# K953337: Beta Hip Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Jan 22, 1996 after 189 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: 15 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
22 later devices descend from it; 4 cite it directly.
0 of 23 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
- K973714: Versys Hip System Beaded Hip Prosthesis (1997), 18 descendants of its own
- K042776: Versys Hip System Beaded Midcoat Low Head Center Hip Prosthesis, Model 00-7840-XXX-XX (2004), 11 descendants of its own
- K061786: Versys Fiber Metal Midcoat Low Head Center Hip Prosthesis (2006), 10 descendants of its own
- K163577: Ecofit® Hip System (2017), 9 descendants of its own
- K180263: EcoFit Vit E Acetabular System (2018), 5 descendants of its own

## Recalls of this device
- Aug 1, 2017 · Class II · Z-0722-2018: The products being recalled exceeded the weight previously tested leading to a possibility of damage to the package and/or a compromised sterile barrier.
- Feb 28, 2017 · Class II · Z-2577-2017: Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
- Feb 28, 2017 · Class II · Z-2579-2017: Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
- Feb 28, 2017 · Class II · Z-2578-2017: Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
- Feb 28, 2017 · Class II · Z-2580-2017: Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
- Feb 28, 2017 · Class II · Z-2581-2017: Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
- Jan 11, 2016 · Class II · Z-0849-2016: LDPE bag containing the implant adheres to the highly polished implant surface.
- Jan 11, 2016 · Class II · Z-1127-2016: 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-1031-2014: 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
- Oct 11, 2013 · Class II · Z-1034-2014: 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-0070-2014: The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.
- Jul 5, 2010 · Not classified · Z-2291-2010: Zimmer, Inc. has determined that there is a potential for a package to be labeled as a 28 mm femoral head but contain a 32 mm femoral head. In addition, there is a potential for the patient record lab
- Jul 5, 2010 · Not classified · Z-2290-2010: Zimmer, Inc. has determined that there is a potential for a package to be labeled as a 28 mm femoral head but contain a 32 mm femoral head. In addition, there is a potential for the patient record lab
- Aug 3, 2009 · Not classified · Z-0198-2010: Manufacturing material may be present on the surface of the implant.
- Apr 15, 2005 · Not classified · Z-1066-05: May be mislabeled as to dimensions; may be 12/14 taper, 28mm dia., neck length +3.5mm.

Source page: https://510kreport.com/device/K953337
Methodology: https://510kreport.com/methodology