Cleared Traditional

K963045 - SYNTHES (U.S.A.) UNIVERSAL SACRAL SYSTEM

K963045 is an FDA 510(k) clearance for SYNTHES (U.S.A.) UNIVERSAL SACRAL SYSTEM, manufactured by Synthes (Usa). The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K963045 · Synthes (Usa) · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
192d
Days
Class 2
Risk

K963045 is an FDA 510(k) clearance for the SYNTHES (U.S.A.) UNIVERSAL SACRAL SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on February 13, 1997 after a review of 192 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 Synthes (Usa) devices

FDA 510(k) Submission Details - K963045

510(k) Number K963045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1996
Decision Date February 13, 1997
Days to Decision 192 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
70d slower than avg
Panel avg: 122d · This submission: 192d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNH Device Classification - Class 2, Special Controls

Product Code MNH Orthosis, Spondylolisthesis Spinal 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 - MNH Orthosis, Spondylolisthesis Spinal Fixation

All 273
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K963045.
ACROMED PEDICLE SCREW
K965102 · Acromed Corp. · May 1997
EBI SPINELINK SYSTEM
K964533 · Electro-Biology, Inc. · Apr 1997
ISOLA TWISTER CONNECTOR
K965046 · Acromed Corp. · Mar 1997
OSTEONICS SPINAL SYSTEM - VARIABLE OFFSET CONNECTOR ASSEMBLY
K964544 · Osteonics Corp. · Feb 1997
OSTEONICS SPINAL SYSTEM-TOPLOADING TRANSVERSE CONNECTOR ASSEMBLY
K964304 · Osteonics Corp. · Jan 1997
SYNERGY(TM) TI POSTERIOR SPINAL SYSTEM
K950099 · Buckman Co., Inc. · Jan 1997