(7 days)
Not Found
No
The document describes standard surgical screws and a bone plating system, with no mention of AI or ML capabilities, image processing, or data analysis.
Yes
The device is used in the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton, which are therapeutic interventions.
No
The device description indicates it is a screw used for fixation of plates to bone in craniomaxillofacial surgery, which is a treatment or reconstructive purpose, not for diagnosing a condition.
No
The device description explicitly states it includes "titanium alloy screws of varying diameters and lengths," which are hardware components, not software.
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 and Intended Use: The provided information clearly describes a surgical implant (screws) used for fixing bone plates in the craniomaxillofacial skeleton. This is a device used within the body during a surgical procedure, not for testing samples outside the body.
The description focuses on the physical characteristics of the screws and their application in surgical fixation, which is the hallmark of a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The modified screw designs for use with the Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery are intended for use in the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton and non-weight bearing fixation, including cranial bone fixation, brow fixation and orbital fixation. Each device is intended for sinqle use only and only in conjunction with other titanium and titanium alloy implants.
Product codes (comma separated list FDA assigned to the subject device)
JEY
Device Description
Modified screw designs for use with the Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery includes titanium allov screws of varving diameters and lengths and are used for fixation of unalloved, commercially pure titanium and titanium alloy plates to the craniofacial bony tissue.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
craniomaxillofacial skeleton, cranial bone, orbital
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.
K013954, K983485, K971297, K974785, K972463
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
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
Modified screw designs for use with the Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery
Common name
Bone plates and bone screws
Classification name
Bone Plate (21 CFR 872.4760)
Predicate Devices
- Walter Lorenz Surgical Instruments, Inc. (1) Lorenz Self Drilling Screw K013954
- (2) Synthes (USA) Self Drilling Screw K983485
- (3) KLS-Martin L.P. Centre-Drive Drill Free Screw K971297
- (4) Osteomed Corp. Auto-Drive Bone Screw K974785
1
- (5) Bioplate. Inc.
Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery K972463
Description of the device
Modified screw designs for use with the Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery includes titanium allov screws of varving diameters and lengths and are used for fixation of unalloved, commercially pure titanium and titanium alloy plates to the craniofacial bony tissue.
Intended used of the device
The modified screw designs for use with the Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery are intended for use in the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton and non-weight bearing fixation, including cranial bone fixation and orbital fixation. Each device is intended for single use only and only in conjunction with other titanium and titanium allov implants.
Comparison of the devices' technological characteristics with those of predicate devices
The modified screw designs for use with the Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery has the same indications for use as the Bioplate. Inc., Walter Lorenz, Synthes USA. Osteomed Corp., and KLS-Martin predicate devices. All of the technical characteristics of the modified screw designs for use with the Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery are substantially equivalent to the corresponding characteristics of the predicate devices, and any minor differences raise no new issues of safety and efficacy.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure with three lines extending above it, resembling a bird in flight. The image is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 6 2002
Ms. Carol E. Jones Chief Operating Officer Bioplate, Incorporated 6911 Melrose Avenue Los Angeles, California 90038
Re: K022890 Trade/Device Name: Regulation Number: 21 CFR 872.4760 Regulation Name: Regulatory Class: II Product Code: JEY Dated: August 30, 2002 Received: August 30, 2002
Dear Ms. Jones:
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.
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 - Ms. Jones
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 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.qov/cdrh/dsma/dsmamain.html
Sincerely yours.
foAluishm fer.
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
510(k) Number (if known):
Device Name: Modified screw designs for use with the Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery.
Indications for Use:
The modified screw designs for use with the Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery are intended for use in the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton and non-weight bearing fixation, including cranial bone fixation, brow fixation and orbital fixation. Each device is intended for sinqle 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 | ✓ | OR | Over-The-Counter Use | |
|---|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) | |||
| Susan Runo: | ||||
| (Division Sign-Off) | ||||
| Division of Anesthesiology, General Hospital, | ||||
| Infection Control, Dental Devices | ||||
| 510(k) Number: | K022890 |