# K121563: Corin Trifit TS Hip

- Pathway: 510(k) (Traditional)
- Applicant: Corin USA
- Decided: Oct 5, 2012 after 129 days
- Product code: MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate)
- 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). 125 ancestors in all.
10 later devices descend from it; 5 cite it directly.
0 of 135 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062994: Lateralized Taperloc Microplasty Femoral Components, Biomet Manufacturing Corp (2007) Summary page 1.
- K010367: Modification to Titanium Tri-Lock Hips Stem, DePuy Orthopaedics, Inc. (2001) Summary page 1.
- K073570: Depuy Tri-Lock Bone Preservation Stem, DePuy Orthopaedics, Inc. (2008) Summary page 1.
- K120362: Metafix Femoral Stem for Hemi-Arthroplasty, Corin USA (2012) Summary page 1.
- K093472: Trinity Acetabular System, Corin USA (2010) Summary page 2.

## Most influential descendants
- K153381: Corin Metafix Hip Stem (2016), 5 descendants of its own
- K153772: Corin TriFit TS Hip (2016), 4 descendants of its own
- K173880: Corin TriFit CF Hip Stem (2018), 3 descendants of its own
- K162942: Corin MetaFix Hip Stem (2017), 3 descendants of its own
- K212069: Corin MetaFix™ Hip Stem (2022), 2 descendants of its own

## Recalls of this device
- Jul 28, 2021 · Class II · Z-2603-2021: 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 indications for the Corin TriFit TS Hip as a total hip arthroplasty, and when used in combination with a Corin hemi arthroplasty head, as a hip hemi-arthroplasty, include: Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis Rheumatoid arthritis Correction of functional deformity Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur Developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip (CDH) The TriFit TS Hip is intended for cementless use only.

Source page: https://510kreport.com/device/K121563
Methodology: https://510kreport.com/methodology
