# K043223: Depuy Cas Knee Instrumentation

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Mar 4, 2005 after 102 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K905070 (1991). 18 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031337: Acumen Surgical Navigation System, Biomet, Inc. (2003) Summary page 1.
- K033011: Zimmer Ortho Guidance Systems- Knee Instruments, Zimmer, Inc. (2004) Summary page 1.
- (no number) VectorVision CT-Free Knee: named in the summary without a submission number

## Most influential descendants
- K053348: Stryker Orthopaedics Rfid Instrumentation (2006), 0 descendants of its own

## Recalls of this device
- Jan 3, 2020 · Class II · Z-1169-2020: The device will not connect to the Specialist 2 Locating Outrigger which renders them unusable in surgery.

## Indications for use
Instruments are tracked by a passive marker sensor system that acquires landmarks of the bone surface when interfaced with computer hardware and software. This enables a surgeon to accurately navigate the position of instrumentation by a virtual 3-D computer generated image for precise bone cuts during minimally invasive intraoperative knee reconstructive procedures. The system is indicated for any medical condition in which the use of stereotaxic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a long bone, can be identified relative to a CT or MR based model of the anatomy. Example orthopaedic procedures for these instruments include, but are not limited to: *Total Knee Replacement *Unicondylar Knee Replacement *Ligament Balancing -Range of Motion Analysis *Cruciate Ligament Surgery -Patella Tracking

Source page: https://510kreport.com/device/K043223
Methodology: https://510kreport.com/methodology