UTF Stem Reduced #0, #00
by United Orthopedic Corporation
510(k) K163193
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK163193 | Date8 Jun 2017 | 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- Withdrawn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
- LPH
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3358
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The UTF Stem Reduced is a cement-free femoral hip prosthesis (product code LPH) designed for primary hip arthroplasty. It features a dual taper wedge stem with a quadrangular, conical shape, engineered to engage cortical bone for enhanced fixation. The reduced profile minimizes bone resection while maintaining metaphyseal fit, and its slim body enables broach-only implantation techniques. This design prioritizes axial and rotational stability through cortical engagement at the stem corners.
Intended for use in orthopedic surgery, the UTF Stem Reduced #0, #00 is supplied sterile and intended for single-use. It is classified under the FDA’s 510(k) pathway (K163193) as substantially equivalent to a predicate device, with clearance granted under the Orthopedic (OR) advisory committee. The device is manufactured by United Orthopedic Corporation and distributed in sizes #0 and #00, adhering to regulatory standards for hip implants. No MRI safety information or reusable specifications are indicated in the available data.
From the manufacturer
The UTF (United Tapered Fit) Reduced Stem Primary Hip System offers a dual taper wedge stem design. This taper-fit concept is intended to engage the cortex in the stem corners to provide excellent fixation and superior axial and rotational stability.
UTF (United Tapered Fit) Reduced Stem - The dual taper wedge stem is designed for primary hip replacement surgery. The UTF reduced stem characterizes refined proximal M/L width to maximize metaphyseal fitting. A slim body and broach-only technique enables minimal bone removal.
The UTF™ stem designed by UNITED ORTHOPEDIC CORPORATION is a self-locking, conical, quadrangular, cement-free stem, partly distally tapered The design promotes maximum joint stability, while the complete instrumentation system responds to the different approaches used by surgeons.
Other devices from United Orthopedic Corporation
Questions
AI-generated answers, 20 Sep 2026
What types of patients is the UTF Stem Reduced designed for in hip arthroplasty procedures?
The UTF Stem Reduced is specifically designed for primary hip arthroplasty, meaning it is intended for initial hip replacement surgeries in patients requiring femoral stem implantation. Its dual taper wedge design and cortical bone engagement are engineered to provide stability for patients undergoing this procedure, particularly those where minimizing bone resection is beneficial.
Is the UTF Stem Reduced meant to be used with bone cement, and how is it implanted?
No, the UTF Stem Reduced is a cement-free femoral hip prosthesis. Its design allows for broach-only implantation techniques, meaning it can be placed directly into the femur without the need for bone cement, relying instead on its quadrangular, conical shape and cortical bone engagement for fixation.
What sizes are available for the UTF Stem Reduced, and how does the reduced profile benefit patients?
The UTF Stem Reduced is available in two sizes: #0 and #00. The reduced profile minimizes the amount of bone that needs to be resected during surgery while still maintaining a secure metaphyseal fit, which can help preserve more of the patient’s natural bone structure and potentially reduce recovery time.
How is the UTF Stem Reduced supplied, and is it reusable?
The UTF Stem Reduced is supplied sterile and is intended for single-use only. This ensures patient safety by preventing cross-contamination and maintaining sterility standards required for orthopedic implants. Reuse is not recommended or indicated for this device.
What regulatory pathway was followed for FDA clearance of the UTF Stem Reduced, and which advisory committee reviewed it?
The UTF Stem Reduced was cleared through the FDA’s 510(k) pathway, specifically under the Orthopedic (OR) advisory committee. The device was determined to be substantially equivalent to a predicate device, with clearance granted on June 8, 2017, following review by the OR committee. This pathway ensures compliance with U.S. regulatory standards for hip implants.