# K060707: Aesculap Bipolar Acetabular Cup

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap, Inc.
- Decided: May 31, 2006 after 76 days
- Product code: KWY (Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3390
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K941847 (1994). 55 ancestors in all.
11 later devices descend from it; 4 cite it directly.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051569: Ringloc BI-Polar Acetabular Component, Biomet, Inc. (2005)
- K982447: Plus Bipolar Prosthesis Cocrmo, Plus Orthopedics (1998) Summary page 1.
- K042344: Excia Total Hip System, Aesculap, Inc. (2005) Summary page 1.
- K040191: Bicontact Hip Stem and Femoral Head, Aesculap (2004) Summary page 1.

## Most influential descendants
- K191569: Implantcast ic-Bipolar Head System (2019), 3 descendants of its own
- K152439: U2 Bipolar Implant and 22mm Femoral Head (2016), 3 descendants of its own
- K240834: EcoFit® short stem cementless cpTi (2024), 1 descendant of its own
- K223103: BethaLoc® stem cementless HA (2023), 1 descendant of its own
- K162957: U2 Femoral Head (2017), 1 descendant of its own

## Indications for use
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

Source page: https://510kreport.com/device/K060707
Methodology: https://510kreport.com/methodology