(35 days)
Not Found
No
The summary describes a mechanical bone fixation system with no mention of software, algorithms, or any technology related to AI/ML. The modifications are purely dimensional.
Yes
The device is used to stabilize and fixate bone grafts for bone regeneration, enabling dental implant placement, which is a therapeutic purpose.
No
Explanation: The device is described as being used to "stabilize and fixate bone grafts and bone filling materials for the regeneration of bone in the oral cavity." This indicates a therapeutic or reconstructive purpose, not a diagnostic one.
No
The device description explicitly states it includes a cassette, instruments, and screws, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to stabilize and fixate bone grafts and bone filling materials in the oral cavity for bone regeneration. This is a surgical procedure performed directly on a patient.
- Device Description: The device includes instruments and screws used for fixation. These are physical tools used in a surgical context.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic or other health-related information. This device is a surgical tool used for bone fixation during a regenerative procedure.
N/A
Intended Use / Indications for Use
Straumann Bone Block Fixation is used to stabilize and fixate bone grafts and bone filling materials for the regeneration of bone in the oral cavity. The bone grafting fixation technique can make it possible for the placement of dental implants in previously unsuitable sites.
Product codes
DZL
Device Description
Straumann Bone Block Fixation includes a cassette, instruments, and screws that are slight modifications of ones previously cleared by FDA under K011698. Modification to the instruments and screws are in dimensions only.
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
Not Found
§ 872.4880 Intraosseous fixation screw or wire.
(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.
0
ATTACHMENT 7
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 Telephone Number: 781-890-0001 781-890-6464 Fax Number: Contact Person: Linda Jalbert Vice President, Regulatory & Clinical Affairs
2. Name of the Device
Trade Name: Common Name: Classification Name:
Straumann Bone Block Fixation Set Bone Block Fixation Set Bone Block Fixation Set 21 CFR 872.4880
3. Legally Marketed Devices to which Equivalence is Claimed (Predicate Devices)
Guided Bone Regeneration System (K011698)
Description of the Device 4.
Straumann Bone Block Fixation includes a cassette, instruments, and screws that are slight modifications of ones previously cleared by FDA under K011698. Modification to the instruments and screws are in dimensions only.
5. Intended Use of the Device
Like the predicate device, the Straumann Bone Block Fixation Set is intended for stabilizing and fixating bone grafts and bone filling materials for the regeneration of bone in the oral cavity.
1
Basis for Substantial Equivalence ర.
The Straumann Bone Block Fixation Set is substantially equivalent to the previously cleared Straumann Guided Bone Regeneration (GBR) System. The intended use is the same. The screws and instruments are similar, and in some cases identical, to the previously cleared GBR System screws and instruments. The screws are composed of CP Grade 4 titanium, which is identical to the previously cleared GBR System screws.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 5 2005
Ms. Linda Jalbert Vice President, Regulatory and Clinical Affairs Straumann USA, Incorporated 1601 Trapelo Road Waltham, Massachusetts 02451
Re: K050515 Trade/Device Name: Bone Block Fixation Set Regulation Number: 21 CFR 872.4880 Regulation Name: Intraosseous Fixation Screw or Wire Regulatory Class: II Product Code: DZL Dated: March 18, 2005 Received: March 21, 2005
Dear Ms. Jalbert:
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.
3
Page 2 - Ms. Jalbert
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,
Anthony D. Winter for
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
4
Indications for Use
510(k) Number (if known): K050515
Bone Block Fixation Set Device Name:
Indications for Use:
Straumann Bone Block Fixation is used to stabilize and fixate bone grafts and bone filling materials for the regeneration of bone in the oral cavity. The bone grafting fixation technique can make it possible for the placement of dental implants in previously unsuitable sites.
X AND/OR Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Inner 1120 i Islon (Sign-Off)
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ം : !slon Sign-Old mileotion Control. Dental Devices
Number. K0R755
Straumann Bone Block Fixation December 20, 2004
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