(90 days)
Not Found
No
The device description and intended use focus on mechanical bone distraction and stabilization, with no mention of AI or ML technologies.
Yes
The device is used to stabilize and lengthen bone for various conditions like mandibular hypoplasia and post-traumatic defects, and to address deficiencies in mid-facial bone. These applications directly involve treating and rectifying medical conditions within the patient's body.
No
The device is described as a bone stabilizer and lengthener for therapeutic purposes, specifically for gradual bone distraction, not for identifying or diagnosing a condition.
No
The device description clearly describes a physical, implantable bone distractor with mechanical components (telescoping components, jack screw, foot plates) and bone screws for fixation. It is a hardware device.
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. These tests are performed outside of the body.
- Device Description and Intended Use: The provided text clearly describes a device that is surgically implanted to physically manipulate bone (stabilize and lengthen). It is used within the body to treat structural conditions.
The device's function and application are entirely different from the purpose of an IVD.
N/A
Intended Use / Indications for Use
The Synthes Single Vector Distractor with Detachable Feet is intended for use as a bone stabilizer and lengthener for conditions such as mandibular hypoplasia or post-traumatic defects of the mandible, where gradual bone distraction is required. The device is ideal for treating forms of clefts of the lip and palate, and congenital mandibular hypoplasia, such as Hemifacial Microsomia, Treacher Collins Syndrome, Nagers Syndrome, Pierre Robin Syndrome, Goldenhar Syndrome, Apert Syndrome, and Crouzon Syndrome.
The Synthes Single Vector Distractor with Detachable Feet is also ideal for treating hypoplasias of an acquired origin such as from post-traumatic growth disorders associated with injury to the temporomandibular joint, temporomandibular ankylosis, and segmental loss of bone.
The Synthes Single Vector Distractor with Detachable Feet can be used for stabilization and advancement of the mid-face, in which a deficiency of mid-facial bone requires gradual bone distraction. Such deficiencies include, but are not limited to Plagiocephaly, Trigonocephaly, Scaphocephaly, and Brachycephaly.
Product codes
MQN
Device Description
The Synthes Single Vector Distractor with Detachable Feet is a subcutaneous bone distractor activated by a drive component. It features two telescoping components activated by a jack screw, fixed to the bone with bone screws. Bone lengthening and distraction are achieved by gradually activating the device. Upon removal, the telescoping components and jack screw are disengaged and removed, leaving the subcutaneous foot plates in the patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandible, mid-face
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)
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
JUN 22 1998
YNTHES
Summary of Safety and Effectiveness Information [510(k) Summary]
SUBMITTER
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:
PREDICATE DEVICE:
Class II, 21 CFR 872.4760 and 872.4880
Howmedica's Hoffmann Mini Lengthening Fixator (K792561)
The Synthes Single Vector Distractor with Detachable Feet is a DESCRIPTION: subcutaneous bone distractor activated by a drive component. It features two telescoping components activated by a jack screw, fixed to the bone with bone screws. Bone lengthening and distraction are achieved by gradually activating the device. Upon removal, the telescoping components and jack screw are disengaged and removed, leaving the subcutaneous foot plates in the patient.
The Synthes Single Vector Distractor with Detachable Feet is INTENDED USE: intended for use as a bone stabilizer and lengthener for conditions such as mandibular hypoplasia or post-traumatic defects of the mandible, where gradual bone distraction is required. The device is ideal for treating forms of clefts of the lip and palate, and congenital mandibular hypoplasia, such as Hemifacial Microsomia, Treacher Collins Syndrome, Nagers Syndrome, Pierre Robin Syndrome, Goldenhar Syndrome, Apert Syndrome, and Crouzon Syndrome.
The Synthes Single Vector Distractor with Detachable Feet is also ideal for treating hypoplasias of an acquired origin such as from post-traumatic growth disorders associated with injury to the temporomandibular joint, temporomandibular ankylosis, and segmental loss of bone.
The Synthes Single Vector Distractor with Detachable Feet can be for stabilization and advancement of the mid-face, in which a deficiency of mid-facial bone requires gradual bone distraction. Such deficiencies include, but are not limited to Plagiocephaly, Trigonocephaly, Scaphocephaly, and Brachycephaly.
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like figure with flowing lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. The logo is simple, yet recognizable, and represents the department's role in promoting the health and well-being of citizens.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Jun 2 2 1998
Ms. Sheri L. Musgnung Regulatory Affairs Associate Synthes® (USA) 1690 Russell Road Post Office Box 1766 Paoli, Pennsylvania 19301
K981075 Re : Synthes® (USA) Single Vector Distractor Trade Name: with Detachable Feet II Requlatory Class: Product Code: MQN Dated: March 23, 1998 Received: March 24, 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) regulation (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. Musqnung
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) 638-2041 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 Synthes logo, which includes a circular symbol to the left of the word "SYNTHES". Below the logo, the text "Indications for Use Statement" is written in a smaller font size. The logo and text are all in black and white.
Page of
K981075 510(k) Number (if known):
Synthes (USA) Single Vector Distractor with Detachable Feet Device Name:
Indications For Use:
The Synthes Single Vector Distractor with Detachable Feet is intended for use as a bone stabilizer and lengthener for conditions such as mandibular hypoplasia or post-traumatic defects of the mandible, where gradual bone distraction is required. The device is ideal for treating forms of clefts of the lip and palate, and congenital mandibular hypoplasia, such as Hemifacial Microsomia, Treacher Collins Syndrome, Nagers Syndrome, Pierre Robin Syndrome, Goldenhar Syndrome, Apert Syndrome, and Crouzon Syndrome.
The Synthes Single Vector Distractor with Detachable Feet is also ideal for treating hypoplasias of an acquired origin such as from post-traumatic growth disorders associated with injury to the temporomandibular joint, temporomandibular ankylosis, and segmental loss of bone.
The Synthes Single Vector Distractor with Detachable Feet can be used for stabilization and advancement of the mid-face, in which a deficiency of mid-facial bone requires gradual bone distraction. Such deficiencies include, but are not limited to Plagiocephaly, Trigonocephaly, Scaphocephaly, and Brachycephaly.
(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
Susan Rumer
ivision Sign-Off) Division of Dental, Infection Control, and General Hos 510(k) Number