(79 days)
Not Found
Not Found
No
The summary describes a mechanical bone distraction system with no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is described as a "bone stabilizer" and "distraction devices" used for gradual distraction to correct congenital deficiencies or post-traumatic defects, which directly implies a therapeutic function.
No
Explanation: The "Intended Use / Indications for Use" section describes the device as a bone stabilizer and distraction device for correcting bone deficiencies, which are therapeutic rather than diagnostic actions.
No
The device description explicitly states that the system includes "implantable distractors" made of Titanium or Stainless Steel, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description and Intended Use: The description clearly states the device is an implantable system used for bone stabilization and gradual distraction of bone in the oral, cranial, and maxillo-facial areas. This is a surgical device used within the body (in vivo) to physically manipulate bone.
There is no mention of analyzing biological specimens or providing diagnostic information based on such analysis.
N/A
Intended Use / Indications for Use
The Lorenz Distraction System includes devices intended as a bone stabilizer, and distraction devices when correction of congenital deficiencies or post traumatic defects of oral (including the mandible, alveolar ridge, palate, and symphysis areas), cranial, and maxillo-facial bone require gradual distraction.
Product codes
MON
Device Description
The Lorenz Distraction System includes several designs of implantable distractors which all have a drive screw mechanism and connection plates. Three basic types are included; without rails, with one rail, and with two rails. Each distractor is made of either Titanium or 316 LVM Stainless Steel materials.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
oral (including the mandible, alveolar ridge, palate, and symphysis areas), cranial, and maxillo-facial bone
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)
Not Found
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.
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NOV 1 9 1999
Summary of Safety and Effectiveness
Device Name: Lorenz Distraction System
Classification Name and Reference: Plate, Fixation, Bone; 87 HRS (21 FR 888.3030)
- Device Description: The Lorenz Distraction System includes several designs of implantable distractors which all have a drive screw mechanism and connection plates. Three basic types are included; without rails, with one rail, and with two rails. Each distractor is made of either Titanium or 316 LVM Stainless Steel materials.
- Intended Use: The Lorenz Distraction System includes devices intended as a bone stabilizer, and distraction devices when correction of congenital deficiencies or post traumatic defects of oral (including the mandible, alveolar ridge, palate, and symphysis areas), cranial, and maxillo-facial bone require gradual distraction.
- Potential Risks: The potential risks associated with the distraction system implants include but may not be limited to the following;
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- Nonunion, delayed union, or premature union may lead to breakage of the device.
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- Bending, loosening, or stripping of the threads or fracture of the device.
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- Metal sensitivity, or allergic reaction to a foreign body.
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- If device remains implanted, decrease in bone density due to stress shielding.
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- Pain, discomfort, or abnormal sensation due to the presence of the device.
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- Nerve damage due to surgical trauma.
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- Necrosis of bone.
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- Biomechanical complications after distraction due to positioning of the device.
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- Inadequate healing.
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- Other conditions brought on by the surgical procedure including skin irritation and infection.
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Apart from these adverse effects there are always possible complications of any surgical procedure such as, but not limited to, infection, nerve damage, and pain which may not be related to the device.
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle with three swooping lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 9 1999
Ms. Diana Preston Requlatory Specialist Walter Lorenz Surgical, Inc. 1520 Tradeport Drive Jacksonville, Florida 32218
K992952 Re : Lorenz Distraction System Trade Name: Requlatory Class: II Product Code: MON August 30, 1999 Dated: Received: September 1, 1999
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 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. 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
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Page 2 - Ms. Preston
obligation you might have under sections 531 through 542 of obligation 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 deberined in four for the equivalence of your device to a legally marketed predicate device results in a classification for your markees production 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 che pffice 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,
K. Clatrid
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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Page 1 of 1
510(k) Number (if known): Unknown K992952
Device Name: Lorenz Distraction System
- Intended Use: The Lorenz Distraction System includes devices intended as a bone stabilizer, and distraction devices when correction of congenital deficiencies or post traumatic defects of oral (including the mandible, alveolar ridge, palate, and symphysis areas), cranial, and maxillo-facial bone require gradual distraction.
(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 FR 801.109)
OR
Susan Rusover
Division Sion-Off
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)