(83 days)
Not Found
No
The device description focuses on physical components (plates, meshes, screws, instruments) and materials (titanium, stainless steel) for bone grafting procedures. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is used for regeneration of bone, which indicates a therapeutic purpose. It stabilizes and fixates bone grafts, filling materials, and membranes for bone regeneration in the oral cavity.
No
The device is intended for stabilizing and fixating bone grafts, bone filling material, and/or barrier membranes for bone regeneration, which are therapeutic actions, not diagnostic.
No
The device description explicitly lists physical components such as bone plates, meshes, screws, and instruments, all made of titanium or stainless steel. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, the Straumann GBR System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Straumann GBR System Function: The description clearly states that the Straumann GBR System is comprised of bone plates, meshes, screws, and instruments used for stabilizing and fixating bone grafts, bone filling material, and/or barrier membranes directly within the oral cavity. These are physical devices used in a surgical procedure, not for analyzing biological samples.
- Intended Use: The intended use is for regeneration of bone in the oral cavity and enabling dental implant placement. This is a therapeutic and reconstructive purpose, not a diagnostic one.
Therefore, the Straumann GBR System falls under the category of a surgical or implantable device, not an IVD.
N/A
Intended Use / Indications for Use
The Straumann GBR System is intended for use in stabilizing and fixating bone grafts, bone filling material, and/or barrier membranes used for regeneration of bone in the oral cavity. The GBR technique can make it possible for the placement of dental implants in previously unsuitable sites.
Product codes (comma separated list FDA assigned to the subject device)
JEY, DZL
Device Description
The Straumann GBR System is comprised of bone plates, meshes, screws, and accompanying instruments. The cranial plates are offered in 2, 4, and 6 hole options. Screws with diameters of 1.2 and 1.5mm are used to secure the cranial plates in place. The plates and screws are composed of commercially pure Grade 4 titanium meeting ASTM F67.
The 0.9 and 1.5 mesh are available in uniform mesh size and pattern, and alternating mesh size and patterns. Screws with diameters of 1.2 and 1.5mm are used to secure the mesh in place. The meshes are composed of commercially pure Grade 1 titanium meeting ASTM F67.
The Straumann GBR System also includes a fixation screw used to stabilize and adapt the membranes. There are two variations of supporting screws which prevent the membrane from collapsing into the defect site, and in conjunction with a head screw, provide membrane fixation and support. The screws are composed of stainless steel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral cavity
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.
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
AUG 2 3 2001
ATTACHMENT 8 - 510(k) Summary
1. Applicant's Name and Address
Straumann USA (on behalf of Institut Straumann AG) Reservoir Place 1601 Trapelo Road Waltham, MA 02451 781-890-0001 Telephone Number: 781-890-6464 Fax Number: Linda Jalbert, Director of Regulatory Affairs Contact Person:
2. Name of the Device
| Trade Name: | Straumann GBR System |
|---|---|
| Common Name: | Craniomaxillofacial Fixation Plates, Meshes and |
| Screws, membrane fixation screws | |
| Classification Name: | Bone plate, 21 CFR § 872.4760, Class II |
| Classification Name: | Intraosseous fixation screws, 21 CFR § 872.4880, |
| Class II | |
| Classification Name: | Surgical Mesh, 21 CFR § 878.3300, Class II |
Legally Marketed Devices to which Equivalence is Claimed (Predicate 3. Devices)
MODUS® System Plates, Mesh, and Screws (K946165) Implant Innovations OsseoFix System (K960914) Straumann Memfix screws (K955369) Leibinger Bone Grafting System Leibinger M-TAM TiMesh titanium mesh cribs
4. Description of the Device
The Straumann GBR System is comprised of bone plates, meshes, screws, and accompanying instruments. The cranial plates are offered in 2, 4, and 6 hole options. Screws with diameters of 1.2 and 1.5mm are used to secure the cranial plates in place. The plates and screws are composed of commercially pure Grade 4 titanium meeting ASTM F67.
The 0.9 and 1.5 mesh are available in uniform mesh size and pattern, and alternating mesh size and patterns. Screws with diameters of 1.2 and 1.5mm are used to secure the mesh in place. The meshes are composed of commercially pure Grade 1 titanium meeting ASTM F67.
The Straumann GBR System also includes a fixation screw used to stabilize and adapt the membranes. There are two variations of supporting screws which prevent the membrane from collapsing into the defect site, and in conjunction 510(k) GBR System
05/31/01 Page 34
1
with a head screw, provide membrane fixation and support. The screws are composed of stainless steel.
Intended Use of the Device న.
The Straumann GBR System is intended for use in stabilizing and fixating bone grafts, bone filling material, and/or barrier membranes used for regeneration of bone in the oral cavity. The GBR technique can make it possible for the placement of dental implants in previously unsuitable sites.
Basis for Substantial Equivalence 6.
The Straumann GBR System is substantially equivalent in intended use to the Previously cleared MODUS® Titanium Osteosynthesis System, Implant Innovations OsseoFix System, Straumann Memfix screws, Leibinger's Bone Grafting and M-TAM Systems, and TiMesh titanium mesh cribs. The plates, Starting and meshes are similar, and in some cases identical, to previously cleared serows, and meshes and meshes and meshes and screws. The plates and screws are MODOS crainolumenal plantanium, which is the identical material to previously cleared MODUS® plates and screws. The meshes are composed of CP Grade 1 titanium, the identical material as that of previously cleared MODUS® mesh.
2
Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is an abstract image of an eagle.
AUG 2 3 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Institut Straumann AG C/O Ms. Linda Jalbert Director of Regulatory Affairs Straumann USA Reservoir Place 1601 Trapelo Road Waltham, Massachusetts 02451
Re : K011698 Straumann GBR System Trade/Device Name: Regulation Number: 872.4760 and 872.4880 Regulatory Class: II Product Code: JEY and DZL Dated: May 31, 2001 Received: June 1, 2001
Dear Ms. Jalbert:
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 legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to che onat 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 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory
3
Page 2 -Ms. Jalbert
In addition, FDA may publish further announcements action. 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.
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 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" (21CFR 807.97). Other qeneral 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.qov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Clin S. E/on
Timothy A. Ulatowski
Timothy A. Ulatows Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1
K011698
Straumann Guided Bone Regeneration System Device Name:
Indications For Use:
510(k) Number (if known):
The Straumann Guided Bone Regeneration (GBR) System is used to stabilize and fixate bone grafts, bone filling materials, and/or barrier membranes used for regeneration of bone grains, vehicle thing the GBR technique can make it possible for the placement of dental implants in previously unsuitable sites.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_V (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-
Harold W. Shinn
for MSR
(Division Sign-Off) Division of Dental, Infection Contr and General Hospital De 510(k) Number _