NEWDEAL INTERPHALANGEAL IMPLANT

K103623 · Newdeal Sas · HTY · Mar 20, 2012 · Orthopedic

Device Facts

• Record ID: K103623
• Device Name: NEWDEAL INTERPHALANGEAL IMPLANT
• Applicant: Newdeal Sas
• Product Code: HTY · Orthopedic
• Decision Date: Mar 20, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

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 Story

The Newdeal Interphalangeal Implant is a metallic bone fixation fastener used for the arthrodesis of the proximal interphalangeal joint of the lesser toes. It is designed to achieve fixation in cases of hammertoe deformity, failed previous procedures, or toe shortening. The device is implanted by a surgeon in a clinical setting. It functions as a mechanical fixation device to stabilize the joint, facilitating fusion. The implant is available in two sizes. By providing stable fixation, the device aims to correct toe deformities and restore function, potentially reducing pain and improving patient mobility.

Clinical Evidence

Substantial equivalence supported by bench testing (static and fatigue bending tests) and clinical data. No specific clinical study metrics or sample sizes provided in the summary.

Technological Characteristics

Metallic bone fixation fastener; smooth or threaded configuration; two size options; intended for intramedullary fixation. Class II device under 21 CFR 888.3040.

Indications for Use

Indicated for patients requiring proximal interphalangeal joint arthrodesis of the lesser toes, specifically for rigid or semi-rigid hammertoe deformity, revision of failed arthroplasty or arthrodesis, or 2nd toe shortening.

Regulatory Classification

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.

Predicate Devices

• Newdeal K-Wire (K022599)
• Memometal Intramedulary Bone Fastener (K070598)
• Merete Medical MetaToe EndoSorb Hammer Toe Pin (K100414)

Submission Summary (Full Text)

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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