Cleared Special

K000425 - ISOBAR SPINAL SYSTEM

K000425 is an FDA 510(k) clearance for ISOBAR SPINAL SYSTEM, manufactured by Encore Orthopedics, Inc.. The device is a Class 2 Orthopedic device with product code MNI cleared through the Special 510(k) pathway after a 27-day FDA review.

K000425 · Encore Orthopedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2000
Decision
27d
Days
Class 2
Risk

K000425 is an FDA 510(k) clearance for the ISOBAR SPINAL SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Encore Orthopedics, Inc. (Austin, US). The FDA issued a Cleared decision on March 7, 2000 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Encore Orthopedics, Inc. devices

FDA 510(k) Submission Details - K000425

510(k) Number K000425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 2000
Decision Date March 07, 2000
Days to Decision 27 days
Submission Type Special
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
95d faster than avg
Panel avg: 122d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

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 162
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K000425.
MODIFICATION TO TSRH SPINAL SYSTEM
K000991 · Medtronic Sofamor Danek, Inc. · Apr 2000
MODIFICATION TO EBI SPINELINK SYSTEM
K001037 · Ebi, L.P. · Apr 2000
MODIFICATION TO SYNTHES USS
K000450 · Synthes Spine · 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