PROFEMUR TL2 Stems
510(k) K191632
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK191632 | Date7 Oct 2019 | 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- Withdrawn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 Profemur TL2 Stems are cementless, collarless femoral stems designed for primary hip arthroplasty. This device features a dual tapered wedge geometry to enhance primary stability and bone ingrowth, with a reduced lateral shoulder to facilitate tissue-sparing surgical approaches. The tapered design distributes loads axially and proximally, promoting long-term fixation in the femoral canal. Intended for use in total hip replacement procedures, it is manufactured from titanium alloy for biocompatibility and structural integrity.
The Profemur TL2 Stems are supplied sterile, single-use, and intended for inpatient orthopedic surgical settings. They are MRI-unsafe due to metallic construction and must be handled per sterile technique protocols. Available in multiple sizes to accommodate varying femoral anatomy, the stems require proper instrumentation for implantation. Authorized for commercial distribution in the U.S. under FDA 510(k) clearance (K191632), compliance with ISO 13485 and CE marking (where applicable) is ensured through manufacturer quality systems.
From the manufacturer
Tapered wedge stem philosophy Designed for primary hip replacement surgery, the Profemur® TL2 hip stem is a dual tapered wedge stem with an innovative geometry. It features a reduced lateral shoulder convenient for tissue-sparing surgical techniques.
Other devices from MicroPort Orthopedics Inc.
Questions
AI-generated answers, 20 Sep 2026
What types of patients are these stems intended for in a clinical setting?
The Profemur TL2 Stems are designed specifically for primary hip arthroplasty, meaning they are intended for patients undergoing their first total hip replacement surgery. The cementless, collarless design with a dual tapered wedge geometry is engineered to provide stable fixation in the femoral canal, making it suitable for patients requiring a durable, long-term solution for hip joint replacement.
Are these stems reusable in a surgical setting, or are they meant for single-use only?
The Profemur TL2 Stems are explicitly supplied as single-use devices. This designation aligns with standard orthopedic surgical protocols, where sterility and contamination control are critical to patient safety. Reuse is not recommended or supported by the manufacturer.
What materials are the stems made from, and why does that matter?
The Profemur TL2 Stems are manufactured from titanium alloy, a material chosen for its biocompatibility and structural integrity. Titanium is well-tolerated by the body, reducing the risk of adverse reactions, while its strength ensures the stem can withstand the mechanical demands of hip replacement without compromising stability or longevity.
How do I properly store these stems before use, given they are sterile?
Since the Profemur TL2 Stems are supplied sterile, they must be stored according to sterile technique protocols to maintain integrity. The manufacturer does not specify exact storage conditions beyond ensuring they remain in their original packaging until use, protected from contamination and physical damage. Always follow the sterile handling guidelines provided in the accompanying surgical kit instructions.
Can these stems be used in patients who require MRI scans after surgery?
No, the Profemur TL2 Stems are not MRI-safe due to their metallic titanium alloy construction. MRI scans generate strong magnetic fields that can interact with metal implants, potentially causing heating, displacement, or artifacts that could compromise patient safety or diagnostic accuracy. Non-MRI-safe implants like these require alternative imaging modalities post-surgery.