# K212069: Corin MetaFix™ Hip Stem

- Pathway: 510(k) (Traditional)
- Applicant: Corin U.S.A. Limited
- Decided: Apr 7, 2022 after 279 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: 17 generations back to K810258 (1981). 132 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 134 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 4.
- K120362: Metafix Femoral Stem for Hemi-Arthroplasty, Corin USA (2012) Summary page 4.
- K121439: Metafix Femoral Hip Stem Size 1, Corin USA (2012) Summary page 4.
- K153381: Corin Metafix Hip Stem, Corin U.S.A. Limited (2016) Summary page 4.
- K162942: Corin MetaFix Hip Stem, Corin U.S.A. Limited (2017) Summary page 4.

## Most influential descendants
- 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 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 and femoral neck fractures • 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/K212069
Methodology: https://510kreport.com/methodology