# K140622: DVR Dorsal Plate, DVR Lateral Plate, DVR Ulna Plate

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: May 13, 2014 after 63 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
Longest line of descent: 2 generations back to K081546 (2008). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081546: Small Bone Locking Plating System, DePuy Orthopaedics, Inc. (2008) Summary page 1.
- K083364: 2.5 MM Multidirectional Threaded Pegs, Models 131211110-131211130, 1.5 MM Locking Screws, Models 131220408-131220424, DePuy Orthopaedics, Inc. (2008) Summary page 1.
- K112345: Distal Volar Radius Plating Systems, Medos International SARL (2011) Summary page 1.

## Recalls of this device
- Jan 29, 2016 · Class II · Z-1082-2016: Components of the DVR ePAKs can oxidize during shipment and storage prior to use. A delay in surgery, less than 30 minutes, may occur if the surgical staff proceeds to re-sterilize the product. If oxi

## Indications for use
The system is intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions (osteotomies) of small bones of the hand, foot, radius, ulna, ankle, humerus, scapula and pelvis, particularly in osteopenic bone.

Source page: https://510kreport.com/device/K140622
Methodology: https://510kreport.com/methodology