510(k) · Cleared
ClearedOsteomed Neuro Rongeur
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteomed · HAE Rongeur, Manual
Cleared on Dec 6, 2013 as substantially equivalent to K081651 (Instrumed International, Inc., 2008) and 1 other predicate after a 168-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Dec 6, 2013
- Review
- 168 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). No later device cites it as a predicate yet.
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) | K131851 | Osteomed Neuro Rongeur | Osteomed | 2013 | — |
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 |
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 |
|---|---|---|---|
| * | K081651 | Instrumed RongeurSummary page 1…me: Manual Rongeur o Product Code: HAE Device Class: 11 Predicate Devices: Instrumed Micro Kerrison Rongeur (K081651) Common Name: Manual Rongeur Classification Name: o Regulation… | 2008 |
| * | K092227 | Jarit, Ruggles, R&B Redmond/ Redmond, Miltex, Meisterhand - Kerrison RongeursSummary page 2…atric population Technological Characteristics: The OsteoMed Neuro Rongeur, the Instrumed Micro Kerrison Rongeur (K081651) and the Integra Kerrison Rongeur (K092227) are predicate devices used for cutting bone and soft tissue during surgery of the skull and the spinal column. The p… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
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 19 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.
- 1 other device also cites its predicate K081651.
How does its category compare?
All HAE devicesHAE Rongeur, Manual: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
The OsteoMed Neuro Rongeur is a manually operated instrument 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/K131851 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131851: Osteomed Neuro Rongeur.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131851
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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