(30 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.
Yes.
The device is an implant used to treat degenerative and post-traumatic arthritis in the MTP joint, which alleviates symptoms and restores function.
No
This is an implant, which is a therapeutic device, not a diagnostic device.
No
The device description clearly states it is a "one piece implant designed to replace the distal head of the metatarsal," indicating it is a physical hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside of the body.
- Device Description and Intended Use: The provided text clearly describes a surgical implant designed to be placed inside the body to treat conditions in the metatarsophalangeal joint. It is a physical device used in a surgical procedure, not a test performed on a specimen.
The information provided is consistent with a description of a surgically implanted medical device, not an IVD.
N/A
Intended Use / Indications for Use
The OsteoMed Metatarsal Resurfacing Implant, a hemi-arthroplasty implant for the metatarsophalangeal (MTP) joint, is indicated for use in the treatment of patients with degenerative and post-traumatic arthritis in the MTP joint in the presence of good bone stock and integrity of the phalangeal base, along with the following clinical conditions; hallux limitus, hallux rigidus, and an unstable or painful MTP joint.
The OsteoMed Metatarsal Resurfacing Implant is intended to be used with bone cement or press fit without bone cement.
The OsteoMed Metatarsal Resurfacing Implant is intended for single use only.
Product codes
KWD
Device Description
The OsteMed Metatarsal Resurfacing Implant is a one piece implant designed to replace the distal head of the metatarsal and provides a smooth articular surface for the adjacent phalangeal base. The implant is available in several sizes in direct proportion to the anatomic construct of the metatarsal head.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
metatarsophalangeal (MTP) joint, metatarsal head
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
OSTEOMED
510(k) Summary
| NAME OF SPONSOR: | OsteoMed L.P
3885 Arapaho Road
Addison, Texas 75001 | AUG - 1 2008 |
|------------------|--------------------------------------------------------------------------------------------|--------------|
| CONTACT PERSON: | Alma Relja
Regulatory Affairs Specialist
Phone (972)-677-4781
Fax: (972)-677-7448 | |
| Date Prepared: | June 25, 2008 | |
| COMMON NAME: | Metatarsal Resurfacing Implant System | |
| CLASSIFICATION: | Class II | |
| DEVICE CODE: | KWD | |
| REGULATION #: | 21 CFR 888.3730 | |
TRADE NAME:
OsteoMed Metatarsal Resurfacing Implant System with Hydroxylapatite Coating
SUBSTANTIALLY EQUIVALENT DEVICE(S):
OsteoMed Metatarsal Resurfacing Implant System (K073065)
SUMMARY:
The OsteoMed Metatarsal Resurfacing Implant, a hemi-arthroplasty implant for the metatarsophalangeal (MTP) joint, is indicated for use in the treatment of patients with degenerative and post-traumatic arthritis in the MTP joint in the presence of good bone stock and integrity of the phalangeal base, along with the following clinical conditions; hallux limitus, hallux rigidus, and an unstable or painful MTP joint.
The OsteoMed Metatarsal Resurfacing Implant is intended to be used with bone cement or press fit without bone cement.
The OsteoMed Metatarsal Resurfacing Implant is intended for single use only.
The OsteMed Metatarsal Resurfacing Implant is a one piece implant designed to replace the distal head of the metatarsal and provides a smooth articular surface for the adjacent phalangeal base. The implant is available in several sizes in direct proportion to the anatomic construct of the metatarsal head.
$$
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1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OsteoMed L.P. % Ms. Alma Relja Regulatory Affairs Specialist 3885 Arapaho Road Addison, Texas 75001
AUG - 1 2008
Re: K081876
Trade/Device Name: OsteoMed Resurfacing Metatarsal Implant System with Hydroxylapatite Coating Regulation Number: 21 CFR 888.3730 Regulation Name: Toe joint phalangcal (hemi-toe) polymer prosthesis Regulatory Class: II Product Code: KWD Dated: June 30, 2008 Received: July 2, 2008
Dear Ms. Relja:
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.
2
Page 2 - Ms. Alma Relja
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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. Millerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
K0818 510(k) Number (if known):
Device Name: OsteoMed Metatarsal Resurfacing Implant with Hydroxylapatite Coating Indications for Use:
The OsteoMed Metatarsal Resurfacing Implant, a hemi-arthroplasty implant for the metatarsophalangeal (MTP) joint, is indicated for use in the treatment of patients with degenerative and post-traumatic arthritis in the MTP joint in the presence of good bone stock and integrity of the phalangeal base, along with the following clinical conditions; hallux limitus, hallux valgus, hallux rigidus, and an unstable or painful MTP joint.
The OsteoMed Metatarsal Resurfacing Implant is intended to be used with bone cement or press fit without bone cement.
The OsteoMed Metatarsal Resurfacing Implant is intended for single use only.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
Mark A. Wilkerson
(Division Sign. Division of Genera នាយ
Page 1 of 1
510(k) Number.