Cleared Traditional

K970089 - INNOVASIVE 2.8MM AND 3.5MM ROC LF SUTURE BONE FASTENER

K970089 is an FDA 510(k) clearance for INNOVASIVE 2.8MM AND 3.5MM ROC LF SUTUR..., 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 74-day FDA review.

K970089 · Innovasive Devices, Inc. · Orthopedic device
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Mar 1997
Decision
74d
Days
Class 2
Risk

K970089 is an FDA 510(k) clearance for the INNOVASIVE 2.8MM AND 3.5MM ROC LF 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. (Marlboro, US). The FDA issued a Cleared decision on March 25, 1997 after a review of 74 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Innovasive Devices, Inc. devices

FDA 510(k) Submission Details - K970089

510(k) Number K970089 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1997
Decision Date March 25, 1997
Days to Decision 74 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
48d faster than avg
Panel avg: 122d · This submission: 74d
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 565
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K970089.
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K970292 · Influence, Inc. · Apr 1997
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K970316 · Innovasive Devices, Inc. · Apr 1997
INNOVASIVE DEVICES ROTATOR CUFF FASTNER
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K965111 · R. Thomas Grotz, M.D., Inc. · Feb 1997
ANSPACH SUTURE ANCHOR
K965069 · The Anspach Effort, Inc. · Feb 1997