Cleared Traditional

K092836 - OMNISPAN MENISCAL REPAIR SYSTEM/0 DEGREE

K092836 is the FDA 510(k) clearance for OMNISPAN MENISCAL REPAIR SYSTEM/0 DEGREE by Depuy Mitek, A Johnson & Johnson Company. It is a Class 2 Orthopedic device (product code MBI) cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K092836 · Depuy Mitek, A Johnson & Johnson Company · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2010
Decision
142d
Days
Class 2
Risk

K092836 is an FDA 510(k) clearance for the OMNISPAN MENISCAL REPAIR SYSTEM/0 DEGREE, MODEL 228140, RAPIDLOC A2 MENISCAL .... 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 Depuy Mitek, A Johnson & Johnson Company (Raynham, US). The FDA issued a Cleared decision on February 4, 2010 after a review of 142 days - within the typical 510(k) review window.

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 Depuy Mitek, A Johnson & Johnson Company devices

Submission Details

510(k) Number K092836 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2009
Decision Date February 04, 2010
Days to Decision 142 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
20d slower than avg
Panel avg: 122d · This submission: 142d
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 390
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