Cleared Traditional

K974538 - MENISCAL REPAIR DEVICE

K974538 is the FDA 510(k) clearance for MENISCAL REPAIR DEVICE by Linvatec Corp.. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K974538 · Linvatec Corp. · Orthopedic device
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Mar 1998
Decision
90d
Days
Class 2
Risk

K974538 is an FDA 510(k) clearance for the MENISCAL REPAIR DEVICE. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Linvatec Corp. (Largo, US). The FDA issued a Cleared decision on March 3, 1998 after a review of 90 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 Linvatec Corp. devices

Submission Details

510(k) Number K974538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1997
Decision Date March 03, 1998
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HWC Screw, Fixation, Bone
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 - HWC Screw, Fixation, Bone

All 556
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K974538.
SYNTHES 3.0 MM PC-FIX SYSTEM
K981372 · Synthes (Usa) · May 1998
HOWMEDICA AND HOWMEDICA LEIBINGER BONE SCREW WASHERS
K980364 · Howmedica Corp. · Apr 1998
DEPUY ORTHOTECH PHANTOM SOF-THREAD SOFT TISSUE INTERFERENCE SCREW
K980440 · Depuy, Inc. · Apr 1998
BIOSCREW ABSORBABLE INTERFERENCE SREW
K973758 · Linvatec Corp. · Feb 1998
ORTHOPEDIC SCREW SYSTEM
K972217 · Ferguson Medical · Nov 1997
THE CORIFIX LIGAMENT ANCHOR
K973005 · Corin USA · Nov 1997