(90 days)
The Arthrex AnaToemic™ Phalangeal Prosthesis is a press-fit implant that is intended to be used in patients with hallux limitus, hallux rigidus, hallux valgus, arthritic degradation of the metatarso-phalangeal joint, degenerative arthritis, rheumatoid arthritis, and bunion deformity associated with arthritis of the metatarsal-phalangeal joint.
The Arthrex AnaToemic™ Phalangeal Prosthesis is a one-piece implant system that replaces only half of the affected joint of the metatarso-phalangeal joint of the big toe. It is anatomically designed to provide an optimal fit to the distal articular surface of the affected joint. The implant has two design elements: 1) a polished, concave oval disk; and, 2) a rough stem with a barbed trapezoid shape with a lozenge cross section. On the stem as well as on the distal portion of the disc the surface is rough. The implant material is cobalt chromium alloy (ASTM F1537).
The provided text describes a 510(k) summary for the Arthrex AnaToemic™ Phalangeal Prosthesis. It is a premarket notification for a medical device seeking substantial equivalence to existing predicate devices.
However, the provided text does not contain information regarding detailed acceptance criteria, a specific study that proves device performance against these criteria, or any of the detailed study parameters (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details).
The text primarily focuses on:
- Device Identification: Manufacturer, contact, trade/common name, product code.
- Predicate Devices: K031859, CAPTM Great Toe Resurfacing Hemi-Arthroplasty; K041595, BioPro Hemi MP Joint.
- Device Description and Intended Use: A one-piece implant for the metatarso-phalangeal joint of the big toe, designed to provide optimal fit, made of cobalt chromium alloy, and intended for conditions like hallux limitus, hallux rigidus, hallux valgus, various forms of arthritis, and bunion deformity associated with arthritis.
- Substantial Equivalence Summary: States that the device is substantially equivalent to predicate devices, with minor design differences that do not raise questions of safety and effectiveness or affect performance, function, or intended use.
- FDA Communication: A letter from the FDA confirming the review of the 510(k) and stating that the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market subject to general controls.
Conclusion:
Based on the provided text, it is not possible to fill out the requested table or provide the detailed study information as the document is a 510(k) summary focused on substantial equivalence rather than a detailed clinical or performance study report. 510(k) submissions often rely on bench testing and comparison to predicate devices rather than extensive new clinical trials with detailed performance metrics against pre-defined acceptance criteria in the manner requested.
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14663558
3 510(k) Summary of Safety and Effectiveness
| Manufacturer/Sponsor | Arthrex, Inc. 1370 Creekside Boulevard Naples, Florida 34108-1945 |
|---|---|
| 510(k) Contact | Nancy HoftRegulatory Affairs AssociateTelephone: 239/643.5553, ext. 1113Fax: 239/598.5539Email: nhoft@arthrex.com |
| Trade Name | Arthrex AnaToemic™ Phalangeal Prosthesis |
| Common Name | Prosthesis, Toe, Hemi-, Phalangeal |
| Product Code | KWD |
| Predicate Devices | K031859, CAPTM Great Toe Resurfacing Hemi-ArthroplastyK041595, BioPro Hemi MP Joint |
| Device Descriptionand Intended Use | The Arthrex AnaToemic™ Phalangeal Prosthesis is a one-pieceimplant system that replaces only half of the affected joint of themetatarso-phalangeal joint of the big toe.It is anatomically designed to provide an optimal fit to the distalarticular surface of the affected joint. The implant has two designelements: 1) a polished, concave oval disk; and, 2) a rough stemwith a barbed trapezoid shape with a lozenge cross section. On thestem as well as on the distal portion of the disc the surface is rough.The implant material is cobalt chromium alloy (ASTM F1537).The Arthrex AnaToemic™ Phalangeal Prosthesis is a press-fitimplant that is intended to be used in patients with hallux limitus,hallux rigidus, hallux valgus, arthritic degradation of the metatarso-phalangeal joint, degenerative arthritis, rheumatoid arthritis, andbunion deformity associated with arthritis of the metatarsal-phalangeal joint. |
| SubstantialEquivalence Summary | Arthrex has determined that the Arthrex AnaToemic™ PhalangealProsthesis is substantially equivalent to the predicate device wherebasic features and intended uses are the same. Any designdifferences between the Arthrex AnaToemic™ PhalangealProsthesis and the predicate device are considered minor and donot raise any questions concerning safety and effectiveness. Anydifferences have been found to have no apparent effect on theperformance, function, or intended use of the device |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Arthrex, Inc. % Ms. Nancy Hoft Regulatory Affairs Associate 1370 Creekside Boulevard Naples, Florida 34108
Re: K063058
Trade/Device Name: Arthrex AnaToemic™ Phalangeal Prosthesis Regulation Number: 21 CFR 888.3730 Regulation Name: Toe joint phalangeal (hemi-toe) polymer prosthesis Regulatory Class: II Product Code: KWD Dated: October 2, 2006 Received: October 6, 2006
JAN - 3 2007
Dear Ms. Hoft:
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 indivious for use stated in the enclosure) to legally marketed predicate devices marketed in intenstate 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, Dr to 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, I usting of devices, good manufacturing practice, labeling, and prohibitions against misbrandi, nomd 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 aftecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, IDA may publish further announcements concerning your device in the Federal Regirster.
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 100-1050.
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Page 2 -- Ms. Nancy Hoft
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in 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 contact the 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 Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
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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2 Indications for Use Form
Indications for Use
53058
510(k) Number:
Device Name:
Arthrex AnaToemic™ Phalangeal Prosthesis
The Arthrex AnaToemic™ Phalangeai Prosthesis is a press-fit implant that is intended to be used in patients with hallux limitus, hallux rigidus, hallux valgus, arthritic degradation of the metatarso-phalangeal joint, degenerative arthritis, theumatoid arthritis, and bunion deformity associated with arthritis of the metatarsal-phalangeal joint.
Prescription Use __ AND/OR Over-The-Counter Use _ (Per 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
PAGE 1 of
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number L03058
Page 5
§ 888.3730 Toe joint phalangeal (hemi-toe) polymer prosthesis.
(a)
Identification. A toe joint phalangeal (hemi-toe) polymer prosthesis is a device made of silicone elastomer intended to be implanted to replace the base of the proximal phalanx of the toe.(b)
Classification. Class II.