Cleared Traditional

K974847 - 5.0MM PARACHUTE CORKSCREW SUTURE ANCHOR MODEL AR-22255, 3.5MM PARACHUTE CORKSCREW SUTURE ANCHOR MODEL AR-22235

K974847 is an FDA 510(k) clearance for 5.0MM PARACHUTE CORKSCREW SUTURE ANCHOR..., manufactured by Arthrex, Inc.. The device is a Class 2 Orthopedic device with product code MBI cleared through the Traditional 510(k) pathway after a 220-day FDA review.

K974847 · Arthrex, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1998
Decision
220d
Days
Class 2
Risk

K974847 is an FDA 510(k) clearance for the 5.0MM PARACHUTE CORKSCREW SUTURE ANCHOR MODEL AR-22255, 3.5MM PARACHUTE CORKS.... 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 Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on August 6, 1998 after a review of 220 days - an extended review cycle.

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 Arthrex, Inc. devices

FDA 510(k) Submission Details - K974847

510(k) Number K974847 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1997
Decision Date August 06, 1998
Days to Decision 220 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
98d slower than avg
Panel avg: 122d · This submission: 220d
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 566
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K974847.
KSEA FLIPPTACK
K982571 · KARL STORZ Endoscopy-America, Inc. · Sep 1998
SHERLOCK THREADED SUTURE ANCHOR (TIN COATED)
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SHORT STRAIGHT-IN BONE SCREW FIXATION SYSTEM
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MENISCAL REPAIR DEVICE
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WASHERLOC SCREW SYSTEM, LIGAMENT SCREW SYSTEM, NO-PROFILE BI-CORTICAL SCREW SYSTEM, CHANNEL LIGAMENT CLAMP, HECKMAN SCRE
K981967 · Arthrotek/Biomet, Inc. · Jul 1998
ANSPACH SUTURE ANCHOR
K981688 · The Anspach Effort, Inc. · Jul 1998