(78 days)
Not Found
No
The description details a mechanical device for bone distraction with no mention of software, algorithms, or any components that would typically incorporate AI/ML.
Yes
The device aids in gradual bone distraction in the mandible for conditions like mandibular deficiency or post-traumatic effects, directly contributing to the treatment and healing of these conditions.
No
The device is described as a "subcutaneous bone distractor" used for "gradual bone distraction," indicating its therapeutic rather than diagnostic function.
No
The device description clearly describes a physical, implantable bone distractor with mechanical components (telescoping components, jack screw, plates, screws, hex driver). It is not software-only.
Based on the provided information, the Synthes Mandible Distractor is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. This includes things like blood, urine, tissue, etc., to provide information about a person's health.
- The Synthes Mandible Distractor is a surgical implant. It is a physical device implanted into the mandible to gradually lengthen the bone.
- The intended use describes a surgical procedure. The device is used in the mandible for conditions requiring bone distraction, not for analyzing bodily fluids or tissues.
The description clearly indicates a mechanical device used for bone manipulation within the body, which falls under the category of a surgical implant or device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Synthes Mandible Distractor is intended to be used in the mandible for conditions such as mandibular deficiency or post-traumatic effects of the mandible, where gradual bone distraction is required.
Product codes
Not Found
Device Description
The Mandible Distractor is a subcutaneous bone distractor. It features two telescoping components activated by a jack screw, fixed to the bone via subcutaneous plates and secured with 2.0 mm or 2.4 mm bone screws. A hex driver is used to activate the required distraction.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandible
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
mechanical test results.
Key Metrics
Not Found
Predicate Device(s)
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.
0
Image /page/0/Picture/0 description: The image shows the logo for SYNTHES. The logo consists of a circular symbol on the left and the word "SYNTHES" in bold, sans-serif font on the right. The circular symbol appears to be a stylized representation of a person or figure. The word "SYNTHES" is in all caps and has a registered trademark symbol next to it.
AUG 30 1996
Attachment VII: Summary of Safety and Effectiveness Information [510(k) Summary]
Synthes (USA) 1690 Russell Road Paoli, PA 19301
Contact: Angela Silvestri (610) 647-9700 June 1996
Synthes Mandible Distractor is compared to the Howmedica's Hoffmann® Mini-Lengthening Fixator (K792561). The device is similar to Howmedica's Mandibular Bone Distractor (K945674).
The Synthes Mandible Distractor is intended to be used in the mandible for conditions such as mandibular deficiency or post-traumatic effects of the mandible, where gradual bone distraction is required.
The Mandible Distractor is a subcutaneous bone distractor. It features two telescoping components activated by a jack screw, fixed to the bone via subcutaneous plates and secured with 2.0 mm or 2.4 mm bone screws. A hex driver is used to activate the required distraction.
It is anticipated that the Mandible Distractor will be used as follows:
- l. An osteotomy or corticotomy (depending on surgeon preference) is made on the desired section of the mandible.
-
- The distraction device is fixated to the bone using 2.0 mm or 2.4 mm screws on both sides of the osteotomy. The fixation portion of the device is subcutaneous.
-
- After a latency period of approximately 7 days (the exact time required is determined by the surgeon) the device is activated and distraction begins at a rate of approximately 1 mm/day (the exact rate of distraction is determined by the surgeon).
- After the desired amount of distraction occurs the device is left until the ঞ্চল করে বাংলাদেশের প্রকল্পে করে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে adequate bone structure has been achieved and the device is removed.
It is our opinion that Synthes Mandible Distractor is substantially equivalent to Howmedica's Hoffmann® Mini-Lengthening Fixator based on mechanical test results.