# K203479: ExtremiLOCK Lateral Ankle Fusion Plates

- Pathway: 510(k) (Traditional)
- Applicant: Osteomed
- Decided: Feb 24, 2021 after 89 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: 12 generations back to K010612 (2001). 109 ancestors in all.
No later device cites it as a predicate yet.
0 of 110 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123347: Normed Ankle Fix System 4.0 and Normed Ankle Fix Plus System 4.0, Normed Medizin-Technik GmbH (2013) Summary page 4.
- K133691: Extrimilock Ankle Plating System, Osteomed LP (2014) Summary page 4.

## Indications for use
The OSTEOMED ExtremiLOCK Ankle Plating System is intended for fixation of fractures, osteotomies, and non-unions of the tibia and fibula as well as arthrodesis of the ankle including Tibiotalar and Tibiotalocalcaneal joint. 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 adolescent (greater than 12-21 years of age) patients.

Source page: https://510kreport.com/device/K203479
Methodology: https://510kreport.com/methodology