Cleared Traditional

K990057 - SYNERGY ADJUSTABLE LENGTH ROD

K990057 is an FDA 510(k) clearance for SYNERGY ADJUSTABLE LENGTH ROD, 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 172-day FDA review.

K990057 · Interpore Cross Intl. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1999
Decision
172d
Days
Class 2
Risk

K990057 is an FDA 510(k) clearance for the SYNERGY ADJUSTABLE LENGTH ROD. 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 28, 1999 after a review of 172 days - an extended review cycle.

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 - K990057

510(k) Number K990057 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 1999
Decision Date June 28, 1999
Days to Decision 172 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
50d slower than avg
Panel avg: 122d · This submission: 172d
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 275
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K990057.
MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM
K992276 · Sulzer Spine-Tech · Oct 1999
CD HORIZON SPINAL SYSTEM
K992928 · Sofamor Danek USA,Inc. · Sep 1999
EBI OMEGA 21 SYSTEM
K991721 · Ebi Electro Biology · Aug 1999
MODIFICATION TO SYNTHES UNIVERSAL SPINAL SYSTEM
K990745 · Synthes Spine · Mar 1999
SYNERGY D2 SPINAL IMPLANTS
K984578 · Interpore Cross Intl. · Mar 1999
OSTEONICS COMBINATION SCREW RING/BLOCKER
K990158 · Osteonics Corp. · Feb 1999