(75 days)
Not Found
No
The 510(k) summary describes a mechanical bone distraction device with no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is described as a "bone stabilizer and lengthener" used for conditions like "mandibular hypoplasia or posttraumatic defects of the mandible, where gradual bone distraction is required," explicitly detailing its role in treating and improving the health of patients with specific musculoskeletal conditions. This aligns with the definition of a therapeutic device.
No
The device is described as a bone stabilizer and lengthener for conditions requiring gradual bone distraction, not for diagnosing conditions.
No
The device description explicitly lists hardware components such as distraction arms, pin clamps, universal clamps, rods, flat head screws, and activation nuts, indicating it is a physical medical device, not software-only.
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, or tissue) to provide information about a person's health.
- Synthes External MVMD function: The Synthes External MVMD is a surgical device used to physically stabilize and lengthen bone in the mandible. It is implanted or attached externally to the patient's body and directly interacts with the bone.
The description clearly indicates a device used for surgical intervention and bone manipulation, not for testing biological samples.
N/A
Intended Use / Indications for Use
Synthes External MVMD 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 any form of congenital mandibular hypoplasia, such as Hemifacial Micorsomia, Treacher Collins Syndrome, Nagers Syndrome, Pierre Robin Syndrome, Goldenhar Syndrome, Apert Syndrome, and Crouzon Syndrome.
Synthes External MVMD 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.
Product codes
DZL
Device Description
The Synthes External MVMD is a bone lengthening and distraction device which is achieved by gradually activating the device in a linear, angular, and/or transverse fashion. Bone stabilization may also be achieved with this device after distraction.
The Synthes External MVMD is comprised of two interchangeable distraction arms, pin clamps, universal clamps, rods, flat head screws, and activation nuts. The pin clamps can accept 2.0 mm k-wires.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandible, temporomandibular joint
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.4880 Intraosseous fixation screw or wire.
(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image shows the date "JUN 29 1998" at the top. Below the date is the logo for SYNTHES, a medical device company. The logo consists of a stylized symbol to the left of the company name, which is written in bold, sans-serif font. A registered trademark symbol is located to the right of the company name.
Summary of Safety and Effectiveness Information Attachment VII: [510(k) Summary] Synthes (USA) SUBMITTER 1690 Russell Road Paoli, PA 19301 (610) 647-9700
Contact: Sheri L. Musgnung
COMMON OR USUAL NAME
Screw, Fixation, Intraosseous
Class II, 21 CFR 872.4880
DEVICE CLASSIFICATION:
PREDICATE DEVICE:
DESCRIPTION:
INTENDED USE:
Howmedica's Mandibular Bone Distractor II (K960297)
The Synthes External MVMD is a bone lengthening and distraction device which is achieved by gradually activating the device in a linear, angular, and/or transverse fashion. Bone stabilization may also be achieved with this device after distraction.
External MVMD is comprised of two The Synthes interchangeable distraction arms, pin clamps, universal clamps, rods, flat head screws, and activation nuts. The pin clamps can accept 2.0 mm k-wires.
Synthes External MVMD 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 any form of congenital mandibular hypoplasia, such as Hemifacial Micorsomia, Treacher Collins Syndrome, Nagers Syndrome, Pierre Robin Syndrome, Goldenhar Syndrome, Apert Syndrome, and Crouzon Syndrome.
Synthes External MVMD 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.
External MVMD 510(k) Synthes (USA)
্যু ব্
CONFIDENTIAL
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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 29 1999
Ms. Sheri L. Musgnung Regulatory Affairs Associate Synthesà (USA) 1690 Russell Road Post Office Box 1766 Paoli, Pennsylvania 19301
Re : K981362
Synthesà (USA) External Multi Vector Trade Name: Mandible Distractor Requlatory Class: II Product Code: DZL Dated: April 14, 1998 April 15, 1998 Received:
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 The general controls provisions of the Act 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 Regulations, Title 21, Parts 800 to 895. ਚ 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. 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 described in your six my puivalence of your device to a legally marketed predicate device results in a classification for your marketed predicate acvice bur device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (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,
Victor Vilatovski
Time 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 word "SYNTHES" in bold black letters, with a registered trademark symbol next to it. To the left of the word is a logo that appears to be a stylized representation of a medical device. Below the word "SYNTHES" are the words "2.0 Indications for Use Statement" in a smaller, less bold font.
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510(k) Number (if known): K481362
Device Name:
Indications For Use:
Synthes External MVMD is intended for use as a bone stabilizer and lengthener for conditions such as mandibular hypoplasia or posttraumatic defects of the mandible, where gradual bone distraction is required. The device is ideal for treating any form of congenital mandibular hypoplasia, such as Hemifacial Micorsomia, Treacher Collins Syndrome, Nagers Syndrome, Pierre Robin Syndrome, Goldenhar Syndrome, Apert Syndrome, and Crouzon Syndrome.
Synthes External MVMD 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.
(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
Fenil Shipp
(Division Sign-C Division of Dental, Infection Contr and General Hospital Der
510(k) Number
External MVMD 510(k) Synthes (USA)
CONFIDENTIAL
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