Cleared Traditional

TITANIUM SPINAL ROD SYSTEM (K980862) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K980862 · United States Surgical, A Division of Tyco Healthc · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1998
Decision
76d
Days
Class 2
Risk

K980862 is an FDA 510(k) clearance for the TITANIUM SPINAL ROD SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by United States Surgical, A Division of Tyco Healthc (Norwalk, US). The FDA issued a Cleared decision on May 20, 1998 after a review of 76 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all United States Surgical, A Division of Tyco Healthc devices

Submission Details

510(k) Number K980862 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1998
Decision Date May 20, 1998
Days to Decision 76 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
46d faster than avg
Panel avg: 122d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MNH Orthosis, Spondylolisthesis Spinal 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 - MNH Orthosis, Spondylolisthesis Spinal Fixation

All 38
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K980862.
SYNTHES PEDIATRIC ROD SYSTEM
K991552 · Synthes (Usa) · Jun 1999
OSTEONICS SPINAL SYSTEM CYLINDRICAL BONE SCREWS
K984302 · Osteonics Corp. · Dec 1998
OSTEONICS SPINAL SYSTEM 5.5MM & 10.0MM BONE SCREWS
K983152 · Osteonics Corp. · Sep 1998
DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM
K980447 · DePuy Orthopaedics, Inc. · Apr 1998
WRIGHT MEDICAL TECHNOLOGY ROD-TO-ROD COUPLER
K980496 · Wrightmedicaltechnologyinc · Apr 1998
AURORA TITANIUM SPINAL ROD SYSTEM
K974734 · United States Surgical, A Division of Tyco Healthc · Mar 1998