Profemur LX Hip Stem
by Wrightmedicaltechnologyinc 510(k)
Active
510(k) K053588
Overview
The Profemur LX Hip Stem is a semi-constrained, metal, uncemented acetabular prosthesis designed for total hip arthroplasty. It is intended to restore hip function and alleviate pain in skeletally mature patients with degenerative joint conditions, including osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, or painful hip dysplasia.
This device is supplied as a reusable surgical implant and is classified under FDA regulation 888.3330. It features a tapered wedge design with a reduced lateral shoulder, facilitating tissue-sparing surgical techniques. The device is subject to FDA 510(k) clearance (K053588) and is intended for orthopedic use in approved clinical settings. Multiple reference codes and registration numbers are associated with its regulatory submission.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK053588 | Date13 Jan 2006 | 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- Withdrawn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
- KWA
- Device Class
- Class III
- Regulation
- 21 CFR Part 888.3330
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Other devices from Wrightmedicaltechnologyinc
Questions
What types of degenerative joint conditions is the Profemur LX Hip Stem intended to address in patients?
The Profemur LX Hip Stem is designed for skeletally mature patients with degenerative joint conditions such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, or painful hip dysplasia. It is intended to restore hip function and alleviate pain in these specific clinical scenarios.
Is the Profemur LX Hip Stem reusable or single-use, and how is it supplied?
The Profemur LX Hip Stem is supplied as a reusable surgical implant, meaning it is intended for multiple uses in approved clinical settings. It is not a single-use device, and its design and regulatory classification reflect this purpose.
What design features of the Profemur LX Hip Stem make it suitable for tissue-sparing surgical techniques?
The Profemur LX Hip Stem features a tapered wedge design with a reduced lateral shoulder, which helps minimize tissue disruption during surgery. This design is intended to facilitate less invasive procedures while maintaining stability and function.
How is the regulatory status of the Profemur LX Hip Stem determined, and what does this mean for its use?
The device holds an FDA 510(k) clearance (K053588) with a classification under 888.3330, indicating it is deemed substantially equivalent to a predicate device. This clearance allows its use in approved clinical settings for orthopedic total hip arthroplasty procedures, as defined by the manufacturer’s intended purpose.
Are there multiple sizes or models available for the Profemur LX Hip Stem, and how would a clinician determine the appropriate fit?
While the provided data lists multiple FEI numbers and registration codes, these are administrative identifiers related to regulatory submissions and do not directly specify individual sizes or models. Clinicians would rely on the manufacturer’s sizing guidelines (not detailed here) and intraoperative assessment to select the appropriate stem size for the patient’s anatomy and clinical needs.