# K181598: Prime E-CLASS XLPE Liner

- Pathway: 510(k) (Traditional)
- Applicant: Microport Orthopedics, Inc.
- Decided: Sep 14, 2018 after 88 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K930712 (1993). 22 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171181: PROCOTYL® PRIME E-CLASS™ XLPE Liner, Microport Orthopedics, Inc. (2017) Summary page 4.
- K180798: Prime Acetabular Cup System, Microport Orthopedics, Inc. (2018). Cleared while this submission was under review Summary page 4.

## Most influential descendants
- K240046: Ethylene Oxide Sterilization Supplier Change for MPO Hips (2024), 0 descendants of its own

## Indications for use
1) non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2) inflammatory degenerative joint disease such as rheumatoid arthritis; 3) correction of functional deformity; and, 4) revision procedures where other treatments or devices have failed. Shells with BIOFOAM® metal foam coating are intended only for uncemented arthroplasty.

Source page: https://510kreport.com/device/K181598
Methodology: https://510kreport.com/methodology