SMS Cementless Stem
by Medacta International S.A. 2 variants
510(k) K201673
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK201673 | Date18 Sep 2020 | 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- Withdrawn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
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3353
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The SMS Cementless Stem is a cementless femoral stem for total hip arthroplasty (THA), classified as a bone-preserving, short metaphyseal-fitting implant. It is designed to provide physiological proximal load transfer and restore individual patient anatomy, available in both collared and collarless configurations.
This device is intended for orthopedic use in surgical settings and is supplied sterile for single-use. It is regulated under FDA 510(k) clearance (K201673) as a substantially equivalent orthopedic implant. Sizes and versions are specified in the manufacturer’s documentation, with no additional regulatory or MRI safety notes provided.
Other devices from Medacta International S.A.
Questions
AI-generated answers, 19 Sep 2026
What types of patients is the SMS Cementless Stem designed to support in total hip arthroplasty procedures?
The SMS Cementless Stem is designed for patients undergoing total hip arthroplasty (THA) who require a bone-preserving solution. Its short metaphyseal-fitting design aims to provide physiological proximal load transfer, helping to restore individual patient anatomy while minimizing bone resection. This makes it suitable for cases where preserving bone stock is a priority.
Is the SMS Cementless Stem available in multiple configurations, and how might that affect my choice?
Yes, the SMS Cementless Stem is available in both collared and collarless configurations. The choice between these depends on clinical factors such as patient anatomy, bone quality, and surgical preference. The collared version may offer enhanced stability for certain patients, while the collarless option provides flexibility for others. The manufacturer’s documentation details which configurations are appropriate for specific cases.
How is the SMS Cementless Stem supplied, and what does that mean for my surgical workflow?
The SMS Cementless Stem is supplied sterile and intended for single-use only. This means it arrives pre-sterilized, ready for immediate use in the operating room, reducing the need for additional sterilization steps. The single-use designation also ensures patient safety by eliminating risks associated with reprocessing reusable implants.
Are there specific size options for the SMS Cementless Stem, and how do I determine the right fit for a patient?
The SMS Cementless Stem comes in multiple sizes, as outlined in the manufacturer’s documentation. Sizing is critical to ensure proper fit and function, so it’s important to follow the manufacturer’s guidelines or use their sizing tools to match the patient’s femoral anatomy. The short metaphyseal design allows for a more tailored fit compared to longer stems, which may influence the selection process.