# K963304: Stryker Tempest Orthopedic Pump

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Endoscopy
- Decided: Jan 22, 1997 after 153 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K910858 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910858: Stryker Arthroscopic Infusion Pump, Stryker Corp. (1991) Summary page 1.

## Indications for use
The Stryker Tempest Orthopedic Pump is intended to be used by surgeons in Orthopedic joints, including the knee, shoulder, ankle, elbow, wrist, and temporomandibular joints. It will be used to distend joints.

Source page: https://510kreport.com/device/K963304
Methodology: https://510kreport.com/methodology