Cleared Traditional

K894184 - BIEDERMANN MOTECH UNIVERSAL SPINAL SYSTEM

K894184 is an FDA 510(k) clearance for BIEDERMANN MOTECH UNIVERSAL SPINAL SYSTEM, manufactured by Biedermann Motech GmbH. The device is a Class 2 Orthopedic device with product code JDN cleared through the Traditional 510(k) pathway after a 313-day FDA review.

K894184 · Biedermann Motech GmbH · Orthopedic device
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Apr 1990
Decision
313d
Days
Class 2
Risk

K894184 is an FDA 510(k) clearance for the BIEDERMANN MOTECH UNIVERSAL SPINAL SYSTEM. Classified as Implant, Fixation Device, Spinal (product code JDN), Class II - Special Controls.

Submitted by Biedermann Motech GmbH (Vs-Schwenningen, DE). The FDA issued a Cleared decision on April 25, 1990 after a review of 313 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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. Elevated predicate reliance profile. 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 Biedermann Motech GmbH devices

FDA 510(k) Submission Details - K894184

510(k) Number K894184 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received June 16, 1989
Decision Date April 25, 1990
Days to Decision 313 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
191d slower than avg
Panel avg: 122d · This submission: 313d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDN Device Classification - Class 2, Special Controls

Product Code JDN Implant, Fixation Device, Spinal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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.