(104 days)
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:
-
- non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
-
- inflammatory degenerative joint disease such as rheumatoid arthritis;
-
- correction of functional deformity; and,
-
- revision procedures where other treatments or devices have failed
Modular necks can be used during either cemented femoral and acetabular arthroplasty.
- revision procedures where other treatments or devices have failed
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
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.
{0}------------------------------------------------
AUG 2 5 2009
K091423
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807, this information serves as a Summary of Safety and Effectiveness for the PROFEMUR® Hip System Modular Necks.
Submitted By:
Date:
Contact Person:
Proprietary Name:
Common Name:
Classification Name and Reference:
Wright Medical Technology, Inc.
April 16, 2009
Ryan Ross Regulatory Affairs Specialist II
PROFEMUR® Hip System Modular Necks
Modular Neck
21 CFR 888.3330 Hip joint metal/ metal semiconstrained, with an uncemented acetabular component, prosthesis Class III
21 CFR 888.3320 Hip joint metal/metal semiconstrained, with a cemented acetabular Class III component, prosthesis
21 CFR 888.3353 Hip ioint semi-constrained metal/ceramic/polymer cemented or nonporous uncemented prosthesis Class II
21 CFR 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Class II
21 CFR 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis, semi-constrained, metal/polymer, uncemented Class II
Subject Device Product Code and Panel Code:
Orthopedics/87/ KWA, JDL, LZO, LWJ, LPH, MBL
{1}------------------------------------------------
DEVICE INFORMATION
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:
-
- non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
-
- inflammatory degenerative joint disease such as rheumatoid arthritis;
-
- correction of functional deformity; and,
-
- revision procedures where other treatments or devices have failed
Modular necks can be used during either cemented femoral and acetabular arthroplasty.
B. 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
C. Substantial Equivalence Information
The indications for use of the PROFEMUR® Hip System Modular Necks are identical to the previously cleared predicate devices. The design features and materials of the subject devices are substantially equivalent to those of the predicate devices. The fundamental scientific technology of the modified device has not changed relative to the predicate devices. The safety and effectiveness of the PROFEMUR® Hip System Modular Necks are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three stylized lines forming the body and wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Wright Medical Technology, Inc. % Mr. Ryan Ross Regulatory Affairs Specialist II 5677 Airline Road Arlington, Tennessee 38002
AUG 2 5 2009
Re: K091423
Trade/Device Name: Profemur Hip System Modular Necks Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis Regulatory Class: III Product Code: KWA, JDL, LWJ, LPH, MBL, LZO
Dated: August 17, 2009 Received: August 18, 2009
Dear Mr. Ross:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{3}------------------------------------------------
Page 2 - Mr. Ryan Ross
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/cdrh/comp/ for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Arbare Muchur
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use
K091423 510(k) Number (if known):
Device Name: PROFEMUR® Hip System Modular Necks
Indications For 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:
- non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, 1. ankylosis, protrusio acetabuli, and painful hip dysplasia; .
-
- inflammatory degenerative joint disease such as rheumatoid arthritis;
-
- correction of functional deformity; and,
- revision procedures where other treatments or devices have failed 4.
Modular necks can be used during either cemented or uncemented femoral and acetabular arthroplasty.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Onutu for Mym
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091423
Page 1 of
1
§ 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.