# K953510: Hip Joint Femoral (Hemi-Hip) Metal/Polymer Cemented or Uncemented Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Encore Orthopedics, Inc.
- Decided: Aug 9, 1995 after 14 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: 18 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
48 later devices descend from it; 3 cite it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K982447: Plus Bipolar Prosthesis Cocrmo (1998), 36 descendants of its own
- K082468: Apex Hip System Bipolar Head, Model H3-822XX and H3-828YY, XX=OD in [MM] (38-43), YY=OD in [MM](44-60) (2009), 21 descendants of its own
- K112158: Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar Heads (2012), 13 descendants of its own
- K060707: Aesculap Bipolar Acetabular Cup (2006), 11 descendants of its own
- K091967: Medacta Bipolar Head (2010), 9 descendants of its own

## Recalls of this device
- Aug 2, 2007 · Not classified · Z-0082-2008: Device mislabeled. Hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date.
- Aug 2, 2007 · Not classified · Z-0083-2008: Device mislabeled. Hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date.
- Aug 2, 2007 · Not classified · Z-0084-2008: Device mislabeled. Hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date.
- Aug 2, 2007 · Not classified · Z-0085-2008: Device mislabeled. Hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date.
- Aug 2, 2007 · Not classified · Z-0088-2008: Device mislabeled; hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date.
- Aug 2, 2007 · Not classified · Z-0090-2008: Device mislabeled; hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date.
- Aug 2, 2007 · Not classified · Z-0091-2008: Device mislabeled; hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date.
- Aug 2, 2007 · Not classified · Z-0094-2008: Device mislabeled; hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date.
- Aug 2, 2007 · Not classified · Z-0095-2008: Device mislabeled; hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date.
- Aug 2, 2007 · Not classified · Z-0096-2008: Device mislabeled; hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date.
- Aug 2, 2007 · Not classified · Z-0097-2008: Device mislabeled; hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date.
- Aug 2, 2007 · Not classified · Z-0099-2008: Device mislabeled; hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date.
- Aug 2, 2007 · Not classified · Z-0086-2008: Device mislabeled. Hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date.
- Aug 2, 2007 · Not classified · Z-0089-2008: Device mislabeled; hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date.
- Aug 2, 2007 · Not classified · Z-0093-2008: Device mislabeled; hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date.
- Aug 2, 2007 · Not classified · Z-0098-2008: Device mislabeled; hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date.
- Aug 2, 2007 · Not classified · Z-0087-2008: Device mislabeled; hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date.
- Aug 2, 2007 · Not classified · Z-0092-2008: Device mislabeled; hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date.

Source page: https://510kreport.com/device/K953510
Methodology: https://510kreport.com/methodology