# K022365: Stryker Navigation System - Hip Module

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Instruments
- Decided: Jan 22, 2003 after 184 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- 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.
125 later devices descend from it; 7 cite it directly.
0 of 126 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 no predicate by number.

## Most influential descendants
- K070731: Pigalileo Total Hip Replacement (THR) System (2007), 81 descendants of its own
- K080875: Pigalileo 4TH Generation System (2008), 79 descendants of its own
- K090420: Smith & Nephew Pigalileo Screw Targeting System V 1.0 (2009), 78 descendants of its own
- K092497: Smith & Nephew Pigalileo Screw Targeting System, Version 1.1 (2009), 77 descendants of its own
- K100107: Smith & Nephew Sureshot Distal Targeting System V2.0 (2010), 75 descendants of its own

## Recalls of this device
- May 4, 2015 · Class II · Z-1810-2015: Stryker initiated a device recall of the Navigation System II-Cart, Camera Articulated Arm because there is a potential that the weld seam between the main stud and the two flaps on the Articulated Ar
- Jun 5, 2008 · Not classified · Z-2288-2008: Instructions have been updated to include new warnings regarding percutaneous pin placement during surgery in order to mitigate the risk of femur fractures.
- Jun 5, 2008 · Not classified · Z-2294-2008: Instructions have been updated to include new warnings regarding percutaneous pin placement during surgery in order to mitigate the risk of femur fractures.
- Jun 5, 2008 · Not classified · Z-2291-2008: Instructions have been updated to include new warnings regarding percutaneous pin placement during surgery in order to mitigate the risk of femur fractures.
- Jun 5, 2008 · Not classified · Z-2289-2008: Instructions have been updated to include new warnings regarding percutaneous pin placement during surgery in order to mitigate the risk of femur fractures.
- Jun 5, 2008 · Not classified · Z-2292-2008: Instructions have been updated to include new warnings regarding percutaneous pin placement during surgery in order to mitigate the risk of femur fractures.
- Jun 5, 2008 · Not classified · Z-2293-2008: Instructions have been updated to include new warnings regarding percutaneous pin placement during surgery in order to mitigate the risk of femur fractures.
- Jun 5, 2008 · Not classified · Z-2290-2008: Instructions have been updated to include new warnings regarding percutaneous pin placement during surgery in order to mitigate the risk of femur fractures.
- Jul 14, 2004 · Not classified · Z-0021-05: The tracker is not locking adequately to the anchoring pin, resulting in unacceptable movement, which will affected the patient tracker system.
- Jul 14, 2004 · Not classified · Z-0020-05: The tracker is not locking adequately to the anchoring pin, resulting in unacceptable movement, which will affected the patient tracker system.

## Indications for use
The system must be used within the operating theatre and 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 of 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/K022365
Methodology: https://510kreport.com/methodology