510(k) · Cleared

Recalled · 2008

Stryker System 4000 Heavy Duty Battery Powered Equipment

K972367510(k) TraditionalCleared Sep 4, 199771-day reviewClass I21 CFR 878.4820Recalls 10

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Stryker Instruments · KIJ Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

Cleared on Sep 4, 1997 after a 71-day review. The FDA summary names its predicate without a number. 2 later devices descend from it. It has been recalled 10 times.

Decided: Sep 4, 1997
Review: 71 days
Class: Class I
Product code: KIJ
Recalls: 10
Predicates: 0

2 later devices descend from it, 2 citing it directly.

This deviceK972367 Stryker System 4000 Heavy Duty Battery Powered EquipmentStryker Instruments · 1997
Descendant · cites it directly · 1 of its ownK112599 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 2 of 2 · See all

K112599Insurgical Single Use Power EquipmentInsurgical, LLC · 2012 · cites it directly1descendant
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
0 (this device)	K972367	Stryker System 4000 Heavy Duty Battery Powered Equipment	Stryker Instruments	1997	—
+1	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
2012	1	0
2024	1	0

FIG. 1 — Lineage of K972367, 1997–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	—	Existing powered instrument systems and accessories marketed by 3M, Zimmer, and Sodem Named without a submission number			—
*	—	Stryker products marketed before the Medical Device Amendments Named without a submission number			—

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K112599	Insurgical Single Use Power Equipment	Insurgical, LLC	2012	1
K240071	Peleton Universal Single Use Power System and Attachments	Peleton Surgical	2024	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Oct 10, 2008	Not classified	Z-1022-2009	Component design/selection	The handpieces may continue to run even when the trigger is not depressed, which could result in the unintended cutting of bone or soft tissue damage.
Oct 10, 2008	Not classified	Z-1023-2009	Component design/selection	The handpieces may continue to run even when the trigger is not depressed, which could result in the unintended cutting of bone or soft tissue damage.
Oct 10, 2008	Not classified	Z-1021-2009	Component design/selection	The handpieces may continue to run even when the trigger is not depressed, which could result in the unintended cutting of bone or soft tissue damage.
Oct 10, 2008	Not classified	Z-1029-2009	Component design/selection	The handpieces may continue to run even when the trigger is not depressed, which could result in the unintended cutting of bone or soft tissue damage.
Oct 10, 2008	Not classified	Z-1026-2009	Component design/selection	The handpieces may continue to run even when the trigger is not depressed, which could result in the unintended cutting of bone or soft tissue damage.
Oct 10, 2008	Not classified	Z-1027-2009	Component design/selection	The handpieces may continue to run even when the trigger is not depressed, which could result in the unintended cutting of bone or soft tissue damage.
Oct 10, 2008	Not classified	Z-1024-2009	Component design/selection	The handpieces may continue to run even when the trigger is not depressed, which could result in the unintended cutting of bone or soft tissue damage.
Oct 10, 2008	Not classified	Z-1025-2009	Component design/selection	The handpieces may continue to run even when the trigger is not depressed, which could result in the unintended cutting of bone or soft tissue damage.
Oct 10, 2008	Not classified	Z-1028-2009	Component design/selection	The handpieces may continue to run even when the trigger is not depressed, which could result in the unintended cutting of bone or soft tissue damage.
Oct 10, 2008	Not classified	Z-1030-2009	Component design/selection	The handpieces may continue to run even when the trigger is not depressed, which could result in the unintended cutting of bone or soft tissue damage.

The 5 latest of 10 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K112599 (Insurgical, LLC, 2012) has gone furthest, with 1 descendant of its own.

How does its category compare?

All KIJ devices

KIJ Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KIJ

1in 2016

2007high 1 (2010) · low 0 (2007)2026

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

2007high 10 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KIJ

4in 2025

2007high 1,080 (2011) · low 0 (2021)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?

The Stryker System 4000 Battery Powered Heavy Duty System 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K972367 · printed Nov 4, 2026

Cite this page

510(k) Report. “K972367: Stryker System 4000 Heavy Duty Battery Powered Equipment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972367

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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