510(k) · Cleared
ClearedJarit, Ruggles, R&B Redmond/ Redmond, Miltex, Meisterhand - 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 Feb 17, 2010 as substantially equivalent to K902819 (Ruggles Corp., 1990) and 1 other predicate after a 209-day review. Its family tree reaches back 1 generation to 1990. 17 later devices descend from it.
- Decided
- Feb 17, 2010
- Review
- 209 days
- Class
- Class II
- Product code
- HAE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K902819 (1990). 2 ancestors in all. 17 later devices descend from it, 6 citing it directly.
- Root · 1 generation backK902819 Laminectomy RogeurRuggles Corp. · 1990
- This deviceK092227 Jarit, Ruggles, R&B Redmond/ Redmond, Miltex, Meisterhand - Kerrison…Integra Lifesciences Corp. · 2010
- Descendant · cites it directly · 10 of its ownK150428 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
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K150428Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles (TM)-Redmons (TM) Kerrison…Integra Lifesciences Corp. · 2015 · cites it directly10descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K902819 | Laminectomy Rogeur | Ruggles Corp. | 1990 | — |
| 0 (this device) | K092227 | Jarit, Ruggles, R&B Redmond/ Redmond, Miltex, Meisterhand - Kerrison Rongeurs | Integra Lifesciences Corp. | 2010 | — |
| +1 | 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 | — |
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 |
|---|---|---|
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 4 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 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? (5)
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 |
|---|---|---|---|
| * | K902819 | Laminectomy RogeurSummary page 1…y Rongeurs J. Jamner Surgical Instruments (Integra LifeSciences) Pre-amendment Ruggles Larninectomny Rongeurs Ruggles Corp. (Integra LifeSciences) K902819 Ruggles Lamninectomny Rongeurs Ruggles Corp. (Integra LifeSciences) K933978 Redmond Ejector Kerrison R… | 1990 |
| * | K933978 | Nedbond Ejector Kerrison RongeurSummary page 1…uggles Larninectomny Rongeurs Ruggles Corp. (Integra LifeSciences) K902819 Ruggles Lamninectomny Rongeurs Ruggles Corp. (Integra LifeSciences) K933978 Redmond Ejector Kerrison Rongeur Redmond Neurotechnologies (Integra LifeSciences) Pre-amendment Miltex Kerrison R… | 1994 |
| * | — | Jarit Laminectomy Rongeurs Named without a submission number | |
| * | — | Ruggles Laminectomy Rongeurs Named without a submission number | |
| * | — | Miltex Kerrison Rongeurs Named without a submission number |
What descends from it? (17)
See all 176 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150428 | Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles (TM)-Redmons (TM) Kerrison… | 2015 | 10 |
| K153243 | Fehling-Punches | 2016 | 7 |
| K150468 | Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs | 2016 | 1 |
| K130541 | Symmetry Kerrison Disposable Tip Rongeurs | 2013 | 1 |
| K152734 | Kerrison Rongeurs | 2016 | 0 |
| K131851 | Osteomed Neuro Rongeur | 2013 | 0 |
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K150428 (Integra Lifesciences Corp., 2015) has gone furthest, with 10 descendants of its own.
How does its category compare?
All HAE devicesHAE Rongeur, Manual: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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™, R&B Redmond™ (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/K092227 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092227: Jarit, Ruggles, R&B Redmond/ Redmond, Miltex, Meisterhand - 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/K092227
Report an extraction error
Are you the manufacturer?
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