# K123705: Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular Shells

- Pathway: 510(k) (Traditional)
- Applicant: Corin USA
- Decided: Feb 12, 2013 after 71 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: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K810258 (1981). 100 ancestors in all.
23 later devices descend from it; 4 cite it directly.
0 of 123 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093472: Trinity Acetabular System, Corin USA (2010) Summary page 2.
- K110087: Corin Trinity Acetbular System with Hxlpe Liners, Corin USA (2011) Summary page 1.
- K122305: Corin Trinity-I Acetabular Shell, Corin USA (2012) Summary page 1.
- K050262: U2 Acetabular Component, United Orthopedic Corp. (2005) Summary page 1.

## Most influential descendants
- K182321: MobileLink Acetabular Cup System (2019), 8 descendants of its own
- K152893: Corin Optimized Positioning System (OPS) (2016), 8 descendants of its own
- K190834: Corin Optimized Position System Functional Hip Analysis (OPS FHA) (2019), 5 descendants of its own
- K192559: Acetabular Bone Screws (for MobileLink Acetabular Cup System) (2019), 4 descendants of its own
- K142761: Corin TaperFit Hip Stem (2015), 4 descendants of its own

## Recalls of this device
- Jul 28, 2021 · Class II · Z-2605-2021: 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.
- Jan 29, 2016 · Class II · Z-1528-2016: Potential for abrasion of the sterile barrier pouches of the new packaging system.
- Jan 29, 2016 · Class II · Z-1527-2016: Potential for abrasion of the sterile barrier pouches of the new packaging system.
- Jan 29, 2016 · Class II · Z-1526-2016: Potential for abrasion of the sterile barrier pouches of the new packaging system.

## Indications for use
The indications for the Trinity Acetabular System as a total hip arthroplastv include: Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis Rheumatoid arthritis Correction of functional deformity Developmental dysplasia of the hip (DDIt or congenital dlysplasia of the hip (CDH) The Trinity Acetabular System is indicated for cementless, single use only.

Source page: https://510kreport.com/device/K123705
Methodology: https://510kreport.com/methodology