DUAFIT INTERGPHALANGEAL IMPLANT, PEEK-FUSE INTERPHALANGEAL IMPLANT

K132912 · In2bones Sas · HWC · Jul 30, 2014 · Orthopedic

Device Facts

• Record ID: K132912
• Device Name: DUAFIT INTERGPHALANGEAL IMPLANT, PEEK-FUSE INTERPHALANGEAL IMPLANT
• Applicant: In2bones Sas
• Product Code: HWC · Orthopedic
• Decision Date: Jul 30, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DUAFIT® Interphalangeal implant is intended for fixation of proximal interphalangeal joint arthrodesis of the lesser toes. Examples include: Rigid or semi-rigid deformity of the PIP joint Revision of failed arthroplasty or arthrodesis 2nd toe shortening.

Device Story

DUAFIT® interphalangeal implant is an intramedullary bone fastener for proximal interphalangeal (PIP) joint arthrodesis of lesser toes. Device features proximal taper with barbs and distal blade for stabilization; available in multiple lengths, diameters, and angles (0°, 10°, 17°). Manufactured from PEEK-OPTIMA® polymer. Used in hospital or outpatient surgery centers by surgeons. Implanted into bone to provide fixation for >30 days. Single-use, gamma-sterilized. Provides mechanical stabilization to facilitate arthrodesis, addressing deformities or failed previous procedures.

Clinical Evidence

Bench testing only. Performed static and cyclic four-point bending tests to demonstrate mechanical equivalence to predicate devices. Results met all acceptance criteria.

Technological Characteristics

Material: PEEK-OPTIMA® polymer (ASTM 2026). Design: Intramedullary fastener with proximal tapered barbs and distal blade; cannulated. Energy: None (passive implant). Sterilization: Gamma irradiation. Connectivity: N/A. Form factor: Multiple lengths (11-20mm) and angles (0°, 10°, 17°).

Indications for Use

Indicated for patients requiring proximal interphalangeal (PIP) joint arthrodesis of the lesser toes, including those with rigid or semi-rigid PIP joint deformities, patients undergoing revision of failed arthroplasty or arthrodesis, and patients requiring 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)
• Metasurg DigiFuse (K111536)
• Parcus PEEK CF push-in suture anchor (K102326)
• WMT Pro-Toe (K120645)
• Arrowhead Arrow-Lok (K112675)
• Smith and Nephew Bioraptor 2.3 PK suture anchor (K071586)
• Merete MetaToe (K100414)
• Synchro Medical Toegrip (K143477)

Submission Summary (Full Text)

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## JUL 3 0 2014

z8, chemin du Petil Bois
69130 Ecully – FRANCE

1 LL -33 (0)4 72 29 26 25
FA> [phone]

[e-mail] www.r. madanes com

## For

| Sponsor identification | In2Bones SAS<br>28 chemin du Petit Bois<br>69130 Ecully - France<br>Phone: [phone]<br>Fax: [phone] |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment registration number | New company. Will register following FDA clearance<br>(Owner/Operator Number: 10046803) |
| Date of preparation | July 23, 2014 |
| Contact person | Norman Estrin<br>Estrin Consulting Group LLC<br>9109 Copenhaver Drive<br>Potomac, MD 20854<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Authorized Agent in the<br>United States | Norman Estrin<br>Estrin Consulting Group LLC<br>9109 Copenhaver Drive<br>Potomac, MD 20854<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Proprietary Name | Duafit® interphalangeal implant |
| Common name | Intramedullary bone fastener |
| Device classification regulation | 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener<br>Class II |
| Device Product<br>Code and Panel | HWC: screw, fixation, bone<br>87 orthopedics |
| Device Description | The DUAFIT® interphalangeal implant is an intramedullary implant,<br>designed to act as a bone fastener for proximal interphalangeal<br>arthrodesis of the lesser rays.<br><br>Design is a combination of a proximal taper with barbs and a distal<br>blade for enhanced stabilization. |
| | It is made available in multiple lengths and diameters, and in 3<br>different angles.<br>The implant is manufactured from PEEK-OPTIMA®, polymer from<br>Invibio®, and is designed for single use only. |
| | <b>Sizes:</b><br>The DUAFIT® interphalangeal implant is available in various angles<br>(straight / 0° - 10° - 17°) and lengths (size 1 to 4, corresponding to 11<br>to 20mm).<br><b>Material:</b> |
| | The DUAFIT® interphalangeal implant is manufactured from<br>Polyetheretherketone PEEK-OPTIMA®, polymer from Invibio®, as per<br>ASTM 2026. It does not have any coating. |
| | <b>Single use:</b><br>The DUAFIT® interphalangeal implant is designed for single use only. |
| | <b>Sterilization:</b><br>The DUAFIT® interphalangeal implant is supplied sterile, using gamma<br>irradiation. |
| | <b>Place of use:</b><br>The DUAFIT® interphalangeal implant is indicated for use in a<br>hospital, or outpatient surgery center where sterile field may be created<br>and maintained. |
| <b>Predicate Devices</b> | Newdeal K-wire (K022599) |
| | Metasurg DigiFuse (K111536) |
| | Parcus PEEK CF push-in suture anchor (K102326) |
| | WMT Pro-Toe (K120645) |
| | Arrowhead Arrow-Lok (K112675) |
| | Smith and Nephew Bioraptor 2.3 PK suture anchor (K071586) |
| | Merete MetaToe (K100414) |
| | Synchro Medical Toegrip (K143477) |
| <b>Indications for use:</b> | The DUAFIT® interphalangeal implant is intended for fixation of<br>proximal interphalangeal joint arthrodesis of the lesser toes. |
| | Examples include: |
| | - rigid or semi-rigid deformity of the PIP joint |
| | - revision of failed arthroplasty or arthrodesis |
| | - 2nd toe shortening |

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| Comparison of | The technological characteristics of the DUAFIT® interphalangeal implant are |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------|
| Technological | the same as the characteristics of predicate devices in terms of intended use and |
| characteristics | design. All these implants have the following features: |
| | Insertion into bone - the DUAFIT® interphalangeal implant and all |
| | predicate devices are intended for surgical implantation into bone for |
| | longer than 30 days. |
| | Tapered barded design in its proximal part - The DUAFIT®<br>1 |
| | interphalangeal implant has similar tapered barded design in its proximal |
| | part, when compared to the Parcus PEEK CF push-in suture anchor |
| | (K102326). Smith and Nephew Bioraptor 2.3 PK suture anchor |
| | (K071586), Metasurg DigiFuse implant (K111536), WMT Pro-Toe |
| | (K120645), Merete MetaToe (K100414) and Synchro Toegrip |
| | (K133477). |
| | Blade design in its distal part - The DUAFIT® interphalangeal implant |
| | has similar blade design in its distal part, when compared to the |
| | Metasurg DigiFuse implant (K111536) and WMT Pro-Toe (K120645). |
| | Its shape is also similar to the distal part of the Synchro Toegrip |
| | (K133477). |
| | Canulated design: The DUAFIT® interphalangeal implant is available<br>- |
| | with a similar canulated design, when compared to the Metasurg |
| | DigiFuse implant (K111536). |
| | Straight / Angled design: The DUAFIT® interphalangeal implant has<br>- |
| | similar straight and angled design, when compared to the Metasurg |
| | DigiFuse implant (K111536), WMT Pro-Toe (K120645) , Arrowhead |
| | Arrow-Lok (K112675) and Synchro Toegrip (K133477) |
| | Made from PEEK: The DUAFIT® interphalangeal implant has exactly<br>- |
| | the same raw material PEEK-OPTIMA®, polymer from Invibio", when |
| | compared to the Smith and Nephew Bioraptor 2.3 PK suture anchor |
| | (K071586). It has similar raw material, when compared to the Parcus |
| | PEEK CF push-in suture anchor (K102326) and Synchro Toegrip |
| | (K133477) . The Newdeal / Integra K-wire (K022599), the WMT Pro- |
| | Toe (K120645) and Arrowhead Arrow-Lok (K112675) are manufactured |
| | from stainless steel 316L, and the Metasurg DigiFuse implant is |
| | manufactured from Titanium Alloy TA6V. The Merete MetaToe is |
| | manufactured from EndoSorb PLGA bioabsorbable material. |
| | Equivalent size range: The DUAFIT® interphalangeal implant has |
| | similar size range, when compared to the Metasurg DigiFuse implant |
| | (K111536), WMT Pro-Toe (K120645), Arrowhead Arrow-Lok |
| | (K112675), Merete MetaToe (K100414) and Synchro Toegrip |
| | (K133477).<br>The DUAFIT® interphalangeal implant has similar intended use and |
| | |
| | mechanical properties when compared to the Merete MetaToe EndoSorb<br>(K100414). Results from testing confirmed that the DUAFIT® |
| | interphalangeal implant is at least equivalent to the predicate device. |
| | |

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| Substantial<br>Equivalence<br>Summary | The DUAFIT® interphalangeal implant has similar indications for use and<br>technological characteristics when compared to the predicate devices. | |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Summary Performance<br>Data | The following tests were performed to demonstrate that the DUAFIT<br>interphalangeal implant is substantially equivalent to other predicate<br>devices:<br>- Static four-point bending test<br>- Cyclic four-point bending test.<br>The results of these studies showed that the DUAFIT interphalangeal<br>implant met the acceptance criteria. | |
| CONCLUSION | Based on the evaluations performed, the design and indications of<br>the DUAFIT® interphalangeal implant are substantially equivalent<br>to the predicate devices identified in the 510(k) submission. No new<br>materials or processes are used in the development of this implant.<br><br>In addition, the results of the testing performed by the test lab<br>indicated that the implants performed as expected for each test.<br><br>The DUAFIT® interphalangeal implants are acceptable for the<br>application. | |

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Image /page/4/Picture/1 description: The image shows a logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three curved shapes that resemble waves or abstract wings. The emblem is positioned to the right of the text.

Public I lealth Service

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

July 30, 2014

In2Bones SAS % Norman F. Estrin, Ph.D. Estrin Consulting Group LLC 9109 Copenhaver Drive Potomac, Maryland 20854

Re: K132912

Trade/Device Name: DUAFIT* Interphalangeal Implant Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: July 3. 2014 Received: July 9, 2014

Dear Dr. Estrin:

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. Iisting 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 is issuance of a substantíal equivalence determination docs 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); medical device reporting (reporting of medical device-rclated adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Dr. Norman F. Estrin

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education 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, Lori A. Wiggins

for

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

Enclosure

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K132912 - page 1 of 1

## Indications for Use

510(k) Number (if known): K132912

Device Name: DUAFIT** Interphalangeal Implant

Indications For Use: The DUAFIT® Interphalangeal implant is intended for fixation of proximal interphalangeal joint arthrodesis of the lesser toes. Examples include: Rigid or semi-rigid deformity of the PIP joint Revision of failed arthroplasty or arthrodesis 2nd toe shortening.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

## Elizabet简介版rank -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K132912

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