# K053348: Stryker Orthopaedics Rfid Instrumentation

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Aug 4, 2006 after 245 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K905070 (1991). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022365: Stryker Navigation System - Hip Module, Stryker Instruments (2003) Summary page 1.
- K010204: Stryker Navigation System-Knee Module, Stryker Corp. (2001)
- K033341: Smith & Nephew Image Guided Surgical Instruments for Hip Applications, Smith & Nephew, Inc. (2004) Summary page 1.
- K043223: Depuy Cas Knee Instrumentation, DePuy Orthopaedics, Inc. (2005) Summary page 1.

## Indications for use
Stryker ® Orthopaedics RFID Instrumentation is intended for use as accessories to the Stryker ® Navigation System's Hip and Knee Modules during orthopedic surgery.

Source page: https://510kreport.com/device/K053348
Methodology: https://510kreport.com/methodology