Cleared Traditional

K952237 - INNOVASICE 2.8MM & 3.5MM ROC SUTURE BON...

K952237 is the FDA 510(k) clearance for INNOVASICE 2.8MM & 3.5MM ROC SUTURE BON... by Innovasive Devices, Inc.. It is a Class 2 Orthopedic device (product code MBI) cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K952237 · Innovasive Devices, Inc. · Orthopedic device
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Dec 1995
Decision
210d
Days
Class 2
Risk

K952237 is an FDA 510(k) clearance for the INNOVASICE 2.8MM & 3.5MM ROC SUTURE BONE FASTENER. Classified as Fastener, Fixation, Nondegradable, Soft Tissue within the MBI classification (a category for soft tissue fixation fasteners and anchoring systems), Class II - Special Controls.

Submitted by Innovasive Devices, Inc. (Hopkinton, US). The FDA issued a Cleared decision on December 8, 1995 after a review of 210 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 Innovasive Devices, Inc. devices

Submission Details

510(k) Number K952237 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received May 12, 1995
Decision Date December 08, 1995
Days to Decision 210 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d slower than avg
Panel avg: 122d · This submission: 210d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MBI Fastener, Fixation, Nondegradable, Soft Tissue
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 - MBI Fastener, Fixation, Nondegradable, Soft Tissue

All 391
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K953702 · Linvatec Corp. · Oct 1995
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K953264 · Wrightmedicaltechnologyinc · Oct 1995
ARTHREX SUTURE ANCHOR SCREW SYSTEM
K934327 · Arthrex, Inc. · Sep 1995