(76 days)
Not Found
Not Found
No
The description focuses on the mechanical components and intended use for bone distraction, with no mention of AI or ML technologies.
Yes
The device is intended for the "treatment of cranial or midface conditions" and is designed to provide "temporary stabilization and gradual lengthening of the cranial or midfacial bones," which are therapeutic actions.
No
The provided text describes a medical device, the Synthes Midface Distractor, which is an implantable device used for reconstructive osteotomy and segment advancement. Its function is to provide temporary stabilization and gradual lengthening of bones, which is a therapeutic rather than a diagnostic purpose. The text does not mention any diagnostic capabilities such as identifying, measuring, or monitoring a disease or condition.
No
The device description clearly states it is a "craniofacial distraction device consisting of two telescoping components with attached footplates" and is intended to be "placed subcutaneously" and "fixed to the bone through unthreaded screw holes using 1.5 mm or 2.0 mm Cortex screws." This describes a physical, implantable hardware device, not software.
Based on the provided information, the Synthes Midface Distractor is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The Synthes Midface Distractor is a surgical implant designed to be placed within the body to gradually lengthen and stabilize bones. It directly interacts with the patient's anatomy and is used for a surgical procedure, not for analyzing biological samples.
Therefore, the device falls under the category of a surgical implant or medical device used for reconstructive surgery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Synthes Midface Distractor is intended for use in adult and pediatric populations for the treatment of cranial or midface conditions for which reconstructive osteotomy and segment advancement are indicated. This includes conditions such as syndromic craniosynostosis and midfacial retrusion. The device is intended to provide temporary stabilization and gradual lengthening of the cranial or midfacial bones.
Product codes (comma separated list FDA assigned to the subject device)
JEY
Device Description
The Synthes Midface Distractor is a craniofacial distraction device consisting of two telescoping components with attached footplates. The device is intended to be placed subcutaneously, with an anterior footplate fastened to the lateral orbital rim, extending down to the maxilla and spanning the zygomaticomaxillary suture; and a posterior footplate fastened to the temporal region of the cranium. The plates are fixed to the bone through unthreaded screw holes using 1.5 mm or 2.0 mm Cortex screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranial or midface, lateral orbital rim, maxilla, zygomaticomaxillary suture, temporal region of the cranium
Indicated Patient Age Range
adult and pediatric populations
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
3. Summary of Safety and Effectiveness Information
| Sponsor | Synthes (USA)
1690 Russell Road
Paoli, PA 19301 |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact | Matthew M. Hull
(610) 647-9700 ext. 7191 |
| Name of the Device | Synthes Midface Distractor |
| Device Classification | Class II, §872.4760 - Bone Plate |
| Substantial Equivalence | Documentation was provided which demonstrated the Synthes
Midface Distractor to be substantially equivalent to other legally
marketed devices. |
| Device Description | The Synthes Midface Distractor is a craniofacial distraction device
consisting of two telescoping components with attached footplates.
The device is intended to be placed subcutaneously, with an anterior
footplate fastened to the lateral orbital rim, extending down to the
maxilla and spanning the zygomaticomaxillary suture; and a posterior
footplate fastened to the temporal region of the cranium. The plates
are fixed to the bone through unthreaded screw holes using 1.5 mm or
2.0 mm Cortex screws. |
| Indications | For use in adult and pediatric populations for the treatment of cranial
or midface conditions for which reconstructive osteotomy and
segment advancement are indicated. This includes conditions such as
syndromic craniosynostosis and midfacial retrusion. The device is
intended to provide temporary stabilization and gradual lengthening of
the cranial or midfacial bones. |
| Materials | Titanium Alloy, Titanium, Chromium Cobalt, Silicone |
Synthes(USA) ﮨ Synthes Midface Distractor 510(k)
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract design of an eagle with three lines extending from its head.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
3 2002
Mr. Matthew M. Hull Senior Regulatory Affairs Associates Synthes (USA) 1690 Russell Road Paoli, Pennsylvania 19301
Re: K022005
Trade/Device Name: Synthes Midface Distractor Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: June 17, 2002 Received: June 19, 2002
Dear Mr. Hull:
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.
2
Page 2 – Mr. Hull
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timothy A. Ulatowski
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 Statement 2.
. "
510(k) Number (if known):
Device Name:
Indications for Use:
Synthes Midface Distractor
The Synthes Midface Distractor is intended for use in adult and pediatric populations for the treatment of cranial or midface conditions for which reconstructive osteotomy and segment advancement are indicated. This includes conditions such as syndromic craniosynostosis and midfacial retrusion. The device is intended to provide temporary stabilization and gradual lengthening of the cranial or midfacial bones.
(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
Sura Kumar
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
Synthes(USA) Synthes Midface Distractor 510(k)
510(k) Number.