# K011978: Synthes LCP Proximal Tibia Plate

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Aug 9, 2001 after 45 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: 1 generation back to K002361 (2000). 1 ancestor in all.
701 later devices descend from it; 16 cite it directly.
1 of 703 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002361: Synthes (Usa) Locking Proximal Plating (L-PTP) System, Synthes (Usa) (2000) Summary page 1.

## Most influential descendants
- 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
- K090675: Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories (2009), 487 descendants of its own

## Indications for use
Synthes LCP Proximal Tibia Plate is intended treatment of non-unions, malunions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft fractures.

Source page: https://510kreport.com/device/K011978
Methodology: https://510kreport.com/methodology