# K094037: TC Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Pro, LLC
- Decided: Mar 10, 2010 after 70 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.
60 later devices descend from it; 3 cite it directly.
0 of 61 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 no predicate by number.

## Most influential descendants
- K123000: Integra Total Foot Systems (2012), 54 descendants of its own
- K143025: Total Compression Plating System (2014), 24 descendants of its own
- K151442: Total Compression Plating (TCP) System (2015), 23 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
The TC Plating System is intended for essentially non load-bearing stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis, and craniomnaxillofacial skeleton.

Source page: https://510kreport.com/device/K094037
Methodology: https://510kreport.com/methodology