510(k) · Cleared
ClearedIntellijoint HIP Generation 2A 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 Mar 2, 2017 as substantially equivalent to K151364 (Intellijoint Surgical, Inc., 2015) and 1 other predicate after a 191-day review. Its family tree reaches back 9 generations to 2001. 7 later devices descend from it.
- Decided
- Mar 2, 2017
- Review
- 191 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K010612 (2001). 23 ancestors in all, the oldest K983831 (1999). 7 later devices descend from it, 3 citing it directly.
- Root · 9 generations backK010612 Vectorvision KneeBrainlab AG · 2001
- 5 generations between
- 3 generations backK110021 Dash HipBrainlab AG · 2011
- 2 generations backK133759 Intellijoint HipIntellijoint Surgical, Inc. · 2014
- 1 generation backK151364 Intellijoint HIP (tm) SystemIntellijoint Surgical, Inc. · 2015
- This deviceK162364 Intellijoint HIP Generation 2A SystemIntellijoint Surgical, Inc. · 2017
- Descendant · cites it directly · 3 of its ownK171525 Intellijoint HIP Generation 2B SystemIntellijoint Surgical, Inc. · 2017
- Descendant · 2 generations on · 2 of its ownK191507 Intellijoint® Navigation SystemIntellijoint Surgical, Inc. · 2019 · Recalled
- Descendant · cites it directly · 1 of its ownK193094 Naviswiss Hip Navigation SystemNaviswiss AG · 2020
- Descendant · cites it directly · 1 of its ownK172849 Intellijoint HIP System (Cart), Intellijoint HIP System (Portable)…Intellijoint Surgical, Inc. · 2017 · Recalled
- Descendant · 3 generations on · 0 of its ownK252847 NextAR Hip PlatformMedacta International S.A. · 2026
Show all 9 generations
- Root · 9 generations backK010612 Vectorvision KneeBrainlab AG · 2001
- 8 generations backK021306 Vectorvision CT-Free KneeBrainlab AG · 2002
- 7 generations backK040368 Vectorvision Hip 3.0Brainlab AG · 2004
- 6 generations backK052213 Navigation SW Hip 3.1 on CIBrainlab AG · 2005
- 5 generations backK060468 Vectorvision HipBrainlab AG · 2006
- 4 generations backK083483 Brainlab Hip Unlimited, CI Hip UnlimitedBrainlab AG · 2009
- 3 generations backK110021 Dash HipBrainlab AG · 2011
- 2 generations backK133759 Intellijoint HipIntellijoint Surgical, Inc. · 2014
- 1 generation backK151364 Intellijoint HIP (tm) SystemIntellijoint Surgical, Inc. · 2015
- This deviceK162364 Intellijoint HIP Generation 2A SystemIntellijoint Surgical, Inc. · 2017
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K171525Intellijoint HIP Generation 2B SystemIntellijoint Surgical, Inc. · 2017 · cites it directly3descendants
- K191507Intellijoint® Navigation SystemIntellijoint Surgical, Inc. · 2019 · 2 generations on2descendants
- K193094Naviswiss Hip Navigation SystemNaviswiss AG · 2020 · cites it directly1descendant
- K172849Intellijoint HIP System (Cart), Intellijoint HIP System (Portable), Intellijoint HIP…Intellijoint Surgical, Inc. · 2017 · cites it directly1descendant
- K252847NextAR Hip PlatformMedacta International S.A. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K010612 | Vectorvision Knee | Brainlab AG | 2001 | — |
| −8 | K021306 | Vectorvision CT-Free Knee | Brainlab AG | 2002 | — |
| −7 | K040368 | Vectorvision Hip 3.0 | Brainlab AG | 2004 | — |
| −6 | K052213 | Navigation SW Hip 3.1 on CI | Brainlab AG | 2005 | — |
| −5 | K060468 | Vectorvision Hip | Brainlab AG | 2006 | — |
| −4 | K083483 | Brainlab Hip Unlimited, CI Hip Unlimited | Brainlab AG | 2009 | — |
| −3 | K110021 | Dash Hip | Brainlab AG | 2011 | — |
| −2 | K133759 | Intellijoint Hip | Intellijoint Surgical, Inc. | 2014 | — |
| −1 | K151364 | Intellijoint HIP (tm) System | Intellijoint Surgical, Inc. | 2015 | — |
| 0 (this device) | K162364 | Intellijoint HIP Generation 2A System | Intellijoint Surgical, Inc. | 2017 | — |
| +1 | K171525 | Intellijoint HIP Generation 2B System | Intellijoint Surgical, Inc. | 2017 | — |
| +2 | K191507 | Intellijoint® Navigation System | Intellijoint Surgical, Inc. | 2019 | 2 |
| +1 | K193094 | Naviswiss Hip Navigation System | Naviswiss AG | 2020 | — |
| +1 | K172849 | Intellijoint HIP System (Cart), Intellijoint HIP System (Portable)… | Intellijoint Surgical, Inc. | 2017 | 1 |
| +3 | K252847 | NextAR Hip Platform | Medacta International S.A. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K151364 | Intellijoint HIP (tm) SystemSummary page 4…Predicate Device Manufacturer 510(k) No. intellijoint HIP® Generation 2 System Intellijoint Surgical Inc. K151364 Navitrack™ System – Total Hip Replacement ORTHOsoft, Inc.… | 2015 |
| * | K041369 | Navitrack System - S&N Image Free Hip, Model Pro-03017Summary page 4…Surgical Inc. K151364 Navitrack™ System – Total Hip Replacement ORTHOsoft, Inc. K041369 CT-Free 5. Device Description The intellijoint HIP® Generation 2A System is an imageless optical naviga… | 2004 |
What descends from it? (7)
3 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)
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 16 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- 4 of the 23 ancestors have a recall of any class.
- Of its descendants, K171525 (Intellijoint Surgical, Inc., 2017) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K151364.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 HIP Generation 2A System is a computer-controlled, optical localizer intended to provide intra-operative measurements to a surgeon to aid in selection and positioning of orthopaedic implant system components, where a reference to a rigid anatomical structure can be identified. The system is only compatible with straight acetabular cup impactors. The Intellijoint HIP Generation 2A System is indicated for patients undergoing orthopaedic…
Read the full statement (115 words)
The Intellijoint HIP Generation 2A System is a computer-controlled, optical localizer intended to provide intra-operative measurements to a surgeon to aid in selection and positioning of orthopaedic implant system components, where a reference to a rigid anatomical structure can be identified. The system is only compatible with straight acetabular cup impactors.
The Intellijoint HIP Generation 2A System is indicated for patients undergoing orthopaedic surgery, and where the use of stereotactic surgery is considered safe and effective. The system aids the surgeon in performing intra-operative measurements including measurements of limb position, joint center-of-rotation, and implant component positioning.
Example orthopaedic surgical procedures include, but are not limited to:
- Total Hip Arthroplasty
- Minimally Invasive Hip Arthroplasty
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162364 · printed Nov 5, 2026
Cite this page
510(k) Report. “K162364: Intellijoint HIP Generation 2A System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K162364
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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