# K140792: Salvation 3DI Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: May 22, 2014 after 52 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K010612 (2001). 143 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 146 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061808: Darco Locking Bone Plate System, Darco International, Inc. (2006) Summary page 1.
- K121651: Ortholoc 3DI Midfoot/Flatfoot System, Wrightmedicaltechnologyinc (2012) Summary page 1.
- K090675: Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories, Smith & Nephew, Inc. (2009) Summary page 1.
- K110670: VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws, Peri-Loc Ankle Fusion Plates, Smith & Nephew, Inc. (2011) Summary page 1.
- K131093: Ortholoc (R) 3DI Ankle Plating System, Wrightmedicaltechnologyinc (2013)

## Most influential descendants
- K233816: REDEMPTION Charcot Plating System (2024), 0 descendants of its own
- K210157: SOLE Medial Column Fusion Plate (2021), 0 descendants of its own

## Recalls of this device
- May 28, 2019 · Class II · Z-2055-2019: Potential for tube leakage

## Indications for use
The SALVATION 3Di Plating System is indicated for the treatment of fracture stabilization/fixation, revision procedures, osteotomies, and reconstruction/arthrodesis of small bones, as well as patients with osteopenic bone. Specific examples include: medial column fusion (talus, navicular, cuboid, first metatarsal) for neuropathic osteoarthropathy (Charcot).

Source page: https://510kreport.com/device/K140792
Methodology: https://510kreport.com/methodology