# K950312: Alpha System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: May 17, 1995 after 111 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 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
- K040389: Coonrad/Morrey Elbow Cement Restrictor (2004), 1 descendant of its own
- K181307: Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow (2019), 0 descendants of its own

## Recalls of this device
- Jan 11, 2016 · Class II · Z-1164-2016: 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.
- Jan 11, 2016 · Class II · Z-1167-2016: 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-1029-2014: 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

Source page: https://510kreport.com/device/K950312
Methodology: https://510kreport.com/methodology