Cleared Traditional

K250997 - Integrity™ Implant (FDA 510(k) Clearance)

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

K250997 · Anika Therapeutics, Inc. · Orthopedic device
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Jun 2025
Decision
77d
Days
Class 2
Risk

K250997 is an FDA 510(k) clearance for the Integrity™ Implant. Classified as Mesh, Surgical, Non-absorbable, Orthopaedics, Reinforcement Of Tendon (product code OWX), Class II - Special Controls.

Submitted by Anika Therapeutics, Inc. (Beford, US). The FDA issued a Cleared decision on June 17, 2025 after a review of 77 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 Anika Therapeutics, Inc. devices

Submission Details

510(k) Number K250997 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2025
Decision Date June 17, 2025
Days to Decision 77 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
45d faster than avg
Panel avg: 122d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OWX Mesh, Surgical, Non-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 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 - OWX Mesh, Surgical, Non-absorbable, Orthopaedics, Reinforcement Of Tendon

Devices cleared under the same product code (OWX) and FDA review panel - the closest regulatory comparables to K250997.
FiberLocker Implant
K253867 · ZuriMED Technologies AG · Jan 2026
SuturePatch Tissue Reinforcement
K243480 · Arthrex, Inc. · May 2025
FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN)
K241219 · ZuriMED Technologies AG · Dec 2024
Integrity Implant
K223538 · Anika Therapeutics, Inc. · Aug 2023