(135 days)
Not Found
No
The summary describes a mechanical implant (tibial insert) and its intended use and design features. There is no mention of software, algorithms, or any technology related to AI or ML. The performance studies are engineering analyses of mechanical properties.
Yes
The device is an orthopedic implant (knee replacement insert) intended to treat various degenerative joint diseases and correct functional deformities, which are therapeutic purposes.
No
This device is a prosthetic insert for knee arthroplasty, used for treatment rather than diagnosis of a condition.
No
The device description clearly states it is a physical tibial insert made from UHMWPE, which is a hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used in the body for surgical procedures (knee arthroplasty) to treat conditions affecting the knee joint. IVDs are used outside the body to examine specimens (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The device is a tibial insert made of UHMWPE, designed to be implanted in the knee. This is a physical implant, not a diagnostic tool.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, diagnostic testing, or providing diagnostic information.
This device is a medical device used for surgical treatment, specifically a component of a total knee replacement system.
N/A
Intended Use / Indications for Use
The EVOLUTION® MP Adaptive PS Insert is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:
- Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
- Inflammatory degenerative joint disease including rheumatoid arthritis;
- Correction of functional deformity;
- Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
The EVOLUTION® Total Knee System is for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
JWH, HRY
Device Description
The purpose of this submission is to introduce a new EVOLUTION® MP Adaptive PS Tibial Insert that allows use of a posterior stabilized femoral component from the EVOLUTION® MP Total Knee System with a tibial base from the ADVANCE® Knee System.
The design features of the EVOLUTION® Adaptive CS Insert are summarized below:
- Tibial inserts manufactured from UHMWPE
- Available in 7 sizes, left and right
- Tibial insert thickness: 10 20mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The EVOLUTION® Adaptive PS Insert was evaluated via engineering analyses for static stability, contact area, wear, post strength, and range of motion. The analysis determined that the subject device does not present a new worst case as compared to the predicate devices; therefore, no additional testing was performed.
Nonclinical testing was not provided for the subject devices.
Clinical data was not provided for the subject devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee 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 have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
Image /page/0/Picture/2 description: The image shows the word "WRIGHT." in a bold, sans-serif font. Below the word, there are three horizontal lines that appear to be stylized representations of wings or feathers. The overall design is simple and modern, with a focus on the typography and the graphic element beneath it.
510(k) Summary
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 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the EVOLUTION® MP Adaptive PS Tibial Insert.
(a){1) Submitted By:
OCT 2 3 2013
Date:
Contact Person:
(a)(2) Proprietary Name of Modified Device:
Common Name:
Classification Name and Reference:
Wright Medical Technology, Inc. 5677 Airline Rd Arlington, TN 38002 (901) 867-4146
June 7, 2013
Theresa Leister Regulatory Affairs Manager
EVOLUTION® MP Adaptive PS Tibial Insert
Tibial Base Insert
21 CFR 888.3560 Knee joint Patellofemorotibial Polymer/Metal/Polymer Semi-Constrained Cemented Prosthesis Class ニ
21 CFR 888.3530 Knee joint Femorotibial Metal/Polymer Semi-Constrained Cemented Prosthesis Class II
Subject Product Code and Panel Code:
(a)(3) Predicate Devices:
Orthopedics/87/ JWH, HRY
EVOLUTION® MP Total Knee System (K093552) EVOLUTION® MP Adaptive CS Insert (K113325)
{a)(4) Device Description
The purpose of this submission is to introduce a new EVOLUTION® MP Adaptive PS Tibial Insert that allows use of a posterior stabilized femoral component from the EVOLUTION® MP Total Knee System with a tibial base from the ADVANCE® Knee System.
Headquarters
Wright Medical Technology, Inc. 5677 Airline Road Arlington, TN 38002 901.867.9971 phone www.wml.com
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EVOLUTION® MP Adaptive PS Tibial Insert Special 510(k) 510(k) Summary
Image /page/1/Picture/2 description: The image shows the word "WRIGHT." in a bold, sans-serif font. Below the word is a stylized graphic consisting of three horizontal lines that curve slightly upward, resembling a stylized wing or swoosh design. The overall impression is a logo or branding element, possibly for a company or product named Wright.
(a)(5) Indications for Use
The EVOLUTION® MP Adaptive PS Insert is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:
- Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, 1. or avascular necrosis;
- Inflammatory degenerative joint disease including rheumatoid arthritis; 2.
-
- Correction of functional deformity;
-
- Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
The EVOLUTION® Total Knee System is for cemented use only.
(a)(6) Technological Characteristics of the Device
The indications for use of the EVOLUTION® Adaptive PS Tibial Insert are identical to the predicate devices. The lock detail of the EVOLUTION® Adaptive PS Tibial Insert is identical to that of the predicate EVOLUTION® Adaptive CS Tibial Insert. The design features are substantially equivalent to those of the predicate devices. The subject device allows use of a femoral component from the EVOLUTION® Total Knee System with a tibial base from the ADVANCE® Knee System. The design features of the EVOLUTION® Adaptive CS Insert are summarized below:
- � Tibial inserts manufactured from UHMWPE
- . Available in 7 sizes, left and right
- Tibial insert thickness: 10 20mm .
The EVOLUTION® Adaptive PS Insert was evaluated via engineering analyses for static stability, contact area, wear, post strength, and range of motion. The analysis determined that the subject device does not present a new worst case as compared to the predicate devices; therefore, no additional testing was performed.
(b)(1) Nonclinical Testing
Nonclinical testing was not provided for the subject devices.
(b)(2) Clinical Testing
Clinical data was not provided for the subject devices.
(b)(3) Conclusions
The indications for use of the EVOLUTION® Adaptive PS Tibial Insert are identical to the predicate devices. The design features 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 EVOLUTION® MP Adaptive PS Insert are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this premarket notification submission.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the caduceus symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 23, 2013
Wright Medical Technology, Incorporated Ms. Theresa Leister Regulatory Affairs Manager 5677 Airline Road Arlington, Tennessee 38002
Re: K131679
Trade/Device Name: EVOLUTION® MP Adaptive PS Insert Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH, HRY Dated: September 23, 2013 Received: September 25, 2013
Dear Ms. Leister:
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21
3
Page 2 - Ms. Theresa Leister
CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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
for
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Image /page/3/Picture/6 description: The image shows the name "Erin Keith" in a stylized font. The letters are bold and black, with a unique design that makes them stand out. The name is written in a clear and legible manner, making it easy to read.
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K131679
Device Name: EVOLUTION® MP Adaptive PS Insert
Indications For Use:
The EVOLUTION® MP Adaptive PS Insert is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:
-
- Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
- Inflammatory degenerative joint disease including rheumatoid arthritis; 2.
- mi Correction of functional deformity;
-
- 'Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
The EVOLUTION® Total Knee System is for cemented use only.
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)
Casey L. Hanley, Ph.D
Division of Orthopedic Devices
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