# K082807: Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded Indications

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Nov 24, 2008 after 61 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
Longest line of descent: 3 generations back to K981372 (1998). 11 ancestors in all.
186 later devices descend from it; 43 cite it directly.
0 of 198 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033669: Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws), Smith & Nephew, Inc. (2003) Summary page 4.
- K993106: Smith & Nephew Bone Plate System (Bone Plates, Bone Screws and Accessories), Smith & Nephew, Inc. (1999) Summary page 4.
- K000682: Synthes Large Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 4.
- K000684: Small Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 4.
- K041911: Synthes (Usa) LCP Curved Plates, Synthes (Usa) (2004) Summary page 4.

## Most influential descendants
- K092609: Synthes 3.5 MM and 4.55 MM Curved Narrow and Broad Locking Compression Plates (LCP) (2009), 51 descendants of its own
- K130009: Variax 2 Compression Plating System (2013), 27 descendants of its own
- K132502: Variax 2 System (2013), 21 descendants of its own
- K162674: BioPro Foot Plating Systems (2017), 19 descendants of its own
- K140769: Variax 2 System (2014), 19 descendants of its own

## Indications for use
The Synthes 3.5 mm Locking Compression Plate (LCP) System is indicated for fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olectranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone for adult patients. These plates are also indicated for fracture fixation of diaphyseal and metaphyseal areas of long bones in pediatric patients. The Synthes 4.5 mm Locking Compression Plate (LCP) System is indicated for fixation of various long bones, such as the humerus, femur and tibia and for use in fixation of peri-prosthetic fractures, osteopenic bone and fixation of non-unions or malunions in adult patients. These plates are also indicated for fracture fixation of diaphyseal and metaphyseal areas of long bones in pediatric patients.

Source page: https://510kreport.com/device/K082807
Methodology: https://510kreport.com/methodology