510(k) Report

510(k) · Cleared

Cleared

Rebellion; Phantom Multi-Bite Kerrison Rongeur

K221818510(k) SpecialCleared Oct 7, 2022106-day reviewClass II21 CFR 882.4840

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Morpheus AG · HAE Rongeur, Manual

Cleared on Oct 7, 2022 as substantially equivalent to K200768 (Morpheus AG, 2021) after a 106-day review. Its family tree reaches back 5 generations to 1990. 1 later device descends from it.

Decided
Oct 7, 2022
Review
106 days
Class
Class II
Product code
HAE
Recalls
None
Predicates
1

Its longest line of descent runs back 5 generations to K902819 (1990). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.

  1. Root · 5 generations backK902819 Laminectomy RogeurRuggles Corp. · 1990
  2. 4 generations backK092227 Jarit, Ruggles, R&B Redmond/ Redmond, Miltex, Meisterhand - Kerrison…Integra Lifesciences Corp. · 2010
  3. 3 generations backK150428 Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles…Integra Lifesciences Corp. · 2015
  4. 2 generations backK153243 Fehling-PunchesFehling Instruments GmbH & Co. KG · 2016
  5. 1 generation backK200768 Rebellion, Phantom Multi-Bite Kerrison RongeurMorpheus AG · 2021
  6. This deviceK221818 Rebellion; Phantom Multi-Bite Kerrison RongeurMorpheus AG · 2022
  7. Descendant · cites it directly · 0 of its ownK230256 Rebellion, Phantom Multi-Bite Kerrison RongeurMorpheus AG · 2023

Most influential descendants

Showing 1 of 1 · See all
  • K230256Rebellion, Phantom Multi-Bite Kerrison RongeurMorpheus AG · 2023 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K902819Laminectomy RogeurRuggles Corp.1990—
−4K092227Jarit, Ruggles, R&B Redmond/ Redmond, Miltex, Meisterhand - Kerrison RongeursIntegra Lifesciences Corp.2010—
−3K150428Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles (TM)-Redmons (TM)…Integra Lifesciences Corp.2015—
−2K153243Fehling-PunchesFehling Instruments GmbH & Co. KG2016—
−1K200768Rebellion, Phantom Multi-Bite Kerrison RongeurMorpheus AG2021—
0 (this device)K221818Rebellion; Phantom Multi-Bite Kerrison RongeurMorpheus AG2022—
+1K230256Rebellion, Phantom Multi-Bite Kerrison RongeurMorpheus AG2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202310
FIG. 1 — Lineage of K221818, 1990–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in HAE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new HAE device

  1. #1 K260446 Tontarra Punches and Rongeursscore 12.6 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K200768Rebellion, Phantom Multi-Bite Kerrison Rongeur
Summary page 5
…Reference Device 510(k) number 510(k) Holder Rebellion; Phantom Multi-Bite -- K200768 Morpheus AG Rebellion Kerrison Rongeur…
Morpheus AG2021—
†K153243Fehling-PunchesFehling Instruments GmbH & Co. KG2016—

Also cleared against K200768: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K230256Rebellion, Phantom Multi-Bite Kerrison RongeurMorpheus AG20230

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 32 years and passes through 4 companies; a new generation was cleared every 4.7 years on median.
  • None of the 6 ancestors has a recall.
  • Of its descendants, K230256 (Morpheus AG, 2023) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K200768.

How does its category compare?

All HAE devices

HAE Rongeur, Manual: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.

FDA decisions per year · HAE

1in 2025

2007: 22008: 22010: 22012: 22013: 22015: 12016: 42018: 12020: 22021: 12022: 22023: 22025: 12026 (partial year): 1
2007high 4 (2016) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HAE

270in 2016

2016: 270 days median
2007high 270 (2016)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HAE

2in 2023

2023: 2
2007high 2 (2023) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HAE

10in 2025

2007: 42008: 52009: 62010: 102011: 312012: 472013: 202014: 152015: 252016: 342017: 252018: 292019: 242020: 252021: 122022: 132023: 102024: 92025: 10
2007high 47 (2012) · low 4 (2007)2025

MAUDE reports naming product code HAE, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—04
20082—05
20090—06
20102—010
20110—031
20122—047
20132—020
20140—015
20151—025
20164270034
20170—025
20181—029
20190—024
20202—025
20211—012
20222—013
20232—210
20240—09
20251—010
20261—0—

What is it indicated for?

The Rebellion is intended for cutting and removing bone, vertebral bodies and tissue in orthopedics, neurosurgery and

spine surgery involving the skull or spinal column.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Cite this page

510(k) Report. “K221818: Rebellion; Phantom Multi-Bite Kerrison Rongeur.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221818

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026