510(k) · Cleared
ClearedOVOMotion Shoulder Arthroplasty System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrosurface, Inc. · HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Cleared on Apr 18, 2018 as substantially equivalent to K142942 (Arthrosurface, Inc., 2014) and 1 other predicate after a 110-day review. Its family tree reaches back 12 generations to 1993.
- Decided
- Apr 18, 2018
- Review
- 110 days
- Class
- Class II
- Product code
- HSD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K920362 (1993). 85 ancestors in all, the oldest K790987 (1979). No later device cites it as a predicate yet.
- Root · 12 generations backK920362 3M Modular Shoulder System3M Health Care, Ltd. · 1993
- 8 generations between
- 3 generations backK121220 Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small…Exactech, Inc. · 2012 · Recalled
- 2 generations backK150583 Aequalis PerFORM+ Shoulder SystemTornier, Inc. · 2015
- 1 generation backK152825 Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC · 2016
- This deviceK173964 OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc. · 2018
Show all 12 generations
- Root · 12 generations backK920362 3M Modular Shoulder System3M Health Care, Ltd. · 1993
- 11 generations backK002683 WMT Ultra-Fit Modular Shoulder SystemWrightmedicaltechnologyinc · 2000
- 10 generations backK032679 Aequalis Shoulder Fracture SystemTornier · 2003
- 9 generations backK043077 Modification to Aequalis Shoulder Fracture System; Aequalis Shoulder…Tornier · 2004
- 8 generations backK060209 Aequalis Shoulder Fracture System & Aequalis Shoulder SystemTornier · 2006
- 7 generations backK081707 Aequalis Shoulder Fracture and Shoulder SystemsTornier, Inc. · 2008
- 6 generations backK093430 Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech…Exactech, Inc. · 2010 · Recalled
- 5 generations backK103419 Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TMExactech, Inc. · 2010 · Recalled
- 4 generations backK111379 Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium…Exactech, Inc. · 2011 · Recalled
- 3 generations backK121220 Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small…Exactech, Inc. · 2012 · Recalled
- 2 generations backK150583 Aequalis PerFORM+ Shoulder SystemTornier, Inc. · 2015
- 1 generation backK152825 Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC · 2016
- This deviceK173964 OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K920362 | 3M Modular Shoulder System | 3M Health Care, Ltd. | 1993 | — |
| −11 | K002683 | WMT Ultra-Fit Modular Shoulder System | Wrightmedicaltechnologyinc | 2000 | — |
| −10 | K032679 | Aequalis Shoulder Fracture System | Tornier | 2003 | — |
| −9 | K043077 | Modification to Aequalis Shoulder Fracture System; Aequalis Shoulder System | Tornier | 2004 | — |
| −8 | K060209 | Aequalis Shoulder Fracture System & Aequalis Shoulder System | Tornier | 2006 | — |
| −7 | K081707 | Aequalis Shoulder Fracture and Shoulder Systems | Tornier, Inc. | 2008 | — |
| −6 | K093430 | Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech Equinoxe Cage… | Exactech, Inc. | 2010 | 1 |
| −5 | K103419 | Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TM | Exactech, Inc. | 2010 | 2 |
| −4 | K111379 | Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium / Large /… | Exactech, Inc. | 2011 | 2 |
| −3 | K121220 | Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small, Left/Right | Exactech, Inc. | 2012 | 2 |
| −2 | K150583 | Aequalis PerFORM+ Shoulder System | Tornier, Inc. | 2015 | — |
| −1 | K152825 | Catalyst CSR Shoulder System | Catalyst Orthoscience, LLC | 2016 | — |
| 0 (this device) | K173964 | OVOMotion Shoulder Arthroplasty System | Arthrosurface, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 2 | 0 |
| 1987 | 2 | 0 |
| 1991 | 3 | 0 |
| 1992 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 9 | 0 |
| 2000 | 6 | 0 |
| 2001 | 10 | 0 |
| 2002 | 1 | 0 |
| 2003 | 6 | 0 |
| 2004 | 6 | 0 |
| 2005 | 1 | 0 |
| 2006 | 5 | 0 |
| 2007 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 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 HSD? 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 HSD device
- #1 K191433 AGILON® XO Shoulder Replacement Systemscore 13.8 · 16 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 |
|---|---|---|---|
| * | K142942 | HemiCAP Humeral Head XL (HHXL) Articular Resurfacing SystemSummary page 5…wing predicate(s) and/or reference devices, which have been previously cleared by the FDA: Primary Predicate: Arthrosurface HemiCAP OVO Humeral System K142942 Additional Predicate: Catalyst CSR Shoulder System K152825 Reference Device: Arthrosurface G… | 2014 |
| * | K152825 | Catalyst CSR Shoulder SystemSummary page 5…Primary Predicate: Arthrosurface HemiCAP OVO Humeral System K142942 Additional Predicate: Catalyst CSR Shoulder System K152825 Reference Device: Arthrosurface GRS™ Glenoid Resurfacing System K091196 Arthrosurface HemiCAP® Shoulder… | 2016 |
| † | K091196 | GRS Glenoid Resurfacing System | 2009 |
| † | K023096 | Contoured Articular Prosthesis (Cap) Humeral Head Resurfacing System | 2003 |
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 25 years and passes through 7 companies; a new generation was cleared every 1.9 years on median.
- 21 of the 85 ancestors have a recall of any class.
How does its category compare?
All HSD devicesHSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · HSD
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HSD
145in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSD
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSD
757in 2025
MAUDE reports naming product code HSD, 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 | 4 | 72 | 0 | 128 |
| 2008 | 3 | 92 | 2 | 259 |
| 2009 | 0 | — | 2 | 156 |
| 2010 | 0 | — | 0 | 225 |
| 2011 | 2 | — | 0 | 241 |
| 2012 | 2 | — | 0 | 254 |
| 2013 | 4 | 218 | 0 | 288 |
| 2014 | 1 | — | 0 | 434 |
| 2015 | 0 | — | 0 | 574 |
| 2016 | 3 | 145 | 0 | 784 |
| 2017 | 0 | — | 3 | 985 |
| 2018 | 1 | — | 1 | 649 |
| 2019 | 0 | — | 0 | 830 |
| 2020 | 2 | — | 1 | 658 |
| 2021 | 0 | — | 0 | 573 |
| 2022 | 1 | — | 0 | 508 |
| 2023 | 0 | — | 0 | 586 |
| 2024 | 1 | — | 0 | 693 |
| 2025 | 0 | — | 0 | 757 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For the reconstruction of painful and/or severely disabled shoulder joints resulting from post-traumatic degenerative disease or avascular necrosis. The humeral head and neck and glenoid vault should be of sufficient bone stock to support loading. The rotator cuff should be intact or reconstructable.
The device is a single use implant intended to be used for hemiarthroplasty or in conjunction with the Arthrosurface glenoid component for total shoulder arthroplasty.
Both humeral and glenoid components of the OVOMotion™ Shoulder Arthroplasty System are intended for cemented use only.
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/K173964 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173964: OVOMotion Shoulder Arthroplasty System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173964
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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