(87 days)
Indicated for partial or complete dislocation of the lesser metatarsophalangeal joint; pain associated with either rheumatoid or osteoarthritis; repair for unsuccessful arthroplasties of the lesser metatarsophalangeal joint; stiffness at the lesser metatarsophalangeal joint associated with joint disease; hammertoe deformity where the proximal phalanx is dorsally located on the metatarsal in a fixed contracture state. Implants are single use only.
The OsteoMed Metatarsophalangeal Flexible Stabilizing Rod System is a stemmed flexible implant specifically designed for replacement of the lesser metatarsophalangeal joints of the foot. It is constructed of medical grade silicone elastomer. The OsteoMed Metatarsophalangeal Flexible Stabilizing Rods are offered in diameters of 2.5mm through 3.0mm. Drills and sizers will also be a part of the system.
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets any acceptance criteria. The document is a 510(k) summary for a medical device called the "OsteoMed Metatarsophalangeal Flexible Stabilizing Rod System." It primarily focuses on demonstrating substantial equivalence to a predicate device (Sgarlato Lesser Toe Implant K884739) based on similarities in intended use, material, design, and operational principle.
The document does not contain details regarding:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or data provenance.
- Number of experts or their qualifications for establishing ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone performance studies.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This type of information is typically associated with performance studies, especially those involving AI/ML devices or novel devices requiring more extensive clinical evidence. The provided document is a regulatory submission for a device deemed substantially equivalent to a predicate, which often does not require new performance studies if the safety and effectiveness are established through the predicate.
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NOV 2 5 2002
KOD2P86
510(k) Summarv
| Device Proprietary Name: | OsteoMed MetatarsophalangealFlexible Stabilizing Rod System |
|---|---|
| Device Common Name: | Toe Implants, Silicone |
| Classification Name: | Prosthesis, Toe Joint,Constrained, Polymer |
| Name of Submitter: | OsteoMed Corporation3750 Realty RoadAddison, Texas 75001Phone: (972) 241-3401Fax: (972) 241-3449 |
| Contact Person: | Dawn T. Holdeman |
| Date Prepared: | August 23, 2002 |
Summarv:
This submission describes the OsteoMed Metatarsophalangeal Flexible Stabilizing Rod System intended for partial or complete dislocation of the lesser metatarsophalangeal joint; pain associated with either rheumatoid or osteoarthritis; repair for unsuccessful arthroplasties of the lesser metatarsophalangeal joint; stiffness at the lesser metatarsophalangeal joint associated with joint disease; hammertoe deformity where the proximal phalanx is dorsally located on the metatarsal in a fixed contracture state. OsteoMed Metatarsophalangeal Flexible Stabilizing Rod Implants are intended for single use only.
The OsteoMed Metatarsophalangeal Flexible Stabilizing Rod System is a stemmed flexible implant specifically designed for replacement of the lesser metatarsophalangeal joints of the foot. It is constructed of medical grade silicone elastomer. The OsteoMed Metatarsophalangeal Flexible Stabilizing Rods are offered in diameters of 2.5mm through 3.0mm. Drills and sizers will also be a part of the system.
Equivalence for this device is based on similarities in intended use, material, design and operational principle to the Sgarlato Lesser Toe Implant (K884739) by Futura Biomedical.
Due to the similarity of materials and design to both pre-enactment and postenactment devices, OsteoMed believes that the OsteoMed Metatarsophalangeal Flexible Stabilizing Rod System does not raise any new safety or effectiveness issues.
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NOV 2 5 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Dawn T. Holdeman Regulatory Affairs / Document Control OsteoMed Corporation 3750 Realty Road Addison, Texas 75001-4311
Re: K022886
Trade/Device Name: Metatarsophalangeal Flexible Stabilizing Rod System Regulation Numbers: 21 CFR 888.3720 Regulation Names: Toe joint polymer constrained prosthesis Regulatory Class: II Product Code: KWH Dated: August 29, 2002 Received: August 30, 2002
Dear Ms. Holdeman:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced aboye 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 - Ms. Dawn T. Holdeman
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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
y Mark n Milliner
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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page 1 of 1
OsteoMed "Indications for Use" Submission
510(k) Number:
| Device Name: | OsteoMed Metatarsophalangeal Flexible StabilizingRod System |
|---|---|
| Indication for Use: | Indicated for partial or complete dislocation of thelesser metatarsophalangeal joint; pain associatedwith either rheumatoid or osteoarthritis; repair forunsuccessful arthroplasties of thelessermetatarsophalangeal joint; stiffness at the lessermetatarsophalangeal joint associated with jointdisease; hammertoe deformity where the proximalphalanx is dorsally located on the metatarsal in afixed contracture state. Implants are single use only. |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 810.109) Over-The Counter-Use (Optical Format 1-)
Mark A. Millam
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number
§ 888.3720 Toe joint polymer constrained prosthesis.
(a)
Identification. A toe joint polymer constrained prosthesis is a device made of silicone elastomer or polyester reinforced silicone elastomer intended to be implanted to replace the first metatarsophalangeal (big toe) joint. This generic type of device consists of a single flexible across-the-joint component that prevents dislocation in more than one anatomic plane.(b)
Classification. Class II.