# K120015: Osteomed Wrist Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Osteomed LP
- Decided: Apr 24, 2012 after 112 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K962616 (1996). 57 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090522: Osteomed Hand Plate and Screw Fixation System, Osteomed LP (2009) Summary page 1.
- K091614: Osteomed Foot Plating System, Osteomed LP (2009) Summary page 1.
- K924018: M3 Lag Screw Fixation System, Osteomed Corp. (1993) Summary page 1.
- K040022: Stryker Leibinger Universal Distal Radius System, Stryker Leibinger (2004) Summary page 2.
- K051735: Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity, Smith & Nephew, Inc. (2005) Summary page 2.
- K083694: Synthes (Usa) 2.4 MM VA-LCP Two Column Volar Distal Radius Plates, Synthes (Usa) (2009) Summary page 2.
- K091644: Synthes (Usa) 2.4MM LCP Volar Column Distal Radius Plates, Synthes (Usa) (2009) Summary page 2.
- K042355: Synthes (Usa) LCP Wrist Fusion Plates, Synthes (Usa) (2004) Summary page 2.
- K052248: Dorsal Nail Plate, Anatomical, Hand Innovations, LLC (2005) Summary page 2.
- K062863: Osteomed Extended 2.0/2.4CANNULATED Screw System, Osteomed LP (2006) Summary page 2.

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

## Indications for use
OsteoMed Wrist Plating System is intended for fracture fixation, fusion and osteotomies of wrist and other bones appropriate for the size of the device. It is intended for use in trauma, general surgery and reconstructive procedures. OsteoMed Wrist Plating System implants are intended for single use only.

Source page: https://510kreport.com/device/K120015
Methodology: https://510kreport.com/methodology