Cleared Traditional

K251690 - Arthrex SpeedFLEX™ Implant (FDA 510(k) Clearance)

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

K251690 · Arthrex, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2025
Decision
120d
Days
Class 2
Risk

K251690 is an FDA 510(k) clearance for the Arthrex SpeedFLEX™ Implant. Classified as Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon (product code OWY), Class II - Special Controls.

Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on September 30, 2025 after a review of 120 days - within the typical 510(k) review window.

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: 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 Arthrex, Inc. devices

Submission Details

510(k) Number K251690 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2025
Decision Date September 30, 2025
Days to Decision 120 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
2d faster than avg
Panel avg: 122d · This submission: 120d
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 K251690.
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
K242631 · Smith & Nephew Inc., Endoscopy Div. · Nov 2024
Regeneten Bioinductive Implant
K222501 · Smith and Nephew, Inc. · May 2023