Cleared Traditional

K990057 - SYNERGY ADJUSTABLE LENGTH ROD

K990057 is the FDA 510(k) clearance for SYNERGY ADJUSTABLE LENGTH ROD by Interpore Cross Intl.. It is a Class 2 Orthopedic device (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

Submission Details

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.

Device Classification

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 K990057.
SYNERGY INTEGRAL SCREWS, MODELS, 2161,2162,2163,2164,2165,2166,2167,2168,2169,2210,2211,2212,2215,2216,2217,2220,2221,22
K992369 · Interpore Cross Intl. · Oct 1999
EBI OMEGA 21 SYSTEM
K992333 · Electro-Biology, Inc. · Oct 1999
CD HORIZON SPINAL SYSTEM
K992928 · Sofamor Danek USA,Inc. · Sep 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