# K072832: Anterolateral and Medial Locking Plating System

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Dec 14, 2007 after 72 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: 1 generation back to K882831 (1988). 4 ancestors in all.
58 later devices descend from it; 2 cite it directly.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990120: Modification of Depuy Ace Timax Medial Pilon Plate, Depuy Ace Medical Co. (1999) Summary page 1.
- K983853: Depuy Ace Timax Meta Plate, Depuy Ace Medical Co. (1998) Summary page 1.
- K905048: Ace 3.5MM Cortical Bone Screw, Ace Medical Co. (1991) Summary page 1.
- K882831: Ace Cancellous Bone Screw, Buckman Co., Inc. (1988). Our reading of the summary gave K882381, FDA’s number for Pti Heart-Lift (TM) Cardiac Retraction Gloves-Steri (Pioneering Technologies, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Cancellous Bone Screws”.

## Most influential descendants
- K092812: Synthes (Usa) 2.7MM/ 3.5MM LCP Anterolateral Distal Tibia Plates (2010), 55 descendants of its own
- K162674: BioPro Foot Plating Systems (2017), 19 descendants of its own
- K153716: GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System. (2016), 15 descendants of its own
- K163361: ANTHEM™ Fracture System (2017), 14 descendants of its own
- K193633: APTUS® Ankle Trauma System 2.8/3.5 (2020), 11 descendants of its own

## Recalls of this device
- Nov 20, 2015 · Class II · Z-0450-2016: These screws have a single lead (instead of a triple lead) thread. The screw may sit proud in the plate, If the screw does not lock into the plate; the screw may back out. If the screw sits proud, sof
- Dec 19, 2013 · Class II · Z-0716-2014: 3.5mmx38mm Locking Cortical Screw, implants are being recalled since an investigation identified that a 3.5mmx28mm Cortical Locking Screw is labeled as a 3.5mmx38mm Cortical Locking Screw.

## Indications for use
The Medial Locking Plate is indicated for: -Pilon Fractures: distal tibial intra-articular fractures -High medial malleolar fractures -Low boot type rotational distal extra-articular shaft fractures while the Anterolateral Locking Plate is indicated for: -Distal intra-articular tibia fractures -Proximal tibia fractures -Proximal and distal humerus fractures

Source page: https://510kreport.com/device/K072832
Methodology: https://510kreport.com/methodology