(30 days)
Wright Medical total hip systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.
Indications for Use
- 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.
Rough grit blast surfaces are intended for uncemented arthroplasty. The PROFEMUR® Z Revision Hip Stem is intended for cementless hip arthroplasty.
Design features of the subject stems are summarized below:
- Cementless modular stems
- Available in 9 sizes
- Manufactured from Titanium alloy with a heavy grit blasted surface.
The subject device is available in 9 sizes (from size 3 to 11). Although the proximal geometries are identical to the predicate from size 3-9, the distal stem length has increased, with two larger sizes (10 and 11) introduced.
This submission (K122778) is for a medical device (PROFEMUR® Z Revision Hip Stem) and as such does not contain information on software acceptance criteria or studies involving AI and human readers. The document details the substantial equivalence of the hip stem to previously cleared predicate devices, primarily through nonclinical (mechanical) testing, rather than clinical studies or algorithm performance evaluations.
Therefore, I cannot provide information on:
- Acceptance criteria and reported device performance related to an algorithm.
- Sample size used for the test set or data provenance for an algorithm.
- Number of experts or their qualifications for establishing ground truth.
- Adjudication method for an algorithm's test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone algorithm performance.
- Type of ground truth for an algorithm.
- Sample size for the training set or how ground truth was established for it.
The document explicitly states: "Clinical data was not provided for the class III hip stem." This further confirms that no clinical studies as you've outlined for AI/software evaluation were performed or submitted.
The "acceptance criteria" in this context are for the mechanical performance of the hip stem and its substantial equivalence to existing devices, evidenced by:
- Nonclinical Testing: The PROFEMUR® Z Revision Hip Stems were tested in distal and proximal fatigue evaluation per the loading regimen prescribed by ISO 7206-4, -6 and -8. This demonstrates the device's mechanical integrity under specified stress conditions. The acceptance criteria for such tests would be successful completion of these fatigue evaluations without failure, meeting the standards set by ISO 7206.
- Substantial Equivalence: The primary "study" is the demonstration of substantial equivalence to predicate devices (K021346, K112080, K121221) based on:
- Identical Indications for Use: The new device shares the exact same intended uses as the predicate devices.
- Similar Design Features and Materials: The subject device is a cementless modular stem, available in 9 sizes, manufactured from Titanium alloy with a heavy grit blasted surface, similar to the predicates. While distal stem length increased and new sizes were introduced, the fundamental scientific technology remained unchanged.
The conclusion is that the safety and effectiveness are supported by this substantial equivalence information, materials information, and analysis data, aligning with the FDA's 510(k) pathway for medical devices.
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K122778 (pg. 1 of 2)
OCT 11 2012
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 use of the PROFEMUR® Z Revision Hip Stem .
Submitted By:
Date:
Contact Person:
Proprietary Name:
Common Name:
Classification Name and Reference:
Wright Medical Technology, Inc. 5677 Airline Rd, Arlington TN, 38002 (800) 238-7188
August 27, 2012
Dean Nachtrab Regulatory Affairs Specialist
PROFEMUR® Z Revision Hip Stem
Hip Stem
888.3330 KWA Hip joint metal/metal semiconstrained, with an uncemented acetabular component prosthesis Class III
888.3320 JDL Hip joint metal/metal semiconstrained, with a cemented acetabular component, prosthesis Class III
Subject Product Code and Panel Code:
Predicate Devices:
Orthopedics/87/ KWA, JDL
STEM Hip Replacement System 510(k)s: K021346
PRESERVE HIP STEM 510(K): K112080
PROFEMUR Z Revision Hip Stem 510(K): K121221
DEVICE INFORMATION
A. Intended Use
Wright Medical total hip systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.
Indications for Use
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K12 2778 (pg. 2 of 2)
- 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; 2.
- correction of functional deformity; and, 3.
- revision procedures where other treatments or devices have failed ধ:
Rough grit blast surfaces are intended for uncemented arthroplasty. The PROFEMUR® Z Revision Hip Stem is intended for cementless hip arthroplasty.
B. Device Description
Design features of the subject stems are summarized below:
- . Cementless modular stems
- Available in 9 sizes ●
- Manufactured from Titanium alloy with a heavy grit blasted surface .
The subject device is available in 9 sizes (from size 3 to 11). Although the proximal geometries are identical to the predicate from size 3-9, the distal stem length has increased, with two larger sizes (10 and 11) introduced.
C. Nonclinical Testing
The PROFEMUR® Z Revision Hip Stems have been tested in distal and proximal fatigue evaluation per the loading regimen prescribed by ISO 7206-4, -6 and -8.
D. Clinical Testing
Clinical data was not provided for the class III hip stem.
E. Conclusions
The indications for use of the PROFEMUR® Z Revision Hip Stems 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 devices has not changed relative to the predicate devices. The safety and effectiveness of the PROFEMUR® Z Revision Hip Stem is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings outstretched.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 1 1 1 2012
Wright Medical Technology, Incorporated
% Mr. Dean Nachtrab
Regulatory Affairs Specialist
5677 Airline Road
Arlington, Tennessee 38002
Re: K122778
Trade/Device Name: PROFEMUR® Z Revision Hip Stem Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis Regulatory Class: Class III Product Code: KWA, JDL Dated: August 29, 2012 Received: September 11, 2012
Dear Mr. Nachtrab:
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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
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Page 2 - Mr. Dean Nachtrab
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Eric Keith
⁄ Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K122778
Device Name: PROFEMUR® Z Revision Hip Stem
Indications For Use:
- non-inflammatory degenerative joint disease such as osteoarthritis, avascular 1. necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
- inflammatory degenerative joint disease such as rheumatoid arthritis; 2.
- correction of functional deformity; and, ന്
- revision procedures where other treatments or devices have failed. 4.
Rough grit blast surfaces are intended for uncemented arthroplasty. The PROFEMUR® Z Revision Hip Stem is intended for cementless hip arthroplasty.
Prescription Use _ × (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)
Peter G. Allen
(Division Sign-C Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K122778
§ 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.