(70 days)
Not Found
Not Found
No
The summary describes a mechanical plating system and makes no mention of AI or ML technology.
No.
The device is used for stabilization and fixation of bone fragments, which is a supportive role in the healing process rather than directly providing therapy.
No.
The device is described as a plating system intended for stabilization and fixation of bone fragments, which is a therapeutic function, not a diagnostic one. It does not mention identifying or characterizing a disease or condition.
No
The device description explicitly states it is comprised of titanium plates, bone screws, and manual surgical instruments, which are all hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The provided description clearly states the TC Plating System is comprised of titanium plates and screws intended for internal fixation of small bone fragments. It is a surgical implant used directly within the body.
- Intended Use: The intended use is for stabilization and fixation of small bone fragments in various anatomical locations. This is a structural and mechanical function within the body, not an analysis of biological specimens.
The device is a surgical implant used for orthopedic and reconstructive procedures, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
The TC Plating System is intended for essentially non load-bearing stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis, and craniomaxillofacial skeleton.
Product codes
HRS
Device Description
The TC Plating System is comprised of a variety of titanium plates with shapes and sizes designed for internal fixation of small bone fragments. The plates include straight, right, and left configurations. The system also includes bone screws. Manual surgical instruments are supplied with the system to facilitate implantation.
Materials: Titanium alloy (Ti 6Al 4V ELI) per ASTM F136
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis, and craniomaxillofacial skeleton
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
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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
510(k) Summary for the TC Plating System
In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the TC Plating System
Date Prepared: 24 December 2009
| 1. | Submitter: | Contact Person: |
|---|---|---|
| OrthoPro LLC | J.D. Webb | |
| 3450 Highland Drive, Ste 303 | The OrthoMedix Group, Inc. | |
| Salt Lake City, UT 84106 | 1001 Oakwood Blvd | |
| 801-746-1056 | Round Rock, TX 78681 | |
| Telephone: 512-388-0199 |
- Trade name: TC Plating System bone plate Common Name: Single/multiple component metallic bone fixation appliances and accessories Classification Name: 21 CFR § 888.3030 KTT Class II
- Predicate or legally marketed devices which are substantially equivalent: 3. The TC Plating System is equivalent to previously cleared bone plating devices.
4. Description of the device:
The TC Plating System is comprised of a variety of titanium plates with shapes and sizes designed for internal fixation of small bone fragments. The plates include straight, right, and left configurations. The system also includes bone screws. Manual surgical instruments are supplied with the system to facilitate implantation.
Materials:
Titanium alloy (Ti 6Al 4V ELI) per ASTM F136
ഗ് Intended Use:
The TC Plating System is intended for essentially non load-bearing stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis, and craniomaxillofacial skeleton.
Comparison of the technological characteristics of the device to predicate and legally marketed devices: 6.
The TC Plating System is equivalent to the predicate devices in terms of:
-
Have the same indications for use and intended use .
-
Have the same basic shape/design .
-
. Use the same operating principle
-
Utilize the same materials .
-
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1
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
MAR 1 0 2010
Ortho-Pro LLC % The Orthomedix Group, Inc. Mr. J.D. Webb 1001 Oakwood Boulevard Round Rock, Texas 78681
Re: K094037
Trade/Device Name: TC Plating 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: February 26, 2010 Received: March 3, 2010
Dear Mr. J.D. Webb:
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.
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
2
Page 2 - Mr. J.D. Webb
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 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/ucm1 | 5809.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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Houbare Buchm
Mark N. Melk erson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
2094037 510(k) Number (if known):
Device Name: TC Plating System
Indications for Use:
The TC Plating System is intended for essentially non load-bearing stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis, and craniomaxillofacial skeleton.
Prescription Use_ × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anita for nxm
(Physician Signature)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K094037
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