# K131952: Corin Metafix Hip Stem

- Pathway: 510(k) (Traditional)
- Applicant: Corin USA
- Decided: Dec 16, 2013 after 172 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K810258 (1981). 123 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 127 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082525: Corin Metafix Femoral Stem, Corin USA (2010) Summary page 2.
- K121439: Metafix Femoral Hip Stem Size 1, Corin USA (2012) Summary page 2.
- K120362: Metafix Femoral Stem for Hemi-Arthroplasty, Corin USA (2012) Summary page 2.
- K130634: Corin Metafix Hip Stem, Corin USA (2013) Summary page 2.
- K130343: Corin Trinity Acetabular System with Extra-Long Heads, Corin USA (2013) Summary page 2.

## Most influential descendants
- K162942: Corin MetaFix Hip Stem (2017), 3 descendants of its own
- K212069: Corin MetaFix™ Hip Stem (2022), 2 descendants of its own
- K241472: Icona Hip Stem (2024), 1 descendant of its own
- K261576: Icona Hip Stem (2026), 0 descendants of its own

## Indications for use
The indications for the Corin Metafix Hip Stem as a total hip arthroplasty and, when used in combination with Corin hemi-arthroplasty femoral heads, as a 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) and congenital dysplasia of the hip (CDH) The Corin Metafix Hip Stem is indicated for cementless use only.

Source page: https://510kreport.com/device/K131952
Methodology: https://510kreport.com/methodology
