Cleared Traditional

Rebellion, Phantom Multi-Bite Kerrison Rongeur  (K200768) - FDA 510(k) Clearance

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

K200768 · Morpheus AG · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2021
Decision
405d
Days
Class 2
Risk

K200768 is an FDA 510(k) clearance for the Rebellion, Phantom Multi-Bite Kerrison Rongeur . Classified as Rongeur, Manual (product code HAE), Class II - Special Controls.

Submitted by Morpheus AG (Spaichingen, DE). The FDA issued a Cleared decision on May 4, 2021 after a review of 405 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4840 - 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 Morpheus AG devices

Submission Details

510(k) Number K200768 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2020
Decision Date May 04, 2021
Days to Decision 405 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
257d slower than avg
Panel avg: 148d · This submission: 405d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HAE Rongeur, Manual
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4840
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.

Regulatory Peers - HAE Rongeur, Manual

All 10
Devices cleared under the same product code (HAE) and FDA review panel - the closest regulatory comparables to K200768.
Rebellion, Phantom Multi-Bite Kerrison Rongeur
K230256 · Morpheus AG · Mar 2023
Rebellion
K221818 · Morpheus AG · Oct 2022
KLS Martin Neuro Rongeurs
K210741 · KLS-Martin L.P. · Jun 2022
Wiggins Medical Surgical Instruments
K200383 · Wiggins Medical · Jul 2020
Ace Medical Surgical Instruments
K200387 · Ace Medical · Jul 2020
Steribite
K180949 · Rjr Surgical, Inc. · Nov 2018