DIP Arthrodesis System

K173616 · In2bones Sas · HTY · Jan 19, 2018 · Orthopedic

Device Facts

• Record ID: K173616
• Device Name: DIP Arthrodesis System
• Applicant: In2bones Sas
• Product Code: HTY · Orthopedic
• Decision Date: Jan 19, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DIP implants are indicated for distal interphalangeal joint fusion of the long fingers. Treatment may include complementary immobilization of the finger (e.g. splint) if considered preferable by the surgeon.

Device Story

DIP Arthrodesis System is an intramedullary bone fastener for distal interphalangeal joint fusion of long fingers; consists of two parts implanted in proximal and distal phalanx; parts lock together to create rigid arthrodesis. Available in multiple lengths and angles (0 or 15 degrees plantar flexion) to accommodate phalangeal size variations. Used by surgeons in clinical settings. Provides rigid fixation to facilitate bone fusion; may be used with complementary splinting. Benefits patient by stabilizing joint and promoting arthrodesis.

Clinical Evidence

Bench testing only. Static and dynamic bending tests performed by independent laboratory compared subject device to predicate. Results met acceptance criteria. Pyrogen testing performed via LAL test per ANSI/AAMI ST72:2011.

Technological Characteristics

Intramedullary bone fastener; PEEK-OPTIMA (PolyEtherEtherKetone) per ASTM F2026; radiolucent; sterile (gamma irradiation); single-use; two-part locking design.

Indications for Use

Indicated for distal interphalangeal joint fusion of long fingers in patients requiring arthrodesis.

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

• StayFuse (K990804)
• X-Fuse (K070598)
• ToeGrip (K133477)
• Reunite Resorbable bone pins (K011522)

Submission Summary (Full Text)

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January 19, 2018

In2Bones SAS % Christine Scifert Executive Vice President MRC-X, LLC 6075 Poplar Avenue Suite 500 Memphis, Tennessee 38119

Re: K173616

Trade/Device Name: DIP Arthrodesis System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HTY Dated: November 21, 2017 Received: November 22, 2017

Dear Christine Scifert:

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 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 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);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Mark N. Melkerson -S

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

Enclosure

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## Indications for Use

510(k) Number (if known) K173616

Device Name DIPArthrodesis System

Indications for Use (Describe)

The DIP implants are indicated for distal interphalangeal joint fusion of the long fingers. Treatment may include complementary immobilization of the finger (e.g. splint) if considered preferable by the surgeon.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/1 description: The image shows a logo for a company called IN2BONES. The logo is set on a gray oval background. A white curved line runs from the top left of the oval to the right of the oval, separating the oval into two sections. The text "IN2BONES" is in white, with the "2" in gray.

### 510(k) SUMMARY For In2Bones Distal InterPhalangeal Implant

| Sponsor identification | In2Bones SAS<br>28 chemin du Petit Bois<br>69130 Ecully – France<br>Phone: [phone]<br>Fax: [phone] |
|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment registration number | 3010470577 |
| Date of preparation | November 21, 2017 |
| Contact person | Christine Scifert, MS, MEM<br>MRC-X, LLC<br>6075 Poplar Avenue, suite 500<br>Memphis, TN 38119<br>Cell: 901-831-8053<br>Email: [e-mail] |
| Proprietary Name | DIP Arthrodesis System |
| Common name | Distal InterPhalangeal Arthrodesis System |
| Device classification regulation | 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener<br>Class II |
| Device Product Code and Panel | HTY: pin, fixation, smooth<br>87 orthopedics |
| Device Description | The Distal InterPhalangeal (DIP) Arthrodesis System, is<br>composed of intramedullary implant, designed to act as a bone<br>fastener for distal interphalangeal arthrodesis of the long fingers.<br>The implant is composed of 2 parts implanted in the proximal<br>and distal phalanx and locked together in a rigid arthrodesis<br>system. |
| | Sizes: The DIP Arthrodesis System is composed of implants<br>available in different lengths and angles. The proximal implant<br>is available in two sizes. The distal implant is available in 2 sizes<br>combined with two angles of plantar flexion: 0 degree or 15<br>degrees to accommodate the size variation of the phalanges<br>across the patient population and interphalangeal angles. |
| | Material: The DIP Arthrodesis System is manufactured from<br>PEEK-OPTIMA® (PolyEtherEtherKetone) polymer from<br>Invibio® as per ASTM F2026, a radiolucent material. |
| | Single use: The DIP Arthrodesis System is designed for single<br>use only. |
| | Sterilization: The DIP Arthrodesis System is supplied sterile,<br>using gamma irradiation. |
| Predicate Devices | Primary predicate:<br>StayFuse (K990804), Pioneer, acquired by Tornier |
| | Additional predicates:<br>X-Fuse (K070598), MemoMetal Implants, acquired by Stryker<br>ToeGrip (K133477), Synchro Medical<br>Reunite Resorbable bone pins (K011522), Biomet |
| Indications for use: | The DIP Arthrodesis System is indicated for distal<br>interphalangeal joint fusion of the long fingers. Treatment may<br>include complementary immobilization of the finger (e.g. splint)<br>if considered preferable by the surgeon. |
| Comparison of the<br>indications for use<br>with the predicate<br>devices: | The indications for use for the In2Bones DIP Arthrodesis<br>System are similar to the predicate devices Tornier StayFuse<br>(K990804), Stryker X-Fuse (K070598), Synchro Medical<br>ToeGrip (K133477) and Biomet Reunite Resorbable bone pins<br>(K011522). |
| | |
| Comparison of<br>Technological<br>characteristics and<br>Substantial<br>Equivalence<br>Summary: | The In2Bones DIP Arthrodesis System is similar to the predicate<br>devices Stryker X-Fuse (K070598), MemoMetal Implants,<br>Tornier StayFuse (K990804), Synchro Medical ToeGrip<br>(K133477), Biomet Reunite Resorbable bone pins (K011522),<br>in intended use, design, size ranges, principle of operation and<br>materials. |
| Summary<br>Performance Data | Performance testing of the DIP Arthrodesis System was assessed<br>through mechanical bench testing performed by an independent<br>test laboratory. Testing performed included static and dynamic<br>bending tests on DIP Arthrodesis System compared to predicate<br>device. The results indicate that the DIP Arthrodesis System met<br>the acceptance criteria. |
| Pyrogen testing | The method used to make the determination that the device meets<br>pyrogen limit specification is the Limulus Amebocyte Lysate<br>(LAL) test in accordance with ANSI/AAMI ST72:2011:<br>Bacterial endotoxins - Test methods, routine monitoring and<br>alternative to batch testing. |
| CONCLUSION | Based on the comparison of indications for use and<br>technological characteristics and the results of the testing<br>performed, the DIP Arthrodesis System is substantially<br>equivalent to the predicate devices identified in the 510(k)<br>submission. |

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