(134 days)
KLS Martin - Zurich Distraction System, KLS Martin - Micro Zurich Distractor
Not Found
No
The device description and intended use focus on mechanical bone distraction and stabilization, with no mention of AI or ML technologies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is used for correction of congenital deficiencies or post-traumatic defects of the mandibular body and ramus by gradually lengthening the bone, which are therapeutic functions aimed at restoring or improving health.
No
The device is described as a "bone stabilizer and lengthening (and/or transport) device" for correcting deficiencies, not for identifying or diagnosing a condition.
No
The device description explicitly states it is comprised of physical components like a distractor body, footplates, and a machine screw, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided text clearly describes a surgical implant used to physically lengthen bone in the jaw (mandible). It is a mechanical device that is implanted in vivo (within the body) to correct structural deficiencies.
- Lack of Specimen Analysis: There is no mention of this device analyzing any biological specimens or providing diagnostic information based on such analysis.
Therefore, based on the provided information, the Synthes Craniomaxillofacial Distraction System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Synthes Craniomaxillofacial Distraction System (CMF 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. The Synthes CMF Distraction System is intended for single use only.
The Synthes Pediatric CMF 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 in children under the age of 12 months. The Synthes Pediatric CMF Distraction System is intended for single use only.
Product codes
MQN
Device Description
The Synthes Craniomaxillofacial Distraction System, which includes the Pediatric CMF Distraction System, is a modular family of internal distraction osteogenesis devices that are used to gradually lengthen the mandible body and ramus. Each device, when assembled, is comprised of a distractor body, two footplates, and a machine screw to secure the assembly. The system also includes optional activation arms, which can be attached to the activation end of the device to move the point of activation to an area accessible by 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
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)
KLS Martin - Zurich Distraction System, KLS Martin - Micro Zurich Distractor
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 design inside. A horizontal line is located underneath the word "SYNTHES".
3.0
:
Kobo138
JUN - 2 2006
| 510(k) Summary | |
|---|---|
| Page | 1 of 1 |
| Sponsor: | Synthes (USA) |
| 1301 Goshen Parkway | |
| West Chester, PA 19380 | |
| (610) 719-6940 | |
| Device Name: | Synthes Craniomaxillofacial (CMF) Distraction System |
| Classification: | Class II, §872.4760 - External mandibular fixation and/or distractor. |
| Predicate Devices: | KLS Martin - Zurich Distraction System |
| KLS Martin - Micro Zurich Distractor | |
| Device Description: | The Synthes Craniomaxillofacial Distraction System, which includes the Pediatric CMF Distraction System, is a modular family of internal distraction osteogenesis devices that are used to gradually lengthen the mandible body and ramus. Each device, when assembled, is comprised of a distractor body, two footplates, and a machine screw to secure the assembly. The system also includes optional activation arms, which can be attached to the activation end of the device to move the point of activation to an area accessible by the activation instrument. |
| Intended Use: | The Synthes Craniomaxillofacial Distraction System (CMF 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. The Synthes CMF Distraction System is intended for single use only. |
| The Synthes Pediatric CMF 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 in children under the age of 12 months. The Synthes Pediatric CMF Distraction System is intended for single use only. | |
| Substantial Equivalence: | Documentation is provided which demonstrates the Synthes CMF Distraction System to be substantially equivalent to other legally marketed devices. |
000005
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the three branches of government. The eagle is surrounded by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 2 2006
Ms. Sheri L. Musgnung Senior Regulatory Affairs Specialist Synthes (USA) 1301 Goshen Park Way West Chester, Pennsylvania 19380
Re: K060138
Trade/Device Name: Synthes (USA) Craniomaxillofacial Distraction System Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: MQN Dated: May 19, 2006 Received: May 22, 2006
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 (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,
Suser Jch...
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. There is a horizontal line below the word "SYNTHES".
Indications for Use
510(k) Number (if known):
Device Name:
Synthes (USA) Craniomaxillofacial Distraction System
INDICATIONS FOR USE:
The Synthes Craniomaxillofacial Distraction System (CMF 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. The Synthes CMF Distraction System is intended for single use only.
The Synthes Pediatric CMF 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 in children under the age of 12 months. The Synthes Pediatric CMF 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)
| Concurrence of CDRH Office of Device Evaluation (ODE) | |
|---|---|
| Division of Anesthesiology, General Hospital, | |
| Division Control, Dental Devices | |
| K06038 |
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