(99 days)
Not Found
Not Found
No
The description focuses solely on the mechanical components and materials of a bone plating system, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is a Foot Plating System, which is used for fixation and reconstruction during surgical procedures, not for therapy.
No
The device description clearly states its purpose is for "trauma, general surgery, and reconstructive procedures of the foot, ankle or other bones" by providing plates and screws for fixation. This describes a therapeutic or surgical device, not one used for diagnosis.
No
The device description explicitly details physical implants (plates, screws, K-wires, washers) and surgical instrumentation made of materials like Titanium, Stainless Steel, aluminum, and polymers, indicating it is a hardware-based medical device system.
Based on the provided information, 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, or tissue) to provide information about a person's health.
- Device Description: The OsteoMed Foot Plating System is described as a system of plates, screws, K-wires, washers, and instrumentation used for surgical procedures on bones. These are implants and surgical tools, not devices that analyze biological samples.
- Intended Use: The intended use is for "trauma, general surgery, and reconstructive procedures of the foot, ankle or other bones." This clearly describes a surgical intervention, not a diagnostic test performed on a sample.
The description focuses on the physical components of the system and their application in surgical procedures, which is characteristic of a surgical implant and instrumentation system, not an IVD.
N/A
Intended Use / Indications for Use
The OsteoMed Foot Plating System is indicated for use in trauma, general surgery, and reconstructive procedures of the foot, ankle or other bones appropriate for the device.
The OsteoMed Foot Plating System implants are intended for single use only.
Product codes
HRS, HWC
Device Description
This submission describes the OsteoMed Foot Plating System consisting of various shape and sizes plates featuring compression, locking, elongated or compression elongated holes, and ulated locking, non-locking and cannulated screws, implantable K-wires, washers, and angulated instrumentation. The OsteoMed Foot Plating System is indicated for use in trauma, general surgery, and reconstructive procedures of the foot, ankle or other bones appropriate for the size of the device. All implants are intended for single use only. Surgical instrumentation is provided to facilitate modification, insertion, and removal of implants.
The system contains several modules based on the size of the device and application site such as fixation/reconstruction of small fragment bones, forefoot, mid-foot, rear-foot, ankle, , or other bones appropriate for the size of the device.
The implants are made of Titanium (ASTM F-67, ASTM F-136, or ASTM F-1472) or Stainless Steel (ASTM F-138 or ASTM F-139). The instrumentation is made from various grades of stainless steel, anodized aluminum, and/or medical grade polymers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot, ankle or other bones appropriate for the size of the device.
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)
Not Found
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
Device Proprietary Name:
Device Common Name:
Classification Name:
Product Code:
Name of Submitter:
K091614 (pg. 1 of 1)
OsteoMed Foot Plate and Screw Rigid Fixation System
OsteoMed Foot Plating System
21 CFR § 888.3030: Single/multiple component metallic bone fixation appliances and accessories
HRS. HWC
OsteoMed L. P. 3885 Arapaho Road Addison, Texas 75001 Phone: (972) 677-4781 Fax: (972) 677-4778
Contact Person:
Date Prepared:
Alma Relja, RAC
June 1, 2009
Summary:
This submission describes the OsteoMed Foot Plating System consisting of various shape and sizes plates featuring compression, locking, elongated or compression elongated holes, and ulated locking, non-locking and cannulated screws, implantable K-wires, washers, and angulated instrumentation. The OsteoMed Foot Plating System is indicated for use in trauma, general surgery, and reconstructive procedures of the foot, ankle or other bones appropriate for the size of the device. All implants are intended for single use only. Surgical instrumentation is provided to facilitate modification, insertion, and removal of implants.
The system contains several modules based on the size of the device and application site such as fixation/reconstruction of small fragment bones, forefoot, mid-foot, rear-foot, ankle, , or other bones appropriate for the size of the device.
The implants are made of Titanium (ASTM F-67, ASTM F-136, or ASTM F-1472) or Stainless Steel (ASTM F-138 or ASTM F-139). The instrumentation is made from various grades of stainless steel, anodized aluminum, and/or medical grade polymers.
Equivalence for this system is based on similarities in intended use, material, design and operational principle to the predicate devices listed in this submission. Also, note that some sections of this system could have been letter to file based on the OsteoMed previously cleared submissions.
Due to the similarity of materials and design to both pre-enactment and post-enactment devices we believe that the OsteoMed Foot Plating System does not raise any new safety or effectiveness issues.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.
SEP 1 0 2009
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Osteomed L.P. % Ms. Alma Relja, RAC Regulatory Affairs Specialist 3885 Arapaho Road Addison, Texas 75001
Re: K091614
Trade/Device Name: OsteoMed Foot Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS. HWC Dated: September 3, 2009 Received: September 4, 2009
Dear Ms. Relja:
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 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); 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.
2
Page 2 - Ms. Alma Relja, RAC
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/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 (240) 276-3150 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Harbarefnehn
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Eyaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): 糸の91614 Device Name: OsteoMed Foot Plating System
Indications for Use:
The OsteoMed Foot Plating System is indicated for use in trauma, general surgery, and reconstructive procedures of the foot, ankle or other bones appropriate for the device.
The OsteoMed Foot Plating System implants are intended for single use only.
Prescription Use X (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)
Sputu for mxn
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091614
Page 1 of 1
(Posted November 13, 2003)