510(k) · Cleared
Recalled · Class II · 2026Harvey (R) Surgical Assistant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthalign, Inc. · OLO Orthopedic Stereotaxic Instrument
Cleared on Jun 18, 2020 as substantially equivalent to K162962 (Orthalign, Inc., 2017) after a 76-day review. Its family tree reaches back 13 generations to 1999. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Jun 18, 2020
- Review
- 76 days
- Class
- Class II
- Product code
- OLO
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 13 generations to K983831 (1999). 44 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 13 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 9 generations between
- 3 generations backK140331 Orthalign Plus SystemOrthalign, Inc. · 2014
- 2 generations backK153237 OrthAlign Plus SystemOrthalign, Inc. · 2016
- 1 generation backK162962 OrthAlign Plus SystemOrthalign, Inc. · 2017
- This deviceK200892 Harvey (R) Surgical AssistantOrthalign, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK262253 Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit…Orthalign, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK253507 Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack…Orthalign, Inc. · 2026
Show all 13 generations
- Root · 13 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 12 generations backK014256 Kolibri Igs SystemsBrainlab AG · 2002
- 11 generations backK031770 CI TKR/UkrBrainlab AG · 2003
- 10 generations backK041899 Vectorvision Uni-KneeBrainlab AG · 2004
- 9 generations backK052966 CI Knee, CI MI TKRBrainlab AG · 2006
- 8 generations backK073615 Brainlab Knee Essential, Brainlab Knee Unlimited CI Knee, CI Knee…Brainlab AG · 2008
- 7 generations backK091411 Kneealign SystemOrthalign, Inc. · 2009
- 6 generations backK093998 Kneealign System with Reference SensorOrthalign, Inc. · 2010
- 5 generations backK103829 Kneealign SystemOrthalign, Inc. · 2011
- 4 generations backK130387 Orthoalign Plus SystemOrthalign, Inc. · 2013
- 3 generations backK140331 Orthalign Plus SystemOrthalign, Inc. · 2014
- 2 generations backK153237 OrthAlign Plus SystemOrthalign, Inc. · 2016
- 1 generation backK162962 OrthAlign Plus SystemOrthalign, Inc. · 2017
- This deviceK200892 Harvey (R) Surgical AssistantOrthalign, Inc. · 2020
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 |
|---|---|---|---|---|---|
| −13 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −12 | K014256 | Kolibri Igs Systems | Brainlab AG | 2002 | — |
| −11 | K031770 | CI TKR/Ukr | Brainlab AG | 2003 | — |
| −10 | K041899 | Vectorvision Uni-Knee | Brainlab AG | 2004 | — |
| −9 | K052966 | CI Knee, CI MI TKR | Brainlab AG | 2006 | — |
| −8 | K073615 | Brainlab Knee Essential, Brainlab Knee Unlimited CI Knee, CI Knee Unlimited | Brainlab AG | 2008 | — |
| −7 | K091411 | Kneealign System | Orthalign, Inc. | 2009 | — |
| −6 | K093998 | Kneealign System with Reference Sensor | Orthalign, Inc. | 2010 | — |
| −5 | K103829 | Kneealign System | Orthalign, Inc. | 2011 | — |
| −4 | K130387 | Orthoalign Plus System | Orthalign, Inc. | 2013 | — |
| −3 | K140331 | Orthalign Plus System | Orthalign, Inc. | 2014 | — |
| −2 | K153237 | OrthAlign Plus System | Orthalign, Inc. | 2016 | — |
| −1 | K162962 | OrthAlign Plus System | Orthalign, Inc. | 2017 | — |
| 0 (this device) | K200892 | Harvey (R) Surgical Assistant | Orthalign, Inc. | 2020 | — |
| +1 | K262253 | Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03) | Orthalign, Inc. | 2026 | — |
| +1 | K253507 | Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee | Orthalign, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 3 | 0 |
| 2001 | 5 | 0 |
| 2002 | 5 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 2 | 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? (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 |
|---|---|---|---|
| * | K162962 | OrthAlign Plus SystemSummary page 4…Stereotaxic Instrument TRADE NAME OrthAlign Harvey® Surgical Assistant (HAS) System PRIMARY PREDICATE DEVICE OrthAlign Plus System (K162962) Reference Device OrthAlign Plus System (K130387) SUBMISSION TYPE Special 510(k) Devic… | 2017 |
| † | K130387 | Orthoalign Plus System | 2013 |
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 |
|---|---|---|---|---|
| Feb 10, 2026 | Class II | Z-1630-2026 | Nonconforming Material/Component | Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm) |
| Feb 10, 2026 | Class II | Z-1629-2026 | Nonconforming Material/Component | Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm) |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- 6 of the 44 ancestors have a recall of any class.
- Of its descendants, K262253 (Orthalign, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K162962.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 HSA system is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. The HSA system facilitates the accurate positioning of implants, relative to these alignment axes.
Example orthopedic surgical procedures include but are not limited to:
• Total Knee Arthroplasty
• Unicompartmental Knee Arthroplasty: Tibial transverse resection.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200892 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200892: Harvey (R) Surgical Assistant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200892
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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