ADVANCE TOTAL KNEE SYSTEM-PATELLA
K122218 · Wrightmedicaltechnologyinc · MBH · Mar 21, 2013 · Orthopedic
Device Facts
| Record ID | K122218 |
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| Device Name | ADVANCE TOTAL KNEE SYSTEM-PATELLA |
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| Applicant | Wrightmedicaltechnologyinc |
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| Product Code | MBH · Orthopedic |
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| Decision Date | Mar 21, 2013 |
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| Decision | SESE |
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| Submission Type | Special |
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| Regulation | 21 CFR 888.3565 |
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| Device Class | Class 2 |
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| Attributes | Therapeutic |
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Intended Use
The ADVANCE® Total Knee System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1. Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2. Inflammatory degenerative joint disease including rheumatoid arthritis; 3. Correction of functional deformity; 4. 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.
Device Story
ADVANCE® Total Knee System expanded to include patellar components; all-polyethylene (UHMWPE) patellae (sizes 25-41, single/tri-peg) and metal-backed patellae (UHMWPE/CoCr alloy, sizes 29-38, tri-peg, porous-coated). Used in orthopedic surgery for total knee arthroplasty. Components implanted by surgeons to restore joint function, correct deformity, or address fractures/failed prior procedures. Metal-backed porous-coated components allow cementless fixation. Device provides mechanical stability and articulation surface for patellofemoral joint.
Clinical Evidence
Bench testing only. Mechanical testing performed on patellar components including static stability, contact area, and interface strength. Porous coating for metal-backed design characterized and tested in static shear. No clinical data provided.
Technological Characteristics
Materials: UHMWPE and CoCr alloy. Design: All-polyethylene (single/tri-peg) and metal-backed (tri-peg) patellae. Fixation: Porous-coated for cementless use or cemented. Mechanical testing: Static stability, contact area, interface strength, static shear testing for porous coating.
Indications for Use
Indicated for skeletally mature patients requiring knee arthroplasty due to noninflammatory degenerative joint disease (osteoarthritis, traumatic arthritis, avascular necrosis), inflammatory degenerative joint disease (rheumatoid arthritis), functional deformity, failed prior treatments, or unmanageable fractures.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- ADVANCE® Total Knee System (K953439, K061223, K894334)
- AXIOM® Total Knee System (K953439, K061223, K894334)
Related Devices
- K061521 — TRIATHLON METAL BACKED PATELLA · Howmedica Osteonics Corp. · Aug 11, 2006
- K993371 — SADDLE SHAPED PATELLA · Wrightmedicaltechnologyinc · Dec 20, 1999
- K080029 — MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM · Mako Surgical Corp. · May 16, 2008
- K191084 — The Optimotion Blue Total Knee System · Optimotion Implants, LLC · Apr 7, 2020
- K061340 — 23 MM SINGLE-PEG PATELLA COMPONENT · Biomet Manufacturing, Inc. · Sep 25, 2006
Submission Summary (Full Text)
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K122218
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#### 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:
- 1. Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
- Inflammatory degenerative joint disease including rheumatoid arthritis; 2.
- 3. 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
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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.
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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
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# 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
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# 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:
- 1. Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
- 2. Inflammatory degenerative joint disease including rheumatoid arthritis;
- 3. Correction of functional deformity;
- 4. 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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