# K170359: Trinity™ Dual Mobility System

- Pathway: 510(k) (Traditional)
- Applicant: Corin U.S.A. Limited
- Decided: Oct 31, 2017 after 267 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K810258 (1981). 139 ancestors in all.
10 later devices descend from it; 5 cite it directly.
0 of 149 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103233: Modular Dual Mobility Liner, X3 Acetabular Insert, Howmedica Osteonics Corp. (2011) Summary page 4.
- K150522: G7 Dual Mobility System, Biomet, Inc. (2015) Summary page 4.
- K110087: Corin Trinity Acetbular System with Hxlpe Liners, Corin USA (2011) Summary page 4.
- K111481: Corin Trinity Acetabular System Ecima Liners, Corin USA (2012) Summary page 4.
- K131647: Trinity Acetabular System, Corin USA (2013) Summary page 4.

## Most influential descendants
- K191831: MobiliT Cup (2020), 3 descendants of its own
- K190535: BiMobile Dual Mobility System - E-Dur Inserts (2019), 3 descendants of its own
- K201657: Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell, MetaFix™ Hip System, TriFit™ CF and TS Hip Systems, TaperFit™ Hip System, Revival™ Modular Hip System, MiniHip™, Trinity™ Dual Mobility, MobiliT, BiPolar-i, OMNI MOD™ Hip System, OMNI K1 and K2 Hip Systems, OMNI Bipolar Heads, Corin Biolox Delta Ceramic Heads, OMNI Delta Ceramic Heads (2021), 2 descendants of its own
- K241472: Icona Hip Stem (2024), 1 descendant of its own
- K200607: LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters (2021), 1 descendant of its own

## Recalls of this device
- Jul 28, 2021 · Class II · Z-2608-2021: The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.

## Indications for use
The Trinity™ Dual Mobility System is intended for use in the following indications: 1. Non-inflammatory degenerative joint disease, including osteoarthritis & avascular necrosis 2. Rheumatoid Arthritis 3. Correction of functional deformity 4. Revision of previously failed total hip arthroplasty, 5. Patients at increased risk of dislocation 6. Developmental dysplasia of the hip (DDH) The TrinityTM Dual Mobility System is indicated for cementless use only.

Source page: https://510kreport.com/device/K170359
Methodology: https://510kreport.com/methodology