Cleared Traditional

K252596 - Tigon Medical Knotless and Dual Javelin...

K252596 is an FDA 510(k) clearance for Tigon Medical Knotless and Dual Javelin..., manufactured by Tigon Medical. The device is a Class 2 Orthopedic device with product code MBI cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K252596 · Tigon Medical · Orthopedic device
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Dec 2025
Decision
111d
Days
Class 2
Risk

K252596 is an FDA 510(k) clearance for the Tigon Medical Knotless and Dual Javelin All-Suture Anchors. Classified as Fastener, Fixation, Nondegradable, Soft Tissue within the MBI classification (a category for soft tissue fixation fasteners and anchoring systems), Class II - Special Controls.

Submitted by Tigon Medical (Millersville, US). The FDA issued a Cleared decision on December 4, 2025 after a review of 111 days - within the typical 510(k) review window.

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 Tigon Medical devices

FDA 510(k) Submission Details - K252596

510(k) Number K252596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2025
Decision Date December 04, 2025
Days to Decision 111 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
11d faster than avg
Panel avg: 122d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MBI Device Classification - Class 2, Special Controls

Product Code MBI Fastener, Fixation, Nondegradable, Soft Tissue
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 Peers - MBI Fastener, Fixation, Nondegradable, Soft Tissue

All 438
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K252596.
Aevumed PROTEKT Suture Anchor
K260004 · Aevumed, Inc. · Jan 2026
QuadLock™ Fixation System
K253618 · Abanza Tecnomed S.L · Jan 2026
Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm
K253895 · Arthrex, Inc. · Dec 2025
GMReis Suture Anchors
K252664 · GM Dos Reis Industria e Comercio Ltda. · Nov 2025
Arthrex SutureTak Suture Anchor
K252314 · Arthrex, Inc. · Oct 2025
Aevumed FASE Suture Anchor
K253040 · Aevumed, Inc. · Oct 2025