510(k) · Cleared
ClearedInsurgical Single Use Power Equipment
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Insurgical, LLC · KIJ Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
Cleared on Nov 6, 2012 as substantially equivalent to K972367 (Stryker Instruments, 1997) after a 426-day review. Its family tree reaches back 1 generation to 1997. 1 later device descends from it.
- Decided
- Nov 6, 2012
- Review
- 426 days
- Class
- Class I
- Product code
- KIJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K972367 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK972367 Stryker System 4000 Heavy Duty Battery Powered EquipmentStryker Instruments · 1997 · Recalled
- This deviceK112599 Insurgical Single Use Power EquipmentInsurgical, LLC · 2012
- Descendant · cites it directly · 0 of its ownK240071 Peleton Universal Single Use Power System and AttachmentsPeleton Surgical · 2024
Most influential descendants
Showing 1 of 1 · See all- K240071Peleton Universal Single Use Power System and AttachmentsPeleton Surgical · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K972367 | Stryker System 4000 Heavy Duty Battery Powered Equipment | Stryker Instruments | 1997 | 10 |
| 0 (this device) | K112599 | Insurgical Single Use Power Equipment | Insurgical, LLC | 2012 | — |
| +1 | K240071 | Peleton Universal Single Use Power System and Attachments | Peleton Surgical | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 KIJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K972367 | Stryker System 4000 Heavy Duty Battery Powered EquipmentSummary page 3…Substantial Equivalence: The Insurgical Single Use Power Equipment is substantially equivalent to Stryker System 4000 Heavy Duty Battery Powered Equipment (K972367). The predicate device has similar technical features, indications for use, and the safety and effectiveness of the… | 1997 |
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 |
|---|---|---|---|
| K240071 | Peleton Universal Single Use Power System and Attachments | 2024 | 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?
How does its category compare?
All KIJ devicesKIJ Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · KIJ
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · KIJ
Too few KIJ 510(k)s in any year since 2007 to give a median.
Recalls per year · KIJ
10in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KIJ
4in 2025
MAUDE reports naming product code KIJ, 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 | 0 | — | 0 | 10 |
| 2008 | 0 | — | 10 | 4 |
| 2009 | 0 | — | 0 | 265 |
| 2010 | 1 | — | 0 | 424 |
| 2011 | 0 | — | 0 | 1,080 |
| 2012 | 1 | — | 0 | 615 |
| 2013 | 0 | — | 0 | 288 |
| 2014 | 0 | — | 0 | 36 |
| 2015 | 0 | — | 0 | 36 |
| 2016 | 1 | — | 0 | 11 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 4 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
InsurgicalTM Single Use Power Equipment is intended for use in the cutting, drilling, decorticating, and smoothing of bone and other bone related tissue in a variety of surgical procedures. It is also usable in the placement or cutting of screws, wires, pins, and other fixation devices. It can also be used to cut metal.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112599 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112599: Insurgical Single Use Power Equipment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112599
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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