Cleared Special

MODIFICATION TO SYNERGY SPINAL SYSTEM (K010515) - FDA 510(k) Clearance

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

K010515 · Interpore Cross Intl. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
28d
Days
Class 2
Risk

K010515 is an FDA 510(k) clearance for the MODIFICATION TO SYNERGY SPINAL SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Interpore Cross Intl. (Irvine, US). The FDA issued a Cleared decision on March 22, 2001 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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

Submission Details

510(k) Number K010515 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2001
Decision Date March 22, 2001
Days to Decision 28 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
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
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 - KWP Appliance, Fixation, Spinal Interlaminal

All 99
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K010515.
XIA STAINLESS STEEL SYSTEM
K012870 · Howmedica Osteonics Corp. · Sep 2001
SYNTHES CERVIFIX SYSTEM
K011969 · Synthes (Usa) · Jul 2001
BUTTERFLY PLATE FUNCTION SYSTEM
K010632 · Medtronic Sofamor Danek USA, Inc. · May 2001
SIMPLICITY SPINAL SYSTEM
K002103 · Medtronic Sofamor Danek USA, Inc. · Nov 2000
XIA SPINE SYSTEM
K002505 · Howmedica Osteonics Corp. · Oct 2000
USS VAS
K002517 · Synthes (Usa) · Sep 2000