(20 days)
No
The 510(k) summary describes a bioabsorbable screw made of PLLA for fracture fixation and does not mention any AI or ML components or functionalities.
No.
The device is an implantable screw used for fracture fixation, which is a structural component for mechanical stability, not a therapeutic agent that treats or prevents disease.
No
The device, Cannulated SmartScrew™, is described as an implant for fracture fixation, not a tool for diagnosing medical conditions. Its intended use is for "maintenance of alignment of cancellous fractures of the malleolus of the ankle in the presence of appropriate immobilization," which is a treatment function.
No
The device description clearly states the device is a physical screw made of PLLA polymer, intended for surgical implantation. There is no mention of software components.
No, 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, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description and intended use of the Cannulated SmartScrew™ clearly indicate it is a surgical implant used for fixing bone fractures. It is a physical device inserted into the body to provide structural support.
The information provided describes a surgical implant, not a device used for testing biological samples outside of the body.
N/A
Intended Use / Indications for Use
The Cannulated SmartScrew™ is intended for maintenance of alignment of cancellous fractures of the malleolus of the ankle in the presence of appropriate immobilization. In conjunction with adequate surgical technique and postoperative immobilization, the Cannulated SmartScrew™ provides secure fixation and will maintain sufficient physical integrity and mechanical holding properties within the bone, well beyond the five to eight weeks needed for complete biological healing and realignment of the fixation site.
The Cannulated SmartScrew™ is not intended for use in and is contraindicated for: 1) Fractures and osteotomies of cortical bone (diaphyseal area), 2) Situations where internal fixation is otherwise contraindicated, e.g., active or potential infection and where patient co-operation cannot be guaranteed (e.g. alcoholism).
Product codes
HWC, MAI
Device Description
The Cannulated SmartScrew™ is composed of 100% poly-L-lactide ("PLLA") polymer. It is supplied with diameter 4.5mm and lengths 40, 45, 50, 55, 60, 65, 70mm. It is cannulated for 1.5mm K-wire.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Malleolus of the ankle
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
K9 2947
SEP 2 1 999
510(k) Summary Bionx Implants Inc. Cannulated SmartScrew™
Submitter's Name, Address, Telephone Number, and Contact Person
Bionx Implants, Inc. 1777 Sentry Parkway West Gwynedd Hall, Suite 400 Bluebell, PA 19422
Contacts:
Gerard S. Carlozzi President and Chief Operating Officer (215) 643-5000 Phone: Facsimile: (215) 653-0984
Bionx Implants Ltd. Tuija Annala Regulatory Affairs Assistant P.O.Box 3 FIN-33721 Tampere Finland Phone: 358-3-316 5679 Facsimile: 358-3-316 5688
August 17th, 1999 Date prepared:
Name of the device:
Trade or Proprietary Name: Cannulated SmartScrew™M A.
1
| B. | Common Name: | Bionx Bioabsorbable Cannulated, Threaded,
Fixation Rod |
|----|----------------------|-----------------------------------------------------------|
| C. | Classification Name: | Biodegradable fixation fastener, bone |
| D. | Device Product Code: | HWC |
Predicate Devices:
Bionx Implants Inc. Biofix® Bioabsorbable SR-PLLA Threaded Fixation Rod (K952471)
Bionx Implants Inc. Biofix® Bioabsorbable, Threaded, Distal Radius Screw (K974876)
Intended Use:
The Cannulated SmartScrew™ is intended for maintenance of alignment of cancellous fractures of the malleolus of the ankle in the presence of appropriate immobilization. In conjunction with adequate surgical technique and postoperative immobilization, the Cannulated SmartScrew™ provides secure fixation and will maintain sufficient physical integrity and mechanical holding properties within the bone, well beyond the five to eight weeks needed for complete biological healing and realignment of the fixation site.
Device Description:
The Cannulated SmartScrew™ is composed of 100% poly-L-lactide ("PLLA") polymer. It is supplied with diameter 4.5mm and lengths 40, 45, 50, 55, 60, 65, 70mm. It is cannulated for 1.5mm K-wire.
2
Substantial Equivalence:
The Bionx Cannulated SmartScrew™ has the following similarities to the Bionx Biofix® Bioabsorbable SR-PLLA Threaded Fixation Rod (K952471):
- has the same indicated use -
- use the same operating principle -
- incorporate the same basic design
- incorporate the same raw material -
- has the same shelf life
- are packaged and sterilized using the same materials and processes -
The Bionx Cannulated SmartScrew™ has the following similarities to the Bionx Biofix® Bioabsorbable, Threaded, Distal Radius Screw (K974876):
- use the same manufacturing process
- is used with the same instrument set
In summary, the Cannulated SmartScrew™ described in this notification is, in our opinion, substantially equivalent to the predicate devices. Furthermore, the minor technological differences between the Cannulated SmartScrew™ and the predicate devices do not raise any new issues of safety or effectiveness.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a bird or a human figure with outstretched arms, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 1 1999
Ms. Tuija Annala Regulatory Affairs Assistant Bionx Implants Ltd. Hermiankatu 6-8 L Tampere, Finland Europe
Re: K992947 Trade Name: Cannulated SmartScrew TM Regulatory Class: II Product Code: HWC and MAI Dated: August 17, 1999 Received: September 1, 1999
Dear Ms. Annala:
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, 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 vour 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 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 action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2-Ms. Tuija Annala
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 labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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 general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its tollfree number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(K) Number (if known): K992947
Device Name:
Cannulated SmartScrew™
Indications for Use:
Cannulated SmartScrew™ is intended for maintenance of alignment of cancellous fractures of the malleolus of the ankle in the presence of appropriate immobilization. In conjunction with adequate surgical technique and postoperative immobilization, the Cannulated SmartScrew™ provides secure fixation and will maintain sufficient physical integrity and mechanical holding properties within the bone, well beyond the five to eight weeks needed for complete biological healing and realignment of the fixation site.
The Cannulated SmartScrew™ is not intended for use in and is contraindicated for: 1) Fractures and osteotomies of cortical bone (diaphyseal area), 2) Situations where internal fixation is otherwise contraindicated, e.g., active or potential infection and where patient co-operation cannot be guaranteed (e.g. alcoholism).
(Please do not write below this line - continue on another page is needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X OR Over-The-Counter Use __
(Per 21 CFR 801.109)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number __K992947