SYNTHES MINI LENGTHENING APPARATUS

K973018 · Synthes (Usa) · MQN · Nov 10, 1997 · Dental

Device Facts

• Record ID: K973018
• Device Name: SYNTHES MINI LENGTHENING APPARATUS
• Applicant: Synthes (Usa)
• Product Code: MQN · Dental
• Decision Date: Nov 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Synthes MLA is intended for use as a stabilizer and lengthener to be used in craniofacial-maxillofacial and mandibular deficiencies or post-traumatic defects, where gradual bone distraction is required.

Device Story

Synthes MLA is a mechanical telescoping tube device used for bone distraction. It consists of two tubes with pin clamps at the ends to secure 2.0 - 2.5 mm K-wires. The device expands or contracts via an outer wheel mechanism (clockwise to contract, counterclockwise to expand), secured by a jack screw with an axially retained threaded shaft. It is available in two length ranges (75-110 mm and 100-160 mm). The device is used by surgeons in a clinical setting to stabilize and gradually lengthen bone in the craniofacial-maxillofacial region. By manually adjusting the wheel, the surgeon facilitates controlled bone distraction to treat deficiencies or defects, promoting bone growth and structural correction.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Telescoping tube mechanism; manual adjustment via outer wheel and jack screw; pin clamps for 2.0-2.5 mm K-wires; available in two sizes (75-110 mm and 100-160 mm). Mechanical device; no software or energy source.

Indications for Use

Indicated for patients with craniofacial-maxillofacial and mandibular deficiencies or post-traumatic defects requiring gradual bone distraction.

Regulatory Classification

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.

Predicate Devices

• Howmedica's Hoffmann Mini Lengthening Apparatus (K792561)

Submission Summary (Full Text)

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**Attachment VII:** Summary of Safety and Effectiveness Info. [510(k) Summary]

| SUBMITTER | Synthes (USA) 1690 Russell Road Paoli, PA 19301 [phone] Contact: Sheri L. Musgnung |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| COMMON OR USUAL NAME: | Wire, Fixation, Intraosseous |
| DEVICE CLASSIFICATION: | Class II, 21 CFR 872.4880 |
| PREDICATE DEVICE: | Howmedica's Hoffmann Mini Lengthening Apparatus (K792561) |
| DESCRIPTION: | Synthes MLA is a telescoping tube mechanism, consisting of two tubes with pin clamps on the end of each tube. The tube mechanism expands and contracts by turning an outer wheel (clockwise to contract and counterclockwise to expand). The wheel is secured in place by a jack screw which has an axially retained threaded shaft with a round end. The pin clamps secure 2.0 - 2.5 mm K-wires to the tubes. The MLA is available in two sizes: One has lengths ranging from 75 mm to 110 mm; the other has lengths ranging from 100 mm to 160 mm. |
| INTENDED USE: | Synthes MLA is intended for use as a stabilizer and lengthener to be used in craniofacial-maxillofacial and mandibular deficiencies or post-traumatic defects, where gradual bone distraction is required. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 10 1997

Ms. Sheri L. Musgnung 'Regulatory Affairs Associate SYNTHES (USA) 1690 Russell Road Post Office Box 1766 Paoli, Pennsylvania 19301

Re : K973018 Synthes Mini Lengthening Apparatus Trade Name: Regulatory Class: Unclassified MON Product Code: Dated: August 12, 1997 Received: August 13, 1997

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 reqistration, listing of devices, qood manufacturing practice, labeling, and prohibitions aqainst 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. ರ್ಗ 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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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 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 and additionally 809.10 for in vitro diaqnostic 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,

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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SYNTHES (USA)

1690 Russell Road Post Office Box 1766 Paoli, Pennsylvania 19301 Telephone [phone]

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KG73018 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The Synthes MLA is intended for use as a stabilizer and lengthener to be used in I no Synaires maxillofacial and mandibular deficiencies or post-traumatic defects, where gradual bone distraction is required.

(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 Runner

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 510(k) Number J