PROFEMUR Preserve Classic Stem
510(k) K150302
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK150302 | Date10 Apr 2015 | 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- Withdrawn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, 18 Sep 2026
The Profemur Preserve Classic Stem is a short femoral hip stem designed for primary Total Hip Arthroplasty. It is engineered to preserve natural bone by minimizing distal fixation, offering a shorter profile compared to traditional long-stem implants. The stem features a reduced lateral shoulder and curved distal geometry to facilitate tissue-sparing surgical techniques, such as superior approaches. Its design prioritizes bone conservation while maintaining stability and alignment in the proximal femur.
This device is supplied as a reusable surgical implant, intended for use in orthopedic procedures under sterile conditions. It is classified under product code LZO and has received FDA 510(k) clearance as substantially equivalent to a predicate device. The stem’s dimensions and geometry are optimized for compatibility with MicroPort Orthopedics’ modular instrumentation system, enabling intraoperative flexibility for various stem configurations. Storage and handling must adhere to aseptic protocols to ensure sterility prior to surgical use.
From the manufacturer
Short stem philosophy Designed to conserve bone in a primary Total Hip Arthroplasty, the Profemur® Preserve hip stem offers a shorter design that allows more of the patient's natural bone to remain in place as compared to a longer distal 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.
Other devices from MicroPort Orthopedics Inc.
Questions
AI-generated answers, 18 Sep 2026
What types of surgical approaches is the Profemur Preserve Classic Stem specifically designed to support, and why does this matter for surgeons?
The Profemur Preserve Classic Stem is engineered to support tissue-sparing surgical techniques, particularly superior approaches to the hip. This matters because its reduced lateral shoulder and curved distal geometry allow for less disruption to surrounding soft tissues, which can reduce postoperative pain, shorten recovery times, and minimize complications like heterotopic ossification. The shorter profile also aligns with minimally invasive procedures, making it a practical choice for surgeons aiming to preserve natural anatomy.
Is the Profemur Preserve Classic Stem intended for reuse, and what does this mean for surgical planning and infection control?
Yes, the Profemur Preserve Classic Stem is supplied as a reusable surgical implant. This means it must be thoroughly cleaned, sterilized, and inspected between uses to maintain sterility and functionality. For surgical planning, this implies that hospitals must have robust reprocessing protocols in place, including validation of sterilization methods (e.g., ethylene oxide or autoclave) and adherence to aseptic handling procedures to mitigate infection risks. Reusability also requires tracking and documentation to ensure compliance with regulatory and institutional standards.
How does the modular instrumentation system compatibility of the Profemur Preserve Classic Stem benefit surgeons during surgery?
The Profemur Preserve Classic Stem is designed to work with MicroPort Orthopedics’ modular instrumentation system, which allows surgeons to adjust stem configurations intraoperatively. This flexibility enables customization to the patient’s anatomy, such as varying stem lengths or angles, without needing to switch tools or implants mid-procedure. It streamlines workflow, reduces surgical time, and enhances precision in achieving optimal alignment and stability in the proximal femur.
What storage and handling precautions should be taken for the Profemur Preserve Classic Stem to ensure it remains sterile before use?
The Profemur Preserve Classic Stem must be stored and handled under aseptic protocols to preserve sterility. This includes keeping the implant in its original, sealed packaging until immediately before use, storing it in a clean, dry environment protected from contamination (e.g., dust, moisture, or direct light), and following manufacturer guidelines for shelf life. If reused, it must undergo validated sterilization processes (e.g., autoclave or ethylene oxide) and undergo rigorous inspection for damage or wear before each use to ensure safety and efficacy.