# K152974: ORTHOLOC® 3Di Foot Plating Reconstruction System

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Dec 11, 2015 after 64 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: 12 generations back to K954385 (1996). 63 ancestors in all.
22 later devices descend from it; 7 cite it directly.
0 of 86 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151442: Total Compression Plating (TCP) System, Wrightmedicaltechnologyinc (2015) Summary page 4.
- K132594: Crosscheck Plating System, Solana Surgical, LLC (2013) Summary page 4.
- K120359: Ortholoc 3DI Hallux System, Wrightmedicaltechnologyinc (2012) Summary page 4.
- K121651: Ortholoc 3DI Midfoot/Flatfoot System, Wrightmedicaltechnologyinc (2012) Summary page 4.

## Most influential descendants
- 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
- K241218: Tyber Medical Anatomical Plating System (2024), 2 descendants of its own
- K233423: Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag System (2023), 2 descendants of its own

## Indications for use
The ORTHOLOC® 3Di Foot Plating Reconstruction System is intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the feet. Specific examples include: Mid / Hindfoot 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 Flatfoot Osteotomies • Lateral Column Lengthening (Evans Osteotomy) • Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton Osteotomy)

Source page: https://510kreport.com/device/K152974
Methodology: https://510kreport.com/methodology