510(k) · Cleared
ClearedEMPHASYS Acetabular System
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 Sep 6, 2022 as substantially equivalent to K071784 (DePuy Orthopaedics, Inc., 2007) and 3 other predicates after a 92-day review. Its family tree reaches back 7 generations to 1993. 7 later devices descend from it.
- Decided
- Sep 6, 2022
- Review
- 92 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K930712 (1993). 18 ancestors in all. 7 later devices descend from it, 4 citing it directly.
- Root · 7 generations backK930712 P.F.C. Total Hip System Porous Coated ModularJohnson & Johnson Orthopaedics, Inc. · 1993
- 6 generations backK983014 Summit Acetabular SystemJohnson & Johnson Professionals, Inc. · 1998
- 5 generations backK000306 Pinnacle Acetabular SystemDePuy Orthopaedics, Inc. · 2000 · Recalled
- 4 generations backK001534 Pinnacle Acetabular SystemDePuy Orthopaedics, Inc. · 2000
- 3 generations backK071784 Depuy Pinnacle with Gripton Acetabular CupsDePuy Orthopaedics, Inc. · 2007
- 2 generations backK090998 Depuy Pinnacle 100 with Gription Acetabular CupsDePuy Orthopaedics, Inc. · 2009
- 1 generation backK093646 Depuy Pinnacle with Gription Acetabular CupsDePuy Orthopaedics, Inc. · 2009
- This deviceK221636 EMPHASYS Acetabular SystemDepuy Ireland UC · 2022
- Descendant · cites it directly · 5 of its ownK231873 DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT…Depuy Ireland UC · 2024
- Descendant · 2 generations on · 1 of its ownK251292 RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC · 2025
- Descendant · cites it directly · 1 of its ownK243977 EMPHASYS Acetabular SystemDepuy Ireland UC · 2025
- Descendant · 3 generations on · 0 of its ownK260173 M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2026
- Descendant · cites it directly · 0 of its ownK253948 Momentum Acetabular Cup SystemUnited Orthopedic Corporation · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC · 2024 · cites it directly5descendants
- K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC · 2025 · 2 generations on1descendant
- K243977EMPHASYS Acetabular SystemDepuy Ireland UC · 2025 · cites it directly1descendant
- K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2026 · 3 generations on0descendants
- K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K930712 | P.F.C. Total Hip System Porous Coated Modular | Johnson & Johnson Orthopaedics, Inc. | 1993 | — |
| −6 | K983014 | Summit Acetabular System | Johnson & Johnson Professionals, Inc. | 1998 | — |
| −5 | K000306 | Pinnacle Acetabular System | DePuy Orthopaedics, Inc. | 2000 | 1 |
| −4 | K001534 | Pinnacle Acetabular System | DePuy Orthopaedics, Inc. | 2000 | — |
| −3 | K071784 | Depuy Pinnacle with Gripton Acetabular Cups | DePuy Orthopaedics, Inc. | 2007 | — |
| −2 | K090998 | Depuy Pinnacle 100 with Gription Acetabular Cups | DePuy Orthopaedics, Inc. | 2009 | — |
| −1 | K093646 | Depuy Pinnacle with Gription Acetabular Cups | DePuy Orthopaedics, Inc. | 2009 | — |
| 0 (this device) | K221636 | EMPHASYS Acetabular System | Depuy Ireland UC | 2022 | — |
| +1 | K231873 | DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip… | Depuy Ireland UC | 2024 | — |
| +2 | K251292 | RECLAIM Monobloc Revision Femoral Stem | Depuy Ireland UC | 2025 | — |
| +1 | K243977 | EMPHASYS Acetabular System | Depuy Ireland UC | 2025 | — |
| +3 | K260173 | M-Vizion Femoral Revision System Extension | Medacta International S.A. | 2026 | — |
| +1 | K253948 | Momentum Acetabular Cup System | United Orthopedic Corporation | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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.
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? (4)
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 |
|---|---|---|---|
| * | K071784 | Depuy Pinnacle with Gripton Acetabular CupsSummary page 4…EMPHASYS Gription Acetabular Cups PSL shell Shell (K071784, K093646) (K983382) DePuy Pinnacle… | 2007 |
| * | K093646 | Depuy Pinnacle with Gription Acetabular CupsSummary page 4…HASYS Gription Acetabular Cups PSL shell Shell (K071784, K093646) (K983382) DePuy Pinnacle… | 2009 |
| * | K132959 | Depuy Pinnacle Altrx Acetabular LinersSummary page 4…e ALTRX Acetabular Liners Stryker Trident System (K132959) X3 Polyethylene Liner EMPHASYS (K062419)… | 2014 |
| * | K033273 | Depuy Pinnacle Acetabular Cup System, Esl Marathon Polyethylene Liners, and Depuy Ultima…Summary page 4…ly Tibia Liners (K193057) (K033273) Page 2 of 4 Traditional 510(k) EMPHASYS Acet… | 2004 |
| † | K983382 | Osteonics HA Generation II Acetabular Component System | 1998 |
| † | K062419 | Trident Large Diameter Acetabular Inserts | 2006 |
| † | K193057 | ATTUNE All-Polyethylene Tibia | 2020 |
What descends from it? (7)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 29 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 2 of the 18 ancestors have a recall of any class.
- Of its descendants, K231873 (Depuy Ireland UC, 2024) has gone furthest, with 5 descendants of its own.
- 6 other devices also cite its predicate K071784.
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. 2022, 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 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 Cups are indicated for cementless use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221636 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221636: EMPHASYS 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/K221636
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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