(421 days)
The Bioplate Resorbable Bone Plating System is intended for use in conjunction with the Bioplate Rigid Fixation Bone Plating System for craniomaxillofacial indications in which resorbable fixation is desired. Plates and screws are used to align and stabilize fractures of bony tissue while normal tissue healing occurs.
The resorbable plates and screws are intended for minimally load bearing fixation for the following indications:
- . Craniofacial fractures
- Reconstructive procedures of the craniomaxillofacial skeleton .
- Cranial bone fixation .
- . Brow lift procedures
The Bioplate® Resorbable Bone Plating System for Craniomaxillofacial Surgery consists of a variety of plate, mesh, and screw configurations intended for use in the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton in which bioresorbable fixation is desired. Plates, mesh and screws are used to align and stabilize fractures of bony tissue while normal tissue healing occurs.
The plates, mesh, and screws are manufactured of a bioresorbable Poly(L-lactide) copolymer which resorbs by hydrolysis into lactic acids that are metabolized by the body. The material is substantially equivalent to that currently being used in fixation devices and is, in some cases, the exact same copolymer material.
Bioplate® resorbable plates, mesh, and screws are provided sterile by gamma radiation and must not be resterilized.
The provided text is a 510(k) summary for a medical device (Bioplate® Resorbable Bone Plating System) seeking substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a study proving the device meets specific performance metrics.
The document primarily focuses on demonstrating substantial equivalence based on:
- Intended Use: Similar to predicate devices for craniomaxillofacial surgery.
- Design: Similar plate, mesh, and screw configurations.
- Dimensions: Implied similarity.
- Materials: Poly(L-lactide) copolymer, deemed substantially equivalent to materials in other resorbable fixation systems (e.g., poly(L-lactide-co-glycolide), poly(L/DL-lactide)).
- Sterilization: Gamma radiation.
The 510(k) process is a premarket notification requirement that aims to demonstrate that the new device is at least as safe and effective as a legally marketed predicate device. It typically relies on direct comparison, and extensive clinical trials or performance studies with defined acceptance criteria are often not required if substantial equivalence can be shown through other means (e.g., material testing, mechanical testing, design similarities).
Therefore, I cannot provide the requested information as it is not present in the given text. The document is about regulatory approval through substantial equivalence, not about performance against specific acceptance criteria in a study.
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JAN 2 4 2001
BIOMEDICS, INC. 6911 Melrose Avenue Los Angeles, California 90038 Tel: (323) 549-9500, FAX: (323) 935-0110
510(k) SUMMARY
The Bioplate® Resorbable Bone Plating System for Craniomaxillofacial Surgery consists of a variety of plate, mesh, and screw configurations intended for use in the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton in which bioresorbable fixation is desired. Plates, mesh and screws are used to align and stabilize fractures of bony tissue while normal tissue healing occurs.
The plates, mesh, and screws are manufactured of a bioresorbable Poly(L-lactide) copolymer which resorbs by hydrolysis into lactic acids that are metabolized by the body. The material is substantially equivalent to that currently being used in fixation devices and is, in some cases, the exact same copolymer material.
Bioplate® resorbable plates, mesh, and screws are provided sterile by gamma radiation and must not be resterilized.
The substantial equivalence of this device is demonstrated by its similarity in intended use, design, dimensions, and materials to the LactoSorb® Trauma Plating System (K955729), which is manufactured from 82:18 poly(L-lactide-co-glycolide),, the Synthes (U.S.A.) Resorbable Fixation System (K974554), which is manufactured from 70:30 poly(L/DL-lactide), and the Howmedica Leibinger Resorbable Fixation System (K982531), manufactured of material described in the 510(k) as "substantially equivalent to that used in the LactoSorb Device".
The device is also substantially equivalent in its intended use and design to the Bioplate® Rigid fixation Bone Plating System for Craniomaxillofacial Surgery (K980983), which is manufactured of non-resorbable titanium.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 4 2001
Mr. Eric V. Hohenstein Engineering & Product Development Manager Bioplate, Incorporated 6911 Melrose Avenue Los Angeles, California 90038
K994060 Re :
The Bioplate® Resorbable Bone Plating Trade Name: System for Craniomaxillofacial Surgery, Biolactate™ Regulatory Class: II Product Code: JEY Dated: October 24, 2000 Received: October 26, 2000
Dear Mr. Hohenstein:
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 devices that 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 regulations 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
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Page 2 – Mr. Hohenstein
In addition, FDA may publish further announcements action. accron. In addition in the Federal Register. Please note: this response to your premarket notification submission does ents response of the might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA deberibed in your and equivalence of your device to a legally marketed predicate device results in a classification for your markets problems, 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 general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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
Tim thy A. Ulatowski Director
Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K994060
DEVICE NAME:
The Bioplate Resorbable Bone Plating System for Craniomaxillofacial Surgery
INDICATIONS FOR USE:
The Bioplate Resorbable Bone Plating System is intended for use in conjunction with the Bioplate Rigid Fixation Bone Plating System for craniomaxillofacial indications in which resorbable fixation is desired. Plates and screws are used to align and stabilize fractures of bony tissue while normal tissue healing occurs.
The resorbable plates and screws are intended for minimally load bearing fixation for the following indications:
- . Craniofacial fractures
- Reconstructive procedures of the craniomaxillofacial skeleton .
- Cranial bone fixation .
- . Brow lift procedures
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
CONCURRANCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)
1 Prescription Use . (Per 21 CFR 801.109
ार
Over-The-Counter Use (Optimal Format 1-2-96)
Teall W. Shiffer
for MSR
Division Sign-Off
510(k) Number K994060
§ 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.