(28 days)
No
The device description focuses on the materials and physical components of the plates and screws, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is described as a "Bioplate® Titanium Fixation System" intended for "non-load bearing fixation, including, but not limited to cranial bone fixation and brow fixation, and the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton." This directly addresses and treats medical conditions, which falls under the definition of a therapeutic device.
No
The device description clearly states it is a "sterile plate and screw kit configurations" intended for "non-load bearing fixation" and "treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton," which are therapeutic, not diagnostic, uses.
No
The device description clearly details physical components made of titanium and titanium alloy (plates and screws) intended for surgical implantation. This is a hardware medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "non-load bearing fixation, including, but not limited to cranial bone fixation and brow fixation, and the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton." This describes a surgical implant used in vivo (within the body) for structural support and repair.
- Device Description: The description details physical components like plates and screws made of titanium alloys, designed for surgical implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
The sterile plate and screw kit configurations for use with the Bioplate® Titanium Fixation System are intended for use in non-load bearing fixation, including cranial bone fixation and brow fixation, and the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton and. Each device is intended for single use only, and only in conjunction with other titanium and titanium alloy implants.
Product codes
JEY
Device Description
The sterile plate and screw kit configurations for use with the Bioplate® Titanium Fixation System includes a variety of plate confiqurations for different anatomical applications. Titanium alloy screws of varying lengths are included for fixation of the plates to the craniomaxillofacial bony tissue. Titanium alloy screws of varying lengths are included for fixation of the plates to the craniomaxillofacial bony tissue.
The bone plates will be manufactured of unalloved, commercially pure titanium and titanium 6AI-4V ELI allov. The materials adhere to the American Society of Testing and Materials (A.S.T.M) F67 Standards and The American Society for Testing and materials (A.S.T.M.) F136 Standard. The screws will be manufactured of a titanium 6Al-4V ELI alloy that meets The American Society for Testing and materials (A.S.T.M.) F136 Standard.
The plate and screw kit confiqurations are sterilized using gamma radiation sterilization methods. Successful completion of sterilization validation and packaging validation studies provides a high level of assurance that sterility of the devices has been achieved and can be maintained.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranial bone, brow, craniomaxillofacial skeleton
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)
K972322, K912932, K923419, K923802, K973145, K921801
Reference Device(s)
K910038, K944561, K944545, K943347, K974017, K945139
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.
0
Summary of Safety and Effectiveness
Submitter's name, address, telephone number and contact person:
Bioplate, Inc. 6911 Melrose Avenue Los Angeles, CA 90038 (323) 549-9500 (323) 935-0110 (fax)
Contact Person: Carol E. Jones
Trade Name of Device
Sterile plate and screw kit configurations for use with the Bioplate® Titanium Fixation System
Common name
Bone plates and bone screws
Classification name
Bone Plate (21 CFR 872.4760)
Predicate Devices
- Walter Lorenz Surgical Instruments, Inc. (1) Lorenz 1.5mm Neuro Pack/Lorenz 2.0FT Plates (Sterile Version) . K972322
- (2) Synthes (USA) Maxillofacial Titanium Micro Set K912932
- (3) TiMesh Inc. Softplates and screws K923419, K923802, K973145
- (4) Techmedica, Inc. Anspach Fixation System K921801
1
- Walter Lorenz Surgical Instruments, Inc. (5) Ultra-micro Titanium Cranial Osteosynthesis System K910038
- KLS-Martin L.P. (6) KLS-Martin Micro Osteosynthesis System (1.0mm) L944561
- KLS-Martin L.P. (7) KLS-Martin Micro Osteosynthesis System (1.5mm) K944545
- KLS-Martin L.P. (8) KLS-Martin Oseosynthesis System (2.0mm) K943347
- Sofamor Danek (છ) Timesh System K974017
- (10) Howmedica, Inc. Luhr Titanium Pan Fixation System K945139
Description of the device
The sterile plate and screw kit configurations for use with the Bioplate® Titanium Fixation System includes a variety of plate confiqurations for different anatomical applications. Titanium alloy screws of varying lengths are included for fixation of the plates to the craniomaxillofacial bony tissue. Titanium alloy screws of varying lengths are included for fixation of the plates to the craniomaxillofacial bony tissue.
The bone plates will be manufactured of unalloved, commercially pure titanium and titanium 6AI-4V ELI allov. The materials adhere to the American Society of Testing and Materials (A.S.T.M) F67 Standards and The American Society for Testing and materials (A.S.T.M.) F136 Standard. The screws will be manufactured of a titanium 6Al-4V ELI alloy that meets The American Society for Testing and materials (A.S.T.M.) F136 Standard.
The plate and screw kit confiqurations are sterilized using gamma radiation sterilization methods. Successful completion of sterilization validation and packaging validation studies provides a high level of
2
assurance that sterility of the devices has been achieved and can be maintained.
Intended used of the device
The sterile plate and screw kit configurations for use with the Bioplate® Titanium Fixation System are intended for use in non-load bearing fixation, including, but not limited to cranial bone fixation and brow fixation, and the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implants.
Comparison of the devices' technological characteristics with those of predicate devices
The sterile plate and screw kit configurations for use with the Bioplate® Titanium Fixation System have the same indications for use as the Bioplate, Inc., Wurzburg, Synthes, TiMesh, and KLS-Martin predicate devices. All of the technical characteristics of the sterile plate and screw kit configurations for use with the Bioplate® Titanium Fixation System are substantially equivalent to the corresponding characteristics of the predicate devices, and any minor differences raise no new issues of safety and efficacy.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes extending from its head, representing the department's mission to protect the health of all Americans. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 9 2002
Bioplate. Incorporated C/O Mr. Bruce F. Mackler Heller. Ehrman, White & Mcauliffe 815 Connecticut Avenue NW Washington, D. C. 20006-4004
Re: K022033
Trade/Device Name: Sterile Plate & Screw Kit Configurations for use with the Bioplate® Titanium Fixation System Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: June 10, 2002 Received: June 21, 2002
Dear Mr. Mackler:
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 vour 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.
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.
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Page 2 - Mr. Mackler -
You must comply with all the Act's requirements, including, but not limited to: registration ないではないとなるとなるならなくなる 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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). 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!
Timothy A. Ulatowski
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
10 ===========================================================================================================================================================================
Device Name: Sterile plate and screw kit configurations for use with the Bioplate® Titanium Fixation System
Indications for Use:
The sterile plate and screw kit configurations for use with the Bioplate® Titanium Fixation System are intended for use in non-load bearing fixation, including cranial bone fixation and brow fixation, and the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton and. Each device is intended for single use only, and only in conjunction with other titanium and titanium alloy implants.
(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) |
OR
| Over-The-Counter Use | |
|---|---|
| (Optional Format 1-2-96) |
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
| 510(k) Number | |
|---|---|
| --------------- | -- |