510(k) · Cleared
ClearedEcoFit® Hip System
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 Feb 3, 2021 as substantially equivalent to K163577 (Implantcast GmbH, 2017) and 2 other predicates after a 76-day review. Its family tree reaches back 13 generations to 1994. 4 later devices descend from it.
- Decided
- Feb 3, 2021
- Review
- 76 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 13 generations to K931641 (1994). 304 ancestors in all, the oldest K810258 (1981). 4 later devices descend from it, 4 citing it directly.
- Root · 13 generations backK931641 Porocoat Porous CoatingDepuy, Inc. · 1994
- 9 generations between
- 3 generations backK161184 iNSitu Total Hip SystemTheken Companies, LLC · 2016
- 2 generations backK163577 Ecofit® Hip SystemImplantcast GmbH · 2017 · Recalled
- 1 generation backK180263 EcoFit Vit E Acetabular SystemImplantcast GmbH · 2018
- This deviceK203420 EcoFit® Hip SystemImplantcast GmbH · 2021
- Descendant · cites it directly · 1 of its ownK240834 EcoFit® short stem cementless cpTiImplantcast GmbH · 2024
- Descendant · cites it directly · 1 of its ownK223103 BethaLoc® stem cementless HAImplantcast GmbH · 2023
- Descendant · cites it directly · 0 of its ownK252451 EPORE® XO cup systemImplantcast GmbH · 2026
- Descendant · cites it directly · 0 of its ownK260037 implantcast Packaging System UpdateImplantcast GmbH · 2026
Show all 13 generations
- Root · 13 generations backK931641 Porocoat Porous CoatingDepuy, Inc. · 1994
- 12 generations backK003800 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- 11 generations backK012364 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- 10 generations backK030236 Acumatch P-Series Porous Press-Fit Femoral ComponentExactech, Inc. · 2003
- 9 generations backK041906 Exactech 12/14 Total Hip SystemExactech, Inc. · 2004 · Recalled
- 8 generations backK042842 Novation 12/14 Press-Fit Femoral StemExactech, Inc. · 2004
- 7 generations backK102487 Novation Femoral Stem, Tapered 12/14 , Standard/Extended Offset…Exactech, Inc. · 2010
- 6 generations backK112802 Pipeline Total Hip SystemPipeline Orthopedics · 2012
- 5 generations backK122158 PBP Total Hip SystemPipeline Biomedical Products, LLC · 2012
- 4 generations backK131237 Pipeline Total Hip SystemPipeline Orthopedics · 2013
- 3 generations backK161184 iNSitu Total Hip SystemTheken Companies, LLC · 2016
- 2 generations backK163577 Ecofit® Hip SystemImplantcast GmbH · 2017 · Recalled
- 1 generation backK180263 EcoFit Vit E Acetabular SystemImplantcast GmbH · 2018
- This deviceK203420 EcoFit® Hip SystemImplantcast GmbH · 2021
Most influential descendants
Showing 4 of 4 · See all- K240834EcoFit® short stem cementless cpTiImplantcast GmbH · 2024 · cites it directly1descendant
- K223103BethaLoc® stem cementless HAImplantcast GmbH · 2023 · cites it directly1descendant
- K252451EPORE® XO cup systemImplantcast GmbH · 2026 · cites it directly0descendants
- 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 |
|---|---|---|---|---|---|
| −13 | K931641 | Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −12 | K003800 | Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| −11 | K012364 | Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| −10 | K030236 | Acumatch P-Series Porous Press-Fit Femoral Component | Exactech, Inc. | 2003 | — |
| −9 | K041906 | Exactech 12/14 Total Hip System | Exactech, Inc. | 2004 | 1 |
| −8 | K042842 | Novation 12/14 Press-Fit Femoral Stem | Exactech, Inc. | 2004 | — |
| −7 | K102487 | Novation Femoral Stem, Tapered 12/14 , Standard/Extended Offset, Plasma… | Exactech, Inc. | 2010 | — |
| −6 | K112802 | Pipeline Total Hip System | Pipeline Orthopedics | 2012 | — |
| −5 | K122158 | PBP Total Hip System | Pipeline Biomedical Products, LLC | 2012 | — |
| −4 | K131237 | Pipeline Total Hip System | Pipeline Orthopedics | 2013 | — |
| −3 | K161184 | iNSitu Total Hip System | Theken Companies, LLC | 2016 | — |
| −2 | K163577 | Ecofit® Hip System | Implantcast GmbH | 2017 | 1 |
| −1 | K180263 | EcoFit Vit E Acetabular System | Implantcast GmbH | 2018 | — |
| 0 (this device) | K203420 | EcoFit® Hip System | Implantcast GmbH | 2021 | — |
| +1 | K240834 | EcoFit® short stem cementless cpTi | Implantcast GmbH | 2024 | — |
| +1 | K223103 | BethaLoc® stem cementless HA | Implantcast GmbH | 2023 | — |
| +1 | K252451 | EPORE® XO cup system | Implantcast GmbH | 2026 | — |
| +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 | 4 | 0 |
| 1987 | 2 | 0 |
| 1988 | 3 | 0 |
| 1990 | 2 | 0 |
| 1991 | 4 | 0 |
| 1992 | 6 | 0 |
| 1993 | 6 | 0 |
| 1994 | 30 | 0 |
| 1995 | 22 | 0 |
| 1996 | 26 | 0 |
| 1997 | 15 | 0 |
| 1998 | 14 | 0 |
| 1999 | 14 | 0 |
| 2000 | 27 | 0 |
| 2001 | 10 | 0 |
| 2002 | 13 | 0 |
| 2003 | 13 | 0 |
| 2004 | 9 | 0 |
| 2005 | 12 | 0 |
| 2006 | 9 | 0 |
| 2007 | 8 | 0 |
| 2008 | 7 | 0 |
| 2009 | 4 | 0 |
| 2010 | 7 | 0 |
| 2011 | 4 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 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 7…ne extension inclusive of additional acetabular inserts and cementless femoral stems. Predicate Devices: Primary Predicate: EcoFit® Hip System (K163577 and K180263); Zimmer Longevity IT Highly Crosslinked Polyethylene Elevated… | 2017 |
| * | K180263 | EcoFit Vit E Acetabular SystemSummary page 7…additional acetabular inserts and cementless femoral stems. Predicate Devices: Primary Predicate: EcoFit® Hip System (K163577 and K180263); Zimmer Longevity IT Highly Crosslinked Polyethylene Elevated Liners, Continuum Acet… | 2018 |
| * | K101229 | Longevity IT Highly Crosslinked Polyethylene Elevated Liners, Continuum Acetabular…Summary page 7…ighly Crosslinked Polyethylene Elevated Liners, Continuum Acetabular System, Trilogy Integrated Taper (IT) Acetabular System (K101229) Substantial This 510(k) is a line extension of the cleared EcoFit® Hip Equivalence: System (K163577 and K180… | 2010 |
What descends from it? (4)
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 27 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 61 of the 303 ancestors have a recall of any class.
- Of its descendants, K240834 (Implantcast GmbH, 2024) 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. 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?
Acetabular Inserts The EcoFit® Hip System is indicated for use as a total hip replacement 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 EcoFit®…
Read the full statement (331 words)
Acetabular Inserts
The EcoFit® Hip System is indicated for use as a total hip replacement 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 EcoFit® Acetabular Cup is intended for uncemented, press-fit fixation.
The MUTARS® Proximal Femur Replacement System is a modular hip replacement system offering various components that can be combined to replace the hip joint and address major bone defects with various options depending upon the size and location of the defects of each patient.
The MUTARS® Proximal Femur System is intended for uncemented use in total hip arthroplasty or hemiarthroplasty for the following indications:
- Proximal femur replacement in oncology cases where radical resection and replacement of bone is required.
- Limb salvage procedures including surgical intervention for severe trauma, failed previous prosthesis, and/or oncology indications, where radical resection and replacement of the bone is required.
Femoral Stems
The EcoFit® Hip System is indicated for use as a total hip replacement 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 EcoFit® Acetabular Cup is intended for uncemented, press-fit fixation.
The MUTARS® ic-Bipolar Head System is intended for uncemented use in hemiarthroplasty, where the femoral head requires replacement but the acetabulum does not, in conjunction with the EcoFit® Hip System and MUTARS® Proximal Femur Replacement 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/K203420 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203420: EcoFit® Hip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203420
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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