# K050512: Stryker Locked Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Mar 21, 2005 after 20 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.
79 later devices descend from it; 9 cite it directly.
0 of 80 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) Stryker Plating 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
- K132502: Variax 2 System (2013), 21 descendants of its own
- K140769: Variax 2 System (2014), 19 descendants of its own

## Indications for use
The SPS Monoaxial Locking Plates in the Stryker Locked Plating System are intended for use in long bone fracture fixation. The SPS Monoaxial Locking Plates are indicated for fixation of long bone fractures including but not limited to fractures of the distal radius, the proximal humerus, the distal tibia, proximal tibia and the distal femur.

Source page: https://510kreport.com/device/K050512
Methodology: https://510kreport.com/methodology