Cleared Traditional

K242631 - REGENETEN™ Bioinductive Implant (FDA 510(k) Clearance)

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

K242631 · Smith & Nephew Inc., Endoscopy Div. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2024
Decision
84d
Days
Class 2
Risk

K242631 is an FDA 510(k) clearance for the REGENETEN™ Bioinductive Implant. Classified as Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon (product code OWY), Class II - Special Controls.

Submitted by Smith & Nephew Inc., Endoscopy Div. (Andover, US). The FDA issued a Cleared decision on November 26, 2024 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 878.3300 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Smith & Nephew Inc., Endoscopy Div. devices

Submission Details

510(k) Number K242631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2024
Decision Date November 26, 2024
Days to Decision 84 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
38d faster than avg
Panel avg: 122d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OWY Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
Definition For Reinforcement Of Soft Tissue Where Weakness Exists In Tendon Repair.
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 Peers - OWY Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon

All 13
Devices cleared under the same product code (OWY) and FDA review panel - the closest regulatory comparables to K242631.
Arthrex SpeedFLEX™ Implant
K251690 · Arthrex, Inc. · Sep 2025
Tapestry Biointegrative Implant
K252647 · Embody, Inc. · Sep 2025
TYBR Collagen Gel
K250109 · Tybr Health · Jun 2025
Tendon Protect (50242)
K243843 · Kerecis Limited · Jun 2025
Regeneten Bioinductive Implant
K222501 · Smith and Nephew, Inc. · May 2023
Tapestry Biointegrative Implant
K220867 · Embody, Inc. · May 2022