# K972367: Stryker System 4000 Heavy Duty Battery Powered Equipment

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Instruments
- Decided: Sep 4, 1997 after 71 days
- Product code: KIJ (Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment)
- Device class: 1
- Regulation: 21 CFR 878.4820
- Recalls of this device: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Existing powered instrument systems and accessories marketed by 3M, Zimmer, and Sodem: named in the summary without a submission number
- (no number) Stryker products marketed before the Medical Device Amendments: named in the summary without a submission number

## Most influential descendants
- K112599: Insurgical Single Use Power Equipment (2012), 1 descendant of its own
- K240071: Peleton Universal Single Use Power System and Attachments (2024), 0 descendants of its own

## Recalls of this device
- Oct 10, 2008 · Not classified · Z-1022-2009: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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.

## Indications for use
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.

Source page: https://510kreport.com/device/K972367
Methodology: https://510kreport.com/methodology