# K171181: PROCOTYL® PRIME E-CLASS™ XLPE Liner

- Pathway: 510(k) (Traditional)
- Applicant: Microport Orthopedics, Inc.
- Decided: Aug 28, 2017 after 126 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: 7 generations back to K930712 (1993). 20 ancestors in all.
10 later devices descend from it; 4 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170444: PROCOTYL® PRIME Acetabular Cup System, Microport Orthopedics, Inc. (2017). Cleared while this submission was under review Summary page 4.
- K002149: Lineage Acetabular System, Wrightmedicaltechnologyinc (2000) Summary page 4.
- K052026: Lineage a-Class Poly Liner, Wrightmedicaltechnologyinc (2005) Summary page 4.
- K082924: Dynasty Porous Acetabular Shell, Dynasty Polyethylene Acetabular Liner, Dynasty Metal Acetabular Liner, Wrightmedicaltechnologyinc (2009) Summary page 4.
- K061547: Dynasty Acetabular Shell; Dynasty a-Class Poly Acetabular Liner, Wrightmedicaltechnologyinc (2006) Summary page 4.
- K070785: Dynasty Acetabular System, Wrightmedicaltechnologyinc (2007) Summary page 4.

## Most influential descendants
- K180263: EcoFit Vit E Acetabular System (2018), 5 descendants of its own
- K203420: EcoFit® Hip System (2021), 4 descendants of its own
- K240834: EcoFit® short stem cementless cpTi (2024), 1 descendant of its own
- K223103: BethaLoc® stem cementless HA (2023), 1 descendant of its own
- K173898: MicroPort Orthopedics Total Hip Systems MR Labeling (2018), 1 descendant of its own

## Indications for use
PROCOTYL® PRIME hip system is intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients. Indications for Use 1) non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankyloses, protrusion 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/K171181
Methodology: https://510kreport.com/methodology