Cleared Traditional

K930980 - INSTRUMENT MAKAR PERFIX INTERFERENCE BO...

K930980 is the FDA 510(k) clearance for INSTRUMENT MAKAR PERFIX INTERFERENCE BO... by Instrument Makar, Inc.. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 350-day FDA review.

K930980 · Instrument Makar, Inc. · Orthopedic device
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Feb 1994
Decision
350d
Days
Class 2
Risk

K930980 is an FDA 510(k) clearance for the INSTRUMENT MAKAR PERFIX INTERFERENCE BONE SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Instrument Makar, Inc. (Washington, US). The FDA issued a Cleared decision on February 10, 1994 after a review of 350 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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

Submission Details

510(k) Number K930980 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received February 25, 1993
Decision Date February 10, 1994
Days to Decision 350 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
228d slower than avg
Panel avg: 122d · This submission: 350d
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 K930980.
M. KUROSAKA INTERFERENCE FIXATION SCREW
K933738 · Depuy, Inc. · Feb 1994
ARTHROTEK INTERFERENCE SCREW
K934469 · Biomet, Inc. · Feb 1994
6.5 MM CANCELLOUS BONE SCREW
K931665 · Encore Orthopedics, Inc. · Feb 1994
IMPLEX ACETABULAR CUP SCREW SYSTEM
K931187 · Implex Corp. · Feb 1994
INTERFERENCE-CANNU-FLEX/SILK SCREWS-SCREW DR/G WIR
K921481 · Acufex Microsurgical, Inc. · Aug 1993
ACUTRACT
K930834 · Acu Med, Inc. · Jul 1993