510(k) · Cleared
ClearedDePuy Actis DuoFix Hip Prosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy (Ireland) · MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Cleared on Jul 19, 2016 as substantially equivalent to K150862 (DePuy Orthopaedics, Inc., 2015) after a 109-day review. Its family tree reaches back 15 generations to 1994. 26 later devices descend from it.
- Decided
- Jul 19, 2016
- Review
- 109 days
- Class
- Class II
- Product code
- MEH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K941847 (1994). 176 ancestors in all, the oldest K810258 (1981). 26 later devices descend from it, 10 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 deviceK160907 DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland) · 2016
- Descendant · cites it directly · 15 of its ownK202472 ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc. · 2020
- Descendant · cites it directly · 13 of its ownK210581 Actis DuoFix Hip Prosthesis- CollarlessDepuy Ireland UC · 2021
- Descendant · cites it directly · 7 of its ownK211703 Insignia Hip StemStryker Orthopaedics · 2021
- Descendant · 2 generations on · 7 of its ownK211657 EMPHASYS Femoral StemsDepuy Ireland UC · 2021
- Descendant · 2 generations on · 6 of its ownK220731 Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker · 2022
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 deviceK160907 DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland) · 2016
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K202472ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc. · 2020 · cites it directly15descendants
- K210581Actis DuoFix Hip Prosthesis- CollarlessDepuy Ireland UC · 2021 · cites it directly13descendants
- K211703Insignia Hip StemStryker Orthopaedics · 2021 · cites it directly7descendants
- K211657EMPHASYS Femoral StemsDepuy Ireland UC · 2021 · 2 generations on7descendants
- K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker · 2022 · 2 generations on6descendants
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) | K160907 | DePuy Actis DuoFix Hip Prosthesis | Depuy (Ireland) | 2016 | — |
| +1 | K202472 | ACTIS Duofix Hip Prosthesis | DePuy Orthopaedics, Inc. | 2020 | — |
| +1 | K210581 | Actis DuoFix Hip Prosthesis- Collarless | Depuy Ireland UC | 2021 | — |
| +1 | K211703 | Insignia Hip Stem | Stryker Orthopaedics | 2021 | — |
| +2 | K211657 | EMPHASYS Femoral Stems | Depuy Ireland UC | 2021 | — |
| +2 | K220731 | Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem | Stryker | 2022 | — |
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 | 2 | 0 |
| 1991 | 5 | 0 |
| 1992 | 5 | 0 |
| 1993 | 4 | 0 |
| 1994 | 19 | 0 |
| 1995 | 12 | 0 |
| 1996 | 12 | 0 |
| 1997 | 7 | 0 |
| 1998 | 7 | 0 |
| 1999 | 5 | 0 |
| 2000 | 18 | 0 |
| 2001 | 10 | 0 |
| 2002 | 10 | 0 |
| 2003 | 7 | 0 |
| 2004 | 7 | 0 |
| 2005 | 6 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 3 | 0 |
| 2025 | 9 | 0 |
| 2026 | 4 | 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? (1)
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 4…21 CFR 888.3353, 888.3358, 888.3360, 888.3390 Product Code(s) MEH, LPH, KWL, KWY Legally marketed device(s) to DePuy Actis DuoFix Hip Prosthesis (K150862, cleared September 25, 2015) which equivalence is claimed Reason for 510(k) submission Line extension of an additional smalle… | 2015 |
What descends from it? (26)
See all 2610 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202472 | ACTIS Duofix Hip Prosthesis | 2020 | 15 |
| K210581 | Actis DuoFix Hip Prosthesis- Collarless | 2021 | 13 |
| K211703 | Insignia Hip Stem | 2021 | 7 |
| K223745 | Novae® Dual Mobility System, Hype® Hip System | 2023 | 1 |
| K261576 | Icona Hip Stem | 2026 | 0 |
| K254043 | TRIVANCE™ Hip Stem | 2026 | 0 |
| K250375 | Allure Hip Stem and Intramedullary Plugs | 2025 | 0 |
| K251166 | Mfinity Femoral System | 2025 | 0 |
| K250444 | NEXUS® Hip Stem | 2025 | 0 |
| K243029 | Origin™ TT Stem | 2025 | 0 |
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 22 years and passes through 8 companies; a new generation was cleared every 1.4 years on median.
- 44 of the 175 ancestors have a recall of any class.
- Of its descendants, K202472 (DePuy Orthopaedics, Inc., 2020) has gone furthest, with 15 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. 2016, 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?
Total hip replacement or hip arthroplasty 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. Certain cases of ankylosis. Partial hip replacement or hip hemi-arthroplasty is indicated in the following conditions: 1. Acute…
Read the full statement (168 words)
Total hip replacement or hip arthroplasty 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. Certain cases of ankylosis.
Partial hip replacement or hip hemi-arthroplasty 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 hemi-arthroplasty.
The DePuy Actis DuoFix Hip Prosthesis is indicated for cementless use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160907 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160907: DePuy Actis DuoFix Hip Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160907
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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