# K072083: Small Fragment Locking Plating System

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Oct 25, 2007 after 87 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). 3 ancestors in all.
37 later devices descend from it; 4 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000684: Small Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 1.
- K882831: Ace Cancellous Bone Screw, Buckman Co., Inc. (1988) Summary page 1.
- K905048: Ace 3.5MM Cortical Bone Screw, Ace Medical Co. (1991) Summary page 1.

## Most influential descendants
- K101421: Medical Plates, Lateral Plates, Posterior Lateral Plates, Olecranon Plates Model 131218704-708; 851318704-708, 131218204 (2010), 32 descendants of its own
- K143697: Biomet Proximal Humerus Plating System (2015), 17 descendants of its own
- K163361: ANTHEM™ Fracture System (2017), 14 descendants of its own
- K173166: ANTHEM Fracture System (2017), 11 descendants of its own
- K113733: Small and Large Fragments Osteosynthesis System Neofix (2012), 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 Small Fragment Locking Plating System is intended for fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone.

Source page: https://510kreport.com/device/K072083
Methodology: https://510kreport.com/methodology