(110 days)
Not Found
No
The 510(k) summary describes a system of plates, screws, and instruments for cranial bone fixation. There is no mention of software, algorithms, image processing, or any terms related to AI or ML. The performance studies focus on mechanical strength and biocompatibility.
No.
The device is a fixation system used for surgical reconstruction and repair of cranial bones, which is a structural support function rather than a therapeutic or healing function.
No
Explanation: The device is described as a fixation system comprised of plates, screws, and instrumentation used for osteotomies, fractures, or reconstructions of cranial bones. Its purpose is to facilitate physical repair, not to diagnose or identify a medical condition.
No
The device description explicitly lists physical components such as plates, screws, and instrumentation made from materials like Titanium Alloy and stainless steel. This indicates it is a hardware-based medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the surgical fixation of cranial bones (osteotomies, fractures, reconstructions). This is a direct surgical intervention on the body.
- Device Description: The device consists of implants (plates and screws) and surgical instruments. These are used in vivo (within the body) during surgery.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
The OsteoMED Low Profile Neuro Fixation System is a surgical implant and instrument system used for orthopedic/neurosurgical procedures.
N/A
Intended Use / Indications for Use
The OsteoMed Low Profile Neuro Fixation System is indicated for use in osteotomies, fractures or reconstruction of the cranial bones. The implants and drills are single use only.
Product codes (comma separated list FDA assigned to the subject device)
GWO, GXR
Device Description
The OSTEOMED Low Profile Neuro Fixation System is comprised of plates, screws and instrumentation. The system features plates ranging from 0.25mm to 1.0mm thick, 1.2 mm to 1.6mm diameter standard screws in lengths from 2.0mm to 8.0mm and Auto-Drive screws in 1.2mm to 1.6mm diameters in lengths from 3.0mm to 8.0mm.
The instruments include drill bits, plate bending forceps, plate holding forceps, plate cutters, cannulae, taps, countersinks and screwdrivers to facilitate the placement of screws and modification of plates.
The screws are made from Titanium Alloy (ASTM F-136). The plates are made from Titanium Alloy (ASTM F-136) or commercially pure Titanium (ASTM F-67). The instrumentation is made from various grades of surgical grade stainless steel, anodized aluminum, and/or medical grade plastic.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranial bones
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)
Verification consisted of mechanical testing and finite element analysis comparisons against the predicate neuro plates. Limulus Amebocyte Lysate (LAL) testing was conducted in accordance to ANSI/AAMI ST72:2002.
The low profile neuro plates performed equivalent or with greater strength than the existing neuro predicate devices based on verification testing.
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
§ 882.5320 Preformed alterable cranioplasty plate.
(a)
Identification. A preformed alterable cranioplasty plate is a device that is implanted into a patient to repair a skull defect. It is constructed of a material, e.g., tantalum, that can be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image shows the logo for Osteomed. The logo is in black and white and features the word "OSTEOMED" in bold, sans-serif letters. The word is enclosed in an oval shape. The bottom half of the oval is filled with a textured pattern.
KIIII76
510(k) Summary
CG 1 5 2011
Submitter Information:
OsteoMed L. P. 3885 Arapaho Road Addison, Texas 75001 Phone: (972) 677-4600 Fax: (972) 677-4601
Piedad Peña Contact Person:
July 27, 2011 Date Prepared:
Device Information:
| Proprietary/Trade Name: | OsteoMed Low Profile Neuro Fixation System |
|---|---|
| Common Name: | Low Profile Neuro Plates |
Classification Name:
- · Regulation Number: 21 CFR 882.5320
- · Regulation Name: Preform alterable cranioplasty plate
- · Product Code: GWO, Plate, cranioplasty, preformed, alterable o o GXR. Burr hole cover
Device Class: 2 510(k): K111176
Predicate Devices:
OsteoMed SBF system, K911936 Classification Name: Intraosseous fixation screw or wire (21CFR 872.4880, Product Code DZL) Device Class: 2
OsteoMed M3 SBF system (Addendum), K924138 Classification Name: Bone Plate (21CFR 872.4760, Product Code JEY) Device Class: 2
Device Description:
The OSTEOMED Low Profile Neuro Fixation System is comprised of plates, screws and instrumentation. The system features plates ranging from 0.25mm to 1.0mm thick, 1.2 mm to 1.6mm diameter standard screws in lengths from 2.0mm to 8.0mm and Auto-Drive screws in 1.2mm to 1.6mm diameters in lengths from 3.0mm to 8.0mm.
OsteoMed L.P. 3885 Arapaho Road Addison, Texas 75001 (972) 677-4600 FAX: (972) 677-4601 Customer Service: (800) 456-7779
Image /page/0/Picture/22 description: The image shows a logo with the word "Colson" in a stylized font inside a black circle. To the right of the circle, there are two letters, "A" and "C", which are likely part of a larger word or phrase. The logo appears to be for a company or organization, with a simple and recognizable design.
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Image /page/1/Picture/0 description: The image shows the logo for Osteomed. The logo is in black and white and features the word "OSTEOMED" in bold, sans-serif letters. The word is enclosed in a black oval shape. The oval has a thick black outline, and the word "OSTEOMED" is in white.
The instruments include drill bits, plate bending forceps, plate holding forceps, plate cutters, cannulae, taps, countersinks and screwdrivers to facilitate the placement of screws and modification of plates.
The screws are made from Titanium Alloy (ASTM F-136). The plates are made from Titanium Alloy (ASTM F-136) or commercially pure Titanium (ASTM F-67). The instrumentation is made from various grades of surgical grade stainless steel, anodized aluminum, and/or medical grade plastic.
Intended Use:
The OsteoMed Low Profile Neuro Fixation System is indicated for use in osteotomies, fractures or reconstruction of the cranial bones. The implants and drills are single use only.
Technological Characteristics:
The basis of substantial equivalence for the modification of the OsteoMed SBF system, K911936, is based on the similarities in design, material, function, performance, sterilization, and intended as the predicate device.
Performance / Clinical Data:
The low profile neuro plates performed equivalent or with greater strength than the existing neuro predicate devices based on verification testing. Verification consisted of mechanical testing and finite element analysis comparisons against the predicate neuro plates. Limulus Amebocyte Lysate (LAL) testing was conducted in accordance to ANSI/AAMI ST72:2002.
Materials used for the device are the same as the predicate device with changes from CP Ti to Ti-Alloy to maintain equivalent or greater strength to the predicate devices. These materials are biocompatible and already part of the predicate neuro devices.
Clinical Testing was not required for this modification to support substantial equivalence.
Conclusion:
The basis of substantial equivalence for the addition of the low profile neuro plates to the current neuro plates of the OsteoMed SBF system, K911936, is based on the similarities in design, material, function, sterilization, and intended use to the predicate device. OsteoMed believes that the modifications do not raise any new safety or effectiveness issues.
Image /page/1/Picture/14 description: The image shows the logo for "A Colson Associate". The logo consists of the word "Colson" inside of a black circle with a vertical line extending from the top of the circle. To the right of the circle is the text "A Colson Associate".
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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a simple, sans-serif font and is horizontally oriented. The words are evenly spaced and the text is likely part of a document or header.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Osteomed L.P. Mr. Piedad Pena Senior Regulatory Specialist 3885 Arapaho Road Addison, Texas 75001
AUG 1 5 2011
Re: K111176
Trade/Device Name: OsteoMed Low Profile Neuro Fixation System Regulation Number: 21 CFR 882.5320 Regulation Name: Preformed Alterable Cranioplasty Plate Regulatory Class: II Product Code: GWO, GXR Dated: July 27, 2011 Received: July 28, 2011
Dear Mr. Pena:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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Page 2 – Mr. Pena
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/.AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Wh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices
Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
OSTEOMED Low Profile Neuro Fixation System ___________________________________________________________________________________________________________________________________ Device Name:
Indications for Use:
The OsteoMED Low Profile Neuro Fixation System is indicated for use in osteotomies, fractures or reconstructions of the cranial bones.
Implants and drills are 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)
Susan Runne
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: 11176
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