Cleared Traditional

K230316 - FlexBand

Also marketed or referenced as:
FlexPatch FlexBand Plus

K230316 is an FDA 510(k) clearance for FlexBand, manufactured by International Life Sciences. The device is a Class 2 Orthopedic device with product code OWW cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K230316 · International Life Sciences · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2023
Decision
109d
Days
Class 2
Risk

K230316 is an FDA 510(k) clearance for the FlexBand. Classified as Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon (product code OWW), Class II - Special Controls.

Submitted by International Life Sciences (Marietta, US). The FDA issued a Cleared decision on May 26, 2023 after a review of 109 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 International Life Sciences devices

FDA 510(k) Submission Details - K230316

510(k) Number K230316 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2023
Decision Date May 26, 2023
Days to Decision 109 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
13d faster than avg
Panel avg: 122d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OWW Device Classification - Class 2, Special Controls

Product Code OWW Mesh, Surgical, Absorbable, 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 During Tendon Repair Procedures.
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.