(239 days)
Not Found
No
The summary describes a mechanical knee implant system and its components, with no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is a knee replacement system used for treating various degenerative joint diseases and correcting functional deformities, which are therapeutic indications.
No
This device is a total knee replacement system, indicated for use in knee arthroplasty, which is a treatment, not a diagnostic procedure. The "Intended Use / Indications for Use" section clearly lists conditions for which the system is used, and it's a replacement component, not something that identifies or diagnoses a condition.
No
The device description clearly outlines physical components (patellar components made of UHMWPE and CoCr alloy) and mechanical testing, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing the knee joint in patients with specific conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is described as a total knee system with patellar components made of materials like UHMWPE and CoCr alloy. These are materials used for implants, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
Therefore, the ADVANCE® Total Knee System is a medical device, specifically a surgical implant, and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ADVANCE® Total Knee System 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.
-
- Correction of functional deformity;
- Revision procedures where other treatments or devices have failed; and treatment of fractures 4. that are unmanageable using other techniques.
Porous-coated total knee replacement components are for use without bone cement.
Product codes (comma separated list FDA assigned to the subject device)
MBH, JWH
Device Description
The purpose of this submission is to add patellar components to the ADVANCE® Total Knee System. The design features of the subject patellae are summarized below:
- . All-poly patellae manufactured from UHMWPE
- . Available in sizes 25-41, single- or tri-peg design
Metal-backed patellae manufactured from UHMWPE and CoCr alloy .
- . Available in sizes 25-41, single- or tri-peg design
- Available in sizes 29-38, tri-peg design with porous coating ■
The ADVANCE® patellar components were evaluated via mechanical testing and engineering analyses; including static stability, contact area, and interface strength. In addition, the porous coating for the metal-backed design was fully characterized as well as tested in static shear. A review of these results indicates that the subject devices are equivalent to predicate devices and are capable of withstanding expected in vivo loading without failure.
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 ADVANCE® patellar components were evaluated via mechanical testing and engineering analyses; including static stability, contact area, and interface strength. In addition, the porous coating for the metal-backed design was fully characterized as well as tested in static shear. A review of these results indicates that the subject devices are equivalent to predicate devices and are capable of withstanding expected in vivo loading without failure.
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
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.
0
K122218
1/2
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
MAR 2 1 2013
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 ADVANCE® Total Knee System.
Submitted By:
Date:
Contact Person:
Danielle Mueller Project Manager
February 19, 2013
(800) 238-7188
Proprietary Name:
Common Name:
Classification Name and Reference:
Project manager.
Wright Medical Technology, Inc. 5677 Airline Rd, Arlington TN, 38002
ADVANCE® Total Knee System
Patella
21 CFR 888.3560 Knee joint Patellofemorotibial Polymer / Metal / Polymer Semi-Constrained Cemented Prosthesis Class II
21 CFR 888.3565 Knee joint Patellofemorotibial Metal / Polymer Porous-Coated Uncemented Prosthesis Class II
Subject Product Code and Panel Code:
Predicate Devices:
Orthopedics/87/JWH, MBH
ADVANCE® Total Knee System AXIOM® Total Knee System 510(k)s: K953439, K061223, K894334
DEVICE INFORMATION
A. Intended Use
The ADVANCE® Total Knee System 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.
-
- Correction of functional deformity;
- Revision procedures where other treatments or devices have failed; and treatment of fractures 4. that are unmanageable using other techniques.
Porous-coated total knee replacement components are for use without bone cement.
B. Device Description
The purpose of this submission is to add patellar components to the ADVANCE® Total Knee System. The design features of the subject patellae are summarized below:
- . All-poly patellae manufactured from UHMWPE
- . Available in sizes 25-41, single- or tri-peg design
1
Metal-backed patellae manufactured from UHMWPE and CoCr alloy .
- Available in sizes 29-38, tri-peg design with porous coating ■
The ADVANCE® patellar components were evaluated via mechanical testing and engineering analyses; including static stability, contact area, and interface strength. In addition, the porous coating for the metal-backed design was fully characterized as well as tested in static shear. A review of these results indicates that the subject devices are equivalent to predicate devices and are capable of withstanding expected in vivo loading without failure.
C. Substantial Equivalence Information
The indications for use of the ADVANCE® Total Knee System are unchanged as a result of the addition of the subject patellar components. The design features and materials of the subject devices are identical 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 patellae of the ADVANCE® Total Knee System are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this premarket notification.
2
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002
March 21, 2013
Wright Medical Technology, Incorporated % Ms. Danielle Mueller Project Manager 5677 Airline Road Arlington, Tennessee 38002
Re: K122218
Trade/Device Name: ADVANCE® Total Knee System Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: II Product Codes: MBH, JWH Dated: February 19, 2013 Received: February 20, 2013
Dear Ms. Mueller:
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
3
Page 2 – Ms. Danielle Mueller
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Image /page/3/Picture/7 description: The image shows the name "Erin J. Keith" in a stylized font. The letters are bold and black, with a decorative design around the "J" and "Keith". The overall design appears to be a logo or signature.
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): K122218
Device Name: ADVANCE® Total Knee System
Indications For Use:
The ADVANCE® Total Knee System 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.
Porous-coated total knee replacement components are for use without bone cement.
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 Orthopaedic Devices
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