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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
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 302
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K070573.
DELTA SPINAL FUSION SYSTEM
K071857 · Jemo Spine, LLC · Aug 2007
NUVASIVE OCT SYSTEM
K071435 · Nuvasive, Inc. · Aug 2007
PILLAR PEDICLE SCREW SYSTEM
K071743 · The 4th Column, LLC · Jul 2007
SINGLE PLANAR MULTI AXIAL (SPMA) PEDICLE SCREW SYSTEM
K070295 · Trinity Orthopedics, LLC · May 2007
ROC LUMBAR SYSTEM
K063668 · Alphatec Spine, Inc. · May 2007
RANGE SPINAL SYSTEM
K070229 · K2m, Inc. · May 2007