# K183114: Corin BiPolar-i

- Pathway: 510(k) (Traditional)
- Applicant: Corin U.S.A. Limited
- Decided: Jun 5, 2019 after 208 days
- Product code: KWY (Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3390
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K953510 (1995). 5 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925897: Corin Bipolar Prosthesis, Corin Orthopedic Products (1993) Summary page 4.
- K800207: Uhr UNIVERSAL6HIP Replacement, Osteonics Corp. (1980) Summary page 4.
- K082468: Apex Hip System Bipolar Head, Model H3-822XX and H3-828YY, XX=OD in [MM] (38-43), YY=OD in [MM](44-60), Omni Life Science, Inc. (2009) Summary page 4.

## Most influential descendants
- 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

## Indications for use
The BiPolar-i is intended for use in the following indications: * Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis in which the acetabulum does not require replacement, » Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur « Revision of failed partial hip replacements in which the acetabulum does not require replacement The BiPolar-i is indicated for cementless use only.

Source page: https://510kreport.com/device/K183114
Methodology: https://510kreport.com/methodology