# K202768: KOSMO Femoral Stem

- Pathway: 510(k) (Traditional)
- Applicant: B-One Ortho, Corp.
- Decided: Apr 1, 2021 after 192 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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) b-ONE Total Hip System KOSMO Femoral Stem: named in the summary without a submission number
- (no number) Zimmer Biomet Avantage Complete Hip Stem: named in the summary without a submission number

## Most influential descendants
- K240528: b-ONE® Total Hip System (2024), 0 descendants of its own

## Indications for use
The b-ONETM 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-ONETM Total Hip System KOSMOTM HA coated stems are intended for cementless use only. The b-ONETM Total Hip System KOSMOTM stainless steel stems are intended for cemented use only. b-ONETM Total Hip System components are not intended for use with other total hip systems.

Source page: https://510kreport.com/device/K202768
Methodology: https://510kreport.com/methodology