# K250444: NEXUS® Hip Stem

- Pathway: 510(k) (Traditional)
- Applicant: Microport Orthopedics, Inc.
- Decided: May 15, 2025 after 90 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: 16 generations back to K941847 (1994). 189 ancestors in all.
No later device cites it as a predicate yet.
2 of 189 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200007: PROFEMUR GLADIATOR Thin HA Classic Hip Stem with Collar, Microport Orthopedics, Inc. (2020) Summary page 5.
- K150302: PROFEMUR Preserve Classic Stem, Microport Orthopedics, Inc. (2015) Summary page 5.
- K150862: DePuy Actis Duofox Hip Prosthesis, DePuy Orthopaedics, Inc. (2015) Summary page 5.
- K160907: DePuy Actis DuoFix Hip Prosthesis, Depuy (Ireland) (2016) Summary page 5.
- K191632: PROFEMUR TL2 Stems, Microport Orthopedics, Inc. (2019) Summary page 5.

## Indications for use
NEXUS® Hip stems are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients. 1) non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2) inflammatory degenerative joint disease such as rheumatoid arthritis; 3) correction of functional deformity; and, 4) revision procedures where other treatments or devices have failed Titanium plasma spray and HA coatings applied to implant surfaces are intended for uncemented arthroplasty.

Source page: https://510kreport.com/device/K250444
Methodology: https://510kreport.com/methodology