# K982222: Synthes (Usa) Distal Femur Plate (DFP) System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Jul 29, 1998 after 35 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
716 later devices descend from it; 3 cite it directly.
1 of 717 devices in its family (counting itself) has 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 Condylar Buttress Plates: named in the summary without a submission number

## Most influential descendants
- K000066: Synthes (Usa) Locking Condylar Plate (LCP) System (2000), 713 descendants of its own
- K033669: Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws) (2003), 690 descendants of its own
- K051735: Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity (2005), 584 descendants of its own
- K062216: Peri-Loc Periarticular Locked Plating System (2006), 501 descendants of its own
- K071563: Peri-Loc Periarticular Locked Plating System (2007), 495 descendants of its own

## Indications for use
Synthes Distal Femur Plate (DFP) System is intended for buttressing multifragmentary distal femur fractures. Distal femur fractures include supra-condylar; condylar; articular and extra-articular fractures; fractures in osteopenic bone; and acute fractures, non-unions and malunions.

Source page: https://510kreport.com/device/K982222
Methodology: https://510kreport.com/methodology