# K070208: Synthes 4.5 MM LCP Posterolateral Proximal Femur Plates

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Mar 28, 2007 after 65 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.
No later device cites it as a predicate yet.
0 of 1 device 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) Synthes LCP Proximal Femur Plate: named in the summary without a submission number
- (no number) Synthes 7.3 mm Cannulated Screws: named in the summary without a submission number

## Indications for use
Synthes 4.5 mm LCP Posterolateral Proximal Femur Plates are intended for treatment of fractures of the femur including: Basilar neck fractures such as Pauwels Type 3, Fractures of the trochanteric region, trochanteric simple, cervicotrochanteric, trochanterodiaphyseal, mutlifragmentary pertrochanteric, intertrochanteric, intertrochanteric reversed or transverse or with additional fracture of medial cortex; Fractures of the proximal end of the femur combined with ipsilateral shaft fractures, metastatic fractures of the proximal femur; and Also for use in fixation of osteopenic bone and fixation of non-unions or malunions.

Source page: https://510kreport.com/device/K070208
Methodology: https://510kreport.com/methodology