Cleared Traditional

Extremity All Suture System (K241695) - FDA 510(k) Clearance

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

K241695 · Field Orthopaedics · Orthopedic device
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Sep 2024
Decision
92d
Days
Class 2
Risk

K241695 is an FDA 510(k) clearance for the Extremity All Suture System. 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 Field Orthopaedics (Teneriffe, AU). The FDA issued a Cleared decision on September 12, 2024 after a review of 92 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 Field Orthopaedics devices

Submission Details

510(k) Number K241695 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2024
Decision Date September 12, 2024
Days to Decision 92 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 122d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 321
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K241695.
OsseoFit Interfacing Anchor
K242494 · Riverpoint Medical, LLC · Nov 2024
Iconix Knotless Anchor
K243323 · Riverpoint Medical · Nov 2024
OC JuggerKnotless Soft Anchor
K243203 · Riverpoint Medical · Oct 2024
VersaTap™ Suture Anchor (ADP050)
K242296 · Ortho-Design (Pty), Ltd. · Aug 2024
Fixone Meniscal Repair
K233601 · Aju Pharm Co., Ltd. · Aug 2024
Grappler Interference Screw System
K241864 · Paragon 28, Inc. · Jul 2024