510(k) · Cleared
Recalled · Class II · 2025TheRay Collared and Collarless Femoral Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nextstep Arthropedix · MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Cleared on Sep 13, 2024 as substantially equivalent to K150862 (DePuy Orthopaedics, Inc., 2015) and 1 other predicate after a 77-day review. Its family tree reaches back 15 generations to 1994. 1 later device descends from it. It has been recalled once.
- Decided
- Sep 13, 2024
- Review
- 77 days
- Class
- Class II
- Product code
- MEH
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 15 generations to K941847 (1994). 277 ancestors in all, the oldest K810258 (1981). 1 later device descends from it, 1 citing it directly.
- Root · 15 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 11 generations between
- 3 generations backK113242 Apex Arc Hip StemOmni Life Science, Inc. · 2012
- 2 generations backK123991 Depuy Corail Amt Hip ProsthesisDepuy France S.A.S. · 2013 · Recalled
- 1 generation backK150862 DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc. · 2015 · Recalled
- This deviceK241875 TheRay Collared and Collarless Femoral StemNextstep Arthropedix · 2024
- Descendant · cites it directly · 0 of its ownK243192 iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with…Nextstep Arthopedix, LLC · 2026
Show all 15 generations
- Root · 15 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 14 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
- 13 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
- 12 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
- 11 generations backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
- 10 generations backK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- 9 generations backK060918 Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc. · 2006
- 8 generations backK062684 Excia Total Hip System 36MM Ceramic HeadAesculap, Inc. · 2006
- 7 generations backK082991 Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc. · 2008
- 6 generations backK083495 Modification to: Metha Hip SystemAesculap Implant Systems, Inc. · 2009
- 5 generations backK090845 Apex Arc Hip StemOmni Life Science, Inc. · 2010 · Recalled
- 4 generations backK111193 Apex Arc Hip StemOmni Life Science, Inc. · 2011
- 3 generations backK113242 Apex Arc Hip StemOmni Life Science, Inc. · 2012
- 2 generations backK123991 Depuy Corail Amt Hip ProsthesisDepuy France S.A.S. · 2013 · Recalled
- 1 generation backK150862 DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc. · 2015 · Recalled
- This deviceK241875 TheRay Collared and Collarless Femoral StemNextstep Arthropedix · 2024
Most influential descendants
Showing 1 of 1 · See all- K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K941847 | 5/8 Porocoat Aml Hip Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −14 | K964650 | TCP-Coated Porocoat Aml Femoral Hip Prosthesis | Depuy, Inc. | 1997 | — |
| −13 | K980711 | Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer, Inc. | 1998 | 1 |
| −12 | K001277 | Triflange Acetabular Cup System | DePuy Orthopaedics, Inc. | 2000 | — |
| −11 | K031495 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | 2003 | — |
| −10 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| −9 | K060918 | Excia Total Hip System 12/14 Trunnion with Ceramic Head | Aesculap, Inc. | 2006 | — |
| −8 | K062684 | Excia Total Hip System 36MM Ceramic Head | Aesculap, Inc. | 2006 | — |
| −7 | K082991 | Biolox Delta Ceramic Femoral Head | Aesculap Implant Systems, Inc. | 2008 | — |
| −6 | K083495 | Modification to: Metha Hip System | Aesculap Implant Systems, Inc. | 2009 | — |
| −5 | K090845 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2010 | 2 |
| −4 | K111193 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2011 | — |
| −3 | K113242 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2012 | — |
| −2 | K123991 | Depuy Corail Amt Hip Prosthesis | Depuy France S.A.S. | 2013 | 1 |
| −1 | K150862 | DePuy Actis Duofox Hip Prosthesis | DePuy Orthopaedics, Inc. | 2015 | 1 |
| 0 (this device) | K241875 | TheRay Collared and Collarless Femoral Stem | Nextstep Arthropedix | 2024 | — |
| +1 | K243192 | iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed… | Nextstep Arthopedix, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 3 | 0 |
| 1986 | 3 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 5 | 0 |
| 1992 | 7 | 0 |
| 1993 | 7 | 0 |
| 1994 | 32 | 0 |
| 1995 | 19 | 0 |
| 1996 | 22 | 0 |
| 1997 | 12 | 0 |
| 1998 | 10 | 0 |
| 1999 | 12 | 0 |
| 2000 | 24 | 0 |
| 2001 | 15 | 0 |
| 2002 | 15 | 0 |
| 2003 | 12 | 0 |
| 2004 | 9 | 0 |
| 2005 | 9 | 0 |
| 2006 | 5 | 0 |
| 2007 | 5 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2010 | 8 | 0 |
| 2011 | 6 | 0 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 MEH? 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 MEH device
- #1 K210581 Actis DuoFix Hip Prosthesis- Collarlessscore 23.9 · 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 |
|---|---|---|---|
| * | K150862 | DePuy Actis Duofox Hip ProsthesisSummary page 6…Company Device Name 510(k) Number(s) Clearance Date Primary Predicate DePuy Synthes Actis K150862 9/25/2015 iNSitu Total Hip System K161184… | 2015 |
| * | K161184 | iNSitu Total Hip SystemSummary page 6…DePuy Synthes Actis K150862 9/25/2015 iNSitu Total Hip System K161184 10/14/2016 Reference Devices NextStep Arthropedix iNSitu Bipolar Hip System K191927… | 2016 |
| † | K191927 | Hinged Laminoplasty System | 2019 |
| † | K191936 | iNSitu Total Hip System | 2019 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243192 | iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi… | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 11, 2025 | Class II | Z-0227-2026 | Package design/selection | Downstream recall for RES 97605, BioPro femoral components. Product failed transit testing. Impacted product may have potential issues with sterile barrier. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 8 companies; a new generation was cleared every 1.6 years on median.
- 57 of the 276 ancestors have a recall of any class.
- Of its descendants, K243192 (Nextstep Arthopedix, LLC, 2026) has gone furthest, with 0 descendants of its own.
- 13 other devices also cite its predicate K150862.
How does its category compare?
All MEH devicesMEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · MEH
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MEH
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MEH
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MEH
470in 2025
MAUDE reports naming product code MEH, 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 | 2 | — | 3 | 25 |
| 2008 | 6 | 79 | 80 | 261 |
| 2009 | 6 | 65 | 51 | 539 |
| 2010 | 5 | 226 | 16 | 462 |
| 2011 | 5 | 95 | 4 | 419 |
| 2012 | 6 | 131 | 3 | 1,606 |
| 2013 | 1 | — | 0 | 1,295 |
| 2014 | 0 | — | 1 | 1,196 |
| 2015 | 2 | — | 1 | 490 |
| 2016 | 6 | 163 | 4 | 347 |
| 2017 | 3 | 209 | 1 | 383 |
| 2018 | 2 | — | 3 | 337 |
| 2019 | 1 | — | 0 | 335 |
| 2020 | 3 | 131 | 1 | 338 |
| 2021 | 3 | 83 | 0 | 372 |
| 2022 | 3 | 150 | 0 | 316 |
| 2023 | 2 | — | 0 | 334 |
| 2024 | 6 | 91 | 0 | 354 |
| 2025 | 5 | 87 | 1 | 470 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
TheRay Collared and Collarless Total Hip System is indicated for use in skeletally mature individuals undergoing surgery for total hip replacement due to: • A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis, or congenital hip dysplasia; • Acute traumatic fracture of the femoral head or neck; • Failed previous hip surgery including joint reconstruction, internal fixation…
Read the full statement (183 words)
TheRay Collared and Collarless Total Hip System is indicated for use in skeletally mature individuals undergoing surgery for total hip replacement due to:
• A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis, or congenital hip dysplasia;
• Acute traumatic fracture of the femoral head or neck;
• Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty or total hip replacement.
TheRay Collared and Collarless Total Hip System femoral stems are intended for cementless fixation. The acetabular cup is intended for cementless fixation. The porous structured surfaces on the acetabular cup provide biological fixation in a cementless application.
The iNSitu Bipolar Hip System is intended for use in combination with the iNSitu Total Hip System Femoral Stem or TheRay Collared or Collarless Femoral Stem for uncemented primary or revision hemiarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate:
• Femoral neck and trochanteric fractures of the proximal femur;
• Osteonecrosis of the femoral head;
• Revision procedures where other devices or treatments for these indications have failed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241875 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241875: TheRay Collared and Collarless Femoral Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241875
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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