510(k) · Cleared

Cleared

PathKeeper System

K222355510(k) TraditionalCleared Mar 8, 2023216-day reviewClass II21 CFR 882.4560

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Pathkeeper Surgical, Ltd. · OLO Orthopedic Stereotaxic Instrument

Cleared on Mar 8, 2023 as substantially equivalent to K162375 (7D Surgical, Inc., 2016) after a 216-day review. Its family tree reaches back 3 generations to 2005.

Decided: Mar 8, 2023
Review: 216 days
Class: Class II
Product code: OLO
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K050438 (2005). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK050438 Stealthstation System UpdateMedtronic Surgical Navigation Technologies · 2005 · Recalled
2 generations backK133444 Stealthstation S7 / I7 / Fusion Navigation Systems, Axiem Navigation…Medtronic Navigation, Inc. · 2014 · Recalled
1 generation backK162375 Envision 3D: Image Guidance System7D Surgical, Inc. · 2016
This deviceK222355 PathKeeper SystemPathkeeper Surgical, Ltd. · 2023

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K050438	Stealthstation System Update	Medtronic Surgical Navigation Technologies	2005	11
−2	K133444	Stealthstation S7 / I7 / Fusion Navigation Systems, Axiem Navigation System	Medtronic Navigation, Inc.	2014	1
−1	K162375	Envision 3D: Image Guidance System	7D Surgical, Inc.	2016	—
0 (this device)	K222355	PathKeeper System	Pathkeeper Surgical, Ltd.	2023	—

FIG. 1 — Lineage of K222355, 2005–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 OLO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new OLO device

#1 K240662 Spine Guidance Software (version 5.0); Xia 3/…score 23.7 · 15 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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	Applicant	Decided	Recalls
*	K162375	Envision 3D: Image Guidance System Summary page 4 …7D Surgical Inc. Device Name and Model Envision 3DTM: Image Guidance System 510(k) Number K162375 Product Code OLO Regulation Number 21 CFR 882.4560 Regula…	7D Surgical, Inc.	2016	—

Also cleared against K162375: 4 other devices →

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 18 years and passes through 4 companies; a new generation was cleared every 6.2 years on median.
2 of the 3 ancestors have a recall of any class.
4 other devices also cite its predicate K162375.

How does its category compare?

All OLO devices

OLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.

FDA decisions per year · OLO

40in 2025

2007high 45 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OLO

119in 2025

2007high 176 (2015) · low 89 (2020)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · OLO

1in 2025

2007high 7 (2023) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · OLO

3,306in 2025

2007high 3,306 (2025) · low 0 (2007)2025

MAUDE reports naming product code OLO, not matched to any one device; reports are not rates.

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	1
2009	11	126	0	4
2010	9	113	1	4
2011	11	138	1	10
2012	7	129	1	60
2013	7	137	0	36
2014	10	119	3	245
2015	10	176	2	466
2016	14	120	3	750
2017	33	91	2	1,076
2018	24	97	1	1,230
2019	35	95	1	1,585
2020	34	89	6	2,746
2021	28	91	0	1,696
2022	40	89	5	1,568
2023	45	90	7 (1)	1,493
2024	44	90	4	2,353
2025	40	119	1	3,306
2026	42	109	6	—

What is it indicated for?

The PathKeeper System is a stereotaxic image guidance system intended for the spatial positioning and orientation of surgical instruments used by orthopedic surgeons and neurosurgeons during posterior approach spinal fusion surgeries when pre-operative CT imagery is available. The System, with PathKeeper spine surgery planning and navigation software and 3D optical camera, is intended as an aid for precisely locating anatomical structures in posterior…

Read the full statement (105 words)

The device is indicated for posterior approach open spine fusion surgery during pedicle screw placement in the thoraco-lumbo-sacral region where reference to a rigid anatomical structure can be identified.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K222355 · printed Nov 4, 2026

Cite this page

510(k) Report. “K222355: PathKeeper System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222355

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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