Cleared Traditional

K952237 - INNOVASICE 2.8MM & 3.5MM ROC SUTURE BONE FASTENER

K952237 is an FDA 510(k) clearance for INNOVASICE 2.8MM & 3.5MM ROC SUTURE BON..., manufactured by Innovasive Devices, Inc.. The device is a Class 2 Orthopedic device with 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

FDA 510(k) Submission Details - K952237

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
Combination Product No
PCCP Authorized No
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.

MBI Device Classification - Class 2, Special Controls

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 564
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K952237.
PRELOADED SOFT TISSUE ANCHOR
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WASHER
K953702 · Linvatec Corp. · Oct 1995
QUESTUS POLYESTER SUTURE SOFT TISSUE ANCHOR SYSTEM
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