Cleared Traditional

K943249 - BIOABSORBABLE INTERFERENCE SCREW

K943249 is an FDA 510(k) clearance for BIOABSORBABLE INTERFERENCE SCREW, manufactured by Instrument Makar, Inc.. The device is a Class 2 Orthopedic device with product code MAI cleared through the Traditional 510(k) pathway after a 390-day FDA review.

K943249 · Instrument Makar, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1995
Decision
390d
Days
Class 2
Risk

K943249 is an FDA 510(k) clearance for the BIOABSORBABLE INTERFERENCE SCREW. Classified as Fastener, Fixation, Biodegradable, Soft Tissue (product code MAI), Class II - Special Controls.

Submitted by Instrument Makar, Inc. (Washington, US). The FDA issued a Cleared decision on July 31, 1995 after a review of 390 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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

FDA 510(k) Submission Details - K943249

510(k) Number K943249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1994
Decision Date July 31, 1995
Days to Decision 390 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
268d slower than avg
Panel avg: 122d · This submission: 390d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MAI Device Classification - Class 2, Special Controls

Product Code MAI Fastener, Fixation, Biodegradable, Soft Tissue
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - MAI Fastener, Fixation, Biodegradable, Soft Tissue

All 209
Devices cleared under the same product code (MAI) and FDA review panel - the closest regulatory comparables to K943249.
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K955003 · Bioscience, Inc. · Jan 1996
ABSORBABLE BONE SCREW
K944544 · Johnson & Johnson Professionals, Inc. · Jan 1996
RESORBABLE SOFT TISSUE ATTACHMENT DEVICE
K950275 · Zimmer, Inc. · Nov 1995
ACUFEX ENDOBUTTON SYSTEM
K933948 · Acufex Microsurgical, Inc. · Jul 1994