(24 days)
Not Found
No
The device description focuses on mechanical components (plates and screws) and their physical properties. There is no mention of software, algorithms, or data processing that would suggest the use of AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
No
A therapeutic device is one that performs therapy, treats a disease, or restores health. While this device is used in reconstructive surgical procedures, its primary function is stabilization and fixation, which is a supportive rather than a therapeutic action in itself.
No
The device is described as a set of plates and screws used for the stabilization and fixation of mandibular fractures and reconstructive surgical procedures, which is a treatment modality, not a diagnostic one.
No
The device description explicitly states it is comprised of titanium fracture and reconstruction plates and screws, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "stabilization and fixation of mandibular fractures and mandibular reconstructive surgical procedures." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is comprised of "titanium fracture and reconstruction plates and screws." These are physical implants used to hold bone fragments together.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a person's health. This device does not interact with biological specimens in this way.
This device is a surgical implant used for internal fixation, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The Titanium Fracture / Reconstructive Devices (TraumaOne) are intended for use in the stabilization and fixation of mandibular fractures and mandibular reconstructive surgical procedures.
Product codes
76 JEY
Device Description
The Mandibular Fracture / Reconstructive Devices (TraumaOne) are comprised of a variety of titanium fracture and reconstruction plates and screws with shapes and sizes designed for internal fixation of mandibular fractures and reconstruction procedures. The screws have locking head features. The plates have threaded through holes (which allows them to work with either the locking screws) and will include straight, angle, double angle, and crescent options with various lengths and thickness.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandibular
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)
Reference Device(s)
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
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for Microfixation, Inc. The logo consists of the word "COMET" in a stylized font with horizontal lines running through the letters. Below the word "COMET" is the text "MICROFIXATION, INC." in a smaller, simpler font.
MAY - 9 2008
510(k) Summary Contact: Biomet Microfixation 1520 Tradeport Drive Jacksonville, FL 32218-2480 Kim Reed. Regulatory Affairs Manager 904-741-9443 fax 904-741-3912
Classification Name Plate, Fixation, Bone Bone Plate Common or Usual Name: Device Product Code: 76 JEY (21 CFR 872.4760) Device Classification: Class II
Reconstruction / Fracture Plating System (TraumaOne) Device Name:
The Titanium Fracture / Reconstructive Devices (TraumaOne) are intended for use in the Intended Use: stabilization and fixation of mandibular fractures and mandibular reconstructive surgical procedures.
Contraindications:
- Active infection. 1.
- Foreign body sensitivity. Where material sensitivity is suspected, testing is to be completed prior to 2. implantation.
- Patients with limited blood supply, insufficient quantity of bone, or latent infection. 3.
- Patients with mental or neurologic conditions who are unwilling or incapable of following postoperative 4. care instructions.
- If used in mandibular resection cases, the mandibular reconstructive devices must be supported using a 5. graft. If mandibular reconstructive devices are not supported by a graft, the devices can be expected to fracture, bend, break or fail.
Description: The Mandibular Fracture / Reconstructive Devices (TraumaOne) are comprised of a variety of titanium fracture and reconstruction plates and screws with shapes and sizes designed for internal fixation of mandibular fractures and reconstruction procedures. The screws have locking head features. The plates have threaded through holes (which allows them to work with either the locking screws) and will include straight, angle, double angle, and crescent options with various lengths and thickness.
Sterility Information: The plates and screws will be marketed as non-sterile, single use devices.
Possible risks:
- Poor bone formation, Osteolysis, Osteolysis, Osteomyelitis, inhibited revascularization, or infection can 1. cause loosening, bending, cracking or fracture of the device.
- Nonunion or delayed union, which may lead to breakage of the implant. 2.
- Migration, bending, fracture or loosening of the implant. 3.
- Metal sensitivity, or allergic reaction to a foreign body. 4.
- Decrease in bone density due to stress shielding. 5.
- Pain, discomfort, abnormal sensation, or palpability due to the presence of the device. 6.
- Increased fibrous tissue response around the fracture site and/or the implant. 7.
- Necrosis of bone. 8.
- Inadequate healing. 9.
- Mandibular devices can fracture, bend, break or fail if used to bridge a mandibular resection site, in the 10. absence of a graft.
Substantial Equivalence Biomet Microfixation considers the Fracture / Reconstructive Devices (TraumaOne) equivalent to the Lorenz Titanium Fracture / Reconstructive Devices cleared under K001238 and Lorenz Reconstruction System cleared under K980512.
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 with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a simple, clean design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 9 2008
Ms. Kim Reed Regulatory Affairs Manager Biomet Microfixation 1520 Tradeport Drive Jacksonville, Florida 32218
Re: K081067
Trade/Device Name: Mandibular Fracture/ Reconstruction Devices (TraumaOne) Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: March 14, 2008 Received: April 15, 2008
Dear Ms. Reed:
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.
2
Page 2 - Ms. Reed
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.
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) 276-0115. 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 its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Sonette H. Mckee Omd.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
K081067 510(k) Number (if known):
Device Name: Mandibular Fracture / Reconstruction Devices (TraumaOne)
Indications For Use:
Intended for use in the stabilization and fixation of mandibular fractures and mandibular reconstructive surgical procedures.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kain Mally Sa MSA
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of
510(k) Number: K081067