Cleared Traditional

MRP-TITAN (K992403) - FDA 510(k) Clearance

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

K992403 · Rotec Medizintechnik GmbH · Orthopedic device
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Jan 2000
Decision
186d
Days
Class 2
Risk

K992403 is an FDA 510(k) clearance for the MRP-TITAN. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Rotec Medizintechnik GmbH (Weisendorf, DE). The FDA issued a Cleared decision on January 21, 2000 after a review of 186 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - 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 Rotec Medizintechnik GmbH devices

Submission Details

510(k) Number K992403 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1999
Decision Date January 21, 2000
Days to Decision 186 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
64d slower than avg
Panel avg: 122d · This submission: 186d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3353
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 - LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

All 292
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K992403.
PLR SPLINED REVISION STEM
K994184 · Biomet, Inc. · Feb 2000
EXETER CERAMIC FEMORAL HEADS
K993889 · Howmedica Osteonics Corp. · Feb 2000
BIOLOX ALUMINA CERAMIC FEMORAL HEAD
K991162 · Smith & Nephew, Inc. · Jan 2000
ZIRCONIA 22.22MM CERAMIC MODULAR HEADS
K991708 · Biomet, Inc. · Jul 1999
OSTEONICS ALUMINA C-TAPER HEAD, OSTEONICS TRIDENT POLYETHYLENE INSERTS
K991952 · Howmedica Osteonics Corp. · Jun 1999
TYPE 3 FEMORAL COMPONENTS
K983404 · Howmedica Corp. · Dec 1998