# K982447: Plus Bipolar Prosthesis Cocrmo

- Pathway: 510(k) (Traditional)
- Applicant: Plus Orthopedics
- Decided: Nov 25, 1998 after 133 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: 1 generation back to K953510 (1995). 1 ancestor in all.
36 later devices descend from it; 5 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953510: Hip Joint Femoral (Hemi-Hip) Metal/Polymer Cemented or Uncemented Prosthesis, Encore Orthopedics, Inc. (1995) Summary page 1.

## Most influential descendants
- K082468: Apex Hip System Bipolar Head, Model H3-822XX and H3-828YY, XX=OD in [MM] (38-43), YY=OD in [MM](44-60) (2009), 21 descendants of its own
- K060707: Aesculap Bipolar Acetabular Cup (2006), 11 descendants of its own
- K091967: Medacta Bipolar Head (2010), 9 descendants of its own
- K082705: Biopro Bipolar Head, Models 18130-18152 (2008), 7 descendants of its own
- K133370: Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem, Evolve Distal Centralizer, Evolve CE (2014), 5 descendants of its own

## Indications for use
The Plus Bipolar Prosthesis CoCrMo in intended for use in arthroplasty therapy as a result of femoral neck fractures and is to be used in conjunction with standard femoral replacement implant. This device is intended for Cementless use only.

Source page: https://510kreport.com/device/K982447
Methodology: https://510kreport.com/methodology