# K161041: OsteoMed ExtremiLOCK Wrist Plating System

- Pathway: 510(k) (Special)
- Applicant: Osteomed
- Decided: May 19, 2016 after 36 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: 9 generations back to K962616 (1996). 59 ancestors in all.
No later device cites it as a predicate yet.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152145: OsteoMed ExtremiLOCK Wrist Plating System, Osteomed (2015) Summary page 4.

## Indications for use
The OsteoMed ExtremiLOCK Wrist Plating System is indicated 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 ExtremiLOCK Wrist Plating System implants are intended for single use only.

Source page: https://510kreport.com/device/K161041
Methodology: https://510kreport.com/methodology