R.I. II Knee Fracture System, DePuy Orthopaedics, Inc. (2000) Summary page 1.
- K040593: Periarticular Locking Plates and Screws, 2358, 2359 Series, Zimmer, Inc. (2004) Summary page 1.

## Most influential descendants
- K143496: Piccolo Composite Plate System (2015), 4 descendants of its own
- K072423: 4.5MM Locking Broad & Narrow Compression Plates, 4.5MM & 5.5MM Cortical & Cancellous Locking Screws, Respectively. (2007), 4 descendants of its own
- K170401: Piccolo Composite® Plate System (2017), 3 descendants of its own
- K103408: Posterior Lateral Plates (2010), 3 descendants of its own
- K182015: Piccolo Composite® Plate System (2018), 1 descendant of its own

## Recalls of this device
- Nov 1, 2010 · Not classified · Z-1586-2011: The firm determined that the 8.0 mm hole threads in the PolyAx Distal Femoral Locking Plate were incorrectly manufactured, which prevents the mating screw from locking in place. The screw should lock 
- Nov 1, 2010 · Not classified · Z-1580-2011: The firm determined that the 8.0 mm hole threads in the PolyAx Distal Femoral Locking Plate were incorrectly manufactured, which prevents the mating screw from locking in place. The screw should lock 
- Nov 1, 2010 · Not classified · Z-1587-2011: The firm determined that the 8.0 mm hole threads in the PolyAx Distal Femoral Locking Plate were incorrectly manufactured, which prevents the mating screw from locking in place. The screw should lock 
- Nov 1, 2010 · Not classified · Z-1581-2011: The firm determined that the 8.0 mm hole threads in the PolyAx Distal Femoral Locking Plate were incorrectly manufactured, which prevents the mating screw from locking in place. The screw should lock 
- Nov 1, 2010 · Not classified · Z-1578-2011: The firm determined that the 8.0 mm hole threads in the PolyAx Distal Femoral Locking Plate were incorrectly manufactured, which prevents the mating screw from locking in place. The screw should lock 
- Nov 1, 2010 · Not classified · Z-1583-2011: The firm determined that the 8.0 mm hole threads in the PolyAx Distal Femoral Locking Plate were incorrectly manufactured, which prevents the mating screw from locking in place. The screw should lock 
- Nov 1, 2010 · Not classified · Z-1585-2011: The firm determined that the 8.0 mm hole threads in the PolyAx Distal Femoral Locking Plate were incorrectly manufactured, which prevents the mating screw from locking in place. The screw should lock 
- Nov 1, 2010 · Not classified · Z-1584-2011: The firm determined that the 8.0 mm hole threads in the PolyAx Distal Femoral Locking Plate were incorrectly manufactured, which prevents the mating screw from locking in place. The screw should lock 
- Nov 1, 2010 · Not classified · Z-1579-2011: The firm determined that the 8.0 mm hole threads in the PolyAx Distal Femoral Locking Plate were incorrectly manufactured, which prevents the mating screw from locking in place. The screw should lock 
- Nov 1, 2010 · Not classified · Z-1582-2011: The firm determined that the 8.0 mm hole threads in the PolyAx Distal Femoral Locking Plate were incorrectly manufactured, which prevents the mating screw from locking in place. The screw should lock 

## Indications for use
The POLYAX Locked Plating System is intended for use in cases requiring stabilization of malunions, non-unions, and osteotomies of the distal femur and proximal tibia and Open Reduction Internal Fixation (ORIF) repair of closed and open fractures of the distal femur and proximal tibia including, but not limited to the following: periarticular fractures, such as simple comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression fractures with associated shaft fractures, and periprosthetic fractures.

Source page: https://510kreport.com/device/K060969
Methodology: https://510kreport.com/methodology