Cleared Traditional

K990922 - OSTEONICS SPINAL SYSTEM VERSATILE CROSS CONNECTOR

K990922 is an FDA 510(k) clearance for OSTEONICS SPINAL SYSTEM VERSATILE CROSS..., manufactured by Howmedica Osteonics Corp.. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K990922 · Howmedica Osteonics Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1999
Decision
75d
Days
Class 2
Risk

K990922 is an FDA 510(k) clearance for the OSTEONICS SPINAL SYSTEM VERSATILE CROSS CONNECTOR. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on June 2, 1999 after a review of 75 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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

FDA 510(k) Submission Details - K990922

510(k) Number K990922 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1999
Decision Date June 02, 1999
Days to Decision 75 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
47d faster than avg
Panel avg: 122d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWP Device Classification - Class 2, Special Controls

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
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 - KWP Appliance, Fixation, Spinal Interlaminal

All 379
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K990922.
DYNA-LOK PLUS SPINAL SYSTEM
K991198 · Sofamor Danek USA,Inc. · Aug 1999
SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM)
K991586 · Osteotech, Inc. · Jul 1999
SYNTHES CERVIFIX SYSTEM
K990965 · Synthes (Usa) · Jul 1999
OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLY
K984375 · Osteonics Corp. · Apr 1999
EBI OMEGA 21 SYSTEM
K990303 · Electro-Biology, Inc. · Apr 1999
MODIFICATION TO PARTS NUMBERED CGT-SL AND CGT-SL-15
K990845 · Advanced Spine Fixation Systems, Inc. · Apr 1999