The 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 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).

Device Description

NuGen™ FX Screw is composed of poly-L,D-lactide copolymer. It is supplied partly threaded with 3.5mm in diameter, lengths 14-40mm and 4.5mm in diameter, lengths 24 - 70mm.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device called the NuGen™ FX Screw. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving performance against specific acceptance criteria through novel studies.

Therefore, many of the requested details about acceptance criteria, study performance, sample sizes, expert involvement, and ground truth establishment are not applicable or extractable from this type of FDA submission. The purpose of a 510(k) is to show that a new device is as safe and effective as a legally marketed predicate device, not necessarily to independently prove its effectiveness with new clinical trials.

Here's an assessment based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Not applicable. This document does not present specific quantitative acceptance criteria or a study designed to measure the NuGen™ FX Screw's performance against such criteria. The "performance" being demonstrated is its substantial equivalence to predicate devices, implying similar safety and effectiveness.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not applicable. There is no mention of a distinct "test set" in the context of device performance testing in this document. The substantial equivalence argument relies on comparing the new device's characteristics (design, materials, intended use, operating principle, packaging, sterilization, shelf life) to those of predicate devices, which would have undergone their own testing previously.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. No ground truth establishment for a test set is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No test set adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is a medical implant device, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI-related effectiveness are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical medical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable. The document discusses substantial equivalence based on the device's characteristics and intended use being similar to existing predicate devices.

8. The sample size for the training set:

Not applicable. No "training set" in the context of algorithm development or performance testing is mentioned.

9. How the ground truth for the training set was established:

Not applicable. No "training set" or ground truth establishment for it is mentioned.

Summary of Device Acceptance and "Study" (Demonstration of Substantial Equivalence):

The "acceptance criteria" for the NuGen™ FX Screw, as presented in this 510(k) submission, are effectively the conditions for demonstrating substantial equivalence to predicate devices. The "study" that proves the device meets these criteria is the comparison and argument presented in the submission itself.

Acceptance Criteria for Substantial Equivalence (implied from the document):

Same indicated use: The NuGen™ FX Screw must have the same intended use as the predicate device(s).
Same operating principle: The fundamental way the device achieves its intended action must be the same.
Same basic design of thread: The screw thread design should be consistent.
Same basic dimensions: The general size ranges should be comparable.
Packaged and sterilized using the same materials and processes: Consistency in these aspects ensures similar safety profiles.
Same shelf life: The stability and integrity over time should be equivalent.
No new issues of safety or effectiveness: Any differences from the predicate devices must not raise new questions about the device's safety or how well it works.
Similar materials: The raw materials used should be the same as or previously accepted for similar devices.

Reported Device Performance (as demonstrated for substantial equivalence):

The document asserts that the NuGen™ FX Screw meets these implicit criteria by stating:

"NuGen™ FX Screw 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"
"This raw material and design of head of screw are already introduced with fully threaded screw model (K012001)."
"In summary, the NuGen™ FX Screw described in this notification is, in our opinion, substantially equivalent to the predicate devices. Furthermore, the minor technological differences between the NuGen™ FX Screw and the predicate devices do not raise any new issues of safety or effectiveness."

The FDA's decision letter (K023022) confirms their agreement with this assessment: "We have reviewed your Section 510(k) premarket notification... 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..."

Summary

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OCT 0 4 2002

510(k) Summary Bionx Implants Inc. NuGen™ FX Screw

K023022
page 1 of 2

Submitter's Name, Address, Telephone Number, and Contact Person

Bionx Implants, Inc. 1777 Sentry Parkway West Gwynedd Hall, Suite 400 Blue Bell, 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: December 19, 2001

Name of the device:

A.	Trade or Proprietary Name:	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. SmartScrew™ (K012001)

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Intended Use:

KC2 3022
page 2 of 2

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 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.

Device Description:

NuGen™ FX Screw is composed of poly-L,D-lactide copolymer. It is supplied partly threaded with 3.5mm in diameter, lengths 14-40mm and 4.5mm in diameter, lengths 24 - 70mm.

Substantial Equivalence:

NuGen™ FX Screw 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

This raw material and design of head of screw are already introduced with fully threaded screw model (K012001).

The predicate device is the Bionx Implants Inc. SmartScrew™ (K952471, K974876, K992947, K003077, K012001). These devices have very similar principles of operation and technological characteristics.

In summary, the NuGen™ FX Screw described in this notification is, in our opinion, substantially equivalent to the predicate devices. 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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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 consists of a stylized eagle with three heads, representing the three branches of government. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 0 4 2002

Mr. Gerard S. Carlozzi President and Chief Executive Officer Bionx Implant. Inc. 1777 Sentry Parkway West Gwynedd Hall, Suite 400 Blue Bell, Pennsylvania 19422

Re: K023022

Trade Name: 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: August 16, 2002 Received: September 11, 2002

Dear Mr. Carlozzi:

We have reviewed your Section 510(k) premarket 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) 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 (OS) 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 - Mr. Gerard S. Carlozzi

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 and additionally 21 CFR Part 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" (21CFR Part 807.97). 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Mark A. Millenson

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): K023022

Device Name:

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

(Per 21 CFR 801.109)

L. Mark N. Milliken

Division Sign-Off Division of General, Restorative and Neurological Devices

510(k) number K023022

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.