# K170444: PROCOTYL® PRIME Acetabular Cup System

- Pathway: 510(k) (Traditional)
- Applicant: Microport Orthopedics, Inc.
- Decided: Jun 26, 2017 after 132 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: 6 generations back to K930712 (1993). 19 ancestors in all.
16 later devices descend from it; 8 cite it directly.
0 of 36 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.
- K864626: Cancellous Bone Screw, Dow Corning Wright (1986) 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.
- K934765: Trilogy Acetabular System, Zimmer, Inc. (1994) Summary page 4.
- K953490: Trilogy Acetabular Shell & Liners 36MM, Zimmer, Inc. (1995) Summary page 4.
- K090998: Depuy Pinnacle 100 with Gription Acetabular Cups, DePuy Orthopaedics, Inc. (2009) Summary page 4.

## Most influential descendants
- K171181: PROCOTYL® PRIME E-CLASS™ XLPE Liner (2017), 10 descendants of its own
- K180263: EcoFit Vit E Acetabular System (2018), 5 descendants of its own
- K203420: EcoFit® Hip System (2021), 4 descendants of its own
- K180798: Prime Acetabular Cup System (2018), 2 descendants of its own
- K240834: EcoFit® short stem cementless cpTi (2024), 1 descendant of its own

## Indications for use
The PROCOTYL® PRIME Acetabular Cup 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. Shells with BIOFOAM® metal foam coating are intended only for uncemented arthroplasty.

Source page: https://510kreport.com/device/K170444
Methodology: https://510kreport.com/methodology