(90 days)
Not Found
Not Found
No
The provided text describes a resorbable bone screw and its intended use in craniomaxillofacial surgery. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses on the material, sterilization, and intended anatomical site and procedures.
Yes
The device is described as an implant used to align and stabilize fractures of bony tissue to facilitate normal tissue healing, which classifies it as a therapeutic device.
No
Explanation: The device is described as a resorbable bone screw intended for fixation and stabilization of fractures and reconstructive procedures. It is a therapeutic device, not one used for diagnosis.
No
The device description explicitly states that the device is a resorbable implant made from a Poly(L-The Dioplates I Rosofbable Bons, which is a physical hardware component.
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 and Intended Use: The provided text clearly describes the Bioplate® Resorbable Bone Screws as implants used for fixation of bone fractures and reconstructive procedures within the craniomaxillofacial skeleton. They are physically placed within the body to stabilize bone.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens taken from the body.
Therefore, based on the provided information, the Bioplate® Resorbable Bone Screws are a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Bioplate® Resorbable Bone Screws are intended for use in conjunction with Codman Craniosorb™ plates and meshes in the treatment of fractures and reconstructive oranioon's of the craniomaxillofacial skeleton in which resorbable fixation is desired. The plates and screws are used to align and stabilize fractures of bony tissue while normal tissue healing occurs.
The Bioplate® Resorbable Bone Screws are intended for minimally load bearing fixation for the following indications:
- Reconstructive procedures of the craniomaxillofacial skeleton
- . Repair of Craniofacial fractures
- Cranial bone fixation .
- Brow lift procedures
Product codes (comma separated list FDA assigned to the subject device)
DZL, JEY
Device Description
The Bioplate® Resorbable Bone Screws are resorbable implants made from a Poly(L-The Dioplates I Rosofbable Bons are provided pre-sterilized by gamma radiation and are not intended to be resterilized by the user.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
craniomaxillofacial skeleton, Craniofacial, Cranial bone
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.
Not Found
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
§ 872.4880 Intraosseous fixation screw or wire.
(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.
0
NOV 2 8 2001
510(k) Summary The Bioplate® Resorbable Bone Screw PAGE 1 OF 2
August 28, 2001
Bioplate, Inc. 6911 Melrose Avenue Los Angeles, CA 90038 Tel: (323) 549-9500, Fax: (323) 935-0110
Contact: Eric V. Hohenstein
PROPRIETARY NAME
Bioplate® Resorbable Bone Screw
COMMON NAME
Absorbable Bone Screw
CLASSIFICATION NAME
Screw, fixation, bone
CLASSIFICATION NO
87HWC
DEVICE CLASSIFICATION
Class II, 21 CFR 888.3040
STATEMENT OF SUBSTANTIAL EQUIVALENCE
The Bioplate® Resorbable Bone Screws are substantially equivalent to the screws of The Bloplate® Hesofbable Done Craniomaxillofacial Surgey, Biolactat™ Indiana the Blophatos Berior Plaing Of the predicate devices in intended use, design, material, and principles of operation.
DESCRIPTION OF DEVICE
The Bioplate® Resorbable Bone Screws are resorbable implants made from a Poly(L-The Dioplates I Rosofbable Bons are provided pre-sterilized by gamma radiation and are not intended to be resterilized by the user.
6911 Melrose Avenue, Los Angeles, California 90038 TEL . (888) BIOPLATE . (323) 549 9500 . FAX . (323) 935 0110 E-MAIL . info@bioplate.com INTERNET . http://www.bioplate.com
1
510(k) Summary The Bioplate Biosorb™ Resorbable Bone Screw PAGE 2 OF 2
INDICATIONS FOR USE:
Bioplate® Resorbable Bone Screws are intended for use in conjunction with Codman Craniosorb™ plates and meshes in the treatment of fractures and reconstructive oranioon's of the craniomaxillofacial skeleton in which resorbable fixation is desired. The plates and screws are used to align and stabilize fractures of bony tissue while normal tissue healing occurs.
The Bioplate® Resorbable Bone Screws are intended for minimally load bearing fixation for the following indications:
- Reconstructive procedures of the craniomaxillofacial skeleton ●
- . Repair of Craniofacial fractures
- Cranial bone fixation .
- Brow lift procedures
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized symbol that resembles an eagle or a bird in flight, with three curved lines representing the wings and body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 8 2001
Mr. Eric Hohenstein Bioplate, Incorporated 6911 Melrose Avenue Los Angeles, California 90038
Re: K012908
Trade/Device Name: Bioplate Resorbable Bone Screw Regulation Number: 872.4880 and 872.4760 Regulation Name: Resorbable Bone Screw Regulatory Class: II Product Code: DZL and JEY Dated: August 28, 2001 Received: August 30, 2001
Dear Mr. Hohenstein:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becases one 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 Interstate commerce prior to that have been reclassified in accordance with the provisions of Amendinents, or to do rioto that in to a ct (Act) that do not require approval of a premarket the Federal Food, Drug, and Cosments , too gray, therefore, subject to the general approval application (1 Milly) - - The general controls provisions of the Act include confors provisions of the Fren - 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 II your device is classified (boo as 10) was a morely. Existing major regulations affecting (PMA), it may of subject to such additions, Title 21, Parts 800 to 898. In your device can be found in the be as nouncements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not Flease be advisod that I DTF 8 ibsudi.co on that your device complies with other requirements mean that I DA mas made a astes and regulations administered by other Federal agencies. of the Act of ally i ederal statutes and reguirements, including, but not limited to: registration
3
Page 2 - Mr. Hohenstein
and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 607), laceling (21 CFR Part 820), and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as set form in als quality ion 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 This letter will anow you to begin maintening of substantial equivalence of your device to 310(K) premarket notification. I secults 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 IT you desire specific as now 809.10 for in vitro diagnostic devices), please contact the and additionally 21 CFR Part 609-4613. Additionally, for questions on the promotion and Office of Confightance at (301) as contact the Office of Compliance at (301) 594-4639. ad verailing on your the regulation entitled, "Misbranding by reference to premarket Also, proase note the togal 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and the Act may be obtained in its be number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours
A. Ulatowski Timot Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
STATEMENT OF INDICATIONS FOR USE
DEVICE NAME:
The Bioplate Resorbable Bone Screw
INDICATIONS FOR USE:
Bioplate Resorbable Bone Screws are intended for use in conjunction with Codman CRANIOSORB™ plates and meshes in the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton in which resorbable fixation is desired. The plates and screws are used to align and stabilize fractures of bony tissue while normal tissue healing occurs.
The Bioplate Resorbable Bone Screws are intended for minimally load bearing fixation for the following indications:
- Reconstructive procedures of the craniomaxillofacial skeleton .
- Repair of Craniofacial fractures
- . 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)
Prescription Use J (Per 21 CFR 801.109
OR
Over-The-Counter Use_ (Optimal Format 1-2-96)
Susan Turner
Division Sign-Off
510(k) Number K 01 290 8