# K071105: Osteomed Calcaneal Plate and Screw Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Osteomed LP
- Decided: Jul 30, 2007 after 102 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: 2 generations back to K981372 (1998). 4 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991407: Synthes Locking Calcaneal Plates, Synthes (Usa) (1999) Summary page 1.
- K061808: Darco Locking Bone Plate System, Darco International, Inc. (2006) Summary page 1.

## Cited in the summary but kept off the family tree
- K041786: Calcamea Plate, New Deal, S.A. (2004). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K131445: Osteomed Extremilock Foot Plating System (2013), 8 descendants of its own
- K191009: Arsenal Plating System (2019), 2 descendants of its own
- K133437: 1ST MTP Plate (2013), 2 descendants of its own
- K143365: Eminent Foot Plate System (2015), 1 descendant of its own
- K251709: MedCAD® AccuStride™ System (2025), 0 descendants of its own

## Indications for use
The OsteoMed Calcaneal Plate and Screw Fixation System Is Intended for fractures and osteotomies of the calcaneus, including, but not limited to extra-articular, intra-articular, joint depression, tongue type and severely comminuted fractures. Plates and screws are intended for single use only.

Source page: https://510kreport.com/device/K071105
Methodology: https://510kreport.com/methodology