# K240528: b-ONE® Total Hip System

- Pathway: 510(k) (Traditional)
- Applicant: B-One Ortho, Corp.
- Decided: Nov 15, 2024 after 266 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3353
- 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 K202768 (2021). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202768: KOSMO Femoral Stem, B-One Ortho, Corp. (2021) Summary page 5.

## Indications for use
The b-ONE® Total Hip System is intended for primary or revision total hip replacement in skeletally mature patients with a severely disabled hip joint and/or hip damage due to the following conditions: Osteoarthritis, traumatic arthritis, avascular necrosis of the femoral head, noninflammatory degenerative joint disease (NIDJD), slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis and congenital dysplasia; treatments of nonunion, acute traumatic fracture of the femoral head or neck; failed endoprosthesis, femoral osteotomy, or Girdlestone resection; and fracture-dislocation of the hip. The b-ONE® Total Hip System KOSMO™ HA coated stems and Grit-Blasted stems are intended for cementless use only. The b-ONE® Total Hip System KOSMO™ Stainless Steel stems are intended for cemented use only. The b-ONE® Cement Restrictor is intended to restrict bone cement migration into the distal medullary canal and aid in cement pressurization during total hip arthroplasty. b-ONE® Total Hip System components are not intended for use with other total hip systems.

Source page: https://510kreport.com/device/K240528
Methodology: https://510kreport.com/methodology