(15 days)
Not Found
No
The summary describes a mechanical external fixator and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is used for mandibular bone lengthening to treat conditions like mandibular asymmetry and hypoplasia, which are therapeutic interventions.
No.
The device is described as an external fixator used for mandibular bone lengthening to treat conditions like mandibular asymmetry and hypoplasia, indicating a therapeutic or treatment-oriented function rather than a diagnostic one.
No
The device description clearly details physical components like threaded rails, a locking collar, and a ball joint, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The Lorenz External Mandibular Distractor is an external fixator used for mandibular bone lengthening. It is a physical device that is surgically attached to the bone to facilitate growth.
- Intended Use: Its purpose is to treat physical conditions (mandibular asymmetry and hypoplasia) by mechanically altering the bone structure.
There is no mention of this device being used to test samples from the body or to provide diagnostic information based on such tests. It is a therapeutic device used for surgical intervention.
N/A
Intended Use / Indications for Use
The Lorenz External Mandibular Distractor is an external Fixator used for mandibular bone lengthening. It is used in treatment of mandibular asymmetry and hypoplasia.
Product codes (comma separated list FDA assigned to the subject device)
MON
Device Description
"The distractor frame is comprised of two threaded rails, a longer straight rail, and a shorter, angled rail to accommodate the anatomic angles of the mandible. These two rails are connected with a locking collar placing the ball joint in the center allowing three-dimensional contouring to match facial curvatures. This biplanar distractor allows for up to 40mm distraction with the straight rail, and up to 30mm distraction with the angled rail."
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandibular bone / mandible
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K992873 (SAME AS ORIGINAL SUBMISSION KOOL238)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
JUN 1 7 2003
Summary of Safety and Effectiveness
Lorenz External Mandibular Distraction Device Name:
The Lorenz External Mandibular Distractor is an external Fixator used for Intended Use: mandibular bone lengthening. It is used in treatment of mandibular asymmetry and hypoplasia.
Contraindications:
-
- Active infection and sepsis.
-
- Foreign body sensitivity. Where material sensitivity is suspected, testing is to be completed prior to implantation.
- Patients with limited blood supply, insufficient quantity or quality of bone, or latent 3. infection.
-
- Patients with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions.
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- Bone disorders which limit bone generation.
(SAME AS ORIGINAL SUBMISSION KOOL238) "The distractor frame is Description: comprised of two threaded rails, a longer straight rail, and a shorter, angled rail to accommodate the anatomic angles of the mandible. These two rails are connected with a locking collar placing the ball joint in the center allowing three-dimensional contouring to match facial curvatures. This biplanar distractor allows for up to 40mm distraction with the straight rail, and up to 30mm distraction with the angled rail."
Sterility Information: The places and screws will be marketed as non-sterile, single use devices
Possible risks:
- Bending, loosening of bone screws, K-wire, or ball joint, stripping of threaded rails, or 1. fracture of the device.
-
- Nonunion, delayed union, or premature union may lead to breakage of the implant.
-
- Metal sensitivity, or allergic reaction to a foreign body.
-
- Pain, discomfort or abnormal sensations due to the presence of the device.
- ર . Nerve damage due to surgical trauma.
-
- Other conditions brought on by the surgical procedure including skin irritation and infection.
-
- Biomechanical complications due to positioning of the device.
1
-
- Poor done formation. Osteoporosis, Osteolysis, Osteomvelitis. inhibited revascularization, or infection can cause loosening, bending, cracking or fracture of the device.
-
- Necrosis of bone or soft tissue.
- Tension of the soft tissue depending on the speed of distraction and quality of the soft 10. tissues and therefore irritation and/or atrophy.
-
- Inadequate healing.
1
Image /page/1/Picture/1 description: The image shows a logo with a stylized bird in the center. The bird is composed of three curved lines that suggest movement or flight. The bird is encircled by text, which is arranged in a circular fashion around the bird. The text is not clearly legible due to the image quality.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 7 2003
Ms. Kim Reed Sr. Regulatory Specialist Walter Lorenz Surgical, Incorporated 1520 Tradeport Drive Jacksonville, Florida 32218-2480
Re: K031696
Trade/Device Name: Lorenz External Mandibular Distractor Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Codes: MON Dated: May 30, 2003 Received: June 05, 2003
Dear Ms. Reed:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially cquivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require annroval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
2
Page 2 - Ms. Kim Reed
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4613. 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Simon Russe
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
STATEMENT OF INDICATIONS FOR USE
510(k) Number:
Device Name: External Mandibular Distractor
Indications For Use:
The Lorenz External Mandibular Distractor is an external Fixator used for mandibular bone lengthening. It is used in treatment of mandibular asymmetry and hypoplasia.
(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)
ﺍ ﻣﺮﺩﺓ، ﺍ
OR
Over-The-Counter-Use (Optional Format 1-2-96)
d
Kain Muluy for M.D.
(Division Sign-or)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K031696