510(k) · Cleared
ClearedLaminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
K2 Medical GmbH & Co. KG · HAE Rongeur, Manual
Cleared on Feb 29, 2016 as substantially equivalent to K092227 (Integra Lifesciences Corp., 2010) and 1 other predicate after a 371-day review. Its family tree reaches back 2 generations to 1994. 1 later device descends from it.
- Decided
- Feb 29, 2016
- Review
- 371 days
- Class
- Class II
- Product code
- HAE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K943635 (1994). 7 ancestors in all, the oldest K902819 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK943635 Ultra-Line RongeurV. Mueller Neuro/Spine · 1994
- 1 generation backK081651 Instrumed RongeurInstrumed International, Inc. · 2008
- This deviceK150468 Laminectomy Rongeurs, Kerrison Rongeurs, IVD RongeursK2 Medical GmbH & Co. KG · 2016
- Descendant · cites it directly · 0 of its ownK210741 KLS Martin Neuro RongeursKLS-Martin L.P. · 2022
Most influential descendants
Showing 1 of 1 · See all- K210741KLS Martin Neuro RongeursKLS-Martin L.P. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K943635 | Ultra-Line Rongeur | V. Mueller Neuro/Spine | 1994 | — |
| −1 | K081651 | Instrumed Rongeur | Instrumed International, Inc. | 2008 | — |
| 0 (this device) | K150468 | Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs | K2 Medical GmbH & Co. KG | 2016 | — |
| +1 | K210741 | KLS Martin Neuro Rongeurs | KLS-Martin L.P. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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? (2)
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…de: HAE 2. Predicate Device: Trade name Integra™ Kerrison Rongeurs Instrumed Rongeur 510(k) No. K092227 K081651 510(k) submitter / Integra LifeSciences Corporation INSTRUMED INTERNATIO… | 2010 |
| * | K081651 | Instrumed RongeurSummary page 4…edicate Device: Trade name Integra™ Kerrison Rongeurs Instrumed Rongeur 510(k) No. K092227 K081651 510(k) submitter / Integra LifeSciences Corporation INSTRUMED INTERNATIONAL, INC. holder 311… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210741 | KLS Martin Neuro Rongeurs | 2022 | 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?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 13.7 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K210741 (KLS-Martin L.P., 2022) has gone furthest, with 0 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. 2016, 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?
Laminectomy Rongeurs, Kerrison Rongeurs and IVD Rongeurs are manually operated instruments indicated for cutting or biting bone during surgery involving the skull or spinal column in patients two years of age or older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150468 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150468: Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150468
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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