Cleared Special

K011437 - SYNERGY 4.0 MM

K011437 is an FDA 510(k) clearance for SYNERGY 4.0 MM, manufactured by Interpore Cross Intl.. The device is a Class 2 Orthopedic device with product code MNI cleared through the Special 510(k) pathway after a 27-day FDA review.

K011437 · Interpore Cross Intl. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2001
Decision
27d
Days
Class 2
Risk

K011437 is an FDA 510(k) clearance for the SYNERGY 4.0 MM, 4.5 MM VLS SCREWS. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Interpore Cross Intl. (Irvine, US). The FDA issued a Cleared decision on June 6, 2001 after a review of 27 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 Interpore Cross Intl. devices

FDA 510(k) Submission Details - K011437

510(k) Number K011437 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2001
Decision Date June 06, 2001
Days to Decision 27 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
95d faster than avg
Panel avg: 122d · This submission: 27d
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 162
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K011437.
ISOLA BAND CLAMP
K010972 · Depuyacromed · Jun 2001
TRI-FIX SPINAL FIXATION SYSTEM
K010903 · Endius, Inc. · Jun 2001
TRI-FIX SPINAL FIXATION SYSTEM
K010922 · Endius, Inc. · Jun 2001
MODIFICATION TO TSRH SPINAL SYSTEM
K011029 · Medtronic Sofamor Danek, Inc. · Jun 2001
MODIFIED USS FRACTURE SYSTEM
K010658 · Synthes (Usa) · Jun 2001
END-TO-END AND SIDE-BY-SIDE CONNECTORS
K010563 · Spinal Concepts, Inc. · May 2001