H-Max S Stem
by Lima Corporate S.P.A. 510(k)
Active
510(k) K160011
Overview
The H-Max S Stem is an uncemented orthopedic femoral stem designed for primary hip arthroplasty. It provides biological fixation to the femur, offering stability and versatility across various surgical approaches. Constructed for long-term integration, it is intended for use in total hip replacement procedures where secure osseous anchorage is required. Its design aligns with modern orthopedic standards for uncemented fixation.
This device is supplied sterile and intended for single-use. It is classified as a Class 2 Orthopedic device under FDA regulations, cleared via the Traditional 510(k) pathway (K160011). The H-Max S Stem is manufactured by Lima Corporate S.P.A. and must be used in accordance with surgical guidelines for hip arthroplasty. Storage and handling follow standard orthopedic implant protocols to maintain sterility and integrity prior to implantation.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK160011 | Date22 Aug 2016 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- MEH
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3353
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Other devices from Lima Corporate S.P.A.
Questions
What is the H-Max S Stem used for?
The H-Max S Stem is designed specifically for primary hip arthroplasty, providing uncemented biological fixation to the femur. This ensures secure osseous anchorage during total hip replacement surgeries, aligning with modern orthopedic standards for uncemented fixation. Its purpose is to offer stability and adaptability across various surgical approaches.
How is the H-Max S Stem supplied and intended for use?
The H-Max S Stem is supplied sterile and is intended for single-use only. This ensures patient safety by preventing contamination and cross-infection risks. Following single-use guidelines is critical to maintaining the device’s integrity and compliance with surgical protocols.
Is the H-Max S Stem reusable or single-use?
The H-Max S Stem is explicitly intended for single-use. Single-use devices are designed to be used once and then discarded, reducing the risk of infection and ensuring sterility for each patient. Reusing medical implants can compromise their sterility and structural integrity, which is why this device follows single-use standards.
What storage and handling precautions should be taken for the H-Max S Stem?
The H-Max S Stem must be stored and handled according to standard orthopedic implant protocols to preserve sterility and structural integrity. This includes maintaining the device in its original packaging until immediately before use, avoiding exposure to moisture, heat, or physical damage, and adhering to manufacturer guidelines for shelf life and storage conditions.
What regulatory pathway was followed for the H-Max S Stem?
The H-Max S Stem was cleared through the Traditional 510(k) pathway by the FDA, with clearance number K160011. This pathway demonstrates that the device is substantially equivalent to a legally marketed predicate device, ensuring it meets established safety and effectiveness standards for orthopedic implants. The device is classified as a Class 2 Orthopedic device under FDA regulations.