510(k) · Cleared
ClearedAesculap Bipolar Acetabular Cup
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap, Inc. · KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Cleared on May 31, 2006 as substantially equivalent to K051569 (Biomet, Inc., 2005) and 3 other predicates after a 76-day review. Its family tree reaches back 6 generations to 1994. 11 later devices descend from it.
- Decided
- May 31, 2006
- Review
- 76 days
- Class
- Class II
- Product code
- KWY
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K941847 (1994). 55 ancestors in all, the oldest K833175 (1983). 11 later devices descend from it, 4 citing it directly.
- Root · 6 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 5 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
- 4 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
- 3 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
- 2 generations backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
- 1 generation backK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- This deviceK060707 Aesculap Bipolar Acetabular CupAesculap, Inc. · 2006
- Descendant · cites it directly · 3 of its ownK191569 Implantcast ic-Bipolar Head SystemImplantcast GmbH · 2019
- Descendant · cites it directly · 3 of its ownK152439 U2 Bipolar Implant and 22mm Femoral HeadUnited Orthopedic Corporation · 2016
- Descendant · 2 generations on · 1 of its ownK240834 EcoFit® short stem cementless cpTiImplantcast GmbH · 2024
- Descendant · 2 generations on · 1 of its ownK223103 BethaLoc® stem cementless HAImplantcast GmbH · 2023
- Descendant · 2 generations on · 1 of its ownK162957 U2 Femoral HeadUnited Orthopedic Corporation · 2017
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K191569Implantcast ic-Bipolar Head SystemImplantcast GmbH · 2019 · cites it directly3descendants
- K152439U2 Bipolar Implant and 22mm Femoral HeadUnited Orthopedic Corporation · 2016 · cites it directly3descendants
- K240834EcoFit® short stem cementless cpTiImplantcast GmbH · 2024 · 2 generations on1descendant
- K223103BethaLoc® stem cementless HAImplantcast GmbH · 2023 · 2 generations on1descendant
- K162957U2 Femoral HeadUnited Orthopedic Corporation · 2017 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K941847 | 5/8 Porocoat Aml Hip Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −5 | K964650 | TCP-Coated Porocoat Aml Femoral Hip Prosthesis | Depuy, Inc. | 1997 | — |
| −4 | K980711 | Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer, Inc. | 1998 | 1 |
| −3 | K001277 | Triflange Acetabular Cup System | DePuy Orthopaedics, Inc. | 2000 | — |
| −2 | K031495 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | 2003 | — |
| −1 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| 0 (this device) | K060707 | Aesculap Bipolar Acetabular Cup | Aesculap, Inc. | 2006 | — |
| +1 | K191569 | Implantcast ic-Bipolar Head System | Implantcast GmbH | 2019 | — |
| +1 | K152439 | U2 Bipolar Implant and 22mm Femoral Head | United Orthopedic Corporation | 2016 | — |
| +2 | K240834 | EcoFit® short stem cementless cpTi | Implantcast GmbH | 2024 | — |
| +2 | K223103 | BethaLoc® stem cementless HA | Implantcast GmbH | 2023 | — |
| +2 | K162957 | U2 Femoral Head | United Orthopedic Corporation | 2017 | — |
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 |
|---|---|---|
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 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? (4)
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 |
|---|---|---|---|
| * | K051569 | Ringloc BI-Polar Acetabular Component | 2005 |
| * | K982447 | Plus Bipolar Prosthesis CocrmoSummary page 1…tially equivalent to the following legally marketed predicate devices: Biomet Ringloc Bi-Polar Acetabular Component (KO51569) Plus Orthopedics Bipolar Prosthesis CoCrMo (K982447) Aesculap Excia Total Hip System (K042344) Aesculap BiContact Hip Stem and Femoral Head (K040191) DEVICE DESCRIPTION The BiPolar… | 1998 |
| * | K042344 | Excia Total Hip SystemSummary page 1…marketed predicate devices: Biomet Ringloc Bi-Polar Acetabular Component (KO51569) Plus Orthopedics Bipolar Prosthesis CoCrMo (K982447) Aesculap Excia Total Hip System (K042344) Aesculap BiContact Hip Stem and Femoral Head (K040191) DEVICE DESCRIPTION The BiPolar cup isa sub-component of an endoprostheti… | 2005 |
| * | K040191 | Bicontact Hip Stem and Femoral HeadSummary page 1…etabular Component (KO51569) Plus Orthopedics Bipolar Prosthesis CoCrMo (K982447) Aesculap Excia Total Hip System (K042344) Aesculap BiContact Hip Stem and Femoral Head (K040191) DEVICE DESCRIPTION The BiPolar cup isa sub-component of an endoprosthetic replacement for the human hip where it assumes the fu… | 2004 |
What descends from it? (11)
See all 114 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 12 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- 17 of the 54 ancestors have a recall of any class.
- Of its descendants, K191569 (Implantcast GmbH, 2019) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K051569.
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.
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 Aesculap BiPolar Cup is for uncemented use in conjunction with a standard cemented or uncemented femoral replacement implant for the following:
1) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
2) Rheumatoid arthritis
3) Correction of functional deformity
4) 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/K060707 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060707: Aesculap Bipolar Acetabular Cup.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060707
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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