510(k) · Cleared
ClearedOrthoscan TAU MVP Mini C-Arm System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ziehm-Orthoscan, Inc. · OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
Cleared on Jan 14, 2026 as substantially equivalent to K250587 (Ziehm-Orthoscan, Inc., 2025) and 1 other predicate after a 152-day review. Its family tree reaches back 11 generations to 1983. 1 of the 61 devices in its family, counting itself, has a Class I recall.
- Decided
- Jan 14, 2026
- Review
- 152 days
- Class
- Class II
- Product code
- OXO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K833587 (1983). 60 ancestors in all, the oldest K771218 (1978). No later device cites it as a predicate yet. 1 of the 61 devices in this family, counting this one, has a Class I recall.
- Root · 11 generations backK833587 Disposable Arthroscopy BladeDyonics, Inc. · 1983
- 7 generations between
- 3 generations backK162475 mi-eye 2, mi-eye 2 monitorTrice Medical · 2016
- 2 generations backK181982 MIDAScope and Introducer Kit, and MIDASystemIntravu, Inc. · 2018
- 1 generation backK243020 MIDASVuIntravu, Inc. · 2024
- This deviceK252579 Orthoscan TAU MVP Mini C-Arm SystemZiehm-Orthoscan, Inc. · 2026
Show all 11 generations
- Root · 11 generations backK833587 Disposable Arthroscopy BladeDyonics, Inc. · 1983
- 10 generations backK900070 Modified Uses of the Arthroscopic Surgical SystemDyonics, Inc. · 1990
- 9 generations backK971253 Various Arthroscopes, Endoscopic Blades, Manual InstrumentsSmith & Nephew, Inc. · 1997
- 8 generations backK043395 Smith & Nephew VideoarthroscopeSmith & Nephew, Inc. · 2005
- 7 generations backK072879 Innervue Diagnostic Scope SystemBiomet Orthopedics, Inc. · 2008 · Recalled
- 6 generations backK082293 Surgview Integrated Visualization SystemBiovision Technologies, LLC · 2008
- 5 generations backK093717 C-Mor Visualization DeviceAxis Surgical Technologies, Inc. · 2010
- 4 generations backK141119 Camera Enabled ProbeTrice Medical, Inc. · 2014
- 3 generations backK162475 mi-eye 2, mi-eye 2 monitorTrice Medical · 2016
- 2 generations backK181982 MIDAScope and Introducer Kit, and MIDASystemIntravu, Inc. · 2018
- 1 generation backK243020 MIDASVuIntravu, Inc. · 2024
- This deviceK252579 Orthoscan TAU MVP Mini C-Arm SystemZiehm-Orthoscan, Inc. · 2026
Class I recalls in this family
- K003837 Flexiview 8800 Digital Mobile Imaging System8 generations back · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K833587 | Disposable Arthroscopy Blade | Dyonics, Inc. | 1983 | — |
| −10 | K900070 | Modified Uses of the Arthroscopic Surgical System | Dyonics, Inc. | 1990 | — |
| −9 | K971253 | Various Arthroscopes, Endoscopic Blades, Manual Instruments | Smith & Nephew, Inc. | 1997 | — |
| −8 | K043395 | Smith & Nephew Videoarthroscope | Smith & Nephew, Inc. | 2005 | — |
| −7 | K072879 | Innervue Diagnostic Scope System | Biomet Orthopedics, Inc. | 2008 | 2 |
| −6 | K082293 | Surgview Integrated Visualization System | Biovision Technologies, LLC | 2008 | — |
| −5 | K093717 | C-Mor Visualization Device | Axis Surgical Technologies, Inc. | 2010 | — |
| −4 | K141119 | Camera Enabled Probe | Trice Medical, Inc. | 2014 | — |
| −3 | K162475 | mi-eye 2, mi-eye 2 monitor | Trice Medical | 2016 | — |
| −2 | K181982 | MIDAScope and Introducer Kit, and MIDASystem | Intravu, Inc. | 2018 | — |
| −1 | K243020 | MIDASVu | Intravu, Inc. | 2024 | — |
| 0 (this device) | K252579 | Orthoscan TAU MVP Mini C-Arm System | Ziehm-Orthoscan, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 5 | 1 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 4 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 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.
1 device in this family has a Class I recall. 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 OXO device
- #1 K253296 Digital C-ARM with 3Dscore 15.1 · 13 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 |
|---|---|---|---|
| * | K250587 | Orthoscan TAU Mini C-ArmSummary page 5…ay system Device: Image-Intensified Fluoroscopic X-ray System, Mobile Product Codes: OXO, JAA, MQB, HRX, GCJ Primary Predicate: Orthoscan TAU Mini C-Arm 510(k) Number: K250587 Regulation: 21 CFR 892.1650 Device Class: Class II Regulation Names: Image-intensified fluoroscopic x-ray system Product Code: OX… | 2025 |
| * | K243020 | MIDASVuSummary page 5…FR 892.1650 Device Class: Class II Regulation Names: Image-intensified fluoroscopic x-ray system Product Code: OXO, JAA, MQB Secondary Predicate: MIDASVu 510(k) Number: K243020 General Description: The proposed Orthoscan TAU MVP (Multi Viewing Platform) Mini C-Arm system models 1000-0022, 1000-0023 retai… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K003837Flexiview 8800 Digital Mobile Imaging SystemGe Oec Medical Systems · 2001 · 8 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 43 years and passes through 9 companies; a new generation was cleared every 3.0 years on median.
- 11 of the 60 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All OXO devicesOXO Image-Intensified Fluoroscopic X-Ray System, Mobile: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · OXO
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OXO
97in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OXO
4in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OXO
118in 2025
MAUDE reports naming product code OXO, 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 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 4 | 48 | 4 | 5 |
| 2013 | 2 | — | 3 | 41 |
| 2014 | 2 | — | 4 | 89 |
| 2015 | 1 | — | 0 | 97 |
| 2016 | 3 | 128 | 3 | 3,820 |
| 2017 | 4 | 57 | 4 | 1,697 |
| 2018 | 1 | — | 11 | 1,647 |
| 2019 | 3 | 213 | 0 | 1,297 |
| 2020 | 0 | — | 0 | 816 |
| 2021 | 2 | — | 0 | 554 |
| 2022 | 0 | — | 0 | 295 |
| 2023 | 0 | — | 0 | 275 |
| 2024 | 2 | — | 4 | 192 |
| 2025 | 4 | 97 | 0 | 118 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Orthoscan TAU MVP system is designed to provide physicians with general fluoroscopic visualization, using pulsed or continuous fluoroscopy, of a patient including but not limited to, diagnostic, surgical, and critical emergency care procedures for patients of all ages including pediatric populations when imaging limbs/extremities, shoulders, at locations including but not limited to, hospitals, ambulatory surgery, emergency, traumatology, orthopedic…
Read the full statement (104 words)
The Orthoscan TAU MVP system is designed to provide physicians with general fluoroscopic visualization, using pulsed or continuous fluoroscopy, of a patient including but not limited to, diagnostic, surgical, and critical emergency care procedures for patients of all ages including pediatric populations when imaging limbs/extremities, shoulders, at locations including but not limited to, hospitals, ambulatory surgery, emergency, traumatology, orthopedic, critical care, or physician office environments.
The scope used with Orthoscan TAU MVP system is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination and visualization of interior cavity joints and other body cavities through a natural or surgical opening.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252579 · printed Nov 3, 2026
Cite this page
510(k) Report. “K252579: Orthoscan TAU MVP Mini C-Arm System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K252579
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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