# K012162: Stryker Plating System Basic Fragment Set

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Aug 31, 2001 after 51 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.
38 later devices descend from it; 3 cite it directly.
0 of 39 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 no predicate by number.

## Most influential descendants
- K123964: Axsos 3 TI Locking Plate System (2013), 19 descendants of its own
- K133440: Axsos 3 TI Locking Plate System Line Extension (2013), 12 descendants of its own
- K173166: ANTHEM Fracture System (2017), 11 descendants of its own
- K180554: ANTHEM Fracture System (2018), 10 descendants of its own
- K072411: Aap Bone Plates and Screw Implants (2008), 9 descendants of its own

## Indications for use
The Basic Fragment Set is intended for use in long bone fracture fixation. Reconstruction plates, wide and narrow straight and waisted compression-plates are indicated for fixation of long bone fractures including but not limited to: Fractures of the femur Fractures of the tibia Fractures of the humerus Fractures of the pelvis T-Plates, T-buttress Plates and L-buttress-Plates are indicated for fractures at the proximal or distal end of long bones including but not limited to: Fractures of the femoral condyles Fractures of the tibial plateau Fractures of the distal tibia Fractures of the proximal-humerus

Source page: https://510kreport.com/device/K012162
Methodology: https://510kreport.com/methodology