# K991585: Bipolar Shoulder Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Aug 18, 1999 after 103 days
- Product code: KWT (Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3650
- 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 K800494 (1980). 2 ancestors in all.
414 later devices descend from it; 7 cite it directly.
1 of 417 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K800494: New Jersey Hemiarthroplasty Sholder Pros, Depuy, Inc. (1980) Summary page 2.
- K802123: Monospherical Shoulder Prosthesis, Howmedica Corp. (1980) Summary page 2.
- (no number) H-J-B Shoulder: named in the summary without a submission number
- (no number) Shoulder Prosthesis: named in the summary without a submission number
- (no number) Neer II Total Shoulder System: named in the summary without a submission number

## Most influential descendants
- K021478: Delta Shoulder (2003), 338 descendants of its own
- K062116: Delta Cta Reverse Shoulder System Humeral Heads (2006), 295 descendants of its own
- K030941: Aequalis Reversed Shoulder Prosthesis (2004), 280 descendants of its own
- K041873: Aequalis Reversed Shoulder Prosthesis (2004), 277 descendants of its own
- K002998: Biomet BI-Polar Shoulder System (2000), 265 descendants of its own

## Indications for use
Biomet’s Bipolar Shoulder Prosthesis is indicated for use in most cases where a conventional shoulder arthroplasty would be indicated, Typical indications include osteoarthritis, avascular necrosis, traumatic arthritis, rheumatoid arthritis, correction of severe functional deformity, revigion proccdurcs where other treatments or devices have failed, fracture, and cuff tear arthropathy. This device is a single use implant intended for cemented application only. It is intended for use with Biomet’s humeral componcats provivusly cleared by the FDA tor cemented application.

Source page: https://510kreport.com/device/K991585
Methodology: https://510kreport.com/methodology