510(k) · Cleared
ClearedIntellijoint HIP Generation 2B 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 30, 2017 as substantially equivalent to K162364 (Intellijoint Surgical, Inc., 2017) and 1 other predicate after a 158-day review. Its family tree reaches back 10 generations to 2001. 3 later devices descend from it.
- Decided
- Oct 30, 2017
- Review
- 158 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K010612 (2001). 26 ancestors in all, the oldest K983831 (1999). 3 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK010612 Vectorvision KneeBrainlab AG · 2001
- 6 generations between
- 3 generations backK133759 Intellijoint HipIntellijoint Surgical, Inc. · 2014
- 2 generations backK151364 Intellijoint HIP (tm) SystemIntellijoint Surgical, Inc. · 2015
- 1 generation backK162364 Intellijoint HIP Generation 2A SystemIntellijoint Surgical, Inc. · 2017
- This deviceK171525 Intellijoint HIP Generation 2B SystemIntellijoint Surgical, Inc. · 2017
- Descendant · cites it directly · 2 of its ownK191507 Intellijoint® Navigation SystemIntellijoint Surgical, Inc. · 2019 · Recalled
- Descendant · 2 generations on · 0 of its ownK252847 NextAR Hip PlatformMedacta International S.A. · 2026
- Descendant · 2 generations on · 0 of its ownK223351 Naviswiss KneeNaviswiss AG · 2023
Show all 10 generations
- Root · 10 generations backK010612 Vectorvision KneeBrainlab AG · 2001
- 9 generations backK021306 Vectorvision CT-Free KneeBrainlab AG · 2002
- 8 generations backK040368 Vectorvision Hip 3.0Brainlab AG · 2004
- 7 generations backK052213 Navigation SW Hip 3.1 on CIBrainlab AG · 2005
- 6 generations backK060468 Vectorvision HipBrainlab AG · 2006
- 5 generations backK083483 Brainlab Hip Unlimited, CI Hip UnlimitedBrainlab AG · 2009
- 4 generations backK110021 Dash HipBrainlab AG · 2011
- 3 generations backK133759 Intellijoint HipIntellijoint Surgical, Inc. · 2014
- 2 generations backK151364 Intellijoint HIP (tm) SystemIntellijoint Surgical, Inc. · 2015
- 1 generation backK162364 Intellijoint HIP Generation 2A SystemIntellijoint Surgical, Inc. · 2017
- This deviceK171525 Intellijoint HIP Generation 2B SystemIntellijoint Surgical, Inc. · 2017
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K010612 | Vectorvision Knee | Brainlab AG | 2001 | — |
| −9 | K021306 | Vectorvision CT-Free Knee | Brainlab AG | 2002 | — |
| −8 | K040368 | Vectorvision Hip 3.0 | Brainlab AG | 2004 | — |
| −7 | K052213 | Navigation SW Hip 3.1 on CI | Brainlab AG | 2005 | — |
| −6 | K060468 | Vectorvision Hip | Brainlab AG | 2006 | — |
| −5 | K083483 | Brainlab Hip Unlimited, CI Hip Unlimited | Brainlab AG | 2009 | — |
| −4 | K110021 | Dash Hip | Brainlab AG | 2011 | — |
| −3 | K133759 | Intellijoint Hip | Intellijoint Surgical, Inc. | 2014 | — |
| −2 | K151364 | Intellijoint HIP (tm) System | Intellijoint Surgical, Inc. | 2015 | — |
| −1 | K162364 | Intellijoint HIP Generation 2A System | Intellijoint Surgical, Inc. | 2017 | — |
| 0 (this device) | K171525 | Intellijoint HIP Generation 2B System | Intellijoint Surgical, Inc. | 2017 | — |
| +1 | K191507 | Intellijoint® Navigation System | Intellijoint Surgical, Inc. | 2019 | 2 |
| +2 | K252847 | NextAR Hip Platform | Medacta International S.A. | 2026 | — |
| +2 | 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 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 |
|---|---|---|---|
| * | K162364 | Intellijoint HIP Generation 2A SystemSummary page 4…Predicate Device Manufacturer 510(k) No. Intellijoint HIP® Generation 2A System Intellijoint Surgical Inc. K162364 Stryker OrthoMap Versatile Hip System Stryker Leibinger GmbH K162937 5. Device Description… | 2017 |
| * | K162937 | Stryker OrthoMap Versatile Hip SystemSummary page 4…t HIP® Generation 2A System Intellijoint Surgical Inc. K162364 Stryker OrthoMap Versatile Hip System Stryker Leibinger GmbH K162937 5. Device Description The Intellijoint HIP® Generation 2B System is an imageless optical navigation system… | 2017 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191507 | Intellijoint® Navigation System | 2019 | 2 |
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.
- 5 of the 26 ancestors have a recall of any class.
- Of its descendants, K191507 (Intellijoint Surgical, Inc., 2019) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K162364.
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 2B 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 HIP Generation 2B System is indicated for patients undergoing orthopedic surgery, and where the use of stereotactic surgery is considered safe and…
Read the full statement (109 words)
The Intellijoint HIP Generation 2B 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 HIP Generation 2B System is indicated for patients undergoing orthopedic 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 orthopedic surgical procedures include, but are not limited to:
- Total Hip Arthroplasty
- Minimally Invasive Hip Arthroplasty
- Revision Hip Arthroplasty
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K171525 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171525: Intellijoint HIP Generation 2B System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171525
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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