Cleared Special

MODIFICATION TO SYNTHES UNIVERSAL SPINAL SYSTEM (K990745) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K990745 · Synthes Spine · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1999
Decision
22d
Days
Class 2
Risk

K990745 is an FDA 510(k) clearance for the MODIFICATION TO SYNTHES UNIVERSAL SPINAL SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Synthes Spine (Paoli, US). The FDA issued a Cleared decision on March 30, 1999 after a review of 22 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 Synthes Spine devices

Submission Details

510(k) Number K990745 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1999
Decision Date March 30, 1999
Days to Decision 22 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 122d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

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 19
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K990745.
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
DEPUY ACROMED MOSS SPINAL SYSTEM
K984378 · Depuy, Inc. · Dec 1998