# K173380: b-ONE® Total Hip System

- Pathway: 510(k) (Traditional)
- Applicant: B-One Ortho, Corp.
- Decided: Aug 30, 2018 after 304 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: 10 generations back to K810258 (1981). 112 ancestors in all.
No later device cites it as a predicate yet.
0 of 113 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052718: V40 Biolox Delta Ceramic Femoral Heads, Howmedica Osteonics Corp. (2005) Summary page 4.
- K010757: Lfit V40 Femoral Head Components, Howmedica Osteonics Corp. (2001) Summary page 4.
- K103479: Novel Tapered Hip Stem, Stryker Corp. (2011) Summary page 4.
- K001448: Trident Acetabular Shells: PS-HA, Howmedica Osteonics Corp. (2000) Summary page 4.
- K121874: G7 Acetabular System, Biomet Manufacturing Corp (2012) Summary page 4.
- K120370: Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners, Zimmer, Inc. (2012) Summary page 4.
- K091508: Zimmer Continuum Acetabular System, Zimmer Trilogy IT Acetabular System, Zimmer, Inc. (2009) Summary page 4.
- K873251: Omnifit Bone Screw, Osteonics Corp. (1987) Summary page 4.

## 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 is intended for cementless use only. b-ONE® Total Hip System components are not intended for use with other total hip systems.

Source page: https://510kreport.com/device/K173380
Methodology: https://510kreport.com/methodology