Cleared Traditional

TUTOPLAST DURA (K910555) - FDA 510(k) Clearance

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

K910555 · Pfrimmer-Viggo GmbH & Co. · Neurology device
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Apr 1992
Decision
438d
Days
Class 2
Risk

K910555 is an FDA 510(k) clearance for the TUTOPLAST DURA. Classified as Human Lyophilized Dura Mater (product code LEM), Class II - Special Controls.

Submitted by Pfrimmer-Viggo GmbH & Co. (Washington, US). The FDA issued a Cleared decision on April 20, 1992 after a review of 438 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5975 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Pfrimmer-Viggo GmbH & Co. devices

Submission Details

510(k) Number K910555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1991
Decision Date April 20, 1992
Days to Decision 438 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
290d slower than avg
Panel avg: 148d · This submission: 438d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LEM Human Lyophilized Dura Mater
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5975
Definition Cber Review Required - Previously Regulated As A Device Under 21 Cfr 882.5975, Now Regulated In Cber Under Section 361 As Banked Human Tissue. See Definition At §1271.3(d). Subject To Donor Eligibility, Good Tissue Practice, Registration And Listing Requirements Under Part 1271" The Good Tissue Practice Regulation Http://www.fda.gov/cber/rules/gtp.pdf Became Final Effective May 25, 2005. It States That "on January 27, 2004, Fda Issued An Interim Final Rule Excepting Human Dura Mater And Human Heart Valve Allografts From The Definition Of Hct/p In § 1271.3(d) (69 Fr 3823). Fda Stated That, When The Comprehensive Framework Is In Place, Fda Intends That Human Dura Mater And Human Heart Valves Will Be Subject To It, And That Fda Intends To Revoke The Interim Rule At That Time (69 Fr 3823 And 3824). With The Effective Date Of This Final Rule, Fda Is Revoking The Interim Rule And Revising The Language In § 1271.3(d)."
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 Neurology devices follow this clearance model.