510(k) · Cleared
ClearedImplantcast ic-Bipolar Head System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Implantcast GmbH · KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Cleared on Aug 28, 2019 as substantially equivalent to K060707 (Aesculap, Inc., 2006) after a 76-day review. Its family tree reaches back 7 generations to 1994. 3 later devices descend from it.
- Decided
- Aug 28, 2019
- Review
- 76 days
- Class
- Class II
- Product code
- KWY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K941847 (1994). 56 ancestors in all, the oldest K833175 (1983). 3 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 6 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
- 5 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
- 4 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
- 3 generations backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
- 2 generations backK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- 1 generation backK060707 Aesculap Bipolar Acetabular CupAesculap, Inc. · 2006
- This deviceK191569 Implantcast ic-Bipolar Head SystemImplantcast GmbH · 2019
- 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 ownK260037 implantcast Packaging System UpdateImplantcast GmbH · 2026
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 |
|---|---|---|---|---|---|
| −7 | K941847 | 5/8 Porocoat Aml Hip Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −6 | K964650 | TCP-Coated Porocoat Aml Femoral Hip Prosthesis | Depuy, Inc. | 1997 | — |
| −5 | K980711 | Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer, Inc. | 1998 | 1 |
| −4 | K001277 | Triflange Acetabular Cup System | DePuy Orthopaedics, Inc. | 2000 | — |
| −3 | K031495 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | 2003 | — |
| −2 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| −1 | K060707 | Aesculap Bipolar Acetabular Cup | Aesculap, Inc. | 2006 | — |
| 0 (this device) | K191569 | Implantcast ic-Bipolar Head System | Implantcast GmbH | 2019 | — |
| +1 | K240834 | EcoFit® short stem cementless cpTi | Implantcast GmbH | 2024 | — |
| +1 | K223103 | BethaLoc® stem cementless HA | 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 |
|---|---|---|
| 1983 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 5 | 0 |
| 1996 | 5 | 0 |
| 1997 | 3 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 1 | 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 KWY? 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 KWY device
- #1 K253357 b-ONE® Bipolar Headscore 11.2 · 1 generation · 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 |
|---|---|---|---|
| * | K060707 | Aesculap Bipolar Acetabular CupSummary page 4…2019 Classification: 21 CFR §888.3390 Class: II Product Codes: KWY Primary Predicate Device: Aesculap Bipolar Acetabular Cup (K060707) Common Name: Bipolar Hip Reference Devices: MUTARS® Proximal Femur Replacement System (K181778)… | 2006 |
| † | K181778 | MUTARS Proximal Femur Replacement System | 2019 |
| † | K163577 | Ecofit® Hip System | 2017 |
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 25 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 17 of the 55 ancestors have a recall of any class.
- Of its descendants, K240834 (Implantcast GmbH, 2024) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K060707.
How does its category compare?
All KWY devicesKWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · KWY
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWY
126in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWY
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWY
180in 2025
MAUDE reports naming product code KWY, 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 | 0 | — | 25 | 370 |
| 2008 | 3 | 123 | 0 | 900 |
| 2009 | 1 | — | 24 | 961 |
| 2010 | 4 | 187 | 1 | 688 |
| 2011 | 1 | — | 0 | 758 |
| 2012 | 1 | — | 1 | 978 |
| 2013 | 2 | — | 2 | 1,148 |
| 2014 | 1 | — | 0 | 1,055 |
| 2015 | 1 | — | 0 | 1,213 |
| 2016 | 1 | — | 3 | 877 |
| 2017 | 1 | — | 2 | 826 |
| 2018 | 3 | 219 | 1 | 1,380 |
| 2019 | 5 | 126 | 1 | 1,530 |
| 2020 | 1 | — | 0 | 1,259 |
| 2021 | 0 | — | 0 | 276 |
| 2022 | 2 | — | 0 | 208 |
| 2023 | 2 | — | 0 | 178 |
| 2024 | 0 | — | 1 | 209 |
| 2025 | 1 | — | 2 | 180 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The ic-Bipolar Heads is for uncemented use in conjunction with the MUTARS® Proximal Femoral Replacement System 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. Use of…
Read the full statement (131 words)
The ic-Bipolar Heads is for uncemented use in conjunction with the MUTARS® Proximal Femoral Replacement System 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.
Use of this prosthesis is generally only indicated in skeletally mature patients.
The ic-Bipolar Heads is for uncemented use in conjunction with the EcoFit® Hip 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 as stated in the FDA summary.
https://510kreport.com/device/K191569 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191569: Implantcast ic-Bipolar Head System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191569
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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