# K082525: Corin Metafix Femoral Stem

- Pathway: 510(k) (Traditional)
- Applicant: Corin USA
- Decided: Feb 4, 2010 after 520 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: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K935452 (1994). 16 ancestors in all.
71 later devices descend from it; 10 cite it directly.
0 of 88 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042992: Corail Amt Hip Prosthesis, DePuy Orthopaedics, Inc. (2005) Summary page 1.

## Most influential descendants
- K120362: Metafix Femoral Stem for Hemi-Arthroplasty (2012), 61 descendants of its own
- K123991: Depuy Corail Amt Hip Prosthesis (2013), 48 descendants of its own
- K150862: DePuy Actis Duofox Hip Prosthesis (2015), 38 descendants of its own
- K170339: Summit Hip System (2018), 27 descendants of its own
- K160907: DePuy Actis DuoFix Hip Prosthesis (2016), 26 descendants of its own

## Recalls of this device
- Jul 22, 2022 · Class II · Z-1509-2022: One MetaFix size 7 collarless stem from batch 478179 which was incorrectly labelled as a MetaFix size 3 collared stem from batch 485630.
- Jul 28, 2021 · Class II · Z-2609-2021: 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 Metafix Hip Stem as a total hip 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 DDH/CDH The Corin Metafix Hip Stern is indicated for cemtentless use only.

Source page: https://510kreport.com/device/K082525
Methodology: https://510kreport.com/methodology