Cleared Traditional

K991862 - MICOMED POSTERIOR DOUBLEROD SYSTEM (MPDS)

K991862 is an FDA 510(k) clearance for MICOMED POSTERIOR DOUBLEROD SYSTEM (MPDS), manufactured by Micomed GmbH. The device is a Class 2 Orthopedic device with product code MNI cleared through the Traditional 510(k) pathway after a 226-day FDA review.

K991862 · Micomed GmbH · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2000
Decision
226d
Days
Class 2
Risk

K991862 is an FDA 510(k) clearance for the MICOMED POSTERIOR DOUBLEROD SYSTEM (MPDS). Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Micomed GmbH (Fullerton, US). The FDA issued a Cleared decision on January 13, 2000 after a review of 226 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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 Micomed GmbH devices

FDA 510(k) Submission Details - K991862

510(k) Number K991862 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1999
Decision Date January 13, 2000
Days to Decision 226 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
104d slower than avg
Panel avg: 122d · This submission: 226d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNI Device Classification - Class 2, Special Controls

Product Code MNI Orthosis, Spinal Pedicle Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
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 - MNI Orthosis, Spinal Pedicle Fixation

All 203
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K991862.
MODIFICATION TO SYNTHES USS
K000450 · Synthes Spine · Mar 2000
ISOBAR SPINAL SYSTEM
K000425 · Encore Orthopedics, Inc. · Mar 2000
SYNERGY VLS CAP NUT MODELS 2206, 6102
K000236 · Interpore Cross Intl. · Feb 2000
OPUS SPINAL SYSTEM
K993402 · Howmedica Osteonics Corp. · Dec 1999
EBI SPINELINK SYSTEM
K992920 · Ebi, L.P. · Nov 1999
ISOBAR SEMI-RIGID SPINAL SYSTEM
K991326 · Scien'Tx USA, Inc. · Nov 1999