Cleared Traditional

K913210 - M. KUROSAKA(TM) FIXATION SCREW

K913210 is an FDA 510(k) clearance for M. KUROSAKA(TM) FIXATION SCREW, manufactured by Depuy, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K913210 · Depuy, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1992
Decision
189d
Days
Class 2
Risk

K913210 is an FDA 510(k) clearance for the M. KUROSAKA(TM) FIXATION SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on January 24, 1992 after a review of 189 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 Depuy, Inc. devices

FDA 510(k) Submission Details - K913210

510(k) Number K913210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1991
Decision Date January 24, 1992
Days to Decision 189 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 122d · This submission: 189d
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 640
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K913210.
CORTICAL BONE SCREW
K915448 · Dow Corning Wright · Feb 1992
BONE SCREW 3.5 MM
K915613 · Acu Med, Inc. · Feb 1992
UNIVERSAL COMPRESION SCREW
K915124 · Howmedica Corp. · Feb 1992
OREGON FIXATION SCREW
K910976 · Acu Med, Inc. · Jan 1992
CANCELLOUS BONE-L.P. AND CORTICAL BONE SCREW
K915187 · Techmedica, Inc. · Dec 1991
MAKAR MINI CANNULATED CANCELLOUS SCREWS
K912021 · Instrument Makar, Inc. · Nov 1991