(167 days)
Indicated for use in trauma and reconstructive procedures in the midface and craniofacial skeleton, including, but not limited to, comminuted fractures of the nasoethmoidal and infraorbital areas, comminuted fractures of the frontal sinus wall and midfacial fractures, and reconstructive procedures of the midface or craniofacial skeleton. The OsteoMed Bioresorbable Fixation System is not intended for use in and is contraindicated for: the mandible and/or full load bearing procedures; in cases of active or suspected infection or in patients who are immunocompromised; in cases where there is limitation of the blood supply or inadequate volume or quality of bone to place the system securely; in patients exhibiting disorders which would cause the patient to ignore the limitations of rigid fixation.
The OsteoMed Bioresorbable Fixation System is comprised of various plates, meshes and screws. Plates and meshes, 0.5mm through 1.2mm thick, are provided in various shapes and sizes. Screws are provided in 1.6mm diameter in lengths of 4.0mm through 8.0mm. Safety screws are 2.0mm diameter in lengths of 4.0mm through 8.0mm. The implanted components of the device are manufactured from 70:30 poly L/D,L-lactide.
The provided 510(k) summary for the OsteoMed Bioresorbable Fixation System does not contain information about acceptance criteria or a study proving the device meets said criteria.
Instead, this document focuses on establishing substantial equivalence to previously cleared devices based on similarities in intended use, material, design, and operational principle.
Therefore, I cannot provide the requested information from the given text.
Specifically, the document lacks information on:
- A table of acceptance criteria and reported device performance.
- Sample size used for a test set, data provenance, or details about a study.
- Number of experts, their qualifications, or ground truth establishment for a test set.
- Adjudication method for a test set.
- MRMC comparative effectiveness study or effect size.
- Standalone performance study.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for a specific study.
- Sample size for a training set.
- How ground truth for a training set was established.
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Image /page/0/Picture/1 description: The image shows the logo for Osteomed Corporation. The logo is in black and white, with the word "Osteomed" in large, bold letters. Below "Osteomed" is the word "Corporation" in smaller letters. The logo is simple and professional.
JAN 1 6 2002
510(k) Summary
Device Proprietary Name: OsteoMed Bioresorbable Fixation System Plating System Device Common Name: HRS. Plate, Fixation, Bone Classification Name: OsteoMed Corporation Name of Submitter: 3750 Realty Road Addison, Texas 75001 Phone: (972) 241-3401 Fax: (972) 241-3507 Dawn T. Holdeman Contact Person: July 31, 2001 Date Prepared:
Summary:
This submission describes the OsteoMed Bioresorbable Fixation System indicated for use in trauma and reconstructive procedures in the midface and craniofacial skeleton, including, but not limited to, comminuted fractures of the nasoethmoidal and infraorbital areas. comminuted fractures of the frontal sinus wall and midfacial fractures, and reconstructive procedures of the midface or craniofacial skeleton. This system is not intended for use in the mandible and/or full load bearing procedures.
The OsteoMed Bioresorbable Fixation System is comprised of various plates, meshes and screws. Plates and meshes, 0.5mm through 1.2mm thick, are provided in various shapes and sizes. Screws are provided in 1.6mm diameter in lengths of 4.0mm through 8.0mm. Safety screws are 2.0mm diameter in lengths of 4.0mm through 8.0mm. The implanted components of the device are manufactured from 70:30 poly L/D,L-lactide.
Equivalence for this device is based on similarities in intended use, material, design and operational principle to the Macropore Protective Sheet (K972913), the Synthes Resorbable Fixation System (K974554) and the Stryker Leibinger Resorbable Fixation System (K993061).
Due to the similarity of materials and design to both pre-enactment and postenactment devices, OsteoMed believes that the OsteoMed Bioresorbable Fixation System does not raise any new safety or effectiveness issues.
Image /page/0/Picture/11 description: The image contains a bold, stylized letter 'M' that is repeated three times and arranged horizontally. The letter is black and has a thick, blocky design. The background is plain white, which makes the letter stand out.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 6 2002
Ms. Dawn T. Holdeman Regulatory Affairs and Document Control OsteoMed Corporation 3750 Realty Road Addison, Texas 75001-4311
Re: K012486
Trade/Device Name: OsteoMed Bioresorbable Fixation Sytem Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: November 26, 2001 Received: November 27, 2001
Dear Ms. Holdeman:
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 appear controls 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 (1 NET), It hay of basyon 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.
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Page 2 - Ms. Holdeman
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.
This letter will allow you to begin marketing your device as described in your Section 11the lection will at to m J.A 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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,
Timothy A. Ulatowski
Timo Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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OsteoMed "Indications for Use" Submission
KO12486
510(k) Number:
| Device Name: | OsteoMed Bioresorbable Fixation System |
|---|---|
| Indications for Use: | Indicated for use in trauma and reconstructive procedures in themidface and craniofacial skeleton, including, but not limited to,comminuted fractures of the nasoethmoidal and infraorbitalareas, comminuted fractures of the frontal sinus wall andmidfacial fractures, and reconstructive procedures of themidface or craniofacial skeleton.The OsteoMed Bioresorbable Fixation System is not intendedfor use in and is contraindicated for: the mandible and/or fullload bearing procedures; in cases of active or suspectedinfection or in patients who are immunocompromised; in caseswhere there is limitation of the blood supply or inadequatevolume or quality of bone to place the system securely; inpatients exhibiting disorders which would cause the patient toignore the limitations of rigid fixation. |
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | V |
|---|---|
| (Per 21 CFR 810.109) |
Over-The Counter-Use (Optical Format 1-)
Susan Russo
'Division Sign-Off) ାvision of Dental, Infection Control, ියේ General Hospital Devices (6) 6 ! . Jik) Number ______________________________________________________________________________________________________________________________________________________________
§ 872.4880 Intraosseous fixation screw or wire.
(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.