510(k) · Cleared
ClearedEMPHASYS Acetabular Shell with RapiTite HA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Ireland UC · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Oct 7, 2024 as substantially equivalent to K221636 (Depuy Ireland UC, 2022) and 4 other predicates after an 83-day review. Its family tree reaches back 19 generations to 1994.
- Decided
- Oct 7, 2024
- Review
- 83 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 19 generations to K941847 (1994). 287 ancestors in all, the oldest K800894 (1980). No later device cites it as a predicate yet.
- Root · 19 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 15 generations between
- 3 generations backK193398 Summit DuoFix HA CoatingDePuy Orthopaedics, Inc. · 2020
- 2 generations backK202472 ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc. · 2020
- 1 generation backK231873 DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT…Depuy Ireland UC · 2024
- This deviceK242084 EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC · 2024
Show all 19 generations
- Root · 19 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 18 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
- 17 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
- 16 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
- 15 generations backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
- 14 generations backK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- 13 generations backK060918 Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc. · 2006
- 12 generations backK062684 Excia Total Hip System 36MM Ceramic HeadAesculap, Inc. · 2006
- 11 generations backK082991 Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc. · 2008
- 10 generations backK083495 Modification to: Metha Hip SystemAesculap Implant Systems, Inc. · 2009
- 9 generations backK090845 Apex Arc Hip StemOmni Life Science, Inc. · 2010 · Recalled
- 8 generations backK111193 Apex Arc Hip StemOmni Life Science, Inc. · 2011
- 7 generations backK113242 Apex Arc Hip StemOmni Life Science, Inc. · 2012
- 6 generations backK123991 Depuy Corail Amt Hip ProsthesisDepuy France S.A.S. · 2013 · Recalled
- 5 generations backK150862 DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc. · 2015 · Recalled
- 4 generations backK170339 Summit Hip SystemDePuy Orthopaedics, Inc. · 2018
- 3 generations backK193398 Summit DuoFix HA CoatingDePuy Orthopaedics, Inc. · 2020
- 2 generations backK202472 ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc. · 2020
- 1 generation backK231873 DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT…Depuy Ireland UC · 2024
- This deviceK242084 EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K941847 | 5/8 Porocoat Aml Hip Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −18 | K964650 | TCP-Coated Porocoat Aml Femoral Hip Prosthesis | Depuy, Inc. | 1997 | — |
| −17 | K980711 | Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer, Inc. | 1998 | 1 |
| −16 | K001277 | Triflange Acetabular Cup System | DePuy Orthopaedics, Inc. | 2000 | — |
| −15 | K031495 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | 2003 | — |
| −14 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| −13 | K060918 | Excia Total Hip System 12/14 Trunnion with Ceramic Head | Aesculap, Inc. | 2006 | — |
| −12 | K062684 | Excia Total Hip System 36MM Ceramic Head | Aesculap, Inc. | 2006 | — |
| −11 | K082991 | Biolox Delta Ceramic Femoral Head | Aesculap Implant Systems, Inc. | 2008 | — |
| −10 | K083495 | Modification to: Metha Hip System | Aesculap Implant Systems, Inc. | 2009 | — |
| −9 | K090845 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2010 | 2 |
| −8 | K111193 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2011 | — |
| −7 | K113242 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2012 | — |
| −6 | K123991 | Depuy Corail Amt Hip Prosthesis | Depuy France S.A.S. | 2013 | 1 |
| −5 | K150862 | DePuy Actis Duofox Hip Prosthesis | DePuy Orthopaedics, Inc. | 2015 | 1 |
| −4 | K170339 | Summit Hip System | DePuy Orthopaedics, Inc. | 2018 | — |
| −3 | K193398 | Summit DuoFix HA Coating | DePuy Orthopaedics, Inc. | 2020 | — |
| −2 | K202472 | ACTIS Duofix Hip Prosthesis | DePuy Orthopaedics, Inc. | 2020 | — |
| −1 | K231873 | DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip… | Depuy Ireland UC | 2024 | — |
| 0 (this device) | K242084 | EMPHASYS Acetabular Shell with RapiTite HA | Depuy Ireland UC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 2 | 0 |
| 1981 | 2 | 0 |
| 1984 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 6 | 0 |
| 1988 | 3 | 0 |
| 1989 | 1 | 0 |
| 1990 | 4 | 0 |
| 1991 | 5 | 0 |
| 1992 | 8 | 0 |
| 1993 | 4 | 0 |
| 1994 | 24 | 0 |
| 1995 | 17 | 0 |
| 1996 | 18 | 0 |
| 1997 | 11 | 0 |
| 1998 | 11 | 0 |
| 1999 | 7 | 0 |
| 2000 | 21 | 0 |
| 2001 | 15 | 0 |
| 2002 | 11 | 0 |
| 2003 | 11 | 0 |
| 2004 | 14 | 0 |
| 2005 | 10 | 0 |
| 2006 | 8 | 0 |
| 2007 | 8 | 0 |
| 2008 | 7 | 0 |
| 2009 | 5 | 0 |
| 2010 | 6 | 0 |
| 2011 | 6 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 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? (5)
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 |
|---|---|---|---|
| * | K221636 | EMPHASYS Acetabular SystemSummary page 6…vices Reference Device to which equivalence is DePuy EMPHASYS Acetabular claimed System (K221636/K231873) (primary predicate) DePuy Pinnacle Duofix HA St… | 2022 |
| * | K231873 | DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Summary page 6…Reference Device to which equivalence is DePuy EMPHASYS Acetabular claimed System (K221636/K231873) (primary predicate) DePuy Pinnacle Duofix HA Stryker Tr… | 2024 |
| * | K031495 | Pinnacle Duofix HA Acetabular Cup ProsthesisSummary page 6…(primary predicate) DePuy Pinnacle Duofix HA Stryker Tritanium® Peri- Acetabular Cup (K031495) Apatite™ Acetabular Shell System (K101072)… | 2003 |
| * | K090998 | Depuy Pinnacle 100 with Gription Acetabular CupsSummary page 6…System (K101072) DePuy Pinnacle with Gription Acetabular Cups (K090998/K093646) Reason for 510(k) The purpose of this 510(k) submission is to obtain market clearance submission… | 2009 |
| * | K093646 | Depuy Pinnacle with Gription Acetabular CupsSummary page 6…System (K101072) DePuy Pinnacle with Gription Acetabular Cups (K090998/K093646) Reason for 510(k) The purpose of this 510(k) submission is to obtain market clearance submission f… | 2009 |
| † | K101072 | Tritanium Peri-Apatitie Acetabular Solid-Backed Shell, Tritanium Peri-Apatite | 2011 |
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 30 years and passes through 8 companies; a new generation was cleared every 1.6 years on median.
- 66 of the 286 ancestors have a recall of any class.
- 3 other devices also cite its predicate K221636.
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. 2024, 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?
Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. The EMPHASYS Acetabular Shell with RapiTite HA is intended for single use only. INDICATIONS Total hip replacement is indicated in the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis…
Read the full statement (129 words)
Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.
The EMPHASYS Acetabular Shell with RapiTite HA is intended for single use only.
INDICATIONS
Total hip replacement is indicated in the following conditions:
1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
5. Certain cases of ankylosis.
EMPHASYS Acetabular Shell with RapiTite HA is indicated for cementless use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242084 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242084: EMPHASYS Acetabular Shell with RapiTite HA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242084
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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