(99 days)
Total ankle arthroplasty is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint. Total ankle arthroplasty is indicated for patients with ankle joints damaged by severe rheumatoid, post traumatic or degenerative arthritis in elderly individuals with reduced activity levels.
CAUTION: The Agility Ankle Prosthesis is intended for cemented use only.
The Agility™ LP Total Ankle Prosthesis proposed in this submission are a line extension to the Agility™ Total Ankle system components (cleared as DePuy Alvine Total Ankle Prosthesis under K920802, December 17, 1992). The Agility LP Ankle is a modular ankle prosthesis that is comprised of a tibial tray, a polyethylene tibial insert and a talar component.
The provided text is a 510(k) summary for the Agility™ LP Total Ankle Prosthesis. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, this document does not contain information about acceptance criteria for device performance, nor details of a study demonstrating such performance.
The 510(k) process for this type of medical device (an ankle prosthesis) primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials or performance studies with specific acceptance criteria in the same way a diagnostic AI device or novel therapeutic might.
Therefore, I cannot fulfill your request for details on acceptance criteria and a study proving the device meets them because this information is not present in the provided text.
Specifically, the document states:
- "The substantial equivalence of the Agility LP Ankle Prosthesis is demonstrated by its similarity in indications for use, design, materials, sterilization and packaging to the Agility Ankle cleared in K920802 (formerly called the Alvine Ankle)."
This statement indicates that the regulatory clearance was based on similarity to a previously approved device, not on specific performance metrics established through a new study with acceptance criteria.
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053569 p.1/2
MAR 3 1 2006
| NAME OF SPONSOR: | DePuy Orthopaedics, Inc.700 Orthopaedic DriveWarsaw, Indiana 46581-0988Est. Reg. No. 1818910 |
|---|---|
| MANUFACTURER: | DePuy Orthopaedics, Inc.700 Orthopaedic DriveWarsaw, Indiana 46581-0988Est. Reg. No. 1818910 |
| 510(K) CONTACT: | Natalie S HeckManager, Regulatory AffairsPhone: (574) 372-7469Fax: (574) 371-4987 |
| TRADE NAME: | Agility™ LP Total Ankle Prosthesis |
| COMMON NAME: | Ankle Prosthesis |
| CLASSIFICATION: | Class II Ankle Joint metal/polymer semi-constrainedcemented prosthesis per 21 CFR §888.3110 |
| DEVICE PRODUCT CODE: | 87 HSN |
| SUBSTANTIALLY EQUIVALENTDEVICES: | DePuy Agility™ Total Ankle Prosthesis(formerly cleared as Alvine Ankle) |
DEVICE DESCRIPTION:
510(k) Summary
The Agility™ LP Total Ankle Prosthesis proposed in this submission are a line extension to the Agility™ Total Ankle system components (cleared as DePuy Alvine Total Ankle Prosthesis under K920802, December 17, 1992). The Agility LP Ankle is a modular ankle prosthesis that is comprised of a tibial tray, a polyethylene tibial insert and a talar component.
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053569, 12/2
510(k) Summary (cont.)
INTENDED USE AND INDICATIONS:
The Agility™ LP Total Ankle Prosthesis components, as part of the DePuy Agility™ Total Ankle The righty - 21 Year thanded for use in patients with end stage ankle disorders as an alternative to ankle fusions.
Total ankle arthroplasty is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint. Total ankle arthroplasty is indicated for patients with ankle joints damaged by severe rheumatoid, post traumatic or degenerative arthritis in elderly individuals with reduced activity levels.
CAUTION: The Agility Ankle Prosthesis is intended for cemented use only.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The substantial equivalence of the Agility LP Ankle Prosthesis is demonstrated by its similarity in indications for use, design, materials, sterilization and packaging to the Agility Ankle cleared in K920802 (formerly called the Alvine Ankle).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized graphic of three human figures, represented by curved lines, symbolizing health and well-being.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 3 1 2006
DePuy Orthopaedics, Inc. c/o Ms. Natalie S. Heck Manager, Regulatory Affairs P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
Re: K053569
Trade/Device Name: Agility™ LP Total Ankle Prosthesis Regulation Number: 21 CFR 888.3110 Regulation Name: Ankle joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: HSN Dated: February 27, 2006 Received: March 1, 2006
Dear Ms. Heck:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
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Page 2 – Ms. Natalie S. Heck
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you'll begin finding of substantial equivalence of your device to a legally premarket notification: "The a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you debit office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Herbert Lerner wo
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K653569
Indications for Use
510(k) Number (if known): Device Name: Agility™ LP Total Ankle Prosthesis
Indications for Use:
Total ankle arthroplasty is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint. Total ankle arthroplasty is indicated for patients with ankle joints damaged by severe r oual antil of the oplants or degenerative arthritis in elderly individuals with reduced activity levels.
CAUTION: The Agility Ankle Prosthesis is intended 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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
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| 510(k) Number | K053569 |
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0000012
§ 888.3110 Ankle joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. An ankle joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an ankle joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces and has no linkage across-the-joint. This generic type of device includes prostheses that have a talar resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a tibial resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.