(102 days)
No
The device description focuses on the physical components (plates, screws, instruments) and their materials and dimensions. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is intended for the fixation of fractures and osteotomies, which are therapeutic interventions.
No
Explanation: The device is described as a "Fixation System" intended for fractures and osteotomies of the calcaneus, comprising plates and screws. These are used for treatment (fixing bones), not for identifying or diagnosing a medical condition.
No
The device description explicitly states it is comprised of various plates, screws, and surgical instruments, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the fixation of fractures and osteotomies of the calcaneus. This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details plates, screws, and surgical instruments used for bone fixation. These are all physical implants and tools used in surgery.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a physiological state, health, disease, or congenital abnormality. This device does not perform any such analysis of specimens.
The OsteoMed Calcaneal Plate and Screw Fixation System is a surgical implant and instrument system used for orthopedic procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The OsteoMed Calcaneal Plate and Screw Fixation System Is Intended for fractures and osteotomies of the calcaneus, including, but not limited to extra-articular, intra-articular, ioint depression, tonque type and severely comminuted fractures. Plates and screws are intended for single use only.
Product codes
HRS
Device Description
The OsteoMed Calcaneal Plate and Screw Fixation System is comprised of various plates and screws. Plates are provided in a variety of arm configurations, in a variety of sizes in lengths of 45mm through 76mm and thickness of 1.0mm through 2.0mm. Screws to be provided in this system are 3.0mm and 3.5mm diameter in lengths of 18mm through 55mm with either standard or locking features. Plates are made of Titanium (ASTM F-67) or Titanium Alloy (ASTM F-136). The Screws are made of Titanium Alloy (ASTM F-136). Drill guides, pilot drills, depth gauge, drivers, bending pliers, plate cutters, guide wires and preparation instruments will also be a part of the system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
calcaneus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Synthes K991407, New Deal K041786, Darco K061808
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for OsteoMed. The logo is in black and white and features the word "OSTEO" in large, bold letters. To the right of "OSTEO" is a smaller word that appears to be "MED." The logo is surrounded by a curved shape that resembles an oval.
JUL 3 0 2007
510(k) Summary
Device Proprietary Name:
Device Common Name:
Classification Name:
Name of Submitter:
OsteoMed Calcaneal Plate and Screw Fixation System
Bone Plate
HRS, Plate, Fixation, Bone
OsteoMed L. P. 3885 Arapaho Road Addison, Texas 75001 Phone: (972) 677-4600 Fax: (972) 677-4601
Contact Person:
Piedad Peña
Date Prepared:
July 27, 2007
Summary:
This submission describes the OsteoMed Calcaneal Plate and Screw Fixation System indicated for fractures and osteotomies of the calcaneus, including, but not limited to extra-articular, intra-articular, joint depression, tongue type and severely comminuted fractures.
The OsteoMed Calcaneal Plate and Screw Fixation System is comprised of various plates and screws. Plates are provided in a variety of arm configurations, in a variety of sizes in lengths of 45mm through 76mm and thickness of 1.0mm through 2.0mm. Screws to be provided in this system are 3.0mm and 3.5mm diameter in lengths of 18mm through 55mm with either standard or locking features. Plates are made of Titanium (ASTM F-67) or Titanium Alloy (ASTM F-136). The Screws are made of Titanium Alloy (ASTM F-136). Drill guides, pilot drills, depth gauge, drivers, bending pliers, plate cutters, guide wires and preparation instruments 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: Synthes K991407, New Deal K041786 and Darco K061808.
Due to the similarity of materials and design to both pre-enactment and postenactment devices, OsteoMed believes that the OsteoMed Calcaneal Plate and Screw Fixation System does not raise any new safety or effectiveness issues.
Image /page/0/Picture/22 description: The image shows a logo with the word "Colson" in a stylized font on the left, next to a vertical line inside of a circle. To the right of the circle is the text "A COLSON ASSOCIAT" in a smaller, sans-serif font. The logo appears to be for a company or organization named Colson Associates.
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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three lines forming its body and wing. The eagle faces right and is positioned within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OsteoMed L.P. % Ms. Piedad Peña Regulatory Affairs Specialist 3885 Arapaho Road Addison, Texas 75001
JUL 3 0 2007
K071105 Re: Trade/Device Name: OsteoMed Calcaneal Plate and Screw System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: July 2, 2007 Received: July 3, 2007
Dear Ms. 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.
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. 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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 vours.
Barbara Buent
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
510(k) Number (if known): _ K/1711055
Device Name: OsteoMed Calcaneal Plate and Screw Fixation System
Indications for Use:
The OsteoMed Calcaneal Plate and Screw Fixation System Is Intended for fractures and osteotomies of the calcaneus, including, but not limited to extra-articular, intra-articular, ioint depression, tonque type and severely comminuted fractures. Plates and screws are intended for single use only.
Prescription Use_ ਮ (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) | |
|---|---|
| (Division Sign-Off) | |
| Division of General, Restorative, | |
| and Neurological Devices | |
| (Posted November 15, 2005) | |
| 510(k) Number | K071105 |