510(k) · Cleared
ClearedVelora Acetabular System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Restor3D, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Dec 5, 2025 as substantially equivalent to K190904 (Conformis, Inc., 2019) and 2 other predicates after a 157-day review. Its family tree reaches back 20 generations to 1994.
- Decided
- Dec 5, 2025
- Review
- 157 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 20 generations to K941847 (1994). 395 ancestors in all, the oldest K800894 (1980). No later device cites it as a predicate yet.
- Root · 20 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 16 generations between
- 3 generations backK202472 ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc. · 2020
- 2 generations backK231873 DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT…Depuy Ireland UC · 2024
- 1 generation backK243977 EMPHASYS Acetabular SystemDepuy Ireland UC · 2025
- This deviceK252067 Velora Acetabular SystemRestor3D, Inc. · 2025
Show all 20 generations
- Root · 20 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 19 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
- 18 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
- 17 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
- 16 generations backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
- 15 generations backK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- 14 generations backK060918 Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc. · 2006
- 13 generations backK062684 Excia Total Hip System 36MM Ceramic HeadAesculap, Inc. · 2006
- 12 generations backK082991 Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc. · 2008
- 11 generations backK083495 Modification to: Metha Hip SystemAesculap Implant Systems, Inc. · 2009
- 10 generations backK090845 Apex Arc Hip StemOmni Life Science, Inc. · 2010 · Recalled
- 9 generations backK111193 Apex Arc Hip StemOmni Life Science, Inc. · 2011
- 8 generations backK113242 Apex Arc Hip StemOmni Life Science, Inc. · 2012
- 7 generations backK123991 Depuy Corail Amt Hip ProsthesisDepuy France S.A.S. · 2013 · Recalled
- 6 generations backK150862 DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc. · 2015 · Recalled
- 5 generations backK170339 Summit Hip SystemDePuy Orthopaedics, Inc. · 2018
- 4 generations backK193398 Summit DuoFix HA CoatingDePuy Orthopaedics, Inc. · 2020
- 3 generations backK202472 ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc. · 2020
- 2 generations backK231873 DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT…Depuy Ireland UC · 2024
- 1 generation backK243977 EMPHASYS Acetabular SystemDepuy Ireland UC · 2025
- This deviceK252067 Velora Acetabular SystemRestor3D, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K941847 | 5/8 Porocoat Aml Hip Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −19 | K964650 | TCP-Coated Porocoat Aml Femoral Hip Prosthesis | Depuy, Inc. | 1997 | — |
| −18 | K980711 | Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer, Inc. | 1998 | 1 |
| −17 | K001277 | Triflange Acetabular Cup System | DePuy Orthopaedics, Inc. | 2000 | — |
| −16 | K031495 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | 2003 | — |
| −15 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| −14 | K060918 | Excia Total Hip System 12/14 Trunnion with Ceramic Head | Aesculap, Inc. | 2006 | — |
| −13 | K062684 | Excia Total Hip System 36MM Ceramic Head | Aesculap, Inc. | 2006 | — |
| −12 | K082991 | Biolox Delta Ceramic Femoral Head | Aesculap Implant Systems, Inc. | 2008 | — |
| −11 | K083495 | Modification to: Metha Hip System | Aesculap Implant Systems, Inc. | 2009 | — |
| −10 | K090845 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2010 | 2 |
| −9 | K111193 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2011 | — |
| −8 | K113242 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2012 | — |
| −7 | K123991 | Depuy Corail Amt Hip Prosthesis | Depuy France S.A.S. | 2013 | 1 |
| −6 | K150862 | DePuy Actis Duofox Hip Prosthesis | DePuy Orthopaedics, Inc. | 2015 | 1 |
| −5 | K170339 | Summit Hip System | DePuy Orthopaedics, Inc. | 2018 | — |
| −4 | K193398 | Summit DuoFix HA Coating | DePuy Orthopaedics, Inc. | 2020 | — |
| −3 | K202472 | ACTIS Duofix Hip Prosthesis | DePuy Orthopaedics, Inc. | 2020 | — |
| −2 | K231873 | DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip… | Depuy Ireland UC | 2024 | — |
| −1 | K243977 | EMPHASYS Acetabular System | Depuy Ireland UC | 2025 | — |
| 0 (this device) | K252067 | Velora Acetabular System | Restor3D, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 2 | 0 |
| 1981 | 2 | 0 |
| 1983 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 3 | 0 |
| 1986 | 4 | 0 |
| 1987 | 6 | 0 |
| 1988 | 3 | 0 |
| 1989 | 1 | 0 |
| 1990 | 4 | 0 |
| 1991 | 7 | 0 |
| 1992 | 9 | 0 |
| 1993 | 9 | 0 |
| 1994 | 33 | 0 |
| 1995 | 22 | 0 |
| 1996 | 25 | 0 |
| 1997 | 18 | 0 |
| 1998 | 13 | 0 |
| 1999 | 15 | 0 |
| 2000 | 26 | 0 |
| 2001 | 19 | 0 |
| 2002 | 14 | 0 |
| 2003 | 16 | 0 |
| 2004 | 19 | 0 |
| 2005 | 15 | 0 |
| 2006 | 9 | 0 |
| 2007 | 12 | 0 |
| 2008 | 10 | 0 |
| 2009 | 8 | 0 |
| 2010 | 12 | 0 |
| 2011 | 9 | 0 |
| 2012 | 5 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 5 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 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 LPH? 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 LPH device
- #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.2 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K190904 | Conformis BeneFIT Hip SystemSummary page 5…de Name Primary Predicate Device BeneFIT Hip System K190904 Now marketed as Cordera Hip System Additional… | 2019 |
| * | K243977 | EMPHASYS Acetabular SystemSummary page 5…Now marketed as Cordera Hip System Additional Predicate Devices K243977 EMPHASYS Acetabular System K190660 G7 Acetabular System E. I… | 2025 |
| * | K190660 | G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System…Summary page 5…Additional Predicate Devices K243977 EMPHASYS Acetabular System K190660 G7 Acetabular System E. Indications for Use The Velora Acetabular System is indicated for u… | 2019 |
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 31 years and passes through 9 companies; a new generation was cleared every 1.6 years on median.
- 89 of the 394 ancestors have a recall of any class.
- 2 other devices also cite its predicate K190904.
How does its category compare?
All LPH devicesLPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · LPH
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPH
153in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPH
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPH
6,163in 2025
MAUDE reports naming product code LPH, 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 | 10 | 116 | 16 | 509 |
| 2008 | 10 | 86 | 1 | 706 |
| 2009 | 3 | 112 | 2 | 1,156 |
| 2010 | 15 | 100 | 22 | 2,007 |
| 2011 | 16 | 110 | 26 | 3,320 |
| 2012 | 25 | 76 | 30 | 3,785 |
| 2013 | 11 | 135 | 9 | 5,002 |
| 2014 | 20 | 129 | 3 | 5,163 |
| 2015 | 18 | 111 | 1 | 5,830 |
| 2016 | 10 | 150 | 8 | 4,900 |
| 2017 | 12 | 121 | 14 | 5,312 |
| 2018 | 9 | 145 | 2 | 5,954 |
| 2019 | 22 | 164 | 8 | 7,130 |
| 2020 | 7 | 164 | 6 | 5,429 |
| 2021 | 8 | 410 | 4 | 5,978 |
| 2022 | 14 | 247 | 2 | 5,223 |
| 2023 | 10 | 111 | 2 | 5,345 |
| 2024 | 6 | 92 | 1 | 5,626 |
| 2025 | 12 | 153 | 4 | 6,163 |
| 2026 | 8 | 256 | 2 | — |
What is it indicated for?
The Velora Acetabular System is indicated for use in skeletally mature individuals undergoing total hip replacement due to:
• A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis, or congenital hip dysplasia.
• Treatment of non-displaced non-unions of the hip, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
• Revision procedures for failed previous hip surgery (excluding situations where hardware is present).
The implants in the Velora Acetabular System are intended for cementless fixation using an anterior or posterior surgical approach.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252067 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252067: Velora Acetabular System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252067
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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