Cleared Traditional

K974538 - MENISCAL REPAIR DEVICE

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

K974538 · Linvatec Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K974538

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.

HWC Device Classification - Class 2, Special Controls

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 920
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K974538.
BIOFIX BIOABSORBABLE SELF-REINFORCED POLY-L-LACTIDE THREADED BROWLIFT SCREW
K972919 · Bionx Implants, Inc. · Mar 1998
AUTO-DRIVE BONE SCREW
K974785 · Osteomed Corp. · Mar 1998
BTI LARGE (7.0MM) CANNULATED TRANSFIXING SCREWS
K974756 · Biodynamic Technologies, Inc. · Mar 1998
BIOSCREW ABSORBABLE INTERFERENCE SREW
K973758 · Linvatec Corp. · Feb 1998
ULTIMATE COMPRESSION SCREW SYSTEM
K972722 · Orthopedic Designs, Inc. · Jan 1998
VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREW
K973309 · Vilex, Inc. · Jan 1998