510(k) · Cleared
ClearedActinia® hip stems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Implantcast GmbH · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Oct 19, 2023 as substantially equivalent to K210678 (Implantcast GmbH, 2022) after a 72-day review. Its family tree reaches back 18 generations to 1994. 1 later device descends from it.
- Decided
- Oct 19, 2023
- Review
- 72 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 18 generations to K941847 (1994). 346 ancestors in all, the oldest K810258 (1981). 1 later device descends from it, 1 citing it directly.
- Root · 18 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 14 generations between
- 3 generations backK170339 Summit Hip SystemDePuy Orthopaedics, Inc. · 2018
- 2 generations backK193398 Summit DuoFix HA CoatingDePuy Orthopaedics, Inc. · 2020
- 1 generation backK210678 implaFit® hip stemsImplantcast GmbH · 2022
- This deviceK232371 Actinia® hip stemsImplantcast GmbH · 2023
- Descendant · cites it directly · 0 of its ownK260037 implantcast Packaging System UpdateImplantcast GmbH · 2026
Show all 18 generations
- Root · 18 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 17 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
- 16 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
- 15 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
- 14 generations backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
- 13 generations backK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- 12 generations backK060918 Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc. · 2006
- 11 generations backK062684 Excia Total Hip System 36MM Ceramic HeadAesculap, Inc. · 2006
- 10 generations backK082991 Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc. · 2008
- 9 generations backK083495 Modification to: Metha Hip SystemAesculap Implant Systems, Inc. · 2009
- 8 generations backK090845 Apex Arc Hip StemOmni Life Science, Inc. · 2010 · Recalled
- 7 generations backK111193 Apex Arc Hip StemOmni Life Science, Inc. · 2011
- 6 generations backK113242 Apex Arc Hip StemOmni Life Science, Inc. · 2012
- 5 generations backK123991 Depuy Corail Amt Hip ProsthesisDepuy France S.A.S. · 2013 · Recalled
- 4 generations backK150862 DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc. · 2015 · Recalled
- 3 generations backK170339 Summit Hip SystemDePuy Orthopaedics, Inc. · 2018
- 2 generations backK193398 Summit DuoFix HA CoatingDePuy Orthopaedics, Inc. · 2020
- 1 generation backK210678 implaFit® hip stemsImplantcast GmbH · 2022
- This deviceK232371 Actinia® hip stemsImplantcast GmbH · 2023
Most influential descendants
Showing 1 of 1 · See all- K260037implantcast Packaging System UpdateImplantcast GmbH · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K941847 | 5/8 Porocoat Aml Hip Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −17 | K964650 | TCP-Coated Porocoat Aml Femoral Hip Prosthesis | Depuy, Inc. | 1997 | — |
| −16 | K980711 | Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer, Inc. | 1998 | 1 |
| −15 | K001277 | Triflange Acetabular Cup System | DePuy Orthopaedics, Inc. | 2000 | — |
| −14 | K031495 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | 2003 | — |
| −13 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| −12 | K060918 | Excia Total Hip System 12/14 Trunnion with Ceramic Head | Aesculap, Inc. | 2006 | — |
| −11 | K062684 | Excia Total Hip System 36MM Ceramic Head | Aesculap, Inc. | 2006 | — |
| −10 | K082991 | Biolox Delta Ceramic Femoral Head | Aesculap Implant Systems, Inc. | 2008 | — |
| −9 | K083495 | Modification to: Metha Hip System | Aesculap Implant Systems, Inc. | 2009 | — |
| −8 | K090845 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2010 | 2 |
| −7 | K111193 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2011 | — |
| −6 | K113242 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2012 | — |
| −5 | K123991 | Depuy Corail Amt Hip Prosthesis | Depuy France S.A.S. | 2013 | 1 |
| −4 | K150862 | DePuy Actis Duofox Hip Prosthesis | DePuy Orthopaedics, Inc. | 2015 | 1 |
| −3 | K170339 | Summit Hip System | DePuy Orthopaedics, Inc. | 2018 | — |
| −2 | K193398 | Summit DuoFix HA Coating | DePuy Orthopaedics, Inc. | 2020 | — |
| −1 | K210678 | implaFit® hip stems | Implantcast GmbH | 2022 | — |
| 0 (this device) | K232371 | Actinia® hip stems | Implantcast GmbH | 2023 | — |
| +1 | K260037 | implantcast Packaging System Update | Implantcast GmbH | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 4 | 0 |
| 1986 | 3 | 0 |
| 1987 | 2 | 0 |
| 1988 | 3 | 0 |
| 1990 | 3 | 0 |
| 1991 | 5 | 0 |
| 1992 | 7 | 0 |
| 1993 | 7 | 0 |
| 1994 | 34 | 0 |
| 1995 | 22 | 0 |
| 1996 | 27 | 0 |
| 1997 | 14 | 0 |
| 1998 | 14 | 0 |
| 1999 | 17 | 0 |
| 2000 | 33 | 0 |
| 2001 | 17 | 0 |
| 2002 | 17 | 0 |
| 2003 | 15 | 0 |
| 2004 | 12 | 0 |
| 2005 | 12 | 0 |
| 2006 | 9 | 0 |
| 2007 | 8 | 0 |
| 2008 | 8 | 0 |
| 2009 | 3 | 0 |
| 2010 | 9 | 0 |
| 2011 | 7 | 0 |
| 2012 | 5 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 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 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? (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 |
|---|---|---|---|
| * | K210678 | implaFit® hip stemsSummary page 6…oFit® Hip System (K163577, K180263 and K191569) and the implantcast ic-Bipolar Head System (K191569). Predicate Devices: • implaFit® hip stems (K210678) • DePuy Orthopaedics, Inc. Corail AMT Hip Prosthesis Reference Devices: (K203167)… | 2022 |
| † | K203167 | DePuy Corail AMT Hip Prosthesis | 2020 |
| † | K163577 | Ecofit® Hip System | 2017 |
| † | K180263 | EcoFit Vit E Acetabular System | 2018 |
| † | K191569 | Implantcast ic-Bipolar Head System | 2019 |
| † | K203420 | EcoFit® Hip System | 2021 |
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 |
|---|---|---|---|
| K260037 | implantcast Packaging System Update | 2026 | 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 29 years and passes through 8 companies; a new generation was cleared every 1.7 years on median.
- 71 of the 345 ancestors have a recall of any class.
- Of its descendants, K260037 (Implantcast GmbH, 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K210678.
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. 2023, 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?
The Actinia® hip stems are intended to be used in total hip arthroplasty for the following indications: * Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; * Rheumatoid arthritis; * Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable by other techniques; and * Revision of previously failed total hip arthroplasty. The Actinia®…
Read the full statement (137 words)
The Actinia® hip stems are intended to be used in total hip arthroplasty for the following indications:
* Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
* Rheumatoid arthritis;
* Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable by other techniques; and
* Revision of previously failed total hip arthroplasty.
The Actinia® hip stems cementless are intended for uncemented, press-fit fixation.
The Actinia® hip stems are intended to be used in partial (hemi) hip arthroplasty in conjunction with the ic-Bipolar Head System for the following indications:
* Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
* Rheumatoid arthritis
* Correction of functional deformity
* Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K232371 · printed Nov 4, 2026
Cite this page
510(k) Report. “K232371: Actinia® hip stems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K232371
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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