(20 days)
K996040, KO12908
Not Found
No
The 510(k) summary describes a resorbable bone fixation tack made of a polymer. There is no mention of software, image processing, AI, ML, or any data-driven components. The device is a physical implant.
No
The device is described as a bone fixation device used to support non-load bearing tissues, which is a structural or supportive function, not a therapeutic one that treats or cures a disease or condition.
No
The device is described as a "bone fixation device" used to "support non-load bearing tissues," which indicates a therapeutic or supportive function rather than a diagnostic one.
No
The device description clearly states it is a "bone fixation device manufactured from a Poly (L-lactide-co-DL-lactide) co-polvmer," indicating it is a physical hardware implant, 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 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.
- Device Description: The Bioplate Resorbable Bone Fixation Tack is a physical implant used to support tissues within the body. It is a surgical device, not a device that analyzes biological samples.
- Intended Use: The intended use is to fix tissues within the craniomaxillofacial anatomy, which is a surgical procedure, not an in vitro diagnostic test.
The information provided clearly describes a surgical implant, not a device used for laboratory testing of biological specimens.
N/A
Intended Use / Indications for Use
The Bioplate Resorbable Bone Fixation Tack will be used to support non-load bearing tissues of the craniomaxillofacial anatomy, including but not limited to brow fixation.
Product codes (comma separated list FDA assigned to the subject device)
JEY
Device Description
The Bioplate Resorbable Bone Tack consists of a bone fixation device manufactured from a Poly (L-lactide-co-DL-lactide) co-polvmer that has been implanted safely for a number of years. The bone fixation devices will be provided sterile to the end-user, using gamma radiation as the method of sterilization and are not intended for re-sterilized by the enduser.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
craniomaxillofacial anatomy, brow
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.
K996040, KO12908
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
JUL 27 2005
SUMMARY OF SAFETY AND EFFECTIVENESS
Submitter's name, address, telephone number and contact person:
Bioplate, Inc. 3643 Lenawee Avenue Los Angeles, CA, 90016 (310) 815-2100 (310) 815-2126 (fax)
Contact Person: Jesus Farinas
Trade name of Device:
Bioplate Resorbable Tack for craniomaxillofacial surgery.
Common Name:
Absorbable Bone Screw
Device Classification:
Class 2, 21 CFR 888,3040
Predicate Devices:
- (1.) Bioplate, Inc. The Bioplate Resorbable Bone Plating System For Craniomaxillofacial Surgery, Biolactate TM (K996040)
- (2.) Bioplate, Inc. The Bloplate Resorbable Bone Screw (KO12908)
1
K051845
Description of the Device:
The Bioplate Resorbable Bone Tack consists of a bone fixation device manufactured from a Poly (L-lactide-co-DL-lactide) co-polvmer that has been implanted safely for a number of years. The bone fixation devices will be provided sterile to the end-user, using gamma radiation as the method of sterilization and are not intended for re-sterilized by the enduser.
Intended Use of the Device:
The Bioplate Resorbable Bone Fixation Tack will be used to support nonload bearing tissues of the craniomaxillofacial anatomy, including but not limited to brow fixation. Each device is intended for single use only,
Comparison of the device's technological characteristics with those of the predicate devices
The Bioplate Resorbable Tack, for use in the support of non-load bearing tissues of the craniomaxillofacial anatomy, including but not limited to brow fixation has some minor modifications to the Indications for Use; but has become more restrictive than the Indications for Use as the Bioplate (K994060) and (K012908). All of the technical characteristics are substantially equivalent to the corresponding characteristics of the predicate devices, and any minor differences raise no new issues of safety and efficacv.
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an abstract eagle design with three stylized lines forming the body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 27 2005
Bioplate, Incorporated c/o Mr. Jesus T. Farinas 3643 Lenawee Avenue Los Angeles, California 90016-4310
Re: K051845
Trade/Device Name: The Bioplate Resorbable Endobrow Fixation System Regulation Number: 21 CFR 872.4760 Regulation Name: Bone plate Regulatory Class: II Product Code: JEY Dated: June 28, 2005 Received: July 7, 2005
Dear Mr. Farinas:
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 - Mr. Farinas
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 (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), 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,
Spitte y. Michael Oms
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
STATEMENT OF INDICATION FOR USE
510(k) Number (if known): K051845
Bioplate Resorbable Bone Fixation Tack DEVICE NAME:
INDICATIONS FOR USE:
The Bioplate Resorbable Bone Fixation Tack will be used to support non-load bearing tixstion The Bioplate Resorbable Bone Fixation Tues will be and the brow fixation.
of the craniomaxillofacial anatomy, including but not limited to brow fixation.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
Division Sign-Off
510(K) Number K051845
Susan Ruaso
(Division Sign-Off) Division of Anesthestalagy, Boneral Hospital, Infoction Control. Dental De
510(k) Number: K051845