(79 days)
Not Found
Synthes Mini External Fixator
No
The device description and intended use are purely mechanical, and there is no mention of AI, ML, or any software-driven analytical capabilities.
Yes
The device is intended to "stabilize and provide treatment for fractures" within the maxillofacial area, indicating a therapeutic function.
No
The device is an external fixator used to stabilize fractures, not to diagnose them. Its intended use is treatment and stabilization, and the components listed are for structural support.
No
The device description explicitly lists physical components such as clamps, screws, K-wires, and rods, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "stabilize and provide treatment for fractures of the maxillofacial area". This is a surgical device used directly on the patient's body.
- Device Description: The components listed (clamps, screws, rods, K-wires) are all physical implants and external fixation components used in surgery.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests.
Therefore, based on the provided information, the Synthes Mandible External Fixator is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Synthes Mandible External Fixator is intended to stabilize and provide treatment for fractures of the maxillofacial area, including severe open mandibular fractures, highly comminuted closed fractures, nonunions and delayed unions (especially associated with infection), fractures associated with infections, tumor resections, facial deformity corrections, gunshot wounds, pan facial fractures, burn maintenance, and bone grafting defects.
Product codes
MQN
Device Description
Synthes Mandible External Fixator consists of the following components: An Adjustable Clamp - MR Safe; 4.0/2.5 Schanz Screws; 2.5 mm K-wires; 4.0 mm Pre-bent Titanium Rods; and 4.0 mm Carbon Fiber Rods. The components of this system are designed for use in the MR environment. The rods and Schanz Screws are available in various lengths.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillofacial area, 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)
The new device is considered to be substantially equivalent to the predicate device based on mechanical test results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Synthes Mini External Fixator
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a stylized figure inside. To the right of the word is a circled "R" symbol, indicating a registered trademark.
| 3.0 | 510(k) Summary | APR 1 4 2004 | Page 1 of 1 |
|---|---|---|---|
| Sponsor: | Synthes (USA) | ||
| 1690 Russell Road | |||
| Paoli, PA 19301 | |||
| (610) 647-9700 | |||
| Device Name: | Synthes Mandible External Fixator | ||
| Classification: | Class II, 21 CFR §888.3030 - Single/multiple component bone fixation | ||
| appliances and accessories. | |||
| Predicate Devices: | Synthes Mini External Fixator | ||
| Device Description: | Synthes Mandible External Fixator consists of the following | ||
| components: An Adjustable Clamp - MR Safe; 4.0/2.5 Schanz Screws; | |||
| 2.5 mm K-wires; 4.0 mm Pre-bent Titanium Rods; and 4.0 mm Carbon | |||
| Fiber Rods. The components of this system are designed for use in the | |||
| MR environment. The rods and Schanz Screws are available in various | |||
| lengths. | |||
| Intended Use: | Synthes Mandible External Fixator is intended to stabilize and provide | ||
| treatment for fractures of the maxillofacial area, including severe open | |||
| mandibular fractures, highly comminuted closed fractures, nonunions | |||
| and delayed unions (especially associated with infection), fractures | |||
| associated with infections, tumor resections, facial deformity | |||
| corrections, gunshot wounds, pan facial fractures, burn maintenance, | |||
| and bone grafting defects. | |||
| Substantial | |||
| Equivalence: | The new device is considered to be substantially equivalent to the | ||
| predicate device based on mechanical test results. |
$$00005$$
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 4 2004
Ms. Sheri L. Musgnung Regulatory Affairs Specialist Synthes (USA) 1690 Russell Road Post Office Box 1766 Paoli, Pennsylvania 19301-0800
Re: K040169
Trade/Device Name: Synthes Mandible External Fixator Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: MQN Dated: January 23, 2004 Received: January 26, 2004
Dear Ms. Musgnung:
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. Musgnung
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 (301) 594-4613. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Ques
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
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Image /page/3/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. A registered trademark symbol is located to the right of the word.
2.0 Indications for Use Statement
Page _________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known):
Cynthia Meredith, Extension Educator
1040169
Device Name:
Synthes Mandible External Fixator
Indications:
Synthes Mandible External Fixator is intended to stabilize and provide treatment for fractures of the maxillofacial area, including severe open mandibular fractures, highly comminuted closed fractures, nonunions and delayed unions (especially associated with infection), fractures associated with infections, turnor resections, facial deformity corrections, gunshot wounds, pan facial fractures, burn maintenance, and bone grafting defects.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
| (Per 21 CFR 801.109) | ✓ | OR | Over-the-Counter Use | |
|---|---|---|---|---|
| ------------------------------------------ | ----------------------------------------- | ---- | ---------------------- | -- |
Sma Anner
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
| 510(k) Number: | -4/13/04 K040169 |
|---|---|
| ---------------- | ------------------ |
CONFIDENTIAL
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