# K052248: Dorsal Nail Plate, Anatomical

- Pathway: 510(k) (Special)
- Applicant: Hand Innovations, LLC
- Decided: Sep 14, 2005 after 27 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K962616 (1996). 5 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023007: Distal Radius Fracture Repair System, Hand Innovations, Inc. (2002) Summary page 1.

## Most influential descendants
- K120015: Osteomed Wrist Plating System (2012), 2 descendants of its own
- K152145: OsteoMed ExtremiLOCK Wrist Plating System (2015), 1 descendant of its own
- K161041: OsteoMed ExtremiLOCK Wrist Plating System (2016), 0 descendants of its own

## Recalls of this device
- Jun 23, 2014 · Class II · Z-2212-2014: The firm received complaints indicating that the drill guide becomes stuck in the jig. The drill guide can be placed in the jig about halfway before it becomes stuck.
- Dec 23, 2008 · Not classified · Z-0981-2009: The DNP nail plate may not attach to the alignment guide (jig) instrument, making it difficult to insert the nail plate into position or to drill needed holes accurately.
- Dec 23, 2008 · Not classified · Z-0982-2009: The DNP nail plate may not attach to the alignment guide (jig) instrument, making it difficult to insert the nail plate into position or to drill needed holes accurately.
- Dec 23, 2008 · Not classified · Z-0983-2009: The DNP nail plate may not attach to the alignment guide (jig) instrument, making it difficult to insert the nail plate into position or to drill needed holes accurately.
- Dec 23, 2008 · Not classified · Z-0984-2009: The DNP nail plate may not attach to the alignment guide (jig) instrument, making it difficult to insert the nail plate into position or to drill needed holes accurately.

## Indications for use
The Dorsal Nail PlateTM, Anatomical is intended for the fixation of fractures and osteotomies involving the distal Radius.

Source page: https://510kreport.com/device/K052248
Methodology: https://510kreport.com/methodology