(112 days)
Not Found
Not Found
No
The summary describes a mechanical device for bone distraction and does not mention any computational or data-driven components indicative of AI/ML.
Yes.
Explanation: The device is intended for the correction of congenital deficiencies or post-traumatic defects of the mandibular body and ramus where gradual bone distraction is required, which directly addresses a medical condition or aims to restore a normal function.
No
The device is described as a bone stabilizer and lengthening device, which is a therapeutic function, not diagnostic.
No
The device description clearly outlines a physical, internal distraction osteogenesis device with hardware components (distractors, bone screws, extension arms, activation instrument). There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The Synthes Curvilinear Distraction System is a surgical implant used to physically stabilize and lengthen bone in the mandible. It is a mechanical device that directly interacts with the patient's body during a surgical procedure.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, detection of biomarkers, or diagnostic testing.
Therefore, this device falls under the category of a surgical implant or medical device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Synthes (USA) Curvilinear Distraction System is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or post-traumatic defects of the mandibular body and ramus where gradual bone distraction is required. This system is intended for use in either adults or pediatric patients over 1 year old. The Synthes (USA) Curvilinear Distraction System is intended for single use only.
Product codes
MQN
Device Description
The Synthes Curvilinear Distractor is an internal distraction osteogenesis device that gradually advances the mandible along a specific path of distraction. The system features various curved and straight distractors which are fixed to the mandible with bone screws. The distractors accept extension arms which move the point of activation to a location that is easily accessible with the activation instrument.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandibular body and ramus
Indicated Patient Age Range
adults or pediatric patients over 1 year old.
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)
Synthes Craniomaxillofacial (CMF) Distraction System, Osteomed Intraoral Mandibular Distraction System, Synthes Multi-Vector Distractor
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.
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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 image inside. To the right of the word is a circled "R", indicating a registered trademark.
MAY 1 4 2008
3.0 510(k) Summary Page _________________________________________________________________________________________________________________________________________________________________________ Sponsor: Synthes (USA) 1301 Goshen Parkway West Chester, PA 19380 Contact: Andrea M. Tasker Phone: (610) 719-6920 Fax: (484) 356-9682 tasker.andrea@synthes.com Device Name: Synthes (USA) Curvilinear Distraction System Classification: Regulation Number: §872.4760 Device: External mandibular fixation and/or distractor Regulation Description: Bone plate Regulation Medical Specialty: Dental Review Panel: Dental Product Code: MQN Predicate Devices: Synthes Craniomaxillofacial (CMF) Distraction System Osteomed Intraoral Mandibular Distraction System Synthes Multi-Vector Distractor Device Description: The Synthes Curvilinear Distractor is an internal distraction osteogenesis device that gradually advances the mandible along a specific path of distraction. The system features various curved and straight distractors which are fixed to the mandible with bone screws. The distractors accept extension arms which move the point of activation to a location that is easily accessible with the activation instrument. Intended Use: The Synthes (USA) Curvilinear Distraction System is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or post-traumatic defects of the mandibular body and ramus where gradual bone distraction is required. This system is intended for use in either adults or pediatric patients over 1 year old. The Synthes (USA) Curvilinear Distraction System is intended for single use only. Documentation is provided which demonstrates the Synthes (USA) Substantial Equivalence: Curvilinear Distraction System to be substantially equivalent to other legally marketed devices such as: Synthes Craniomaxillofacial (CMF) Distraction System Osteomed Intraoral Mandibular Distraction System Synthes Multi-Vector Distractor
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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 consists of a stylized eagle with three stripes forming its wing. The eagle is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 4 2008
Ms. Andrea M. Tasker Synthes (USA) 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K080153 Trade/Device Name: Synthes (USA) Curvilinear Distraction System Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: MQN Dated: April 10, 2008 Received: April 11, 2008
Dear Ms. Tasker:
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 (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 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.
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Page 2 - Ms. Tasker
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Clwes
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 black and white logo. The logo is a circle with a design inside of it. The word "SYNTHES" is a sans-serif font.
Indications for Use
K 080153
510(k) Number (if known):
Device Name:
2.0
Indications for Use:
Synthes (USA) Curvilinear Distraction System
The Synthes (USA) Curvilinear Distraction System is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or post-traumatic defects of the mandibular body and ramus where gradual bone distraction is required.
This system is intended for use in either adults or pediatric patients over 1 year old.
The Synthes (USA) Curvilinear Distraction System is intended for single use only.
Prescription Use X (Per 21 CFR 801.109)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Susan Raine Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K080152
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