# K001945: Synthes (Usa) Medial Distal Tibia Plates

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Sep 22, 2000 after 88 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.
112 later devices descend from it; 17 cite it directly.
0 of 113 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 Small T-Plate: named in the summary without a submission number
- (no number) Synthes One-Third Tubular Plate: named in the summary without a submission number
- (no number) Synthes 3.5 mm Cortex Screw: named in the summary without a submission number

## Most influential descendants
- K102282: The Varia Fibula Locked Plating System Line Extension Addition of Straight Plates (2010), 77 descendants of its own
- K123000: Integra Total Foot Systems (2012), 54 descendants of its own
- K063672: Fibula Plate Prolock with Angular Stability (2007), 25 descendants of its own
- K132594: Crosscheck Plating System (2013), 23 descendants of its own
- K152974: ORTHOLOC® 3Di Foot Plating Reconstruction System (2015), 22 descendants of its own

## Indications for use
Synthes Medial Distal Tibia Plates are indicated for the fixation of fractures of the distal tibia including, but not limited to, .ankle fractures, periarticular, intraarticular and distal tibia fractures with a shaft extension, malleolar and distal fibular fractures.

Source page: https://510kreport.com/device/K001945
Methodology: https://510kreport.com/methodology