NEWDEAL INTERPHALANGEAL IMPLANT

• K Number: K103623
• Device Name: NEWDEAL INTERPHALANGEAL IMPLANT
• Manufacturer: NEWDEAL SAS
• Date Cleared: 2012-03-20 ( 466 days)
• Product Code: HTY
• Regulation Number: 888.3040
• Type: Traditional
• Panel: Orthopedic
• Reference & Predicate Devices: K022599 , K100414 , K070598
• Predicate For: N/A

Intended Use

The Newdeal Interphalangeal Implant is intended for fixation of proximal interphalangeal joint arthrodesis of the lesser toes.

Examples include:

• rigid or semi-rigid hammertoe deformity .
• revision of failed arthroplasty or arthrodesis .
• 2nd toe shortening .

Device Description

The Newdeal Interphalangeal implant is designed to respect anatomical flexion to achieve fixation of interphalangeal arthrodesis of the lesser toes in case of:

• . Fixed or semi-fixed hammer toe
• Revision of failed arthrodesis or arthroplasty ●
• . Shortening due to length excess of the second toe

This interphalangeal implant configuration will be offered in two different sizes.

AI/ML Overview

The provided text describes the Newdeal® Interphalangeal implant and its substantial equivalence to other devices. It focuses on the regulatory submission (510(k) summary) for this medical device. As such, the information required to populate the table (acceptance criteria and device performance based on a study of AI/algorithm performance) and subsequent questions about AI/algorithm-related studies are not present in the document. This document is a regulatory submission for a physical medical implant, not an AI or algorithm-based device.

Therefore, I cannot provide the requested information.

Here's why:

• Acceptance Criteria & Device Performance: The document mentions "Static and Fatigue Bending tests were performed comparing the mechanical properties" but does not detail specific quantitative acceptance criteria or the reported device performance against those criteria. It only states that the results "helped to support substantial equivalence."
• AI/Algorithm Related Questions (2-7): The entire submission is for a physical orthopedic implant. It does not involve an AI or algorithm. Therefore, there are no test sets, data provenance, experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth types related to AI.
• Training Set (8-9): Similarly, the concept of a "training set" and establishing ground truth for it is irrelevant for a physical mechanical implant.

Summary

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K103623 . 1/2

Image /page/0/Picture/1 description: The image shows the logo for Newdeal, an Integra LifeSciences Company. The logo features the word "newdeal" in bold, black letters, with a small registered trademark symbol next to the "l". To the left of the word is a circular graphic with five circles around the perimeter, one of which is filled in black. Below the word "newdeal" is the text "An Integra LifeSciences Company" in a smaller font.

MAR 2 0 2012

510(k) SUMMARY

Newdeal® Interphalangeal implant

Submitter's name and address:

Newdeal SAS Immeuble Séquoïa 2 97 allée Alexandre Borodine · Parc Technologique de la Porte des Alpes 69800 Saint Priest - France Tel: [phone] Fax: [phone] Establishment Registration Number: 9615741

Contact Person and telephone number:

Marilyse Latour Regulatory Affairs Manager Newdeal SAS Immeuble Séquoïa 2 97 allée Alexandre Borodine Parc Technologique de la Porte des Alpes 69800 Saint Priest - FRANCE Tel: [phone] Fax: [phone] Email: marilyse.latour(@integralife.com

Alternate Contact

Allison Weiser Regulatory, Quality, and Clinical Affairs Associate Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536, USA Tel: [phone] Fax: [phone] Email: [e-mail]

Authorized Agent in the United States

Judith E. O'Grady Sr. Vice President, Regulatory Affairs, Quality Assurance and Clinical Affairs Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536, USA Tel: [phone] Fax: [phone] E-mail: [e-mail]

Date summary was prepared: March 12, 2012

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Image /page/1/Picture/0 description: The image shows the logo for Newdeal, an Integra LifeSciences Company. The logo features the word "newdeal" in bold, black letters, with a circle to the left of the word. The circle contains five smaller circles, one of which is filled in black. Below the word "newdeal" is the text "An Integra LifeSciences Company" in a smaller font.

Name of the device:

Propriety Name: ' Newdeal® Interphalangeal implant Pin. Fixation, Smooth Common Name: Classification Name: Smooth or threaded metallic bone fixation fastener (21CFR 888.3040) Device Product Code: HTY Classification Panel: Orthopedic

Substantial Equivalence:

The Newdeal Interphalangeal implant is substantially equivalent to the commercially marketed devices. Newdeal® K-Wire, (K022599), Memometal Intramedulary Bone Fastener (K070598) and Merete Medical MetaToe EndoSorb Hammer Toe Pin (K100414).

Device description:

The Newdeal Interphalangeal implant is designed to respect anatomical flexion to achieve fixation of interphalangeal arthrodesis of the lesser toes in case of:

• . Fixed or semi-fixed hammer toe
• Revision of failed arthrodesis or arthroplasty ●
• . Shortening due to length excess of the second toe

This interphalangeal implant configuration will be offered in two different sizes.

Indications for Use:

The Newdeal® Interphalangeal implant is intended for fixation of proximal interphalangeal joint arthrodesis of the lesser toes.

Examples include:

• · rigid or semi-rigid hammertoe deformity
• revision of failed arthroplasty or arthrodesis ●
• · 2nd toe shortening

Testing and Test Results:

Static and Fatigue Bending tests were performed comparing the mechanical properties of Newdeal K-wire (K022599) and the Merete Medical MetaToe EndoSorb Hammer Toe Pin (K100414) to the Newdeal Interphalangeal Implant. Results from both analyses helped to support substantial equivalence. Clinical data were also provided to support equivalence.

Conclusion:

The Newdeal® Interphalangeal implant is substantially equivalent to the commercially marketed devices, Newdeal K-Wire (K022599), Memometal Intramedulary Bone Fastener (K070598) and Merete Medical MetaToe EndoSorb Hammer Toe Pin (K100414).

The proposed device does not change the intended use or fundamental scientific technology of the predicate devices, and does not raise any new issues of safety or effectiveness.

K103623

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of a human figure with outstretched arms.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Newdeal SAS % Ms. Marilyse Latour Immeuble Séquoïa 2 97 allée Alexandre Borodine Parc Technologique de la Porte des Alpes 69800 Saint Priest - FRANCE

MAR 2 0 2012

Re: K103623

Trade/Device Name: Newdeal Interphalangeal Implant Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HTY Dated: March 12, 2012 Received: March 13, 2012

Dear Ms. Latour:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 – Ms. Marilyse Latour

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

incerely yours,

for

Mark N. Mellecker

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K103623

Device Name: Newdeal Interphalangeal Implant

Indications For Use:

The Newdeal Interphalangeal Implant is intended for fixation of proximal interphalangeal joint arthrodesis of the lesser toes.

Examples include:

• rigid or semi-rigid hammertoe deformity .
• � revision of failed arthroplasty or arthrodesis .
• 2nd toe shortening .

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Dixision Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K103623

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.