# K143025: Total Compression Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Dec 5, 2014 after 45 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: 10 generations back to K954385 (1996). 52 ancestors in all.
24 later devices descend from it; 1 cites it directly.
0 of 77 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K094037: TC Plating System, Ortho-Pro, LLC (2010) Summary page 4.
- K121651: Ortholoc 3DI Midfoot/Flatfoot System, Wrightmedicaltechnologyinc (2012) Summary page 4.
- K120359: Ortholoc 3DI Hallux System, Wrightmedicaltechnologyinc (2012) Summary page 4.

## Most influential descendants
- K151442: Total Compression Plating (TCP) System (2015), 23 descendants of its own
- K152974: ORTHOLOC® 3Di Foot Plating Reconstruction System (2015), 22 descendants of its own
- K203817: Tyber Medical Anatomical Plating System (2021), 10 descendants of its own
- K222465: Tyber Medical Anatomical Plating System (2023), 9 descendants of its own
- K232652: Anatomical Plating System (various) (2023), 3 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 and pelvis. Specific examples of use in the foot include: Mid / Flatfoot Fusions • LisFranc Arthrodesis and/or Stabilization • 1st (Lapidus), 2nd, 3rd, 4th, and 5th Tarsometatarsal (TMT) Fusions • Intercuneiform Fusions • Navicular-Cuneiform (NC) Fusion • Talo-Navicular (TN) Fusion • Calcaneo-Cuboid (CC) Fusion • Medial Column Fusion First metatarsal osteotomies for hallux valgus correction including: • Opening base wedge osteotomy • Closing base wedge osteotomy • Crescentic osteotomy • Proximal Chevron osteotomy • Distal Chevron osteotomy (Austin) First metatarsal fracture fixation Arthrodesis of the first metatarsalcuneiform joint (Lapidus Fusion) Arthrodesis of the first metatarsophalangeal joint (MTP) including: • Primary MTP Fusion due to hallux ridgidus and/or hallux valgus • Revision MTP Fusion • Revision of failed first MTP Arthroplasty implant

Source page: https://510kreport.com/device/K143025
Methodology: https://510kreport.com/methodology