(65 days)
Not Found
No
The summary describes a physical implant and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is an implant for joint replacement, which is a structural or mechanical intervention, not a therapeutic agent or method in the sense of directly treating or curing a disease process itself. It addresses the symptoms and mechanical issues of arthritis by providing a replacement joint.
No
The device is a Hemi-arthroplasty implant intended for the treatment of arthritis, specifically for replacement and not for diagnosis.
No
The device description clearly states it is an "implant" and a "single use implant intended to be used with bone cement," indicating it is a physical medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. They are used to diagnose diseases or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease. Examples include blood tests, urine tests, and genetic tests.
- This device is an implant. It is a physical object surgically placed into the body to treat a condition (arthritis in the metatarsophalangeal joint).
The description clearly states it's a "Hemi-arthroplasty implant" and an "implant intended to be used with bone cement." This is a medical device used in the body, not a diagnostic tool used on specimens from the body.
N/A
Intended Use / Indications for Use
Hemi-arthroplasty implant for the metatarsophalangeal joint for use in the treatment of patients with degenerative and post-traumatic arthritis in the metatarsal joint in the presence of good bone stock along with the following clinical conditions: hallux valgus or hallux limitus, hallux rigidus, and an unstable or painful metatarsal/phalangeal (MTP) joint. The device is a single use implant intended to be used with bone cement.
Product codes (comma separated list FDA assigned to the subject device)
KWD
Device Description
The 7.0mm MTP Taper Post is a reduced length and diameter version of the sponsor's previously cleared and commercially marketed 8.0mm Taper Post, but is otherwise identical.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
metatarsophalangeal joint
Indicated Patient Age Range
Not Found
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)
Not Found
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
§ 888.3730 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.
0
K063370 p qe 'f²
| 510(k) Owner: | Arthrosurface, Inc.
28 Forge Parkway
Franklin, MA 02038 |
|---------------|---------------------------------------------------------------|
| Tel: | 508.520.3003 |
| Fax: | 508.528.4604 |
JAN 12 2007
| Contact: | Dawn Wilson
Director, Quality Systems |
|----------------------------|-----------------------------------------------------------------------------------|
| Date of Preparation: | October 18, 2006 |
| Trade Name: | Contoured Articular Prosthetic (CAP) ™
7.0mm MTP Resurfacing Hemi-arthroplasty |
| Common Name: | 7.0mm MTP Resurfacing Prosthesis |
| Device: | Prosthesis, Toe, Hemi-, Phalangeal |
| Classification Regulation: | Regulation Number 888.3730 |
| Device Class: | Class II |
| Review Panel: | Orthopedic |
| Product Code: | KWD |
Device Intended Use
Hemi-arthroplasty implant for the metatarsophalangeal joint for use in the treatment of patients with degenerative and post-traumatic arthritis in the metatarsal joint in the presence of good bone stock along with the following clinical conditions: hallux valgus or hallux limitus, hallux rigidus, and an unstable or painful metatarsal/phalangeal (MTP) joint. The device is a single use implant intended to be used with bone cement.
Device Description
The 7.0mm MTP Taper Post is a reduced length and diameter version of the sponsor's previously cleared and commercially marketed 8.0mm Taper Post, but is otherwise identical.
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000015
Substantial Equivalency:
The intended use, materials, design features and application of the Proposed Device are substantially equivalent to the sponsor's previously cleared and commercially marketed device (K031859 Toe joint phalangeal (hemi-toe) polymer prosthesis, Arthrosurface, Inc.).
The fundamental scientific technology of the proposed device has not changed relative to the predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle-like bird with three stylized stripes forming its body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Arthrosurface, Inc. % Ms. Dawn Wilson Director, Quality Systems 28 Forge Parkway Franklin, Massachusetts 02038
JAN 1 2 2007
Re: K063370
Trade/Device Name: Contoured Articular Prosthetic CAP™ 7.0mm MTP Resurfacing Hemi-arthroplasty Regulation Number: 21 CFR 888.3730 Regulation Name: Toe joint phalangeal (hemi-toe) polymer prosthesis Regulatory Class: II Product Code: KWD Dated: November 2, 2006 Received: November 13, 2006
Dear Ms. Wilson:
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 udications for use stated in the enclosure) to legally marketed predicate devices marketed in internate 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 Fedral Food, Or us, 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 misbaandijng 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, TDA 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 proctice 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.
3
Page 2 - Ms. Dawn Wilson
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 fuchund
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): _ Kob 3370
Device Name:
Contoured Articular Prosithetic (CAP) ™ 7.0mm MTP Resurfacing Hemi-arthroplasty
Indications for Use:
Hemi-arthroplasty implant for the metatarsophalangeal joint for use in the treatment of patients with degenerative and post-traumatic arthritis in the metatarsal joint in the presence of good bone stock along with the following clinical conditions: hallux valgus or hallux limitus, hallux rigidus, and an unstable or painful metatarsal/phalangeal (MTP) joint. The device is a single use implant intended to be used with bone cement.
Prescription Use X Over-The-Counter Use Prescription Ose -------------------------------------------------------------------------------------------------------------------------------------------------------------(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Brichum
Division of General, Restorative, and Neurological Devices
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510(k) Number K063370 000013