Cleared Traditional

K960555 - BIOASBSORBABLE MINI-SCREW SUTURE ANCHOR

K960555 is an FDA 510(k) clearance for BIOASBSORBABLE MINI-SCREW SUTURE ANCHOR, 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 151-day FDA review.

K960555 · Instrument Makar, Inc. · Orthopedic device
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Jul 1996
Decision
151d
Days
Class 2
Risk

K960555 is an FDA 510(k) clearance for the BIOASBSORBABLE MINI-SCREW SUTURE ANCHOR. Classified as Fastener, Fixation, Biodegradable, Soft Tissue (product code MAI), Class II - Special Controls.

Submitted by Instrument Makar, Inc. (Lansing, US). The FDA issued a Cleared decision on July 9, 1996 after a review of 151 days - an extended review cycle.

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. 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 - K960555

510(k) Number K960555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1996
Decision Date July 09, 1996
Days to Decision 151 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
29d slower than avg
Panel avg: 122d · This submission: 151d
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 214
Devices cleared under the same product code (MAI) and FDA review panel - the closest regulatory comparables to K960555.
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RESORBABLE SOFT TISSUE ATTACHMENT DEVICE
K961789 · Zimmer, Inc. · Aug 1996
BIOFIX BIODEGRADABLE MENISCUS ARROW SYSTEM
K955768 · Bioscience, Inc. · Mar 1996
BIO-ANCHOR
K955486 · Linvatec Corp. · Feb 1996
PANALOK WEDGE ABSORABLE SUTURE ANCHOR SYSTEM
K952687 · Ethicon, Inc. · Feb 1996