# K092812: Synthes (Usa) 2.7MM/ 3.5MM LCP Anterolateral Distal Tibia Plates

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: May 11, 2010 after 239 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: 2 generations back to K882831 (1988). 8 ancestors in all.
55 later devices descend from it; 10 cite it directly.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080522: Synthes 3.5 MM LCP Distal Tibia T Plates, Synthes (Usa) (2008) Summary page 1.
- K013248: Synthes LCP Distal Tibia Plates, Synthes (Usa) (2001) Summary page 1.
- K020602: Synthes Pilon Plate, Synthes (2002) Summary page 1.
- K072832: Anterolateral and Medial Locking Plating System, DePuy Orthopaedics, Inc. (2007) Summary page 1.

## Most influential descendants
- K162674: BioPro Foot Plating Systems (2017), 19 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
- K193633: APTUS® Ankle Trauma System 2.8/3.5 (2020), 11 descendants of its own
- K193222: Tyber Medical Anatomical Plating System (2020), 11 descendants of its own

## Indications for use
Synthes 2.7mm / 3.5mm LCP Anterolateral Distal Tibia Plates are indicated for fractures, osteotomies, and non-unions of the distal tibia, especially in osteopenic bone.

Source page: https://510kreport.com/device/K092812
Methodology: https://510kreport.com/methodology