# K153381: Corin Metafix Hip Stem

- Pathway: 510(k) (Traditional)
- Applicant: Corin U.S.A. Limited
- Decided: Jan 21, 2016 after 59 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K810258 (1981). 127 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 132 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.
- K121439: Metafix Femoral Hip Stem Size 1, Corin USA (2012) Summary page 4.
- K120362: Metafix Femoral Stem for Hemi-Arthroplasty, Corin USA (2012) Summary page 4.
- K042992: Corail Amt Hip Prosthesis, DePuy Orthopaedics, Inc. (2005) Summary page 4.
- K121563: Corin Trifit TS Hip, Corin USA (2012) Summary page 4.

## 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
- K201657: Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell, MetaFix™ Hip System, TriFit™ CF and TS Hip Systems, TaperFit™ Hip System, Revival™ Modular Hip System, MiniHip™, Trinity™ Dual Mobility, MobiliT, BiPolar-i, OMNI MOD™ Hip System, OMNI K1 and K2 Hip Systems, OMNI Bipolar Heads, Corin Biolox Delta Ceramic Heads, OMNI Delta Ceramic Heads (2021), 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

## 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.

## 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) or congenital dysplasia of the hip (CDH) The Corin Metafix Hip Stem is intended for cementless, single use only.

Source page: https://510kreport.com/device/K153381
Methodology: https://510kreport.com/methodology