(277 days)
No
The description focuses on the material properties and mechanical function of the fixation system, with no mention of AI or ML.
Yes.
The device is intended for surgical repair procedures and stabilization of bone during healing, which directly addresses a medical condition to restore health.
No
The device is described as a "Bioabsorbable Fixation System" intended for "surgical repair procedures" and to "stabilize bone during healing." These descriptions indicate a therapeutic or treatment-oriented function, not a diagnostic one.
No
The device description explicitly details physical components such as plates, fasteners (screws), and an instrument set containing bone drills, taps, screwdrivers, plate benders, and cheek retractors. These are all hardware components, not software.
Based on the provided text, 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, or tissue) to detect diseases, conditions, or infections.
- Device Description: The BioSorbFX O/M 2.0/2.4 System is described as a system of plates and fasteners (screws) made of a bioabsorbable material. These are implanted into the body to stabilize bone during healing.
- Intended Use: The intended use is for surgical repair procedures in trauma and reconstructive procedures of the midface, maxilla, and mandible. This involves direct surgical intervention and implantation, not testing of samples outside the body.
The device is clearly an implantable medical device used for surgical fixation, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
The BioSorbFX O/M 2.0/2.4 System is intended for use in trauma and reconstructive procedures in the midface, maxilla and mandible. Specifically, the device is indicated for use in surgical repair procedures in the treatment of trauma to the midface, maxilla and mandible, and in orthognathic and reconstructive procedures of the midface, maxilla or mandible. The BioSorbFX O/M 2.0/2.4 System stabilizes bone during healing, in conjunction with appropriate postoperative immobilization. Especially in mandible BioSorbFX O/M System must be used in conjunction of appropriate maxillomandibular fixation (MMF).
The BioSorbFX O/M 2.0/2.4 System implants are not intended for use in and are contraindicated for:
-
- Mandibular tumor resection.
-
- Situations where internal fixation is otherwise contraindicated e.g., active or potential infection; patient conditions, including blood supply limitations, insufficient quantity or quality of bone; and where patient co-operation cannot be guaranteed (e.g., alcoholism).
-
- Significant comminuted fractures, including significant bone loss; of the mandible.
- Intermaxillary fixation without an appropriate external fixation by other means.
Product codes
JEY
Device Description
The BioSorbFX™ O/M 2.0/2.4 Bioabsorbable Fixation Systems consists of various place configurations, which are attached to the bone by 2.0, 2.4 and 2.8mm/threaded fasteners (i.c., screws) of various lengths. The specifications for the BioSprbFXTM O/M 2.0/2.4 System plates and fastencrs will require a self-reinforced copolymer derived from Llactide and D/L-lactide ("PLA copo."), which consists of 70 molar percent poly-L-lactide and 30 molar percent poly-D, L-lactide, with strength retention time 18-36 weeks.
Properly used, in the presence of adcquate immobilization, absortuble BioSprtFX'"> O/M 2.0/2.4 System implants stabilize bone during healing. The BioSorbFX™ O/M 2.0/2.4 System implants gradually lose their strength during 18-36, weeks. Biodegradation takes place within two to three years. The BioSorbFX™ Ont 2.0/2.4 System includes an instrument set containing bone drills, bone taps, screwdrivers, plate benders and cheek retractors.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
midface, maxilla, mandible
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)
K982139, K982721, K981666, K992158, K003786, K002083, K000696
Reference Device(s)
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
FEB 2 2 2002
510(k) Summary Bionx Implants Inc.'s BioSorbFX™ O/M 2.0/2.4 Bioabsorbable Fixation System
Submitter's Name, Address, Telephone Number, and Contact Person
Bionx Implants, Inc. 1777 Sentry Parkway West Gwynedd Hall, Suite 400 Bluc Bell, PA 19422
Contacts:
Gerard S. Carlozzi President and Chief Executive Officer (215) 643-5000 Phone: Facsimile: (215) 653-0984
Bionx Implants Ltd. Tuija Annala Quality Manager P.O.Box 3 FIN-33721 Tampere Finland Phone: 358-3-316 5679 358-3-316 2629 Facsimile:
February 22, 2002 Date prepared:
Name of the Device: BioSorbFX ()/M 2.0/2.4 Bioabsorbable Fixation System
Common or Usual Name:
Bioabsorbable Craniofacial Bone Plates and Plate Fasteners
Classification Name: Bone Plate and fasteners (Product Code 76 JEY)
Predicate Devices:
-
- Bionx Inplants, Inc. BioSorbFX™ 1.5/2.0 Bioabsorbable Fixation! System ("BioSorbFX"M 1.5/2.0 System") (K982139)
-
- Bionx Implants, Inc. BioSorbFX™ O/M 2.0/2.4 Bioabsorbable Fixation System ("BioSorbFXTM O/M 2.0/2.4 System") (K982721)
-
- Biomet Inc. 2.5mm LactoSorb® Screws (K981666)
-
- Biomet Inc. LactoSorb@ Sheets (K992158)
- 5.1 Synthes SMF Resorbable Meshes and Sheets (K003786)
-
- Lorenz Resorbable Distractor System (K002083)
-
- Macropore MacroporeMX Mandibular Fixation System (K000696)
1
8. Macropore Protective Sheet (K983360)
Intended Use
. .
The BioSorbPX O/M 2.0/2.4 System is intended for use in traum: and reconstructive The Bloodbres in the midface, maxilla and mandible. Specifically, the device is indicated processives in and repair procedures in the treatment of trauma to the midface, maxilla and mandible, and in orthognathic and reconstructive procedures of the]midface, maxilla or mandible. The BioSorbFX O/M 2.0/2.4 System stallizes bone during healing, in conjunction with appropriate postoperative immobilization. Which used in the mandible, the BioSorbFX O/M System must be used in conjunction with appropriale maxillomandibular fixation (MMF).
The BioSorbFX O/M 2.0/2.4 System implants are not intended for use in and are contraindicated for:
-
- Mandibular tumor resection.
-
- Situations where internal fixation is otherwise contraindicated e.g., active or potential infection; patient conditions, including blood supply limitations, insufficient quantity or quality of bone; and where patient co-operation cannot be guaranteed (e.g., alcoholism).
- Significant comminuted fractures, including significant bone loss, of the 3. mandible.
-
- Intermaxillary fixation without an appropriate external fixation by other uncans.
Technological Characteristics and Substantial Equivalence
The BioSorbFX™ O/M 2.0/2.4 Bioabsorbable Fixation Systems consists of various place configurations, which are attached to the bone by 2.0, 2.4 and 2.8mm/threaded fasteners (i.c., screws) of various lengths. The specifications for the BioSprbFXTM O/M 2.0/2.4 System plates and fastencrs will require a self-reinforced copolymer derived from Llactide and D/L-lactide ("PLA copo."), which consists of 70 molar percent poly-L-lactide and 30 molar percent poly-D, L-lactide, with strength retention time 18-36 weeks.
Properly used, in the presence of adcquate immobilization, absortuble BioSprtFX'"> O/M 2.0/2.4 System implants stabilize bone during healing. The BioSorbFX™ O/M 2.0/2.4 System implants gradually lose their strength during 18-36, weeks. Biodegradation takes place within two to three years. The BioSorbFX™ Ont 2.0/2.4 System includes an instrument set containing bone drills, bone taps, screwdrivers, plate benders and cheek retractors. This instrument set is identical with the previously cleared BioSorbFX™ 2.0/2.4 System (K982721) and substantially equivalent with the previously cleared BioSorbFX™ 1.5/2.0 System (K982139) and BioSorb™ Endobrow ScrewTM (K972919).
The BioSorbFX™ O/M 2.0/2.4 System has the same intended use and printiples of operation and is substantially equivalent to the devices previously cleared by FDA operation the Bionx Implants Inc. BioSorbFX™ 2.0/2.4 System (K982721),
2
BioSorbFX™ 1.5/2.0 System (K982139), Biomet, Inc. 2.5mm LactoSorb® Screws (K981666) and LactoSorb® Sheets (K992158), Synthes SMF Resorbable Meshes and Sheets (K003786), Lorenz Resorbable Distractor System (K002083), Macropore Sheets (1000-78), Mandibular Fixation System (K000696) and Macropore Protective Sheet (K983360) -
The BioSorbFX O/M 2.0/2.4 System has following similarities with previously cleared BioSorbFX 2.0/2.4 System (K982139):
- Uses the same operating principles ー
- Incorporates the same basic design ।
- Is manufactured, packaged and sterilized using the same machinery and । processes.
The BioSorbFX O/M 2,0/2.4 System has following similarities with previously cleared Biomet Inc. 2.5mm LactoSorb® Screws (K981666) and LactoSorb@ Sheets (K992158), Synthes SMF Resorbable Meshes and Sheets (K003786), Lorenz Resorbable Distractor System (K002083), Macropore MacroporeMX Mandibular Fixation System (K000696) and Macropore Protective Sheet (K98.3360).
- Uses the same operating principles -
- Incorporates the same design principles -
- Is used for similar indications ।
In summary the BioSorbPX O/M 2.0/2.4 System described in this submission is, in our opinion, substantially equivalent to the predicate devices.
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 2 2002
Bionx Implants, Incorporated Ms. Tuija Annala Director, Quality and Regulatory Affairs Bionx Implants, Limited Hermiankatu 6-8 L Tampere, FINLAND
Re: K011569
Trade/Device Name: BioSorbFX™ O/M 2.0/2/4 System Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: November 22, 2001 Received: November 26, 2001
Dear Ms. Annala:
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.
4
Page 2 - Ms. Annala
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 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.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Swoon Quarr
Image /page/4/Picture/5 description: The image shows a black and white drawing of an abstract symbol. The symbol appears to be composed of curved and straight lines, forming a complex shape. The lines are thick and bold, creating a strong contrast against the white background. The symbol's design is somewhat geometric, with a sense of movement or flow.
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE
510(K) Number (if known):
Device Name:
BioSorbFX™ O/M 2.0/2.4 Bioalisorbable Fixation System
Indications for Use:
Indications for Ose.
The BioSorbFX O/M 2:0/2.4 System is intended for use in trauma and recorpstituctive The Blosotor'A One 2.0/2.4 Bystein a mandible. Specifically, the device is 'ndicated for use in surgical repair procedures in the treatment of trauma to the midface, maxilla and mandible, and in orthognathic and reconstructive procedures of the midface, maxilla or mandible. The BioSorbFX O/M 2.0/2.4 System stabilizes borge duling healing, in conjunction with appropriate postoperative immobilization. Especially in mandible BioSorbFX O/M System must be used in conjunction of appropriate maxillomandibular fixation (MMF).
The BioSorbFX O/M 2.0/2.4 System implants are not intended for use in and are contraindicated for:
-
- Mandibular tumor resection.
-
- Situations where internal fixation is otherwise contraindicated e.g., active or potential infection; patient conditions, including blood supply limitations, insufficient quantity or quality of bone; and where patient co-operation cannot be guaranteed (e.g., alcoholism).
-
- Significant comminuted fractures, including significant bone loss; of the mandible.
- Intermax illary fixation without an appropriate external fixation by other means.
. (Please do not write below this line - continue on another page is needed) Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-off Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _
ﺳﺎ Prescription Use_ : (Per 21 CFR 801.109)
Over-The-Counter Use OR
Siven Rung
(Timision Sign-Off) intelan Sign-Um)
Inform of Dental, Infection Control, - oneral Hospital Devices ﺗﻘﺪﻳﻢ ﺍﻟﻤﺘﺎﺑﻌﺔ ﺍﻟﺘﻲ ﻳﺘﻢ ﺍﻟﺘﻲ ﻳﺘﻢ ﺍﻟﺘﻲ ﻳﺘﻢ ﺍﻟﺘﻲ ﻳﺘﻢ ﺍﻟﺘﻲ ﻳﺘﻢ ﺍﻟﺘﻲ ﻳﺘﻢ ﺍﻟﺘﻲ ﻳﺘﻢ ﺍﻟﺘﻲ ﻳﺘﻢ ﺍﻟﺘﻲ ﻳﺘﻢ ﺍﻟﺘﻲ ﻳﺘﻢ ﺍﻟﺘﻲ ﻳﺘﻢ ﺍﻟﺘﻲ ﻳﺘﻢ ﺍﻟﺘﻲ ﻳﺘﻢ ﺍﻟﺘﻲ ﻳﺘﻢ ﺍﻟﺘﻲ ﻳﺘﻢ ﺍﻟﺘﻲ ﻳﺘﻢ ﺍﻟﺘﻲ ﻳﺘﻢ ﺍﻟﺘﻲ