United Orthopedic Corporation UTS Hip Stem

Vendor/Manufacturer: United Orthopedic Corporation

Product/Product Line: UTS Stem

FDA Regulation Medical Specialty: Orthopedic Devices - Prosthetic Devices

FDA Regulation Number: 888.3358

FDA Regulation Description Classification Name:

Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis

FDA Classification Product Code: LPH

FDA Classification Product Code Device Name:

Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

SUBSTANTIALLY EQUIVALENT to the following products:

1. Depuy Tri-lock Bone Preservation Stem

2. United Orthopedic Corporation UTF Stem

3. United Orthopedic Corporation UTF Stem, Reduced

4. United Orthopedic Corporation UTF Stem-reduced, Additional Sizes

5. United Orthopedic Corporation UTF Stem, reduced, #0, #00

Device Description:

UTS Stem is a modular, wedge-shaped stem with 12/14 neck taper and 130° neck angle, which is made from forging Ti-6Al-4V alloy (ASTM F136-13) and the proximal part of each femoral stem is coated with CP Ti powder (ASTM F1580-12) provides biological fixation. UTS Stem is available with standard offset and high offset to restore hip biomechanics. The standard offset is available in sizes #00~#14; the high offset is available in sizes #1~#14.

Indications for Use:

This device is indicated for use in total hip replacement or bipolar hip replacement undergoing primary and revision surgery for the following conditions:

1. Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusion acetabuli, and painful hip dysplasia.

2. Inflammatory degenerative joint disease such as rheumatoid arthritis.

3. Correction of functional deformity.

4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

5. Revision procedures where other treatments or devices have failed.

This device is designed for cementless use.