# K943323: Stryker Surgical Instruments and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corp.
- Decided: Nov 28, 1994 after 140 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- 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.
33 later devices descend from it; 1 cites it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K120434: Power Adaptor Instrument Accessory (2012), 32 descendants of its own
- K152632: XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument Accessory (2015), 31 descendants of its own
- K170496: Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument Accessory (2017), 15 descendants of its own
- K163604: SeaSpine® Daytona® Small Stature Spinal System (2017), 12 descendants of its own
- K172724: XIA® 4.5 Spinal System, Power Adaptor Instrument Accessory (2017), 9 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.

Source page: https://510kreport.com/device/K943323
Methodology: https://510kreport.com/methodology