510(k) · Cleared
ClearedimplaFit® 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 Aug 17, 2022 as substantially equivalent to K163577 (Implantcast GmbH, 2017) and 2 other predicates after a 530-day review. Its family tree reaches back 17 generations to 1994. 3 later devices descend from it.
- Decided
- Aug 17, 2022
- Review
- 530 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 17 generations to K941847 (1994). 345 ancestors in all, the oldest K810258 (1981). 3 later devices descend from it, 3 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 backK170339 Summit Hip SystemDePuy Orthopaedics, Inc. · 2018
- 1 generation backK193398 Summit DuoFix HA CoatingDePuy Orthopaedics, Inc. · 2020
- This deviceK210678 implaFit® hip stemsImplantcast GmbH · 2022
- Descendant · cites it directly · 1 of its ownK232371 Actinia® hip stemsImplantcast GmbH · 2023
- Descendant · cites it directly · 0 of its ownK260037 implantcast Packaging System UpdateImplantcast GmbH · 2026
- Descendant · cites it directly · 0 of its ownK252401 implaFit® short stemsImplantcast GmbH · 2026
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 backK170339 Summit Hip SystemDePuy Orthopaedics, Inc. · 2018
- 1 generation backK193398 Summit DuoFix HA CoatingDePuy Orthopaedics, Inc. · 2020
- This deviceK210678 implaFit® hip stemsImplantcast GmbH · 2022
Most influential descendants
Showing 3 of 3 · See allView 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 | K170339 | Summit Hip System | DePuy Orthopaedics, Inc. | 2018 | — |
| −1 | K193398 | Summit DuoFix HA Coating | DePuy Orthopaedics, Inc. | 2020 | — |
| 0 (this device) | K210678 | implaFit® hip stems | Implantcast GmbH | 2022 | — |
| +1 | K232371 | Actinia® hip stems | Implantcast GmbH | 2023 | — |
| +1 | K260037 | implantcast Packaging System Update | Implantcast GmbH | 2026 | — |
| +1 | K252401 | implaFit® short stems | 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 |
|---|---|---|
| 2023 | 1 | 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 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? (3)
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 |
|---|---|---|---|
| * | K163577 | Ecofit® Hip SystemSummary page 5…e from cobalt chromium (CoCrMo). They are fixed using cement. Predicate Devices: Primary Predicate: - EcoFit® Hip System (K163577) Reference Devices: - EcoFit® Hip System (K180263, K191569) - D… | 2017 |
| * | K193398 | Summit DuoFix HA CoatingSummary page 5…- EcoFit® Hip System (K180263, K191569) - DePuy Orthopaedics, Inc. Summit DuoFix Hip (K193398) - Summit Cemented Hip Prosthesis (K013352) Substantial The implaFit® hip stems cementless are s… | 2020 |
| * | K013352 | Summit Cemented Hip ProsthesisSummary page 5…- DePuy Orthopaedics, Inc. Summit DuoFix Hip (K193398) - Summit Cemented Hip Prosthesis (K013352) Substantial The implaFit® hip stems cementless are similar to Equivalence: components previously cleared wit… | 2001 |
| † | K180263 | EcoFit Vit E Acetabular System | 2018 |
| † | K191569 | Implantcast ic-Bipolar Head System | 2019 |
What descends from it? (3)
3 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 28 years and passes through 8 companies; a new generation was cleared every 1.7 years on median.
- 71 of the 344 ancestors have a recall of any class.
- Of its descendants, K232371 (Implantcast GmbH, 2023) has gone furthest, with 1 descendant of its own.
- 6 other devices also cite its predicate K163577.
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. 2022, 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 implaFit® hip stems are indicated for use in cases of: - 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 implaFit® hip stems, when used in conjunction with…
Read the full statement (134 words)
The implaFit® hip stems are indicated for use in cases of:
- 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 implaFit® hip stems, when used in conjunction with the ic-Bipolar Heads, are intended 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.
The implaFit® hip stems cementless are intended for uncemented, press-fit fixation. The implaFit® hip stems cemented are intended for cemented fixation.
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/K210678 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210678: implaFit® hip stems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210678
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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