(100 days)
K980512, I 001228
No
The description focuses on pre-bent plates based on CT scans, which is a form of patient-specific customization, but there is no mention of AI/ML being used in the process of generating these pre-bent shapes or in any other aspect of the device's function.
No
The device is described as plates and screws used for stabilization and fixation of mandibular fractures, which are implants for structural support rather than active therapeutic intervention.
No
This device is described as reconstructive, used for stabilization and fixation of mandibular fractures and reconstructive surgical procedures, not for diagnosing conditions.
No
The device description explicitly details titanium plates and screws, which are physical hardware components. While a CT scan is used for pre-shaping, the core device is a physical implant.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the stabilization and fixation of mandibular fractures and reconstructive surgical procedures. This is a surgical intervention on the body, not a test performed on samples taken from the body to diagnose a condition.
- Device Description: The device is comprised of plates and screws designed for surgical implantation. This is consistent with a surgical device, not an IVD.
- Anatomical Site: The device is used on the mandibular (jawbone), which is part of the patient's body. IVDs typically analyze samples like blood, urine, or tissue.
- Input Imaging Modality: While a CT scan is used, it's for pre-shaping the plate for surgical use, not for diagnostic analysis of the image itself.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information about a patient's health status.
Therefore, this device falls under the category of a surgical implant or device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Lorenz Titanium Fracture / Reconstructive Devices and Pre-bent Plates are intended for use in the stabilization and fixation of mandibular fractures and mandibular reconstructive surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
76 JEY (21 CFR 872.4760)
Device Description
The Lorenz Titanium Fracture / Rexastructive Devices are comprised of a variety of titanium fracture and reconstruction plates and screws with shapes and sizes designed for neassion of modition of marco on a varior of manum natures. The screws have both cross drive and canter dive head features, lag sames and as males will includes will includes straight, angle, double angle, and crescent, options with various lengths and thickness.
The Lorenz Titanium Fracture / Reconstructive Pre-Bent Plates are comprised of a specific range of existing plates. The plate is pre-shaped based on a CT Scan provided by the Surgeon specifically for a certain patient.
The Pro-batt plates may, in special cases, be attached to our Temporary Add-on Condyle (cleared under K002790). In these cases, the package inserts for both the Temporary Add-on Condyle will be included with the product. The poduct of the postkage insert for the Temporay Add-on Condyle is specific in identifying that on only indicated for temporary reconstruction and is not intended to a permanent implant
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT Scan
Anatomical Site
Mandibular
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.
K980512, I 001228
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.
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.
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ATTACHMENT 2
Image /page/0/Picture/2 description: The image shows the logo for W. Lorenz Surgical, a Biomet Company. The logo features the text "W. LORENZ" in a bold, sans-serif font, with the "W" stylized with a lightning bolt. Below the name, the word "SURGICAL" is written in a smaller, sans-serif font, and below that, the text "A Biomet Company" is written in an even smaller font.
510(k) Summary
November 9, 2006
| Contact: | Walter Lorenz Surgical, Inc. |
|---|---|
| 1520 Tradeport Drive | |
| Jacksonville, FL 32218-2480 | |
| Kim Reed, Sr. Regulatory Specialist | |
| 904-741-9443 fax 904-741-3912 |
Common or Usual Name: Bone Plate Classification Name Plate, Fixation, Bone Device Classification: Class II Device Product Code: 76 JEY (21 CFR 872.4760)
Lorenz Titanium Fracture / Reconstruction Devices and Pre-bent Plates
Intended Use: The Lorenz Titanium Fracture / Reconstructive Devices and Pre-bent Plates are intended for use in the stabilization and fixation of mandibular fractures and mandibular reconstructive surgical procedures.
Contraindications:
Device Name:
- Active infection. 1.
- Foreign body sensitivity. Where material sensitivity is suspected, testing is to be completed prior to implantation. 2.
-
- Patients with limited blood supply, insufficient quantity of bone, or latent infection.
- Patients with mental or neurologic conditions who are unvilling or incept macht mecallering postoperative care instructions. 1. If used in mandbular resertion cases, the mandibular reconstructive devices must be supported using a graft. If mandibular reconstructive devices are not supported by a graft, the devices can be expected to fracture, bend, brouk por fail.
Description: The Lorenz Titanium Fracture / Rexastructive Devices are comprised of a variety of titanium fracture and reconstruction plates and screws with shapes and sizes designed for neassion of modition of marco on a varior of manum natures. The screws have both cross drive and canter dive head features, lag sames and as males will includes will includes straight, angle, double angle, and crescent, options with various lengths and thickness.
The Lorenz Titanium Fracture / Reconstructive Pre-Bent Plates are comprised of a specific range of existing plates. The plate is pre-shaped based on a CT Scan provided by the Surgeon specifically for a certain patient.
The Pro-batt plates may, in special cases, be attached to our Temporary Add-on Condyle (cleared under K002790). In these cases, the package inserts for both the Temporary Add-on Condyle will be included with the product. The poduct of the postkage insert for the Temporay Add-on Condyle is specific in identifying that on only indicated for temporary reconstruction and is not intended to a permanent implant
Sterility Information: The places and screws will be marketed as non-sterile, single use devices.
Possible risks:
-
- Poor bone formation, Osteoporosis, Osteonyelitis, inhibited revasularization, or infection can cause loosening, bending one ing one fracture of the device.
-
- Nonunion or delayed union, which may lead to breakage of the implant.
-
- Migration, bending, fracture or loosening of the implant.
-
- Metal sensitivity, or allergic reaction to a foreign body.
-
- Decrease in bone density due to stress shielding.
-
- Pain, discomfort, abnormal sensation, or palpability due to the presence of the device.
-
- Increased fibrous tissue response around the fracture site and/or the implant.
-
- Necrosis of bone.
-
- Inadequate healing.
- 10.Mandibular devices can fracture, bend, break or fail if used to bridge a mandibular resection site, in the absence of a graft.
Substantial Equivalence W. Lorenz Chianian Fracture/ Reconstructive Devices and Pre-bent plate Modifications equivalent to the Lorenz Titanium Fracture / Reconstructive Devices cleared under K980512 and I 001228.
JAN 1 2 2007
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three overlapping wing or feather shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Kim Reed Senior Regulatory Specialist Walter Lorenz Surgical, Incorporated 1520 Tradeport Drive Jacksonville, Florida 32218
JAN 1 2 2007
Re: K063052
Trade/Device Name: Mandibular Fracture/Reconstruction Devices and Pre-Bent Plates Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: December 21, 2006 Received: December 22, 2006
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 equivalent (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 approval 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. 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 (OS) 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 (240) 276-0115. 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 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/industry/support/index.html.
Sincerely yours.
Judite J. Michael Dmd
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
KO 6 3052 510(k) Number (if known):
Device Name: Mandibular Fracture/Reconstruction Devices and Pre-bent plates
Indications For Use:
Intended for use in the stabilization and fixation of mandibular fractures and mandibular reconstructive surgical procedures.
Prescription Use xx xx _______________________________________________________________________________________________________________________________________________________
(Part 21 CFR 801 Over-The-Counter Use Subpart D) (21 CFR 801 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of
Susan Runser
(Division Sign-Off) (Division Sign-OH)
Division of Anesthesiology, General Hospital, Division of Affesthesionsion Control, Dental Devices
510(k) Number: