Cleared Traditional

OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLY (K984375) - FDA 510(k) Clearance

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

K984375 · Osteonics Corp. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Apr 1999
Decision
144d
Days
Class 2
Risk

K984375 is an FDA 510(k) clearance for the OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLY. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on April 30, 1999 after a review of 144 days - within the typical 510(k) review window.

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: 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 Osteonics Corp. devices

Submission Details

510(k) Number K984375 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1998
Decision Date April 30, 1999
Days to Decision 144 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
22d slower than avg
Panel avg: 122d · This submission: 144d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 98
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K984375.
SYNTHES CERVIFIX SYSTEM
K994187 · Synthes (Usa) · Dec 1999
SYNTHES CERVIFIX SYSTEM
K990965 · Synthes (Usa) · Jul 1999
OSTEONICS SPINAL SYSTEM VERSATILE CROSS CONNECTOR
K990922 · Howmedica Osteonics Corp. · Jun 1999
TITANIUM VERSALOK
K990708 · Wrightmedicaltechnologyinc · Mar 1999
SYNTHES SPINE CERVIFIX SYSTEM
K984377 · Synthes (Usa) · Jan 1999
ROGOZINSKI SPINAL ROD SYSTEM
K983904 · United States Surgical, A Division of Tyco Healthc · Dec 1998