# K143113: Klassic BiPolar System

- Pathway: 510(k) (Traditional)
- Applicant: Total Joint Orthopedics
- Decided: Jan 28, 2015 after 90 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K810258 (1981). 84 ancestors in all.
No later device cites it as a predicate yet.
0 of 85 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100761: Biopro Polar Head, Biopro, Inc. (2010) Summary page 5.
- K100445: Klassic HD Hip System, Total Joint Orthopedics, Inc. (2010) Summary page 5.
- K823726: Spectron Conversion Endoprosthesis Cup, Richard'S Medical Equip., Inc. (1983) Summary page 5.

## Cited in the summary but kept off the family tree
- K082785: Nihon Kohden Bedside Monitor, BSM 9100A Series, Nihon Kohden America, Inc. (2008). Our reading of the summary gave K082785, FDA’s number for Nihon Kohden Bedside Monitor, BSM 9100A Series (Nihon Kohden America, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “BioPro Bipolar Femoral Head”. Kept off the family tree. Summary page 5.

## Recalls of this device
- Sep 23, 2025 · Class II · Z-0432-2026: Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.

## Indications for use
The Klassic™ BiPolar System is intended for use in combination with a Total Joint Orthopedics Femoral Stem for primary or revision hemiarthroplasty of the hip, without the use of bone cement, for treatment of the following conditions: Femoral neck and trochanteric fractures of the proximal femur (Osteonecrosis of the femoral head Revision procedures where other devices or treatments for these indications have failed.

Source page: https://510kreport.com/device/K143113
Methodology: https://510kreport.com/methodology