# K050615: Stryker Navigation System - CT-Based Hip Module, Model 6007-621-000

- Pathway: 510(k) (Special)
- Applicant: Stryker Instruments
- Decided: Apr 21, 2005 after 43 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: 1 generation back to K993239 (2000). 3 ancestors in all.
29 later devices descend from it; 3 cite it directly.
0 of 33 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.
- K993239: Stryker Navigation System - Neuro Module, Model 6000-XXX-XXX, Stryker Corp. (2000) Summary page 1.
- K010602: Vectorvision Hip, Brainlab AG (2001). Our reading of the summary gave K011602, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “VectorVision Hip System”.

## Most influential descendants
- K162962: OrthAlign Plus System (2017), 15 descendants of its own
- K171780: OrthAlign Plus System (2017), 12 descendants of its own
- K093425: Mako Surgical Corp Robotic Arm Interactive Orthopedic System-Tha (2010), 11 descendants of its own
- K121064: Makoplasty Total Hip Application, Rio Standard System (2012), 9 descendants of its own
- K172462: OrthAlign Plus System (2017), 8 descendants of its own

## Indications for use
The system should be operated only by trained personnel such as orthopedic surgeons and clinic staff. The Stryker Navigation System - Hip Module supports, but is not limited to the following surgical procedures * Any form of Total Hip Athroplasty (THA), e.g. open or minimal-invasive - Precisely position instruments, implants and bony tissue during orthopedic surgery, such as operations performed with Hip and bones in the upper extremities • Revisions

Source page: https://510kreport.com/device/K050615
Methodology: https://510kreport.com/methodology