(114 days)
Not Found
No
The document describes a physical implant and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is an implantable prosthetic used to treat medical conditions like degenerative and post-traumatic arthritis in the MTP joint, which aligns with the definition of a therapeutic device.
No
Explanation: The device is an implantable medical device (a hemi-arthroplasty implant) used for the treatment of certain medical conditions, not for diagnosing them.
No
The device is a physical implant designed to replace a portion of the metatarsal bone, clearly indicating it is a 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 perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description: The OsteoMed Metatarsal Resurfacing Implant is a physical implant designed to be surgically placed inside the body to replace a joint surface. It is a surgical implant, not a diagnostic test.
- Intended Use: The intended use is to treat specific conditions of the MTP joint by surgically replacing a damaged part of the bone. This is a therapeutic intervention, not a diagnostic process.
The information provided clearly describes a surgical implant used for treatment, not a device used for testing samples outside the body.
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 (comma separated list FDA assigned to the subject device)
KWD
Device Description
This submission describes the OsteoMed Metatarsal Resurfacing Implant System, a hemi arthroplasty implant system, for the metatarsophalangeal (MTP) joint for use in treatment of patients with degenerative and post-traumatic arthritis in the MTP joints 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 painfull MTP joint. OsteoMed Metatarsal Resurfacing Implant is intended for single use only.
The OsteoMed 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. Primary fixation is intended to be used with bone cement or press fit without bone cement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
metatarsophalangeal (MTP) 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.
K031859, K063370, K070052, K060536, K922211, K041595
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
K07 3065
Image /page/0/Picture/1 description: The image shows the logo for OsteoMed. The logo is black and white and features the word "OsteoMed" in a bold, sans-serif font. The word is slightly curved and is surrounded by a black oval shape. The logo is simple and modern.
21 21 :
510(k) Summarv
| Device Proprietary Name: | OsteoMed Metatarsal
Resurfacing Implant System |
|--------------------------|----------------------------------------------------------------------------------------------------------------|
| Device Common Name: | Metatarsal Resurfacing Implant
System |
| Classification Name: | KWD, Prosthesis, Toe, Hemi-,
Phalangeal |
| Name of Submitter: | OsteoMed L. P.
3885 Arapaho Road
Addison, Texas 75001
Phone: (972) 677-4600
Fax: (972) 677-4601 |
| Contact Person: | Piedad Peña |
Contact Person:
M
Date Prepared:
February 8, 2008
Summary:
This submission describes the OsteoMed Metatarsal Resurfacing Implant System, a hemi arthroplasty implant system, for the metatarsophalangeal (MTP) joint for use in treatment of patients with degenerative and post-traumatic arthritis in the MTP joints 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 painfull MTP joint. OsteoMed Metatarsal Resurfacing Implant is intended for single use only.
The OsteoMed 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. Primary fixation is intended to be used with bone cement or press fit without bone cement.
Equivalence for this device is based on similarities in intended use, materials, design and operational principle to the Arthrosurface CAP Great Toe Resurfacing Hemi- Arthroplasty Implant (K031859) and CAP Prosthetic 7.0mm MTP Resurfacing Hemi- arthroplasty (K063370), Vilex Met-Head Resurfacing Hemi- Arthroplasty Implant (K070052), OsteoMed 1st MPJ Hemi Implant System (K060536) and ReFlexion Great Toe System (K922211), and BioPro Hemi MPJoint (K041595).
OsteoMed L.P. 3885 Aranaho Road Addison, Texas 75001 (972) 677-4600 FAX: (972) 677-4601 Customer Service: (800) 456-7779
Colson A COLSON ASSOCIATE
1
073065
$\rho.^{2}/2$
Due to the similarity in intended use, materials, design and operational principle to the predicate devices, OsteoMed believes that the OsteoMed Metatarsal Resurfacing Implant System does not raise any new safety or effectiveness issues.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with outstretched wings. The bird is composed of three curved lines that create the impression of feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 1 2008
OsteoMed L.P. % Ms. Piedad Peña Regulatory Affairs Specialist 3885 Arapaho Road Addison, TX 75001
Re: K073065
Trade/Device Name: OsteoMed Metatarsal Resurfacing Implant System Regulation Number: 21 CFR 888.3730 Regulation Name: Toe joint phalangeal (hemi-toe) polymer prosthesis Regulatory Class: Class II Product Code: KWD Dated: February 8, 2008 Received: February 11, 2008
Dear Ms. Peña:
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.
3
Page 2 - Ms. Piedad Peña
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 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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N Mulhausen
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: OsteoMed Metatarsal Resurfacing Implant System
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.
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)
Oubarebnem
Division of General, Restorative, Page 1 of 1 and Neurological Devices
(Posted November 13, 2003)
510(k) Number_ 1 0 7 300