PROFEMUR HIP SYSTEM MODULAR NECKS

• K Number: K091423
• Device Name: PROFEMUR HIP SYSTEM MODULAR NECKS
• Manufacturer: WRIGHT MEDICAL TECHNOLOGY, INC.
• Date Cleared: 2009-08-25 ( 104 days)
• Product Code: KWA , JDL , LPH , LWJ , LZO , MBL
• Regulation Number: 888.3330
• Type: Traditional
• Panel: OR
• Reference & Predicate Devices: N/A

Intended Use

The PROFEMUR® Hip System Modular Necks are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

• 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
• 2. inflammatory degenerative joint disease such as rheumatoid arthritis;
• 3. correction of functional deformity; and,
• 4. revision procedures where other treatments or devices have failed
     Modular necks can be used during either cemented femoral and acetabular arthroplasty.

Device Description

The design features of the PROFEMUR® Hip System Modular Necks are summarized below:

• . Manufactured from Cobalt Chrome Alloy
• 12/14 SLT tapered cone for modular femoral head connection
• Offered in two length options .
• . Each length option is offered in six versions

AI/ML Overview

The provided text is a 510(k) summary for a medical device called the PROFEMUR® Hip System Modular Necks. It describes the device's intended use, features, and declares substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert involvement, ground truth establishment, or multi-reader multi-case studies.

Therefore, I cannot fulfill your request for the tables and details about the study that proves the device meets acceptance criteria, as that information is not present in the provided text. The document primarily focuses on regulatory approval based on demonstrating substantial equivalence, not on presenting performance study results against specific acceptance criteria.

Regulation Number and Section

§ 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.

(a)
Identification. A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.