(86 days)
Biomedics, Inc., W.L. Lorenz, Synthes (USA.)
Not Found
No
The summary describes a system of plates and screws made of titanium for bone fixation, with no mention of software, algorithms, or any technology that would typically incorporate AI/ML.
Yes.
The device is intended for the treatment of fractures and reconstructive procedures, which are therapeutic interventions.
No
The document describes a surgical bone plating system used for treating fractures and performing reconstructive procedures, not for diagnosing conditions.
No
The device description explicitly states that the device is manufactured from commercially pure titanium and a titanium alloy, which are physical materials used for implants. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton. This involves direct surgical intervention on the patient's body.
- Device Description: The device description details the materials and construction of plates and screws, which are physical implants used in surgery.
- 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 treatment.
IVD devices are used outside the body to analyze samples. This device is used inside the body for structural support and fixation.
N/A
Intended Use / Indications for Use
The plate and screw designs for use in conjunction with the Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery is intended for use in the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton and non-load bearing fixation, e.g. midface, calvarial and mandibular Indications include selective trauma, orthognathic surgery, reconstructive procedures, bone grafting, and osteotomies. Specific applications include: Cranial fixation, cranial bone flap fixation, orbital rim fixation, maxillary fixation, graft fixation, bone fixation, brow fixation. The device is intended for single use only and only in conjunction with other titanium and titanium alloy implants.
Product codes
JEY
Device Description
The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery is manufactured of commercially pure titanium and a titanium 6A1-4V ELI alloy, materials that have been implanted safely for many years. These materials are recognized as acceptable for implantation purposes through device classification (for example, see 21 Code of Federal Regulations, sections 888.3030.) The plates are substantially equivalent in construction and design to the predicate devices manufactured by Biomedics, Inc., W.L. Lorenz and Synthes (USA.) The screws are manufactured of a titanium alloy that is at least equivalent to commercially pure titanium in strength and they are substantially equivalent in design to the predicate devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Craniomaxillofacial skeleton, midface, calvarial, mandibular, Cranial, orbital rim, maxillary, 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)
Biomedics, Inc., W.L. Lorenz, Synthes (USA.)
Reference Device(s)
Not Found
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
SEP 2 5 1997
17 1163
BIOMEDICS, INC. 536 South Rimpau Boulevard Los Angeles, California 90020-4832 Tel: (213) 934-4700, FAX: (213) 934-8212
Summary of Safety and Effectiveness
This statement regarding 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery is manufactured of commercially pure titanium and a titanium 6A1-4V ELI alloy, materials that have been implanted safely for many years. These materials are recognized as acceptable for implantation purposes through device classification (for example, see 21 Code of Federal Regulations, sections 888.3030.)
The plates are substantially equivalent in construction and design to the predicate devices manufactured by Biomedics, Inc., W.L. Lorenz and Synthes (USA.) The screws are manufactured of a titanium alloy that is at least equivalent to commercially pure titanium in strength and they are substantially equivalent in design to the predicate devices.
1
Image /page/1/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.
SEP 2 5 1997
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Carol E. Jones Biomedics, Incorporated 536 South Rimpau Boulevard Los Angeles, California 90020
Re : K972463 The Bioplate Rigid Fixation Bone Plating Trade Name: System for Craniomaxillofacial Surgery II Requlatory Class: Product Code: JEY July 1, 1997 Dated: Received: July 1, 1997
Dear Ms. Jones:
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 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Ms. Jones
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 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 labelinq regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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" (21 CFR 807.97). Other qeneral 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/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timõ 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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Page_l_of_l
510(k) Number (if known):
The plate and screw designs for use in conjunction with the Bioplate Rigid Fixation Bone Plating Device Name: System for Craniomaxillofacial Surgery
Indications For Use:
The plate and screw designs for use in conjunction with the Bioplate Rigid Fixation Bone Plaing rne place and Sorow dooging for use intended for use in the treatment of fractures and System for Orahomaxillolation ourgery is keleton and non-load bearing fixation, stration, stration, stration, stration, start fixstion, start fixstien, start fixstien reconstructive proovative of the nation, orbital rim fixation , maxillary fixation, graft fixation bone lixation, brow likation, Eygendate 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) | |
|---|---|
| Susan Gunnes | |
| (Division Sign-Off) | |
| Division of Dental, Infection Control, | |
| and General Hospital Devices | |
| 510(k) Number | Ka 72463 |
| Prescription Use | ✓ (Per 21 CFR 801.109) OR Over-The-Counter Use _______ (Optional Format 1-2-96) |