# K053182: Drlock Distal Radius Volar System

- Pathway: 510(k) (Traditional)
- Applicant: Orthohelix Surgical Designs, Inc.
- Decided: Feb 27, 2006 after 105 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 K030310 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030310: Synthes Stainless Steel Modular Hand System, Synthes (Usa) (2003) Summary page 1.

## Cited in the summary but kept off the family tree
- K002277: Fresenius Optiflux 200NR, Fresenius Medical Care North America (2000). Our reading of the summary gave K002277, FDA’s number for Fresenius Optiflux 200NR (Fresenius Medical Care North America). Its FDA name has none of the distinctive words the summary uses for the device it names, “Hand Innovations Distal Volar Radius Fracture Repair System”. Kept off the family tree. Summary page 1.

## Recalls of this device
- Sep 4, 2007 · Not classified · Z-0136-2008: Seat/Fit problems: The heads of the distal screws/pegs rest above the surface of the distal plate after the screws/pegs are fully tightened.
- Aug 3, 2006 · Not classified · Z-0349-2007: The 48 distal locking-screws (ranging from 10-24mm) contained in the kit are not within established specifications, specifically the minor diameter of the screws are undersized.

## Indications for use
The DRLock Distal Radius Volar System is indicated for the fixation of unstable distal radius fractures and osteotomies.

Source page: https://510kreport.com/device/K053182
Methodology: https://510kreport.com/methodology