# K233816: REDEMPTION Charcot Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Vilex, LLC
- Decided: Aug 28, 2024 after 272 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: 14 generations back to K962616 (1996). 173 ancestors in all.
No later device cites it as a predicate yet.
0 of 174 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221558: ALPHALOK Plating System, Vilex, LLC (2022) Summary page 5.
- K140792: Salvation 3DI Plating System, Wrightmedicaltechnologyinc (2014) Summary page 5.
- K140408: Salvation Osteopenic Screw, Wrightmedicaltechnologyinc (2014) Summary page 5.

## Indications for use
The REDEMPTION ™ Charcot Plating System bone plates and screws are indicated for use in bone fractures, osteotomies, and fixation of bones and bone fragments in the upper and lower extremities, primarily of the hand, wrist, foot, ankle, and digits. Specific examples include: medial column fusion (talus, navicular, cuboid, first metatarsal) for patients with osteopenic bone in neuropathic osteoarthropathy (Charcot).

Source page: https://510kreport.com/device/K233816
Methodology: https://510kreport.com/methodology