Cleared Traditional

MICOMED POSTERIOR DOUBLEROD SYSTEM (MPDS) (K991862) - FDA 510(k) Clearance

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

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

Submission Details

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
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.

Device Classification

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 30
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K991862.
MODIFIED USS FRACTURE SYSTEM
K010658 · Synthes (Usa) · Jun 2001
SMALL STATURE USS
K994121 · Synthes (Usa) · Oct 2000
MULTI-AXIAL CROSS (MAC) CONNECTOR
K000965 · Howmedica Osteonics Corp. · May 2000
OPUS SPINAL SYSTEM
K993402 · Howmedica Osteonics Corp. · Dec 1999
OSTEONICS COMBINATION SCREW RING/BLOCKER
K990158 · Osteonics Corp. · Feb 1999
OSTEONICS SPINAL SYSTEM-EXPANDED INDICATIONS
K990059 · Howmedica Osteonics Corp. · Jan 1999