Cleared Traditional

K033242 - KNEE INTERPOSITIONAL MINI-REPAIR SYSTEM (KIMRS) (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K033242 · Imaging Therapeutics, Inc. · Orthopedic device
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Dec 2003
Decision
85d
Days
Class 2
Risk

K033242 is an FDA 510(k) clearance for the KNEE INTERPOSITIONAL MINI-REPAIR SYSTEM (KIMRS). Classified as Prosthesis, Knee, Hemi-, Tibial, Resurfacing (uncemented) (product code HSH), Class II - Special Controls.

Submitted by Imaging Therapeutics, Inc. (San Mateo, US). The FDA issued a Cleared decision on December 31, 2003 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3590 - 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 Imaging Therapeutics, Inc. devices

Submission Details

510(k) Number K033242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 2003
Decision Date December 31, 2003
Days to Decision 85 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 122d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HSH Prosthesis, Knee, Hemi-, Tibial, Resurfacing (uncemented)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3590
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.