Cleared Traditional

K992359 - MRS-TITAN

K992359 is an FDA 510(k) clearance for MRS-TITAN, manufactured by Rotec Medizintechnik GmbH. The device is a Class 2 Orthopedic device with product code LZO cleared through the Traditional 510(k) pathway after a 219-day FDA review.

K992359 · Rotec Medizintechnik GmbH · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2000
Decision
219d
Days
Class 2
Risk

K992359 is an FDA 510(k) clearance for the MRS-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 February 18, 2000 after a review of 219 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

FDA 510(k) Submission Details - K992359

510(k) Number K992359 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1999
Decision Date February 18, 2000
Days to Decision 219 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
97d slower than avg
Panel avg: 122d · This submission: 219d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LZO Device Classification - Class 2, Special Controls

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 506
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K992359.
BOFOR REVISION COUP
K993874 · Plus Orthopedics · Jun 2000
RESPONSE 2000 HIP STEM
K000392 · DePuy Orthopaedics, Inc. · Apr 2000
RESPONSE 2000 CEMENTED HIP STEM
K000432 · DePuy Orthopaedics, Inc. · Apr 2000
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