510(k) · Cleared
Recalled · Class II · 2026Intellijoint® Navigation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intellijoint Surgical, Inc. · OLO Orthopedic Stereotaxic Instrument
Cleared on Oct 1, 2019 as substantially equivalent to K103829 (Orthalign, Inc., 2011) and 1 other predicate after a 117-day review. Its family tree reaches back 11 generations to 2001. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Oct 1, 2019
- Review
- 117 days
- Class
- Class II
- Product code
- OLO
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 11 generations to K010612 (2001). 39 ancestors in all, the oldest K983831 (1999). 2 later devices descend from it, 2 citing it directly.
- Root · 11 generations backK010612 Vectorvision KneeBrainlab AG · 2001
- 7 generations between
- 3 generations backK151364 Intellijoint HIP (tm) SystemIntellijoint Surgical, Inc. · 2015
- 2 generations backK162364 Intellijoint HIP Generation 2A SystemIntellijoint Surgical, Inc. · 2017
- 1 generation backK171525 Intellijoint HIP Generation 2B SystemIntellijoint Surgical, Inc. · 2017
- This deviceK191507 Intellijoint® Navigation SystemIntellijoint Surgical, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK252847 NextAR Hip PlatformMedacta International S.A. · 2026
- Descendant · cites it directly · 0 of its ownK223351 Naviswiss KneeNaviswiss AG · 2023
Show all 11 generations
- Root · 11 generations backK010612 Vectorvision KneeBrainlab AG · 2001
- 10 generations backK021306 Vectorvision CT-Free KneeBrainlab AG · 2002
- 9 generations backK040368 Vectorvision Hip 3.0Brainlab AG · 2004
- 8 generations backK052213 Navigation SW Hip 3.1 on CIBrainlab AG · 2005
- 7 generations backK060468 Vectorvision HipBrainlab AG · 2006
- 6 generations backK083483 Brainlab Hip Unlimited, CI Hip UnlimitedBrainlab AG · 2009
- 5 generations backK110021 Dash HipBrainlab AG · 2011
- 4 generations backK133759 Intellijoint HipIntellijoint Surgical, Inc. · 2014
- 3 generations backK151364 Intellijoint HIP (tm) SystemIntellijoint Surgical, Inc. · 2015
- 2 generations backK162364 Intellijoint HIP Generation 2A SystemIntellijoint Surgical, Inc. · 2017
- 1 generation backK171525 Intellijoint HIP Generation 2B SystemIntellijoint Surgical, Inc. · 2017
- This deviceK191507 Intellijoint® Navigation SystemIntellijoint Surgical, Inc. · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K010612 | Vectorvision Knee | Brainlab AG | 2001 | — |
| −10 | K021306 | Vectorvision CT-Free Knee | Brainlab AG | 2002 | — |
| −9 | K040368 | Vectorvision Hip 3.0 | Brainlab AG | 2004 | — |
| −8 | K052213 | Navigation SW Hip 3.1 on CI | Brainlab AG | 2005 | — |
| −7 | K060468 | Vectorvision Hip | Brainlab AG | 2006 | — |
| −6 | K083483 | Brainlab Hip Unlimited, CI Hip Unlimited | Brainlab AG | 2009 | — |
| −5 | K110021 | Dash Hip | Brainlab AG | 2011 | — |
| −4 | K133759 | Intellijoint Hip | Intellijoint Surgical, Inc. | 2014 | — |
| −3 | K151364 | Intellijoint HIP (tm) System | Intellijoint Surgical, Inc. | 2015 | — |
| −2 | K162364 | Intellijoint HIP Generation 2A System | Intellijoint Surgical, Inc. | 2017 | — |
| −1 | K171525 | Intellijoint HIP Generation 2B System | Intellijoint Surgical, Inc. | 2017 | — |
| 0 (this device) | K191507 | Intellijoint® Navigation System | Intellijoint Surgical, Inc. | 2019 | — |
| +1 | K252847 | NextAR Hip Platform | Medacta International S.A. | 2026 | — |
| +1 | K223351 | Naviswiss Knee | Naviswiss AG | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2003 | 4 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2026 | 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 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
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K103829 | Kneealign SystemSummary page 4…Device Name Manufacturer 510(k) No. KneeAlign 2 System OrthAlign, Inc. K103829 Additional Predicate: Device Name Manufacturer… | 2011 |
| * | K171525 | Intellijoint HIP Generation 2B SystemSummary page 4…this submission is to gain clearance for updates to the indications for use for the Intellijoint HIP Generation 2B System, which has been previously cleared in K171525. The updated product will be referred to as the Intellijoint® Navigation System throughout the submission.… | 2017 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 28, 2026 | Class II | Z-0119-2027 | Nonconforming Material/Component | A navigation system used to aid in selection and positioning of orthopedic implant system components has a workstation that may contain a 15-inch MacBook Pro battery, subject to an Apple battery recall, that may overheat and pose a fire… |
| Feb 11, 2020 | Class II | Z-1559-2020 | Software design | During total knee arthroplasty (TKA), the software may incorrectly calculate femur resection depth. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- 5 of the 39 ancestors have a recall of any class.
- Of its descendants, K252847 (Medacta International S.A., 2026) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K103829.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · OLO
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLO
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · OLO
3,306in 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 Intellijoint® Navigation System is a computer-controlled, optical localizer intended to provide intra-operative measurements to a surgeon to aid in selection and positioning of orthopedic implant system components, where a reference to a rigid anatomical structure can be identified. The Intellijoint Navigation System is indicated for patients undergoing orthopedic surgery, and where the use of stereotactic surgery is considered safe and effective.…
Read the full statement (129 words)
The Intellijoint® Navigation System is a computer-controlled, optical localizer intended to provide intra-operative measurements to a surgeon to aid in selection and positioning of orthopedic implant system components, where a reference to a rigid anatomical structure can be identified. The Intellijoint Navigation System is indicated for patients undergoing orthopedic surgery, and where the use of stereotactic surgery is considered safe and effective.
Intellijoint HIP aids the surgeon in performing intra-operative measurements including measurements of limb position, joint center-of-rotation, and implant component positioning.
Intellijoint KNEE aids the surgeon in performing intra-operative measurements including alignment of instrumentation and bony cuts for implant component positioning.
Example orthopedic surgical procedures include, but are not limited to:
- Total Hip Arthroplasty
- Minimally Invasive Hip Arthroplasty
- Revision Hip Arthroplasty
- Total Knee Arthroplasty
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191507 · printed Nov 5, 2026
Cite this page
510(k) Report. “K191507: Intellijoint® Navigation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K191507
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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