SMARTSCREW II, MODELS 232010, 232012, 232014, 232016, 232018, 232020

• K Number: K042295
• Device Name: SMARTSCREW II, MODELS 232010, 232012, 232014, 232016, 232018, 232020
• Manufacturer: LINVATEC BIOMATERIALS, LTD.
• Date Cleared: 2004-09-16 ( 23 days)
• Product Code: HWC
• Regulation Number: 888.3040

Intended Use

SmartScrew® II is generally intended for maintenance of alignment and fixation of fractures, osteotomies, arthrodeses of cancellous bone with the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and 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Device Description

SmartScrew® II is generally intended for maintenance of alignment and fixation of fractures, osteotomies, arthrodeses of cancellous bone with the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and 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Predicate Devices

K012001

Reference Devices

K012001

AI/ML (Artificial Intelligence / Machine Learning)

Based on the provided text, there is no indication that the SmartScrew® II device contains an AI model.

The description focuses solely on its intended use as a medical implant for maintaining alignment and fixation of bone fractures, osteotomies, and arthrodeses. This is a purely mechanical function.

The repetitive nature of the text about "cancellous bone within the condylar aspects of long bones" seems to be an error in the source material, but it doesn't suggest any AI functionality.

Therapeutic

No.
The intended use of the SmartScrew® II is for alignment and fixation of bone fractures, osteotomies, and arthrodeses. While these involve the healing process, the device itself is not described as directly administering therapy or treating a condition beyond providing mechanical support for healing.

Diagnostic

No.
The device is intended for the maintenance of alignment and fixation of fractures, osteotomies, and arthrodeses, which are therapeutic and reconstructive uses, not diagnostic.

SaMD (Software as a Medical Device)

No

The intended use describes a physical implant (screw) for fracture fixation, which is a hardware medical device. The name "SmartScrew® II" also implies a physical screw. The description does not mention any software component or function.

IVD (In Vitro Diagnostic)

Based on the provided intended use, the SmartScrew® II is not an In Vitro Diagnostic (IVD) device.

Here's why:

• IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
• The intended use of the SmartScrew® II describes a device used for surgical fixation and alignment of bone fractures, osteotomies, and arthrodeses. This is a direct intervention on the human body for structural support and healing.

Therefore, the SmartScrew® II is a surgical implant or orthopedic device, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

SmartScrew® II is generally intended for maintenance of alignment and fixation of fractures, osteotomies, arthrodeses of cancellous bone 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 metacarpal 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.

SmartScrew® II is not intended for use in and is contraindicated for: 1) Fractures and osteotomies of cortical bone (except about the hand and foot) and proximal femoral fixation. 2) Situations where patient co-operation cannot be guaranteed (e.g., active or potential infection and traumatic injury). 3) Defects which would not be appropriate for fixation with metallic screws. 4) Patients with suspected or known allergy to the implant material.

Product codes

HWC

Device Description

The Ø 2.0mm fully threaded, solid SmartScrew® II has the following similarities to the cleared model Ø 2.0mm fully threaded, solid NuGenFX Screw (K012001):

• 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
  The purpose of this special 510(k) premarket notification is introduction of the new revised head design for Ø 2.0mm fully threaded, solid screw model and introduction of new trade name, SmartScrew® II. Originally the screw head design of Ø 2.0mm fully threaded, solid NuGenFX Screw (K012001) was designed as a cloverleaf head. Further development of head design for smaller outer diameter and easier insertion of Ø 2.0mm screw model continued and finally new head design with outer attachment of screw driver was finalized. The main purposes were smaller size of screw head and improvement of installation properties without scarifying torsion properties of the screw model. The revision of head design has no effect on intended use, principles of operation, production methods, raw material or sterilization.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

phalangeal, metacarpal, carpal, wrist, olecranon, radial head, humeral condylar, malleolus, ankle, 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)

K012001

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

0

K042295
page 1/2

SEP 1 6 2004

510(k) Summary Linvatec Biomaterials SmartScrew II

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: Facsimile: 358-3-316 5629

Date prepared: May 26, 2004

Name of the device:

• A. Trade or Proprietary Name: SmartScrew II
• Common Name: B.

e. Smartscrew II
Dischargeable. Th

• C.
  Bioabsorbable, Threaded, Fixation Rod

HWC and MAI

Classification Name: Biodegradable fixation fastener, bone

• D. Device Product Code:

Predicate Devices:

Linvatec Biomaterials (the previous Bionx Implants Inc). SmartScrew™M (K012001)

The predicate device is the previously cleared Linvatec Biomaterials (the previous Bionx Implants) Ø 2.0mm fully threaded, solid NuGenFX Screw (K012001). Purpose of this special 510(k) premarket notification is introduction of the new revised head design for Ø 2.0mm fully threaded, solid screw model and introduction of new trade name, SmartScrew® II.

Originally the screw head design of Ø 2.0mm fully threaded, solid NuGenFX Screw (K012001) was designed as a cloverleaf head. Further development of head design for smaller outer diameter and easier insertion of Ø 2.0mm screw model continued and finally new head design with outer attachment of screw driver was finalized. The main purposes were smaller size of screw head and improvement of installation properties without scarifying torsion properties of the screw model.

The revision of head design has no effect on intended use, principles of operation, production methods, raw material or sterilization.

1

pge 华2

The Ø 2.0mm fully threaded, solid SmartScrew® II has the following similarities to the cleared model Ø 2.0mm fully threaded, solid NuGenFX Screw (K012001):

• u 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 Ø 2.0mm fully threaded, solid SmartScrew® II is, in our opinion, substantially equivalent to the predicate device.

2

Image /page/2/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, depicted with three stylized lines forming its body and wings.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 6 2004

Ms. Tuija Annala Director, Quality and Regulatory Affairs Linvatec Biomaterials Ltd. P.O. Box 3 Hermiankatu 6-8 L FIN 33721 Tampere, Finland

Re: K042295

Trade/Device Name: SmartScrew® II Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: May 18, 2004 Received: August 24, 2004

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.

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.

3

Page 2 - Ms. Tuija Annala

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), please contact the Office of Compliance at [phone]. 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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

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):

Ko42795

SmartScrew® II Device Name:

Indications For Use:

SmartScrew® II is generally intended for maintenance of alignment and fixation of SmartScrew® II is generally intended for manats within the condylar aspects of tractures, osteolomies, arthroucses of conce . 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 metacarpal fractures, olecranon fractures, radial head fractures, humeral condylar fractures ractures, cancellous fractures and osteotomies of the malleolus, ankle fractures, metatarsal osteotomies and correction of hallux valgus.

SmartScrew® II is not intended for use in and is contraindicated for: 1) Fractures and SmartScrew® 11 1s not mended for about the hand and foot) and proximal femoral ostedtomies of contical oolic (cxcopt thereal fixation is otherwise contraindicated, e.g., Iractures. 2) Situations where interestient co-operation cannot be guaranteed (c.g. active of potential intection and which would not be appropriate for fixation with metallic screws. 4) Patients with suspected or known allergy to the implant material.

h 22 Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use_ No (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

(Division Sign-Off) (Division DigDivision of General, Restorative, and Neurological Devices

510(k) Number K642295

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