# K030597: Synthes 3.5MM Titanium LCP Proximal Tibia Plates

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Mar 20, 2003 after 23 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.
56 later devices descend from it; 13 cite it directly.
0 of 57 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 its predicate without a number.
- (no number) Synthes 3.5mm SS LCP Proximal Tibia Plate: named in the summary without a submission number
- (no number) Synthes Large Fragment LCP T- Plate: named in the summary without a submission number

## Most influential descendants
- K061211: NCB Plating System, Proximal Tibia Plates (2006), 25 descendants of its own
- K153716: GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System. (2016), 15 descendants of its own
- K163361: ANTHEM™ Fracture System (2017), 14 descendants of its own
- K192217: NCB Plating System Distal Femur and Proximal Tibia (2019), 11 descendants of its own
- K173166: ANTHEM Fracture System (2017), 11 descendants of its own

## Indications for use
Synthes Titanium 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/K030597
Methodology: https://510kreport.com/methodology