# K221342: REDEMPTION Beaming System

- Pathway: 510(k) (Traditional)
- Applicant: Vilex, LLC
- Decided: Dec 13, 2022 after 218 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K962616 (1996). 129 ancestors in all.
No later device cites it as a predicate yet.
0 of 130 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014154: Vilex/Duval/Orthex Cannulated Bone Screw DB1 Thread, Model F25-XX-09; Vilex Solid Bone Screws DB1 Thread,Model F20-XX-00, Vilex, Inc. (2002) Summary page 4.
- K041287: Vilex Bone Plate System, Vilex, Inc. (2004) Summary page 4.
- K124027: Monster Screw System, Apogee Orthosolutions (2013) Summary page 4.
- K151418: Monster Screw System, Paragon 28 (2015) Summary page 4.
- K190586: Monster® Screw System, Paragon 28, Inc. (2019) Summary page 4.
- K203011: Monster Screw System, Paragon 28, Inc. (2020) Summary page 4.

## Indications for use
The REDEMPTION Beaming System is indicated for fracture fixation, osteotomies, reconstruction procedures, and fusions of bones in the foot and ankle including the Metatarsals, Cuneiforms, Cuboid, Navicular, Calcaneus and Talus. Specific examples include: Medial Column Fusion and Lateral Column Fusion resulting from neuropathic osteoarthropathy (Charcot). The REDEMPTION Ø3.5mm Headless Screws are indicated for small bone fragments fracture and osteotomy in the lower extremities primarily the foot.

Source page: https://510kreport.com/device/K221342
Methodology: https://510kreport.com/methodology