510(k) · Cleared
ClearedWaypoint GPS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Waypoint Orthopedics, Inc. · QWP Optical Neurosurgical Nerve Locator
Cleared on May 12, 2023 as substantially equivalent to K201454 (Spineguard S.A., 2021) after a 298-day review. Its family tree reaches back 9 generations to 1993.
- Decided
- May 12, 2023
- Review
- 298 days
- Class
- Class II
- Product code
- QWP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K921979 (1993). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK921979 Root ZXJ. Morita USA, Inc. · 1993
- 5 generations between
- 3 generations backK152747 DSG Threaded Drill SystemSpineguard S.A. · 2016
- 2 generations backK162884 SpineGuard DSG Zavation Screw SystemSpineguard S.A. · 2017
- 1 generation backK201454 DSG Connect TechnologySpineguard S.A. · 2021
- This deviceK222106 Waypoint GPSWaypoint Orthopedics, Inc. · 2023
Show all 9 generations
- Root · 9 generations backK921979 Root ZXJ. Morita USA, Inc. · 1993
- 8 generations backK972407 Root Apex LocatorToei Electric Co., Ltd. · 1997
- 7 generations backK022020 Justwo Model Tme-601 Root Apex LocatorToei Electric Co., Ltd. · 2002
- 6 generations backK030526 Pediguard Nerve Detector SystemSpine Vision, Inc. · 2004
- 5 generations backK123390 Pediguard Nerve Detector SystemSpineguard S.A. · 2013
- 4 generations backK143159 Cannulated PediGuard Needle#1, Cannulated PediGuard Needle#2…Spineguard S.A. · 2015
- 3 generations backK152747 DSG Threaded Drill SystemSpineguard S.A. · 2016
- 2 generations backK162884 SpineGuard DSG Zavation Screw SystemSpineguard S.A. · 2017
- 1 generation backK201454 DSG Connect TechnologySpineguard S.A. · 2021
- This deviceK222106 Waypoint GPSWaypoint Orthopedics, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K921979 | Root ZX | J. Morita USA, Inc. | 1993 | — |
| −8 | K972407 | Root Apex Locator | Toei Electric Co., Ltd. | 1997 | — |
| −7 | K022020 | Justwo Model Tme-601 Root Apex Locator | Toei Electric Co., Ltd. | 2002 | — |
| −6 | K030526 | Pediguard Nerve Detector System | Spine Vision, Inc. | 2004 | — |
| −5 | K123390 | Pediguard Nerve Detector System | Spineguard S.A. | 2013 | — |
| −4 | K143159 | Cannulated PediGuard Needle#1, Cannulated PediGuard Needle#2, Cannulated… | Spineguard S.A. | 2015 | — |
| −3 | K152747 | DSG Threaded Drill System | Spineguard S.A. | 2016 | — |
| −2 | K162884 | SpineGuard DSG Zavation Screw System | Spineguard S.A. | 2017 | — |
| −1 | K201454 | DSG Connect Technology | Spineguard S.A. | 2021 | — |
| 0 (this device) | K222106 | Waypoint GPS | Waypoint Orthopedics, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QWP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K201454 | DSG Connect TechnologySummary page 4…s: II Product Code: QWP III. PREDICATE DEVICE(S) The subject device is equivalent to the following devices: • K201454 DSG Connect Technology IV. DEVICE DESCRIPTION: The Waypoint GPS™ is comprised of a single use, disposable device and… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- None of the 12 ancestors has a recall.
How does its category compare?
All QWP devicesQWP Optical Neurosurgical Nerve Locator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QWP
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · QWP
Too few QWP 510(k)s in any year since 2007 to give a median.
Recalls per year · QWP
No recall names QWP since 2007.
Adverse event reports per year · QWP
No MAUDE report names QWP since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Waypoint GPS™ is indicated for use during pedicle screw pilot hole drilling to provide visual feedback to the
surgeon of changes in color to the tissue at the tip of the probe that may indicate contact with soft tissues and
possible vertebral cortex perforation. The Waypoint GPS™ is indicated for use in both open and percutaneous
(MIS) procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222106 · printed Nov 5, 2026
Cite this page
510(k) Report. “K222106: Waypoint GPS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K222106
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026