510(k) · Cleared
ClearedEMPHASYS Femoral Stems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Ireland UC · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Aug 5, 2021 as substantially equivalent to K190344 (Depuy (Ireland), 2019) and 7 other predicates after a 69-day review. Its family tree reaches back 17 generations to 1994. 7 later devices descend from it.
- Decided
- Aug 5, 2021
- Review
- 69 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 17 generations to K941847 (1994). 190 ancestors in all, the oldest K810258 (1981). 7 later devices descend from it, 2 citing it directly.
- Root · 17 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 13 generations between
- 3 generations backK150862 DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc. · 2015 · Recalled
- 2 generations backK160907 DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland) · 2016
- 1 generation backK210581 Actis DuoFix Hip Prosthesis- CollarlessDepuy Ireland UC · 2021
- This deviceK211657 EMPHASYS Femoral StemsDepuy Ireland UC · 2021
- 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 · 2 generations on · 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 · 3 generations on · 0 of its ownK252067 Velora Acetabular SystemRestor3D, Inc. · 2025
Show all 17 generations
- Root · 17 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 16 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
- 15 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
- 14 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
- 13 generations backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
- 12 generations backK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- 11 generations backK060918 Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc. · 2006
- 10 generations backK062684 Excia Total Hip System 36MM Ceramic HeadAesculap, Inc. · 2006
- 9 generations backK082991 Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc. · 2008
- 8 generations backK083495 Modification to: Metha Hip SystemAesculap Implant Systems, Inc. · 2009
- 7 generations backK090845 Apex Arc Hip StemOmni Life Science, Inc. · 2010 · Recalled
- 6 generations backK111193 Apex Arc Hip StemOmni Life Science, Inc. · 2011
- 5 generations backK113242 Apex Arc Hip StemOmni Life Science, Inc. · 2012
- 4 generations backK123991 Depuy Corail Amt Hip ProsthesisDepuy France S.A.S. · 2013 · Recalled
- 3 generations backK150862 DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc. · 2015 · Recalled
- 2 generations backK160907 DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland) · 2016
- 1 generation backK210581 Actis DuoFix Hip Prosthesis- CollarlessDepuy Ireland UC · 2021
- This deviceK211657 EMPHASYS Femoral StemsDepuy Ireland UC · 2021
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 · 2 generations on1descendant
- K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2026 · 3 generations on0descendants
- K252067Velora Acetabular SystemRestor3D, Inc. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K941847 | 5/8 Porocoat Aml Hip Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −16 | K964650 | TCP-Coated Porocoat Aml Femoral Hip Prosthesis | Depuy, Inc. | 1997 | — |
| −15 | K980711 | Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer, Inc. | 1998 | 1 |
| −14 | K001277 | Triflange Acetabular Cup System | DePuy Orthopaedics, Inc. | 2000 | — |
| −13 | K031495 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | 2003 | — |
| −12 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| −11 | K060918 | Excia Total Hip System 12/14 Trunnion with Ceramic Head | Aesculap, Inc. | 2006 | — |
| −10 | K062684 | Excia Total Hip System 36MM Ceramic Head | Aesculap, Inc. | 2006 | — |
| −9 | K082991 | Biolox Delta Ceramic Femoral Head | Aesculap Implant Systems, Inc. | 2008 | — |
| −8 | K083495 | Modification to: Metha Hip System | Aesculap Implant Systems, Inc. | 2009 | — |
| −7 | K090845 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2010 | 2 |
| −6 | K111193 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2011 | — |
| −5 | K113242 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2012 | — |
| −4 | K123991 | Depuy Corail Amt Hip Prosthesis | Depuy France S.A.S. | 2013 | 1 |
| −3 | K150862 | DePuy Actis Duofox Hip Prosthesis | DePuy Orthopaedics, Inc. | 2015 | 1 |
| −2 | K160907 | DePuy Actis DuoFix Hip Prosthesis | Depuy (Ireland) | 2016 | — |
| −1 | K210581 | Actis DuoFix Hip Prosthesis- Collarless | Depuy Ireland UC | 2021 | — |
| 0 (this device) | K211657 | EMPHASYS Femoral Stems | Depuy Ireland UC | 2021 | — |
| +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 | — |
| +2 | K243977 | EMPHASYS Acetabular System | Depuy Ireland UC | 2025 | — |
| +3 | K260173 | M-Vizion Femoral Revision System Extension | Medacta International S.A. | 2026 | — |
| +3 | K252067 | Velora Acetabular System | Restor3D, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 2 | 0 |
| 1987 | 2 | 0 |
| 1990 | 3 | 0 |
| 1991 | 5 | 0 |
| 1992 | 5 | 0 |
| 1993 | 4 | 0 |
| 1994 | 20 | 0 |
| 1995 | 12 | 0 |
| 1996 | 12 | 0 |
| 1997 | 8 | 0 |
| 1998 | 7 | 0 |
| 1999 | 5 | 0 |
| 2000 | 19 | 0 |
| 2001 | 11 | 0 |
| 2002 | 11 | 0 |
| 2003 | 8 | 0 |
| 2004 | 7 | 0 |
| 2005 | 6 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 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 LZO? 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 LZO device
- #1 K192827 Quadra-Pscore 19.3 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (8)
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 |
|---|---|---|---|
| * | K190344 | DePuy Corail AMT Hip ProsthesisSummary page 4…uncemented prosthesis Product Code(s) LZO, KWL, KWY, MEH Legally marketed device(s) to DePuy Corail AMT Hip Prosthesis (K190344) – Primary predicate which equivalence is claimed Corail AMT Hip Prosthesis (K042992) DePuy Co… | 2019 |
| * | K042992 | Corail Amt Hip ProsthesisSummary page 4…O, KWL, KWY, MEH Legally marketed device(s) to DePuy Corail AMT Hip Prosthesis (K190344) – Primary predicate which equivalence is claimed Corail AMT Hip Prosthesis (K042992) DePuy Corail AMT Hip Prosthesis (K123991) DePuy Corail AMT Hip P… | 2005 |
| * | K123991 | Depuy Corail Amt Hip ProsthesisSummary page 4…thesis (K190344) – Primary predicate which equivalence is claimed Corail AMT Hip Prosthesis (K042992) DePuy Corail AMT Hip Prosthesis (K123991) DePuy Corail AMT Hip Prosthesis (K173960) DePuy Corail AMT Hip P… | 2013 |
| * | K173960 | DePuy Corail AMT Hip ProsthesisSummary page 4…l AMT Hip Prosthesis (K042992) DePuy Corail AMT Hip Prosthesis (K123991) DePuy Corail AMT Hip Prosthesis (K173960) DePuy Corail AMT Hip Prosthesis (K192946) Summit Hip System (K00… | 2018 |
| * | K192946 | DePuy Corail AMT Hip ProsthesisSummary page 4…l AMT Hip Prosthesis (K123991) DePuy Corail AMT Hip Prosthesis (K173960) DePuy Corail AMT Hip Prosthesis (K192946) Summit Hip System (K001991)… | 2019 |
| * | K001991 | Titan Porocoat Hip ProsthesisSummary page 4…DePuy Corail AMT Hip Prosthesis (K173960) DePuy Corail AMT Hip Prosthesis (K192946) Summit Hip System (K001991) K211657 Page 2 of 3… | 2000 |
| * | K170339 | Summit Hip SystemSummary page 5…= Page 5 === K211657 Page 2 of 3 Summit Hip System (K170339) Actis DuoFix Hip Prosthesis - Collarless (K210581) Reason for 510(k) submission The purpose of… | 2018 |
| * | K210581 | Actis DuoFix Hip Prosthesis- CollarlessSummary page 5…K211657 Page 2 of 3 Summit Hip System (K170339) Actis DuoFix Hip Prosthesis - Collarless (K210581) Reason for 510(k) submission The purpose of this submission is to obtain market clearance for the… | 2021 |
What descends from it? (7)
2 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 27 years and passes through 9 companies; a new generation was cleared every 1.4 years on median.
- 44 of the 189 ancestors have a recall of any class.
- Of its descendants, K231873 (Depuy Ireland UC, 2024) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K190344.
How does its category compare?
All LZO devicesLZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · LZO
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZO
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZO
3,244in 2025
MAUDE reports naming product code LZO, 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 | 9 | 87 | 2 | 138 |
| 2008 | 11 | 63 | 13 | 125 |
| 2009 | 7 | 83 | 42 | 189 |
| 2010 | 15 | 78 | 0 | 394 |
| 2011 | 13 | 87 | 10 | 544 |
| 2012 | 14 | 98 | 14 | 963 |
| 2013 | 26 | 100 | 0 | 1,370 |
| 2014 | 13 | 85 | 1 | 1,477 |
| 2015 | 12 | 115 | 1 | 1,348 |
| 2016 | 10 | 177 | 9 | 1,728 |
| 2017 | 16 | 257 | 5 | 2,165 |
| 2018 | 18 | 163 | 2 | 3,133 |
| 2019 | 28 | 109 | 4 | 3,066 |
| 2020 | 18 | 112 | 3 | 1,963 |
| 2021 | 12 | 170 | 0 | 2,199 |
| 2022 | 11 | 279 | 4 | 1,985 |
| 2023 | 10 | 122 | 2 | 2,066 |
| 2024 | 11 | 111 | 1 | 2,586 |
| 2025 | 14 | 119 | 1 | 3,244 |
| 2026 | 9 | 102 | 0 | — |
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…
Read the full statement (169 words)
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.
Partial hip replacement is indicated in the following conditions:
1. Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated with internal fixation.
2. Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation.
3. Avascular necrosis of the femoral head.
4. Non-union of femoral neck fractures.
5. Certain high subcapital and femoral neck fractures in the elderly.
6. Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement.
7. Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hip hemiarthroplasty.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211657 · printed Nov 3, 2026
Cite this page
510(k) Report. “K211657: EMPHASYS Femoral Stems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K211657
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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