Cleared Traditional

K242529 - Tigon Medical All-Suture Anchors (ASA)

K242529 is an FDA 510(k) clearance for Tigon Medical All-Suture Anchors (ASA), 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 116-day FDA review.

K242529 · Tigon Medical · Orthopedic device
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Dec 2024
Decision
116d
Days
Class 2
Risk

K242529 is an FDA 510(k) clearance for the Tigon Medical All-Suture Anchors (ASA). 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 20, 2024 after a review of 116 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 - K242529

510(k) Number K242529 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2024
Decision Date December 20, 2024
Days to Decision 116 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
6d faster than avg
Panel avg: 122d · This submission: 116d
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 K242529.
Osprey Suture Anchor
K243726 · Responsive Arthroscopy, Inc. · Jan 2025
Argo Knotless GENESYS Anchor
K244025 · Conmed Corporation · Jan 2025
OTS 25-L (100-5)
K241234 · Ots Medical , Ltd. · Jan 2025
Fix2Lock (PEEK Self Punching)
K243470 · Osteonic Co., Ltd. · Dec 2024
OsseoFit Interfacing Anchor
K242494 · Riverpoint Medical, LLC · Nov 2024
Iconix Knotless Anchor
K243323 · Riverpoint Medical · Nov 2024