Cleared Traditional

K991326 - ISOBAR SEMI-RIGID SPINAL SYSTEM

K991326 is an FDA 510(k) clearance for ISOBAR SEMI-RIGID SPINAL SYSTEM, manufactured by Scien'Tx USA, Inc.. The device is a Class 2 Orthopedic device with product code MNI cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K991326 · Scien'Tx USA, Inc. · Orthopedic device
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Nov 1999
Decision
203d
Days
Class 2
Risk

K991326 is an FDA 510(k) clearance for the ISOBAR SEMI-RIGID SPINAL SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Scien'Tx USA, Inc. (Austin, US). The FDA issued a Cleared decision on November 8, 1999 after a review of 203 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 Scien'Tx USA, Inc. devices

FDA 510(k) Submission Details - K991326

510(k) Number K991326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1999
Decision Date November 08, 1999
Days to Decision 203 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
81d slower than avg
Panel avg: 122d · This submission: 203d
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 K991326.
MICOMED POSTERIOR DOUBLEROD SYSTEM (MPDS)
K991862 · Micomed GmbH · Jan 2000
OPUS SPINAL SYSTEM
K993402 · Howmedica Osteonics Corp. · Dec 1999
EBI SPINELINK SYSTEM
K992920 · Ebi, L.P. · Nov 1999
ISOBAR SPINAL SYSTEM
K992738 · Encore Orthopedics, Inc. · Nov 1999
SYNERGY INTEGRAL SCREWS, MODELS, 2161,2162,2163,2164,2165,2166,2167,2168,2169,2210,2211,2212,2215,2216,2217,2220,2221,22
K992369 · Interpore Cross Intl. · Oct 1999
EBI OMEGA 21 SYSTEM
K992333 · Electro-Biology, Inc. · Oct 1999