# K112085: Synthes LCP Pediatric Plate Systems

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (USA) Products, LLC
- Decided: Nov 17, 2011 after 119 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: 5 generations back to K981372 (1998). 16 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062872: Synthes (Usa) Pediatric LCP Hip Plate System, Synthes (Usa) (2007) Summary page 1.
- K072095: Synthes (Usa) Pediatric LCP Hip Plate System Modifications, Synthes (Usa) (2007) Summary page 1.
- K914546: Angled Blade Plate, Synthes (Usa) (1991) Summary page 1.
- K092609: Synthes 3.5 MM and 4.55 MM Curved Narrow and Broad Locking Compression Plates (LCP), Synthes (Usa) (2009) Summary page 1.

## Most influential descendants
- K200246: JPS JuniOrtho Plating System (2020), 1 descendant of its own
- K230527: WishBone Medical Plate and Screw System (2023), 0 descendants of its own
- K213572: JuniOrtho Plating System™ (2022), 0 descendants of its own
- K160553: DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist Fusion Plate (WFP) – MR Conditional, DePuy Synthes Large Fragment Dynamic Compression Locking (DCL) System –MR Conditional, DePuy Synthes Small Fragment Dynamic Compression Locking (DCL) System – MR Conditional, DePuy Synthes Modular Foot System – MR Conditional, DePuy Synthes T-Plates – MR Conditional, DePuy Synthes One-third Tubular Plate with Collar (OTPC) – MR Conditional, DePuy Synthes Stainless S (2017), 0 descendants of its own

## Indications for use
The Synthes (USA) Pediatric LCP Plate System is indicated for fixation of fractures (including pathologic and impending pathologic fractures) and osteotomies of the femur in infants, children, adolescents and small statured adults. Specific indications for the 100°, 110°, 120° 130°. 140° 150° plates include: Varus, valgus, rotational and/or shortening osteotomies Femoral neck and/or pertrochanteric fractures Proximal metaphyseal fractures Diaphyseal fractures Pathologic fractures Prophylactic use for impending pathologic fractures Specific indications for the 90° plates include: Varus, valgus, rotational and/or shortening osteotomies Femoral neck and/or pertrochanteric fractures Proximal and distal metaphyseal fractures Diaphyseal fractures Pathologic fractures Prophylactic use for impending pathologic fractures

Source page: https://510kreport.com/device/K112085
Methodology: https://510kreport.com/methodology