# K142119: Procotyl L-O Acetabular System

- Pathway: 510(k) (Traditional)
- Applicant: Microport Orthopedics, Inc.
- Decided: Feb 27, 2015 after 207 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K072656 (2008). 5 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002149: Lineage Acetabular System, Wrightmedicaltechnologyinc (2000) Summary page 4.
- K052026: Lineage a-Class Poly Liner, Wrightmedicaltechnologyinc (2005) Summary page 4.
- K130376: Dynasty Acetabular System with Ceramic, Wrightmedicaltechnologyinc (2013) Summary page 4.
- K140043: Dynasty Shell, Dynasty a-Class Crosslinked Poly Liner, Biolox Delta Femoral Head, Microport Orthopedics, Inc. (2014) 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
The PROCOTYL® L-O Acetabular System is intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 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 The PROCOTYL® L-O Acetabular System utilizes single use components, intended for use in conjunction with associated ceramic femoral heads as part of uncemented total hip arthroplasty.

Source page: https://510kreport.com/device/K142119
Methodology: https://510kreport.com/methodology