# K081546: Small Bone Locking Plating System

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Aug 26, 2008 after 85 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
116 later devices descend from it; 11 cite it directly.
0 of 117 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
- K083364: 2.5 MM Multidirectional Threaded Pegs, Models 131211110-131211130, 1.5 MM Locking Screws, Models 131220408-131220424 (2008), 90 descendants of its own
- K101962: Mini Maxlock Extreme Plating System (2010), 85 descendants of its own
- K111041: Mini Variable System (2011), 77 descendants of its own
- K120157: Mini Maxlock Extreme Plating System (2012), 64 descendants of its own
- K121437: Mini Maxlock Extreme Plating System (2012), 38 descendants of its own

## Recalls of this device
- Jul 12, 2018 · Class II · Z-2965-2018: A size 22mm threaded peg was found in the package of a 10mm unit.

## Indications for use
The DePuy Small Bone Locking Plating System is intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis and craniomaxillofacial skeleton, particularly in osteopenic bone.

Source page: https://510kreport.com/device/K081546
Methodology: https://510kreport.com/methodology