SYNTHES (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTOR

K981362 · Synthes (Usa) · DZL · Jun 29, 1998 · Dental

Device Facts

• Record ID: K981362
• Device Name: SYNTHES (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTOR
• Applicant: Synthes (Usa)
• Product Code: DZL · Dental
• Decision Date: Jun 29, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4880
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

External bone distraction device; used for mandibular lengthening and stabilization. Components include interchangeable distraction arms, pin clamps, universal clamps, rods, flat head screws, and activation nuts. Pin clamps accept 2.0 mm k-wires. Device functions by manual activation to achieve linear, angular, or transverse bone distraction. Used by surgeons in clinical settings to treat congenital or acquired mandibular hypoplasia. Provides mechanical stabilization and gradual distraction to promote bone growth/correction.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and intended use comparison to predicate device.

Technological Characteristics

External bone distraction system. Components: distraction arms, pin clamps, universal clamps, rods, flat head screws, activation nuts. Compatible with 2.0 mm k-wires. Mechanical operation via manual activation. No software or electronic components.

Indications for Use

Indicated for patients requiring mandibular bone lengthening or stabilization due to congenital mandibular hypoplasia (e.g., Hemifacial Microsomia, Treacher Collins, Nagers, Pierre Robin, Goldenhar, Apert, Crouzon Syndromes) or acquired hypoplasia (e.g., post-traumatic growth disorders, TMJ injury, ankylosis, segmental bone loss).

Regulatory Classification

Identification

An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.

Predicate Devices

• Howmedica's Mandibular Bone Distractor II (K960297)

Submission Summary (Full Text)

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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.

K981362

Summary of Safety and Effectiveness Information Attachment VII: [510(k) Summary] Synthes (USA) SUBMITTER 1690 Russell Road Paoli, PA 19301 [phone]

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)

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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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