# K200376: Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral Registration

- Pathway: 510(k) (Traditional)
- Applicant: Navbit Pty, Ltd.
- Decided: Dec 10, 2020 after 296 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: 15 generations back to K983831 (1999). 52 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172462: OrthAlign Plus System, Orthalign, Inc. (2017) Summary page 4.

## Most influential descendants
- K261410: Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit)) (2026), 0 descendants of its own

## Indications for use
For Lateral Patient Registration: The Navbit® Sprint 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® Sprint System facilitates the accurate positioning of implants, relative to these alignment axes. The clinical setting and target population for the Navbit® Sprint System is that of a patient undergoing a Hip Arthroplasty surgical procedure by any approach with the patient in a lateral decubitus position. The Navbit® Sprint System for lateral patient registration 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. For Supine Patient Registration: The Navbit® Sprint 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® Sprint System facilitates the accurate positioning of implants, relative to these alignment axes. The clinical setting and target population for the Navbit® Sprint System is that of a patient undergoing a Hip Arthroplasty surgical procedure by any approach with the patient in a supine position. The Navbit® Sprint System for supine patient registration 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/K200376
Methodology: https://510kreport.com/methodology