Cleared Traditional

K980761 - SYNTHES SPINE PEDIATRIC ROD SYSTEM

K980761 is an FDA 510(k) clearance for SYNTHES SPINE PEDIATRIC ROD SYSTEM, manufactured by Synthes Spine. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K980761 · Synthes Spine · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1998
Decision
158d
Days
Class 2
Risk

K980761 is an FDA 510(k) clearance for the SYNTHES SPINE PEDIATRIC ROD SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Synthes Spine (Paoli, US). The FDA issued a Cleared decision on August 4, 1998 after a review of 158 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 Synthes Spine devices

FDA 510(k) Submission Details - K980761

510(k) Number K980761 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1998
Decision Date August 04, 1998
Days to Decision 158 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
36d slower than avg
Panel avg: 122d · This submission: 158d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNH Device Classification - Class 2, Special Controls

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 270
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K980761.
ISOBAR SPINAL SYSTEM
K990118 · Scien'Tx USA, Inc. · Mar 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
TIMX LOW BACK SYSTEM TITANIUM MX ROD BASED LOW BACK SYSTEM
K981714 · Acromed Corp. · Jun 1998
PEDIATRIC PRC
K981113 · Acromed Corp. · May 1998
TITANIUM SPINAL ROD SYSTEM
K980862 · United States Surgical, A Division of Tyco Healthc · May 1998