# K991990: Tri-Polar System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Sep 10, 1999 after 88 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
No predicates in its family tree.
105 later devices descend from it; 5 cite it directly.
0 of 106 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) THARIES Surface Replacement System: named in the summary without a submission number
- (no number) Indiana Conservative Hip: named in the summary without a submission number
- (no number) Mallory Head Total Hip: named in the summary without a submission number

## Most influential descendants
- K070278: Polarcup Dual Mobility System (2007), 78 descendants of its own
- K083116: Versafit Cup Double Mobility System (2009), 59 descendants of its own
- K111572: Novae Sunfit TH Dual Mobility Acetabular Cup Model Sunfit TH (Metal-Back), Novae E TH Dual Mobility Acetabular Cup Model (2011), 27 descendants of its own
- K051569: Ringloc BI-Polar Acetabular Component (2005), 25 descendants of its own
- K101336: E1 Avantage Head (2011), 24 descendants of its own

## Indications for use
a.) Non-inflammatory degenerative joint disease including osteoarthritis and avascular NECrosis. b.) Rheumatoid arthritis c.) Correction of functional deformity d.) Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. e.) Revision of previously failed total hip arthroplasty due to recurrent dislocation. The Tri-Polar System is intended for cemented or press-fit application for general use in skeletally mature individuals undergoing surgery for rehabilitating hip joints.

Source page: https://510kreport.com/device/K991990
Methodology: https://510kreport.com/methodology