# K133691: Extrimilock Ankle Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Osteomed LP
- Decided: Feb 24, 2014 after 84 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: 8 generations back to K981372 (1998). 25 ancestors in all.
10 later devices descend from it; 4 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011335: Synths One-Third Tubular DCL Plate, Synthes (Usa) (2001) Summary page 1.
- K091614: Osteomed Foot Plating System, Osteomed LP (2009) Summary page 1.
- K954330: Super Screw 3.5 MM, Osteomed Corp. (1995) Summary page 2.
- K120787: Merete Locking Bone Plate System Iii, Merete Medical GmbH (2012) Summary page 2.

## Most influential descendants
- K160191: Align Anterior Ankle Fusion Plate (2016), 5 descendants of its own
- K181067: AlignX Ankle Fusion System (2018), 4 descendants of its own
- K173121: Ankle Fusion Plating System (2017), 2 descendants of its own
- K231887: ARIX Ankle Distal Tibia System (2023), 1 descendant of its own
- K213069: CoLink NeoFuse Plating System (2021), 1 descendant of its own

## Indications for use
The OsteoMed ExtremiLOCK Ankle Plating System is intended for fixation of fractures, arthrodesis, osteotomies, and non-unions of the tibia and fibula. The ExtremiLOCK Ankle Plating System implants are intended for single use only. The 1/3 tubular plates, hook plates, screws, and washers are also intended for use in trauma, general surgery, and reconstructive procedures of bones appropriate for the size of the device. The OsteoMed ExtremiLOCK Ankle Plating System can be used for adult and pediatric patients.

Source page: https://510kreport.com/device/K133691
Methodology: https://510kreport.com/methodology