# K833991: Bipolar Hip Device

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer
- Decided: Jan 30, 1984 after 70 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: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Nov 29, 2017 · Class II · Z-1014-2018: The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed fro
- Jan 11, 2016 · Class II · Z-0845-2016: LDPE bag containing the implant adheres to the highly polished implant surface.
- Jan 11, 2016 · Class II · Z-1114-2016: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
- Oct 11, 2013 · Class II · Z-1019-2014: Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packag
- Aug 30, 2013 · Class II · Z-0068-2014: The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.
- Aug 31, 2012 · Class II · Z-0410-2013: Zimmer Inc. is initiating a removal of the Multipolar Bipolar Cup Liner 22 mm J.D. (item 00-5001-040-22) due to reports that the split poly ring was incorrectly assembled.

Source page: https://510kreport.com/device/K833991
Methodology: https://510kreport.com/methodology