# K080522: Synthes 3.5 MM LCP Distal Tibia T Plates

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: May 23, 2008 after 87 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.
113 later devices descend from it; 10 cite it directly.
0 of 114 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 One Third Tubular LCP Plate: named in the summary without a submission number
- (no number) Synthes 3.5 mm LCP Straight Plate: named in the summary without a submission number

## Most influential descendants
- K081407: Orthopediatrics Pediplates System (2008), 65 descendants of its own
- K083286: Orthopediatrics Pediloc Locking Plate System (2009), 60 descendants of its own
- K092812: Synthes (Usa) 2.7MM/ 3.5MM LCP Anterolateral Distal Tibia Plates (2010), 55 descendants of its own
- K120689: Synthes 3.5 MM VA-LCP Proximal Tibia Plate System (2012), 28 descendants of its own
- K162674: BioPro Foot Plating Systems (2017), 19 descendants of its own

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

Source page: https://510kreport.com/device/K080522
Methodology: https://510kreport.com/methodology