510(k) · Cleared
ClearedOMNIVision system
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corin USA · OLO Orthopedic Stereotaxic Instrument
Cleared on Apr 12, 2021 as substantially equivalent to K172849 (Intellijoint Surgical, Inc., 2017) and 1 other predicate after a 110-day review. Its family tree reaches back 11 generations to 2001.
- Decided
- Apr 12, 2021
- Review
- 110 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K010612 (2001). 28 ancestors in all, the oldest K983831 (1999). No later device cites it as a predicate yet.
- 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 backK172849 Intellijoint HIP System (Cart), Intellijoint HIP System (Portable)…Intellijoint Surgical, Inc. · 2017 · Recalled
- This deviceK203751 OMNIVision systemCorin USA · 2021
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 backK172849 Intellijoint HIP System (Cart), Intellijoint HIP System (Portable)…Intellijoint Surgical, Inc. · 2017 · Recalled
- This deviceK203751 OMNIVision systemCorin USA · 2021
View 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 | K172849 | Intellijoint HIP System (Cart), Intellijoint HIP System (Portable)… | Intellijoint Surgical, Inc. | 2017 | 1 |
| 0 (this device) | K203751 | OMNIVision system | Corin USA | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 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 |
|---|---|---|---|
| * | K172849 | Intellijoint HIP System (Cart), Intellijoint HIP System (Portable), Intellijoint HIP…Summary page 4…OLO - Class II Classification Panel: Orthopedic Regulation Number: 21 CFR 882.4560 C1. PRIMARY PREDICATE DEVICE K172849 Intellijoint Surgical Inc., Intellijoint HIP@ Generation 2C System C1. PREDICATE DEVICE K05… | 2017 |
| * | K050615 | Stryker Navigation System - CT-Based Hip Module, Model 6007-621-000Summary page 4…C1. PRIMARY PREDICATE DEVICE K172849 Intellijoint Surgical Inc., Intellijoint HIP@ Generation 2C System C1. PREDICATE DEVICE K050615 Stryker Navigation System - CT Based Hip Module December 22, 2020 OMNIVision Sys… | 2005 |
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 20 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- 7 of the 28 ancestors have a recall of any class.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 OMNIVisionTM system is intended to be used as an intra-operative system to assist in the alignment of prosthetic components during Total Hip Arthroplasty, where a reference to a rigid anatomical structure can be identified. The system achieves this by displaying intra-operative measurements of the acetabular component to the user calculated from visual information from a camera detecting fiducial markers. The OMNIVisionTM system is compatible for use…
Read the full statement (116 words)
The OMNIVisionTM system is intended to be used as an intra-operative system to assist in the alignment of prosthetic components during Total Hip Arthroplasty, where a reference to a rigid anatomical structure can be identified.
The system achieves this by displaying intra-operative measurements of the acetabular component to the user calculated from visual information from a camera detecting fiducial markers.
The OMNIVisionTM system is compatible for use with the legally marketed products
* OPSInsightM and
* the Corin Trinitym Acetabular System,
* Trinity-iTm Acetabular shells and
* TrinitvTM non-occluded titanium plasma sprayed (TPS) acetabular shells.
The OMNIVisionTM system is indicated for use with the posterior, anterolateral and direct anterior surgical approaches for primary Total Hip Arthroplasty.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203751 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203751: OMNIVision system.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203751
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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