Cleared Traditional

K984578 - SYNERGY D2 SPINAL IMPLANTS

K984578 is an FDA 510(k) clearance for SYNERGY D2 SPINAL IMPLANTS, manufactured by Interpore Cross Intl.. The device is a Class 2 Orthopedic device with product code MNI cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K984578 · Interpore Cross Intl. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1999
Decision
90d
Days
Class 2
Risk

K984578 is an FDA 510(k) clearance for the SYNERGY D2 SPINAL IMPLANTS. 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 March 23, 1999 after a review of 90 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. 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 Interpore Cross Intl. devices

FDA 510(k) Submission Details - K984578

510(k) Number K984578 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1998
Decision Date March 23, 1999
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 274
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K984578.
EBI OMEGA 21 SYSTEM
K991721 · Ebi Electro Biology · Aug 1999
SYNERGY ADJUSTABLE LENGTH ROD
K990057 · Interpore Cross Intl. · Jun 1999
MODIFICATION TO SYNTHES UNIVERSAL SPINAL SYSTEM
K990745 · Synthes Spine · Mar 1999
OSTEONICS COMBINATION SCREW RING/BLOCKER
K990158 · Osteonics Corp. · Feb 1999
OSTEONICS SPINAL SYSTEM-EXPANDED INDICATIONS
K990059 · Howmedica Osteonics Corp. · Jan 1999
TIMX LOW BACK SYSTEM
K984348 · Depuy Motech Acromed · Jan 1999