Cleared Traditional

K993402 - OPUS SPINAL SYSTEM

K993402 is the FDA 510(k) clearance for OPUS SPINAL SYSTEM by Howmedica Osteonics Corp.. It is a Class 2 Orthopedic device (product code MNI) cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K993402 · Howmedica Osteonics Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1999
Decision
73d
Days
Class 2
Risk

K993402 is an FDA 510(k) clearance for the OPUS SPINAL SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on December 20, 1999 after a review of 73 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 Howmedica Osteonics Corp. devices

Submission Details

510(k) Number K993402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1999
Decision Date December 20, 1999
Days to Decision 73 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
49d faster than avg
Panel avg: 122d · This submission: 73d
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 159
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K993402.
MODIFICATION TO SYNTHES USS
K000450 · Synthes Spine · Mar 2000
ISOBAR SPINAL SYSTEM
K000425 · Encore Orthopedics, Inc. · Mar 2000
SYNERGY VLS CAP NUT MODELS 2206, 6102
K000236 · Interpore Cross Intl. · Feb 2000
EBI SPINELINK SYSTEM
K992920 · Ebi, L.P. · Nov 1999
ISOBAR SPINAL SYSTEM
K992738 · Encore Orthopedics, Inc. · Nov 1999
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