(47 days)
The Ortho/Pro Hemi Toe is designed to supplement first metatarsal joint arthroplasty. Indications include hallux limitus or hallux rigidius, painful hallux valgus, revision of failed previous surgery and painful arthritis.
The Ortho/Pro Hemi Toe is a single stemmed resurfacing prosthesis for the first proximal phalanx designed to supplement first metatarsal phalangeal joint arthroplasty. The concave congruent articular surface has a mirror finish to minimize friction and matches the adiacent metatarsal head. The oval shape helps to reduce impingement on the metatarsal head, majntain range of motion and reduce pain without altering the joint biomechanics. The Hemi Tor requires minimal bone resection and provides full range of motion of the first metatarsophalangeal joint (MPJ).
The provided text does not contain information about acceptance criteria and a study proving the device meets those criteria. The document is a 510(k) summary for a medical device (OrthoPro Hemi Toe) and primarily focuses on establishing substantial equivalence to predicate devices, not on performance criteria or clinical study results.
The key statement regarding testing is: "The Ortho/Pro Hemi Toe does not incorporate any new technological characteristics as compared to the predicate devices. The Ortho/Pro Hemi Toe and the predicate devices are made ofinial the same material." This indicates that the regulatory approval was likely based on equivalence in design, materials, and intended use, rather than a specific performance study with acceptance criteria.
Therefore, I cannot provide the requested table or details about a study, as that information is not present in the provided text.
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510(k) Summary OrthoPro Hemi Toe
| Date | September 25, 2006 | |
|---|---|---|
| Submitter | OrthoPro LLC3450 Highland Dr.#303Salt Lake City, UT 84106 | NOV 1 3 2006 |
| Contact person | J.D. Webb1001 Oakwood BlvdRound Rock, TX 78681512-388-0199 | |
| Trade Name | OrthoPro Hemi toe | |
| Common name | Hemi toe | |
| Classification name | prosthesis, toe, hemi-, phalangealClass II per 21 CFR section 888.3730 | |
| Product Code | KWD | |
| Equivalent Device | Futura Biomedical Metal Hemi Toe Implant (K971047)Kinetikos Medical K2 Hemi Toe Implant System (K023770)Townley Great Toe Joint (K911378) |
Device Description
The Ortho/Pro Hemi Toe is a single stemmed resurfacing prosthesis for the first proximal phalanx designed to supplement first metatarsal phalangeal joint arthroplasty. The concave congruent articular surface has a mirror finish to minimize friction and matches the adiacent metatarsal head. The oval shape helps to reduce impingement on the metatarsal head, majntain range of motion and reduce pain without altering the joint biomechanics. The Hemi Tor requires minimal bone resection and provides full range of motion of the first metatarsophalangeal joint (MPJ).
Intended Use
The Ortho/Pro Hemi Toe is a single stemmed resurfacing prosthesis for the first proximal phalanx designed to supplement first metatarsal phalangeal joint arthroplasty. Indications include hallux limitus or hallux rigidius, painful hallux valgus, revision of failed previous surgery and painful arthritis.
Summary Nonclinical Tests
The Ortho/Pro Hemi Toe does not incorporate any new technological characteristics as compared to the predicate devices. The Ortho/Pro Hemi Toe and the predicate devices are made ofinial the same material.
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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 bird is facing to the left. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 3 2006
OrthoPro LLC % Mr. J.D. Webb 1001 Oakwood Boulevard Round Rock, Texas 78681
Re: K062908
Trade/Device Name: Ortho/Pro Hemi Toe Regulation Number: 21 CFR 888.3730 Regulation Name: Toe joint phalangeal (hemi-toe) polymer prosthesis. Regulatory Class: II Product Code: KWD Dated: September 25, 2006 Reccived: September 27, 2006
Dear Mr Webb:
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- Mr. J.D. Webb
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.
Barbara Buchner
to
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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Indications for Use
510(k) Number (if known): KOLA908
Device Name: _________________________________________________________________________________________________________________________________________________________________ Ortho/Pro Hemi Toe -----------------------------------------------------------------------------------------------------------------------------------------------------------
Indications for Use:
The Ortho/Pro Hemi Toe is designed to supplement first metatarsal joint arthroplasty. Indications include hallux limitus or hallux rigidius, painful hallux valgus, revision of failed previous surgery and painful arthritis.
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)
Darvare Broud for WXW
(Division Sign-Off) Division of General, Restorative, and Meurological Devices
516(A) Number K062908
র পর ব
§ 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.