NEXUS Hip Stem
by MicroPort Orthopedics Inc. 2 variants
510(k) K250444
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK250444 | Date15 May 2025 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LZO
- FDA applicant
- Microport Orthopedics, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3353
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The Nexus Hip Stem is a femoral component for total hip arthroplasty, classified as an uncemented titanium alloy (Ti6Al4V) hip prosthesis. It is designed to replace diseased or damaged hip joints by providing structural support and facilitating bone integration through titanium plasma spray and hydroxyapatite (HA) coatings.
Implanted by orthopedic surgeons in a clinical or hospital setting, the device is intended for use in primary hip arthroplasty procedures. Manufactured from titanium alloy, it is supplied sterile and intended for single-use. The device holds an FDA 510(k) clearance under the product code LZO, with a K-number of K250444, and is intended for uncemented fixation.
From the manufacturer
Femurs vary greatly from patient to patient: overall size, canal shape, neck angle and bone quality are variables the surgeon must consider when selecting the appropriate stem. The Profemur® line of primary and revision hip stems are designed for intra-operative flexibility, allowing for one set of instruments for multiple stems.
MicroPort Orthopedics acetabular cup systems focus on bone conservation and flexibility for the surgeon.
Manufacturer's product page: Acetabular Hip Systems