(21 days)
Not Found
No
The document describes a physical implantable screw made of a specific material with defined dimensions and intended uses, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is used for the "maintenance of alignment and fixation of fractures, osteotomies, arthrodeses or condylar grafts" and is implanted into the body to treat various musculoskeletal conditions.
No
The device description and intended use indicate that the SmartScrew™ is for maintenance of alignment and fixation of fractures and osteotomies, which are treatment functions, not diagnostic ones.
No
The device description explicitly states the SmartScrew™ is composed of poly-L,D-lactide copolymer and is supplied as a physical screw with specific dimensions, indicating it is a hardware device.
Based on the provided information, the SmartScrew™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes a device for the mechanical fixation and alignment of bones during fracture healing and surgical procedures. This is a structural and mechanical function within the body.
- Device Description: The description details the material (poly-L,D-lactide copolymer) and physical characteristics (threaded screw with specific dimensions). This aligns with a surgical implant.
- 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 in vitro (outside the body) to analyze biological samples. The SmartScrew™ is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The SmartScrew™ is generally intended for maintenance of alignment and fixation of fractures, osteotomies, arthrodeses or condylar grafts within the condylar aspects of the upper extremity, ankle and foot, in the presence of appropriate brace and/or immobilization. Specifically, it is intended for phalangeal fusion and fracture, metacarpal fusion and fracture, carpal fusion and fracture, wrist arthrodesis, Distal radius fractures, olecranon fractures, radial head fractures, humeral condylar fractures, cancellous fractures and osteotomies of the malleolus, ankle fractures, metatarsal osteotomies and correction of hallux valgus.
The SmartScrew™ is not intended for use in and is contraindicated for: 1) Fractures and osteotomies of cortical bone (except those in the hand and foot) and proximal femoral fractures, 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 (comma separated list FDA assigned to the subject device)
HWC, MAI
Device Description
The SmartScrew™ is composed of poly-L,D-lactide copolymer. It is supplied fully threaded with diameters 2.0mm - 4.5mm and lengths 10 - 70mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper extremity, ankle, foot, phalangeal, metacarpal, carpal, wrist, Distal radius, olecranon, radial head, humeral condylar, malleolus, metatarsal, hallux valgus
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.
K003077, K952471, K974876, K992947
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
§ 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
JUL 1 8 2001
510(k) Summary Bionx Implants Inc. 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 Executive Officer Phone: (215) 643-5000 Facsimile: (215) 653-0984
Bionx Implants Ltd. Tuija Annala Director, Quality and Regulatory Affairs P.O.Box 3 FIN-33721 Tampere Finland Phone: 358-3-316 5679 Facsimile: 358-3-316 5629
Date prepared: June 13, 2001
Name of the device:
- A. Trade or Proprietary Name:
- B. Common Name:
SmartScrew™ Bioabsorbable, Threaded, Fixation Rod
Classification Name: C.
Device Product Code: D.
Biodegradable fixation fastener, bone HWC
Predicate Devices:
Bionx Implants Inc. Biofix® Bioabsorbable SR-PLLA Threaded Fixation Rod (K952471)
Bionx Implants Inc. Biofix® Bioabsorbable, Threaded, Distal Radius Screw (K974876, K992947)
Bionx Implants Inc. SmartScrew™ (K003077)
1
Intended Use:
The SmartScrew™ is generally intended for maintenance of alignment and fixation of fractures, osteotomies, arthrodeses or condylar grafts within the condylar aspects of the upper extremity, ankle and foot, in the presence of appropriate brace and/or immobilization. Specifically, it is intended for phalangeal fusion and fracture, metacarpal fusion and fracture, carpal fusion and fracture, wrist arthrodesis, Distal radius fractures, olecranon fractures, radial head fractures, humeral condylar fractures, cancellous fractures and osteotomies of the malleolus, ankle fractures, metatarsal osteotomies and correction of hallux valgus.
The SmartScrew™ is not intended for use in and is contraindicated for: 1) Fractures and osteotomies of cortical bone (except those in the hand and foot) and proximal femoral fractures, 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).
Device Description:
The SmartScrew™ is composed of poly-L,D-lactide copolymer. It is supplied fully threaded with diameters 2.0mm - 4.5mm and lengths 10 - 70mm.
Substantial Equivalence:
The SmartScrew™ has the following similarities to the Bionx Implants The new SmartScrew™ has the following similarities to the cleared SmartScrew (K003077):
- has the same indicated use -
- uses the same operating principle -
- incorporates the same basic design of thread "
- utilizes the same basic dimensions
- is packaged and sterilized using the same materials and processes -
- has the same shelf life -
- has the same trade name -
The predicate device is the Bionx Implants Inc. SmartScrew™ (K952471, K974876, K992947, K003077). These devices have very similar principles of operation and technological characteristics.
In summary, the SmartScrew™M described in this notification is, in our opinion, substantially equivalent to the predicate devices. Furthermore, the minor technological differences between the SmartScrew™ and the predicate devices do not raise any new issues of safety or effectiveness.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three wing-like shapes, suggesting movement or flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 8 2001
Ms. Tuija Annala Director, Quality and Regulatory Affairs Bionx Implants, Ltd. P.O. Box 3 Hermiankatu 6-8L FIN-33721 Tampere Finland
Re: K012001
Trade Name: SmartScrewTM Regulation Number: 888.3040 Regulatory Class: II Product Codes: HWC and MAI Dated: June 14, 2001 Received: June 27, 2001
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 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 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.
3
Page 2 - Ms. Tuija Annala
This letter will allow you to begin marketing your device as described in your 510(k) premarket This letter will and in you of substantial equivalence of your device to a legally marketed nouthoution. The I Drian 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 11 you desire specific articles for a stic devices), please contact the Office of Compliance at additionally 607.10 for in 10 mile promotion and advertising of your device, (2017) 594-4639. I reading 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 miromation on your responsibility free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
tmblellmfor
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Devices Evaluation Center for Devices and Radiological Devices
Enclosure
4
INDICATIONS FOR USE
Kollool
510(K) Number (if known):
Device Name:
SmartScrew™
Indications for Use:
The SmartScrew™ is generally intended for maintenance of alignment and fixation of fractures, osteotomies, arthrodeses or condylar grafts within the condylar aspects of the upper extremity, ankle and foot, in the presence of appropriate brace and/or Specifically, it is intended for phalangeal fusion and fracture, immobilization. metacarpal fusion and fracture, carpal fusion and fracture, wrist arthrodesis, Distal radius fractures, olecranon fractures, radial head fractures, humeral condylar fractures, cancellous fractures and osteotomies of the malleolus, ankle fractures, metatarsal osteotomies and correction of hallux valgus.
The SmartScrew™ is not intended for use in and is contraindicated for: 1) Fractures and osteotomies of cortical bone (except those in the hand and foot) and proximal femoral fractures, 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_
OR Over-The-Counter Use_
(Per 21 CFR 801.109)
Psmt culture for cml
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K012001