Cleared Traditional

K912021 - MAKAR MINI CANNULATED CANCELLOUS SCREWS

K912021 is an FDA 510(k) clearance for MAKAR MINI CANNULATED CANCELLOUS SCREWS, manufactured by Instrument Makar, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K912021 · Instrument Makar, Inc. · Orthopedic device
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Nov 1991
Decision
199d
Days
Class 2
Risk

K912021 is an FDA 510(k) clearance for the MAKAR MINI CANNULATED CANCELLOUS SCREWS. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Instrument Makar, Inc. (Okemos, US). The FDA issued a Cleared decision on November 22, 1991 after a review of 199 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 Instrument Makar, Inc. devices

FDA 510(k) Submission Details - K912021

510(k) Number K912021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1991
Decision Date November 22, 1991
Days to Decision 199 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
77d slower than avg
Panel avg: 122d · This submission: 199d
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 K912021.
CANCELLOUS BONE-L.P. AND CORTICAL BONE SCREW
K915187 · Techmedica, Inc. · Dec 1991
ALPHATEC CANNULATED BONE SCREWS
K914004 · Alphatec Mfg., Inc. · Dec 1991
ACE CORTICAL BONE SCREW
K912598 · Ace Medical Co. · Nov 1991
AESCULAP TITANIUM BONE SCREWS
K913415 · Aesculap, Inc. · Oct 1991
HUENE FIXATION SCREW
K910193 · Acu Med, Inc. · Aug 1991
UNIVERSAL COMPRESSION SCREW
K904809 · Howmedica Corp. · Jun 1991