# K063875: Stryker Foot Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Mar 15, 2007 after 76 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
No predicates in its family tree.
167 later devices descend from it; 13 cite it directly.
0 of 168 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Profyle® System: named in the summary without a submission number
- (no number) Stryker® Plating System: named in the summary without a submission number
- (no number) DARCO Locking Bone Plate System: named in the summary without a submission number
- (no number) Synthes LCP Locking Calcaneal Plates and Modular Foot System: named in the summary without a submission number

## Most influential descendants
- K073527: Variax Elbow System (2008), 61 descendants of its own
- K101056: Variax Elbow System (2010), 58 descendants of its own
- K113760: Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks & Joystick (2012), 40 descendants of its own
- K140397: Paralock Plating System / Tuffnek Screw (2014), 31 descendants of its own
- K131722: I.T.S. Extremity Fixation Systems (2013), 24 descendants of its own

## Indications for use
The Stryker® Foot Plating System is intended for use in internal fixation, reconstruction or arthrodeses of small bones including the fore, mid- and hind foot and ankle. Examples of these procedures may include but are not limited to replantation, lag screw techniques, joint fusions, corrective osteotomies, and the treatment of fractures.

Source page: https://510kreport.com/device/K063875
Methodology: https://510kreport.com/methodology