Cleared Traditional

K894184 - BIEDERMANN MOTECH UNIVERSAL SPINAL SYSTEM (FDA 510(k) Clearance)

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

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

Submission Details

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.

Device Classification

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.