Cleared Traditional

REDEMPTION Beaming System (K221342) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K221342 · Vilex, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2022
Decision
218d
Days
Class 2
Risk

K221342 is an FDA 510(k) clearance for the REDEMPTION Beaming System. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Vilex, LLC (Mcminnville, US). The FDA issued a Cleared decision on December 13, 2022 after a review of 218 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Vilex, LLC devices

Submission Details

510(k) Number K221342 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2022
Decision Date December 13, 2022
Days to Decision 218 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d slower than avg
Panel avg: 122d · This submission: 218d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Consultant

Telos Partners, LLC
Roshana Ahmed

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HWC Screw, Fixation, Bone

All 404
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K221342.
OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mm
K221193 · OSSIO , Ltd. · Dec 2022
BRM TOOL Screws, BIOPLAN Subtalar Implant
K222820 · Brm Extremities · Dec 2022
Phantom Metatarsal Shortening System
K223184 · Paragon 28, Inc. · Dec 2022
Metal Bone Screw
K220921 · Double Medical Technology, Inc. · Dec 2022
Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and 4.0mm Cannulated Screws
K222967 · Avanti Orthopaedics, Inc. · Nov 2022
Treace Medical Concepts (TMC) Hammertoe Fixation System
K222564 · Treace Medical Concepts, Inc. · Nov 2022