510(k) · Cleared
ClearedSteribite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rjr Surgical, Inc. · HAE Rongeur, Manual
Cleared on Nov 8, 2018 as substantially equivalent to K150428 (Integra Lifesciences Corp., 2015) after a 211-day review. Its family tree reaches back 3 generations to 1990.
- Decided
- Nov 8, 2018
- Review
- 211 days
- Class
- Class II
- Product code
- HAE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K902819 (1990). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK902819 Laminectomy RogeurRuggles Corp. · 1990
- 2 generations backK092227 Jarit, Ruggles, R&B Redmond/ Redmond, Miltex, Meisterhand - Kerrison…Integra Lifesciences Corp. · 2010
- 1 generation backK150428 Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles…Integra Lifesciences Corp. · 2015
- This deviceK180949 SteribiteRjr Surgical, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K902819 | Laminectomy Rogeur | Ruggles Corp. | 1990 | — |
| −2 | 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 | — |
| 0 (this device) | K180949 | Steribite | Rjr Surgical, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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 |
|---|---|---|---|
| * | K150428 | Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles (TM)-Redmons (TM) Kerrison…Summary page 4…Class II Classification 21 CFR 882.4840 Manual Rongeur Product Code HAE Predicate Device K150428 Integra® Kerrison Rongeurs 21 CFR 882.4840 Manual Rongeur… | 2015 |
| † | K140927 | Universal Navigation Instruments | 2014 |
| † | K150468 | Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs | 2016 |
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 28 years and passes through 3 companies; a new generation was cleared every 5.2 years on median.
- None of the 4 ancestors has a recall.
- 4 other devices also cite its predicate K150428.
How does its category compare?
All HAE devicesHAE Rongeur, Manual: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Steribite® 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/K180949 · printed Nov 4, 2026
Cite this page
510(k) Report. “K180949: Steribite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180949
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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