(252 days)
Not Found
No
The summary describes a biodegradable bone fixation screw and its intended use, materials, and dimensions. There is no mention of any software, algorithms, or data processing that would indicate the presence of AI or ML.
Yes
The device is intended for the "maintenance of alignment and fixation of fractures, osteotomies, arthrodeses or condylar grafts," which are medical conditions that it helps to treat or alleviate.
No
The device is a biodegradable bone fixation screw, intended for therapeutic purposes like maintaining alignment and fixation of fractures, osteotomies, and arthrodeses, not for diagnosing conditions.
No
The device description clearly states it is a biodegradable bone fixation screw composed of poly-L/D-lactide copolymer with specific lengths and diameters, indicating it is a physical implant, not software.
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, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the Cannulated NuGen™ FX Screw is a bone fixation screw intended for the maintenance of alignment and fixation of fractures, osteotomies, arthrodeses, or condylar grafts. This is a surgical implant used directly within the body to provide structural support.
- Lack of Diagnostic Function: There is no mention of this device being used to analyze samples or provide diagnostic information about a patient's condition. Its function is purely mechanical and therapeutic.
Therefore, based on the provided information, the Cannulated NuGen™ FX Screw is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Cannulated NuGen™ FX Screw 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.
Product codes
HWC
Device Description
The device description of the Cannulated NuGen™ FX Screw biodegradable bone fixation screw is as follows.
- Composed of poly-L/D-lactide copolymer
- Lengths 14 70mm -
- Diameters 3.5mm with cannulation for 1.2mm K-wire and 4.5 mm with cannulation for 1.6mm K-wire.
- Fully and partly threaded models -
The only modifications that were made are:
- Amendment of screw models with cannulation
- Amendment of suitable instruments into instrumentation accordingly.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
condylar aspects of the upper extremity, ankle and foot; phalangeal, metacarpal, carpal, wrist, Distal radius, olecranon, radial head, humeral condylar, malleolus, metatarsal.
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)
K952471, K974876, K992947, K003077, K012001, K023022
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.
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K033447
page 1 of 2
510(k) Summary Linvatec Biomaterials Cannulated NuGen™ FX Screw
Submitter's Name, Address, Telephone Number, and Contact Person
Linvatec Biomaterials Ltd. Tuija Annala Director, Quality and Regulatory Affairs P.O.Box 3 FIN-33721 Tampere Finland, Europe 358-3-316 5600 Phone: 358-3-316 5629 Facsimile:
July 29, 2003 Date prepared:
Name of the device:
| A. | Trade or Proprietary Name: | Cannulated NuGen™ FX Screw | |
|---|---|---|---|
| B. | Common Name: | Bioabsorbable, 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, K992947) Bionx Implants Inc. SmartScrew™ (K003077) Bionx Implants Inc. SmartScrewTM (K012001) Bionx Implants Inc. NuGen™ FX Screw (K023022)
Intended Use:
Cannulated NuGen™ FX Screw 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.
1
K03>447
page 2 of
The NuGen™ FX Screw 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). 3) Highly comminuted fractures, which would not be appropriate for fixation with metallic screws. 4) Patients with suspected or known allergy to the implant material.
Device Description:
The device description of the Cannulated NuGen™ FX Screw biodegradable bone fixation screw is as follows.
- Composed of poly-L/D-lactide copolymer ।
- Lengths 14 70mm -
- Diameters 3.5mm with cannulation for 1.2mm K-wire and 4.5 mm with cannulation for 1.6mm K-wire.
- Fully and partly threaded models -
The only modifications that were made are:
- Amendment of screw models with cannulation ।
- Amendment of suitable instruments into instrumentation accordingly. -
Substantial Equivalence:
The Cannulated NuGen FX Screw™ has the following similarities to the cleared models of NuGen FX Screw (K012001, K023022):
- has the same indicated use -
- uses the same operating principle -
- incorporates the same basic design of thread -
- utilizes the same basic dimensions
- is manufactured by machining -
- is packaged and sterilized using the same materials and processes -
- has the same shelf life
In summary, the Cannulated NuGen™ FX Screw described in this notification is, in our opinion, substantially equivalent to the predicate device. Furthermore, the minor technological differences between the NuGen™ FX Screw and the predicate devices do not raise any new issues of safety or effectiveness.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white and has a simple, clean design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 6 2004
Ms. Tuija Annala Director, Quality and Regulatory Affairs Linvatec Biomaterials Ltd. Hermiankatu 6-8 L FIN 33721 Tampere, Finland
Re: K032447
Trade/Device Name: Cannulated NuGen™ FX Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: March 24, 2004 Received: March 29, 2004
Dear Ms. Annala:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications felevelocal above and nave determined by marketed predicate devices marketed in interstate for use stated in the encrosure) (o regars) the enactment date of the Medical Device Amendments, or to commence provide to May 20, 1970, the eccordance with the provisions of the Federal Food, Drug, devices that have been rechasined in asse approval of a premarket approval application (PMA). and Cosmette rear (110) that as nevice, subject to the general controls provisions of the Act. The 1 ou may, morelore, mainer of the Act include requirements for annual registration, listing of general controls provisions of wactice, labeling, and prohibitions against misbranding and adultcration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is bassified (600 a00 70) as . 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.
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 that I 27 Has Intact and regulations administered by other Federal agencies. You must or any I edelar statutes and equirements, 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.
3
Page 2 - Ms. Tuija Annala
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms lotter will and my Journe FDA finding of substantial equivalence of your device to a legally premaince notineatem - 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), please 11 you attire office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Oivision 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,
Sincerely yours,
Mark N. Mikkelson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(K) Number (if known): K032447
Device Name:
Cannulated NuGen™ FX Screw
Indications for Use:
The Cannulated NuGen™ FX Screw 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 Cannulated NuGen™ FX Screw 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). 3) Highly comminuted fractures, which would not be appropriate for fixation with metallic screws. 4) Patients with suspected or known allergy to the implant material.
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 No
(Per 21 CFR 801.109)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number K032447