510(k) · Cleared
ClearedIntegra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles (TM)-Redmons (TM) Kerrison Rongeurs, Integra (R) Miltex (R) Kerrison Rongeurs, Integra (R) Meisterhand (R) Kerrison Rongeurs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integra Lifesciences Corp. · HAE Rongeur, Manual
Cleared on Apr 16, 2015 as substantially equivalent to K092227 (Integra Lifesciences Corp., 2010) after a 56-day review. Its family tree reaches back 2 generations to 1990. 10 later devices descend from it.
- Decided
- Apr 16, 2015
- Review
- 56 days
- Class
- Class II
- Product code
- HAE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K902819 (1990). 3 ancestors in all. 10 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK902819 Laminectomy RogeurRuggles Corp. · 1990
- 1 generation backK092227 Jarit, Ruggles, R&B Redmond/ Redmond, Miltex, Meisterhand - Kerrison…Integra Lifesciences Corp. · 2010
- This deviceK150428 Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles…Integra Lifesciences Corp. · 2015
- Descendant · cites it directly · 7 of its ownK153243 Fehling-PunchesFehling Instruments GmbH & Co. KG · 2016
- Descendant · 2 generations on · 2 of its ownK200768 Rebellion, Phantom Multi-Bite Kerrison RongeurMorpheus AG · 2021
- Descendant · 2 generations on · 1 of its ownK223596 SQ.line KERRISONAesculap, Inc. · 2023
- Descendant · 3 generations on · 1 of its ownK221818 Rebellion; Phantom Multi-Bite Kerrison RongeurMorpheus AG · 2022
- Descendant · cites it directly · 0 of its ownK260446 Tontarra Punches and RongeursTontarra Medizintechnik GmbH · 2026
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K153243Fehling-PunchesFehling Instruments GmbH & Co. KG · 2016 · cites it directly7descendants
- K200768Rebellion, Phantom Multi-Bite Kerrison RongeurMorpheus AG · 2021 · 2 generations on2descendants
- K223596SQ.line KERRISONAesculap, Inc. · 2023 · 2 generations on1descendant
- K221818Rebellion; Phantom Multi-Bite Kerrison RongeurMorpheus AG · 2022 · 3 generations on1descendant
- K260446Tontarra Punches and RongeursTontarra Medizintechnik GmbH · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K902819 | Laminectomy Rogeur | Ruggles Corp. | 1990 | — |
| −1 | K092227 | Jarit, Ruggles, R&B Redmond/ Redmond, Miltex, Meisterhand - Kerrison Rongeurs | Integra Lifesciences Corp. | 2010 | — |
| 0 (this device) | K150428 | Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles (TM)-Redmons (TM)… | Integra Lifesciences Corp. | 2015 | — |
| +1 | K153243 | Fehling-Punches | Fehling Instruments GmbH & Co. KG | 2016 | — |
| +2 | K200768 | Rebellion, Phantom Multi-Bite Kerrison Rongeur | Morpheus AG | 2021 | — |
| +2 | K223596 | SQ.line KERRISON | Aesculap, Inc. | 2023 | — |
| +3 | K221818 | Rebellion; Phantom Multi-Bite Kerrison Rongeur | Morpheus AG | 2022 | — |
| +1 | K260446 | Tontarra Punches and Rongeurs | Tontarra Medizintechnik GmbH | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
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 K260446 Tontarra Punches and Rongeursscore 12.6 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K092227 | Jarit, Ruggles, R&B Redmond/ Redmond, Miltex, Meisterhand - Kerrison RongeursSummary page 4…1 CFR 882.4840) Regulatory Class: Class II Product Code: HAE III. PREDICATE DEVICE Integra® Jarit®, Ruggles™ -Redmond™, Miltex®, and MeisterHand® Kerrison Rongeurs, K092227 This predicate device has not been subject to a design-related recall. IV. DEVICE DESCRIPTION Integra® Kerrison Rongeurs ar… | 2010 |
What descends from it? (10)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 25 years and passes through 2 companies; a new generation was cleared every 19.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K153243 (Fehling Instruments GmbH & Co. KG, 2016) has gone furthest, with 7 descendants of its own.
- 5 other devices also cite its predicate K092227.
How does its category compare?
All HAE devicesHAE Rongeur, Manual: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · HAE
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HAE
270in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HAE
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HAE
10in 2025
MAUDE reports naming product code HAE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 4 |
| 2008 | 2 | — | 0 | 5 |
| 2009 | 0 | — | 0 | 6 |
| 2010 | 2 | — | 0 | 10 |
| 2011 | 0 | — | 0 | 31 |
| 2012 | 2 | — | 0 | 47 |
| 2013 | 2 | — | 0 | 20 |
| 2014 | 0 | — | 0 | 15 |
| 2015 | 1 | — | 0 | 25 |
| 2016 | 4 | 270 | 0 | 34 |
| 2017 | 0 | — | 0 | 25 |
| 2018 | 1 | — | 0 | 29 |
| 2019 | 0 | — | 0 | 24 |
| 2020 | 2 | — | 0 | 25 |
| 2021 | 1 | — | 0 | 12 |
| 2022 | 2 | — | 0 | 13 |
| 2023 | 2 | — | 2 | 10 |
| 2024 | 0 | — | 0 | 9 |
| 2025 | 1 | — | 0 | 10 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Integra® (Jarit®, Ruggles™-Redmond™, Miltex®, MeisterHand®) Kerrison Rongeurs are manually operated instruments indicated for cutting or biting bone during surgery involving the skull or spinal column.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150428 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150428: Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles (TM)-Redmons (TM) Kerrison Rongeurs, Integra (R) Miltex (R) Kerrison Rongeurs, Integra (R) Meisterhand (R) Kerrison Rongeurs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150428
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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