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.

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.

AI/ML Overview

This submission is a 510(k) premarket notification for a medical device called the Cannulated NuGen™ FX Screw. As such, it focuses on demonstrating substantial equivalence to previously cleared devices rather than robust clinical studies with acceptance criteria and detailed performance reporting as would be seen in a PMA (Premarket Approval) application.

Therefore, many of the requested categories of information for a study and acceptance criteria are not applicable or available within this 510(k) submission. 510(k)s typically rely on design principles, material equivalence, and potentially limited bench testing rather than extensive clinical trials.

Here's the breakdown of what can be extracted and what is not available:

1. Table of Acceptance Criteria and Reported Device Performance:

Not Applicable/Available: This document does not present formal acceptance criteria or detailed device performance metrics from a study in the way a clinical trial would. The basis of this 510(k) is substantial equivalence to predicate devices rather than meeting specific performance thresholds in a de novo study. The "performance" demonstrated here is the similarity to the predicate devices.

2. Sample Size Used for the Test Set and Data Provenance:

Not Applicable/Available: No test set in the sense of a clinical trial or large-scale performance evaluation is described. The submission focuses on product modifications and demonstrating equivalence to existing cleared devices. Data provenance is not relevant as no specific patient data is analyzed or referenced for a test set.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not Applicable/Available: Ground truth is not established in this context. The submission relies on regulatory judgment of substantial equivalence based on device design, materials, and intended use, not expert consensus on diagnostic or prognostic outcomes.

4. Adjudication Method for the Test Set:

Not Applicable/Available: No test set means no adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not Applicable/Available: This type of study is for evaluating human performance, often in diagnostic imaging, with and without AI assistance. This device is an orthopedic implant, so an MRMC study is entirely irrelevant.

6. Standalone (Algorithm Only) Performance:

Not Applicable/Available: This device is a physical implant, not an algorithm, so standalone performance is not applicable.

7. Type of Ground Truth Used:

Not Applicable/Available: As mentioned, no ground truth is established as part of this submission. The "truth" in a 510(k) is whether the new device is substantially equivalent to existing, legally marketed predicate devices.

8. Sample Size for the Training Set:

Not Applicable/Available: This device is not an AI/ML algorithm or a diagnostic tool that relies on a training set.

9. How the Ground Truth for the Training Set Was Established:

Not Applicable/Available: As above, no training set.

Summary of Relevant Information from the K033447 Submission:

This 510(k) submission (K033447) by Linvatec Biomaterials Ltd. for the Cannulated NuGen™ FX Screw seeks to demonstrate substantial equivalence to several predicate devices, primarily existing NuGen™ FX Screw models (K012001, K023022) and other Bionx Implants Inc. Biofix® and SmartScrew™ products.

The core argument for equivalence is based on the following similarities to the cleared predicate NuGen FX Screw models:

Same indicated use
Same operating principle
Same basic design of thread
Same basic dimensions
Manufactured by machining
Packaged and sterilized using the same materials and processes
Same shelf life

The only modifications introduced in this new device are:

Amendment of screw models with cannulation
Amendment of suitable instruments into instrumentation accordingly

The FDA's review letter (pages 2-3 of the provided text) confirms that they found the device substantially equivalent for the stated indications for use. This means FDA determined that the device is as safe and effective as a legally marketed device that does not require premarket approval (PMA).

In essence, the "acceptance criteria" here implicitly revolve around demonstrating that the new device, despite minor modifications (cannulation), does not raise new questions of safety or effectiveness when compared to its existing, predicate counterparts. The "study" is the submission's argument and evidence of this substantial equivalence based on design, materials (poly-L/D-lactide copolymer), and manufacturing processes.

Summary

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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:
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.

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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.

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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.

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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,

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

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INDICATIONS FOR USE

510(K) Number (if known): K032447

Device Name:

Cannulated NuGen™ FX Screw

Indications for Use:

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

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.