(88 days)
The Lorenz Maxilla (Le Fort) Distraction System is intended for use in the maxilla as a bone stabilizer and lengthening device when correction of congenital midfacial deficiencies or post traumatic defects require gradual bone distraction.
This device is a linear distractor with a drive screw and two connection plates. Normally both a left and right device is implanted together. The two plates cap the resected zygoma such that the screws only prevent the device from slipping but are not relied upon to carry the distraction load. The device is placed internally with the drive mechanism protruding through the skin anteriorly. Two lengths for the threaded rod will allow up to 32mm (1.27") of distraction. After distraction is complete, the drive mechanism can be detached and the plates and screws and drive screw may be left under the skin. The device is advanced using a separate torque wrench.
The provided text describes a medical device submission (K982604) for the Lorenz Maxilla (Le Fort) Distraction System. However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.
The document appears to be a summary of safety and effectiveness, an FDA clearance letter, and an indications for use statement, which are typical components of a 510(k) submission for demonstrating substantial equivalence to a predicate device.
Therefore, I cannot provide the requested table and study details. The information necessary to answer your request is not present in the provided text.
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OCT 2 3 1998
Summary of Safety and Effectiveness
Device Name: Lorenz Maxilla (Le Fort) Distraction System
Classification Name and Reference: Plate, Fixation, Bone; 87 HRS (21 FR 888.3030)
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Device Description: This device is a linear distractor with a drive screw and two connection plates. Normally both a left and right device is implanted together. The two plates cap the resected zygoma such that the screws only prevent the device from slipping but are not relied upon to carry the distraction load.
The device is placed internally with the drive mechanism protruding through the skin anteriorly. Two lengths for the threaded rod will allow up to 32mm (1.27") of distraction. After distraction is complete, the drive mechanism can be detached and the plates and screws and drive screw may be left under the skin. The device is advanced using a separate torque wrench. -
Intended Use: The Lorenz Maxilla (Le Fort) Distraction System is intended for use in the maxilla as a bone stabilizer and lengthening device when correction of congenital midfacial deficiencies or post traumatic defects require gradual bone distraction
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Potential Risks: The potential risks associated with the maxilla distraction implant include but are not limited to the following;
- Inadequate bone quality
- Nonunion or delayed union .
- Metal sensitivity or allergic reaction to the foreign body .
- Malpositioning of implant
- . Infection
- Nerve Injury
- Bending, loosening, stripping, or fracture of implant
Substantially Equivalent Devices: The device is believed to be substantially equivalent to Howmedica Leibinger's Guerrero-Bell Distractor (K972166), and Cohen Distractor (K972154), and Synthes Mini Lengthening Apparatus (K973018)
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 3 1998
Ms. Diana Preston Requlatory Affairs Specialist Walter Lorenz Surgical, Incorporated 1520 Tradeport Drive Jacksonville, Florida 32218-2480
K982604 Re : Trade Name: Lorenz Maxilla (Le Fort) Distraction System Requlatory Class: II Product Code: MQN July 24, 1998 Dated: Received: July 27, 1998
Dear Ms. Preston:
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 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 requlations 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) requlation (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 Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Preston
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 labelinq 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,
Patricia Cuisinier for
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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510(k) Number (if known): Unknown
Device Name: Lorenz Maxilla (Le Fort) Distraction System
Indications For Use: The Lorenz Maxilla (Le Fort) Distraction System is intended for use in the maxilla as a bone stabilizer and lengthening device when correction of congenital midfacial deficiencies or post traumatic defects require gradual bone distraction.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Gerald Shippe
Division of Dental, Infection Control, and General Hospital II 510(k) Number
Prescription Use
(Per 21 FR 801.109) ✓
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
§ 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.