(78 days)
Not Found
Not Found
No
The device description and intended use describe a mechanical distraction device with a ratcheting mechanism. There is no mention of software, algorithms, or any features that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes
The device is intended for correcting deficiencies in craniofacial bones, especially orthognathic mandible lengthenings, which suggests a therapeutic purpose.
No
The device description indicates it is a "Ratcheting Distractor" used for bone lengthening (distraction), which is a treatment or surgical intervention, not a diagnostic process.
No
The device description clearly states it is an "intra-oral distraction device" made from a titanium alloy with physical components like telescoping components, contoured legs, screw holes, and a ratcheting mechanism. This indicates a hardware device, not software only.
No, 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, tissue) to provide information about a person's health.
- Device description: The Synthes Ratcheting Distractor is an implantable surgical device used to physically lengthen bone. It is fixed directly to bone and is used in vivo (within the living body) during surgery.
- Intended Use: The intended use is for surgical procedures to correct bone deficiencies, not for testing biological samples.
Therefore, based on the provided information, the Synthes Ratcheting Distractor clearly falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Synthes Ratcheting Distractor is intended for craniofacial surgery, reconstructive procedures, and selective orthognathic surgery of the mandible and maxilla. Specifically, it is indicated for correcting deficiencies in craniofacial bones, especially orthognathic mandible lengthenings.
Product codes
MQN
Device Description
The Synthes Ratcheting Distractor is an intra-oral distraction device. It features two telescoping components, with contoured legs that have threaded screw holes, that are fixed to bone via 1.3 mm - 3.0 mm screws. The distractor is available in right and left versions; has a ratcheting mechanism that is activated by an "activation instrument"; and is capable of distraction lengths of up to 30 mm. It is manufactured from a titanium alloy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
craniofacial bones, mandible, maxilla
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Synthes Mini Lengthening Apparatus (MLA)
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 text "JUN 25 1998" at the top. Below that is the word "SYNTHES" in large, bold letters. To the left of the word is a logo that appears to be a stylized image of a person. To the right of the word is a registered trademark symbol.
Attachment V
SUBMITTER
Summary of Safety and Effectiveness Information [510(k) Summary]
Synthes (USA) 1690 Russell Road Paoli, PA 19301 (610) 647-9700
Contact: Sheri L. Musgnung
COMMON OR USUAL NAME
Plate, Bone Screw, Fixation, Intraosseous
DEVICE CLASSIFICATION: Class II, 21 CFR 872.4760 and 872.4880
Synthes Mini Lengthening Apparatus (MLA) PREDICATE DEVICE:
DESCRIPTION:
INTENDED USE:
The Synthes Ratcheting Distractor is an intra-oral distraction device. It features two telescoping components, with contoured legs that have threaded screw holes, that are fixed to bone via 1.3 mm - 3.0 mm screws. The distractor is available in right and left versions; has a ratcheting mechanism that is activated by an "activation instrument"; and is capable of distraction lengths of up to 30 mm. It is manufactured from a titanium alloy.
Synthes Ratcheting Distractor is intended for craniofacial surgery, reconstructive procedures, and selective orthognathic surgery of the mandible and maxilla. Specifically, it is indicated for correcting deficiencies in craniofacial bones, especially orthognathic mandible lengthenings.
Synthes Ratcheting Distractor 510(k) Synthes (USA)
CONFIDENTIAL
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 25 1998
Ms. Sheri L. Musgnung Regulatory Affairs Associate Synthes® (USA) 1690 Russell Road Post Office Box 1766 Paoli, Pennsylvania 19301
Re : K981275 Synthes® (USA) Ratcheting Distractor Trade Name: Regulatory Class: II Product Code: MQN Dated: April 7, 1998 Received: April 8, 1998
Dear Ms. Musgnung:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
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Page 2 - Ms. Musgnung
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-20#1 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital 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 logo for SYNTHES. The logo consists of a circular icon to the left of the word "SYNTHES". The icon appears to be a stylized representation of a person or figure. The word "SYNTHES" is written in a bold, sans-serif font, with the letters slightly slanted to the right.
Indications for Use Statement 2.0
Page of I of of of load
510(k) Number (if known):
Synthes (USA) Ratcheting Distractor Device Name:
Indications For Use:
Synthes Ratcheting Distractor is intended for craniofacial surgery, reconstructive procedures, and selective orthognathic surgery of the mandible and maxilla. Specifically, it is indicated for correcting deficiencies in craniofacial bones, especially orthognathic mandible lengthenings.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 CFR 801.109)
OR
Over-The-Counter Use Counter Count
Gerald Shupp
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices 510(k) Number
CONFIDENTIAL