# K261410: Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))

- Pathway: 510(k) (Traditional)
- Applicant: Suite 201, National Innovation Centre
- Decided: Jul 30, 2026 after 91 days
- Product code: OLO (Orthopedic 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: 16 generations back to K983831 (1999). 53 ancestors in all.
No later device cites it as a predicate yet.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200376: Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral Registration, Navbit Pty, Ltd. (2020) Summary page 5.

## Indications for use
The Navbit MARQ System is a computer-controlled system intended to assist the surgeon in determining alignment in relation to reference axes during orthopedic surgical procedures. The Navbit MARQ System facilitates the accurate positioning of implants, relative to these alignment axes. The clinical setting and target population for the Navbit MARQ System is that of a patient undergoing a Hip Arthroplasty surgical procedure by any approach with the patient in a supine or lateral decubitus position. The Navbit MARQ System is indicated for use: - in Hip Arthroplasty surgical procedures; - with acetabular cups that are uncemented and allow for post-impaction correction; - when post-impaction confirmatory measurement checks can be obtained.

Source page: https://510kreport.com/device/K261410
Methodology: https://510kreport.com/methodology