# K934381: Apollo Knee Tibial Baseplate/Knee Tibial Insert

- Pathway: 510(k) (Traditional)
- Applicant: Intermedics Orthopedics
- Decided: Feb 8, 1995 after 518 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: 1 (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
- Feb 25, 2014 · Class II · Z-1259-2014: A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a

Source page: https://510kreport.com/device/K934381
Methodology: https://510kreport.com/methodology