# K191449: ZCA All-Poly Acetabular Cups

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Jul 16, 2020 after 412 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K901240 (1990). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K901240: Astel Non-Metal Backed Acetabular Cup for Cemented, Med-Tek Corp. (1990) Summary page 4.
- K030153: Zca All-Poly Acetabular Cup, Snap-in, Model 8005-946/958-32, Zimmer, Inc. (2003) Summary page 4.

## Most influential descendants
- K252824: Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head (2026), 0 descendants of its own

## Indications for use
The acetabular cup is indicated for cemented use in skeletally mature individuals undergoing primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

Source page: https://510kreport.com/device/K191449
Methodology: https://510kreport.com/methodology