(108 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, 1. ankylosis, protrusio acetabuli, and painful hip dysplasia;
-
- inflammatory degenerative joint disease such as rheumatoid arthritis;
- correction of functional deformity; and, 3.
-
- revision procedures where other treatments or devices have failed
The PROFEMUR® Z Revision Hip Stem is intended for cementless hip arthroplasty.
- . 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.
The provided text describes a 510(k) premarket notification for a medical device, the PROFEMUR® Z Revision Hip Stem. It does not contain information about acceptance criteria, device performance, or a study demonstrating the device meets such criteria in the way typically associated with AI/software-as-a-medical-device (SaMD) clearances.
Instead, this document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, which is the cornerstone of the 510(k) pathway for many Class II medical devices.
Here's an analysis based on the provided text, addressing the points where information is available and noting where it is not applicable or not provided:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable in the context of this 510(k) submission. This document does not present acceptance criteria for a specific performance metric (like accuracy, sensitivity, specificity for an AI algorithm) nor does it report such performance. The clearance is based on substantial equivalence, not on meeting predefined performance thresholds from a clinical trial in humans.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. There was no "test set" in the context of clinical performance evaluation for this 510(k). The evaluation involved nonclinical testing of the device hardware.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. There was no ground truth for a test set established by experts in this submission.
4. Adjudication Method for the Test Set
Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No. A MRMC study is typically for evaluating the impact of AI on human reader performance, which is not relevant for this revision hip stem.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study Was Done
Not applicable. This device is a physical hip stem, not an algorithm.
7. The Type of Ground Truth Used
Not applicable.
8. The Sample Size for the Training Set
Not applicable. Again, this is a physical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
Summary of Device Evaluation for K121221 (PROFEMUR® Z Revision Hip Stem):
- Acceptance Criteria & Performance: The acceptance criteria for this 510(k) submission revolved around demonstrating substantial equivalence to predicate devices. This means proving that the new device is as safe and effective as a legally marketed device. The "performance" assessment was primarily through nonclinical testing (mechanical fatigue evaluation) and comparison of design features and materials to predicate devices.
- 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. The assumption is that the device met the requirements of these ISO standards, thereby demonstrating acceptable mechanical performance equivalent to other devices cleared under these standards. The specific results (cycles to failure, load limits, etc.) are not detailed in this summary but would have been part of the full submission.
- Study Type: The submission relies on nonclinical testing (fatigue evaluation) and a comparative analysis of design features, materials, and intended use against predicate devices (STEM Hip Replacement System K021346 and PRESERVE HIP STEM K112080).
- Clinical Data: Explicitly stated: "Clinical data was not provided for the class II hip stem." This indicates no human clinical trials were performed for this specific submission to demonstrate safety and effectiveness, as it was deemed unnecessary due to substantial equivalence.
- Ground Truth/Training Data: Not applicable as this is a physical implant and not an AI/ML algorithm.
Conclusion from the document: The FDA found the PROFEMUR® Z Revision Hip Stem to be substantially equivalent to its predicate devices based on:
* Identical indications for use.
* Similar design features and materials.
* The same fundamental scientific technology.
* Adequate support from "substantial equivalence information, materials information, and analysis data provided within this Premarket Notification."
This 510(k) successfully navigated the regulatory pathway by demonstrating that the changes were minor enough (e.g., increased distal stem length, two new sizes) and supported by nonclinical mechanical testing, making a full clinical trial for performance unnecessary.
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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
9 2012 AUG
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
February 7, 2012
Yuan Li, Ph.D Regulatory Affairs Specialist
PROFEMUR® Z Revision Hip Stem
Hip Stem
888.3353 LZO Hip joint metal/ceramic/ polymer, cemented or non-porous, uncemented prosthesis Class II
888.3350 JDI Hip joint metal/polymer semiconstrained cemented prosthesis Class II
Subject Product Code and Panel Code:
Predicate Devices:
Orthopedics/87/LZO, JDI
STEM Hip Replacement System 510(k)s: K021346
PRESERVE HIP STEM 510(K): K112080
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
- 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, 3.
-
- revision procedures where other treatments or devices have failed
The PROFEMUR® Z Revision Hip Stem is intended for cementless hip arthroplasty.
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K171221
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 II 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.
Page 2 of 2
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Image /page/2/Picture/1 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the circumference of the circle. In the center of the circle is a stylized symbol that resembles an eagle or bird with outstretched wings. The image is in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Wright Medical Technology, Inc. % Mr. Yuan Li 5677 Airline Rd. Arlington, TN 38002 US
AUG 9 2012
Re: K121221
Trade/Device Name: Profemur Z Revision Hip Stem Regulation Number: 21 CFR 888.3353 Regulation Name: Hip Joint Metal/Ceramic/Polymer Cemented or Non-Porous Uncemented Prosthesis Regulatory Class: Class II Product Code: LZO, JDI Dated: July 9, 2012 Received: July 10, 2012
Dear Mr. Li:
We have reviewed vour 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 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
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Page 2 - Mr. Yuan Li
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,
Mark A. Mikkelson
Mark N. Melkerson Director Division of Surgical, Orthopedic & Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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KIZIZZI
Indications for Use
510(k) Number (if known):
Device Name: PROFEMUR® Z Revision Hip Stem
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.
The PROFEMUR® Z Revision Hip Stem is intended for cementless hip 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)
Aho
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
从121221 510(k) Number
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.