Cleared Special

K070573 - SYNAPSE SYSTEM

K070573 is an FDA 510(k) clearance for SYNAPSE SYSTEM, manufactured by Synthes Spine Co.Lp. The device is a Class 2 Orthopedic device with product code MNI cleared through the Special 510(k) pathway after a 100-day FDA review.

K070573 · Synthes Spine Co.Lp · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2007
Decision
100d
Days
Class 2
Risk

K070573 is an FDA 510(k) clearance for the SYNAPSE SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Synthes Spine Co.Lp (West Chester, US). The FDA issued a Cleared decision on June 8, 2007 after a review of 100 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Co.Lp devices

FDA 510(k) Submission Details - K070573

510(k) Number K070573 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2007
Decision Date June 08, 2007
Days to Decision 100 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
22d faster than avg
Panel avg: 122d · This submission: 100d
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 193
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K070573.
Optima ZS Transition Screw
K071880 · Zimmer Spine, Inc. · Oct 2007
PSS SYSTEM
K071438 · Spinal USA · Aug 2007
NUVASIVE OCT SYSTEM
K071435 · Nuvasive, Inc. · Aug 2007
ROC LUMBAR SYSTEM
K063668 · Alphatec Spine, Inc. · May 2007
RANGE SPINAL SYSTEM
K070229 · K2m, Inc. · May 2007
CAPSURE PEDICLE SCREW SYSTEM
K070245 · Spine Wave, Inc. · Apr 2007