# K083843: Locking Anatomic & Composite Plating System

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Mar 20, 2009 after 86 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
No predicates in its family tree.
106 later devices descend from it; 5 cite it directly.
0 of 107 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K113014: Claw II Polyaxial Compression System and Ortholoc 3DSI Locking Screws (2012), 97 descendants of its own
- K121651: Ortholoc 3DI Midfoot/Flatfoot System (2012), 95 descendants of its own
- K140397: Paralock Plating System / Tuffnek Screw (2014), 31 descendants of its own
- K143025: Total Compression Plating System (2014), 24 descendants of its own
- K151442: Total Compression Plating (TCP) System (2015), 23 descendants of its own

## Recalls of this device
- May 14, 2020 · Class II · Z-2308-2020: Distributed to the field without having completed design history files or design transfer activities
- May 14, 2020 · Class II · Z-2310-2020: Distributed to the field without having completed design history files or design transfer activities

## Indications for use
The DePuy Locking Anatomic & Composite Plating System is intended for fixation of fractures, osteotomies and non-unions of the fibula, malleolus, metatarsals and metacarpals, olecranon, clavicle, scapula, distal humerus and humeral head, radius, ulna and distal tibia, particularly in osteopenic bone.

Source page: https://510kreport.com/device/K083843
Methodology: https://510kreport.com/methodology