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 Description

The Distal InterPhalangeal (DIP) Arthrodesis System, is composed of intramedullary implant, designed to act as a bone fastener for distal interphalangeal arthrodesis of the long fingers. The implant is composed of 2 parts implanted in the proximal and distal phalanx and locked together in a rigid arthrodesis system.
Sizes: The DIP Arthrodesis System is composed of implants available in different lengths and angles. The proximal implant is available in two sizes. The distal implant is available in 2 sizes combined with two angles of plantar flexion: 0 degree or 15 degrees to accommodate the size variation of the phalanges across the patient population and interphalangeal angles.
Material: The DIP Arthrodesis System is manufactured from PEEK-OPTIMA® (PolyEtherEtherKetone) polymer from Invibio® as per ASTM F2026, a radiolucent material.
Single use: The DIP Arthrodesis System is designed for single use only.
Sterilization: The DIP Arthrodesis System is supplied sterile, using gamma irradiation.

AI/ML Overview

This is a 510(k) premarket notification for a medical device called the "DIP Arthrodesis System". It's a bone fixation fastener used for distal interphalangeal joint fusion of the long fingers.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Mechanical Bench Testing	Met acceptance criteria.
* Static bending tests	The DIP Arthrodesis System was compared to a predicate device (Tornier StayFuse and others). The results indicated that the DIP Arthrodesis System met the acceptance criteria for static bending. (Specific numerical values for acceptance criteria or performance are not provided in this summary.)
* Dynamic bending tests	The DIP Arthrodesis System was compared to a predicate device. The results indicated that the DIP Arthrodesis System met the acceptance criteria for dynamic bending. (Specific numerical values for acceptance criteria or performance are not provided in this summary.)
Pyrogen Testing	Met pyrogen limit specification.
* Limulus Amebocyte Lysate (LAL) test	The device was tested using the LAL test in accordance with ANSI/AAMI ST72:2011: Bacterial endotoxins - Test methods, routine monitoring and alternative to batch testing. This method determined that the device meets the pyrogen limit specification. (Specific pyrogen limit or test results are not provided in this summary.)

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify exact sample sizes for the mechanical bench testing. It only states that the testing was performed on the "DIP Arthrodesis System compared to predicate device." This implies a comparative study, but the number of devices tested for each condition (test device vs. predicate) is not detailed.

The data provenance is not explicitly mentioned (e.g., country of origin). However, given that it's a bench test for device performance, the "data provenance" would refer to the testing facility and the conditions under which the tests were run. The summary states it was performed by an "independent test laboratory."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This information is not applicable for this type of device and study. The "ground truth" for mechanical bench testing is established by engineering standards and specifications (e.g., ASTM standards for material properties, specified load limits, fatigue cycles). It does not involve human expert interpretation of clinical data in the same way an AI diagnostic device would.

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or studies involving human readers to resolve discrepancies in expert interpretations. Mechanical bench testing relies on objective measurements and established engineering protocols.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. MRMC studies are typically used to evaluate the performance of diagnostic devices, often involving human readers interpreting medical images with and without AI assistance. This device is a bone fixation fastener, and its evaluation is based on mechanical performance and biocompatibility, not diagnostic accuracy.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes, in a sense, a standalone evaluaton was done. The mechanical bench testing and pyrogen testing are evaluations of the device itself (standalone performance) against predefined engineering and safety standards, without human intervention in the device's function during the test. There is no "algorithm" in the context of this mechanical device.

7. The Type of Ground Truth Used:

The ground truth used for this device's evaluation consists of:

Engineering Standards and Specifications: For mechanical bench testing, the ground truth is established by accepted engineering principles for bone fixation devices, performance characteristics of the PEEK-OPTIMA® material (ASTM F2026), and comparison against the performance of legally marketed predicate devices. The acceptance criteria would be derived from these standards and the performance of the predicates.
Regulatory Standards: For pyrogen testing, the ground truth is defined by regulatory standards such as ANSI/AAMI ST72:2011, which specifies acceptable limits for bacterial endotoxins.

8. The Sample Size for the Training Set:

This information is not applicable. "Training set" refers to data used to develop and train machine learning algorithms. This device is a physical, mechanical implant and does not involve AI or machine learning algorithms. Therefore, there is no training set.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable as there is no training set for this type of device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized emblem. To the right is the FDA logo, with the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG' and 'ADMINISTRATION' in blue text. The logos are positioned side by side, indicating a connection between the two organizations.

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);

{1}------------------------------------------------

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K173616

Device Name DIPArthrodesis System

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

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 SAS28 chemin du Petit Bois69130 Ecully – FrancePhone: +33.4.72.29.26.26Fax: +33.4.72.29.26.29
Establishment registration number	3010470577
Date of preparation	November 21, 2017
Contact person	Christine Scifert, MS, MEMMRC-X, LLC6075 Poplar Avenue, suite 500Memphis, TN 38119Cell: 901-831-8053Email: christine.scifert@mrc-x.com
Proprietary Name	DIP Arthrodesis System
Common name	Distal InterPhalangeal Arthrodesis System
Device classification regulation	21 CFR 888.3040: Smooth or threaded metallic bone fixation fastenerClass II
Device Product Code and Panel	HTY: pin, fixation, smooth87 orthopedics
Device Description	The Distal InterPhalangeal (DIP) Arthrodesis System, iscomposed of intramedullary implant, designed to act as a bonefastener for distal interphalangeal arthrodesis of the long fingers.The implant is composed of 2 parts implanted in the proximaland distal phalanx and locked together in a rigid arthrodesissystem.
	Sizes: The DIP Arthrodesis System is composed of implantsavailable in different lengths and angles. The proximal implantis available in two sizes. The distal implant is available in 2 sizescombined with two angles of plantar flexion: 0 degree or 15degrees to accommodate the size variation of the phalangesacross the patient population and interphalangeal angles.
	Material: The DIP Arthrodesis System is manufactured fromPEEK-OPTIMA® (PolyEtherEtherKetone) polymer fromInvibio® as per ASTM F2026, a radiolucent material.
	Single use: The DIP Arthrodesis System is designed for singleuse only.
	Sterilization: The DIP Arthrodesis System is supplied sterile,using gamma irradiation.
Predicate Devices	Primary predicate:StayFuse (K990804), Pioneer, acquired by Tornier
	Additional predicates:X-Fuse (K070598), MemoMetal Implants, acquired by StrykerToeGrip (K133477), Synchro MedicalReunite Resorbable bone pins (K011522), Biomet
Indications for use:	The DIP Arthrodesis System is indicated for distalinterphalangeal joint fusion of the long fingers. Treatment mayinclude complementary immobilization of the finger (e.g. splint)if considered preferable by the surgeon.
Comparison of theindications for usewith the predicatedevices:	The indications for use for the In2Bones DIP ArthrodesisSystem are similar to the predicate devices Tornier StayFuse(K990804), Stryker X-Fuse (K070598), Synchro MedicalToeGrip (K133477) and Biomet Reunite Resorbable bone pins(K011522).

Comparison ofTechnologicalcharacteristics andSubstantialEquivalenceSummary:	The In2Bones DIP Arthrodesis System is similar to the predicatedevices Stryker X-Fuse (K070598), MemoMetal Implants,Tornier StayFuse (K990804), Synchro Medical ToeGrip(K133477), Biomet Reunite Resorbable bone pins (K011522),in intended use, design, size ranges, principle of operation andmaterials.
SummaryPerformance Data	Performance testing of the DIP Arthrodesis System was assessedthrough mechanical bench testing performed by an independenttest laboratory. Testing performed included static and dynamicbending tests on DIP Arthrodesis System compared to predicatedevice. The results indicate that the DIP Arthrodesis System metthe acceptance criteria.
Pyrogen testing	The method used to make the determination that the device meetspyrogen limit specification is the Limulus Amebocyte Lysate(LAL) test in accordance with ANSI/AAMI ST72:2011:Bacterial endotoxins - Test methods, routine monitoring andalternative to batch testing.
CONCLUSION	Based on the comparison of indications for use andtechnological characteristics and the results of the testingperformed, the DIP Arthrodesis System is substantiallyequivalent to the predicate devices identified in the 510(k)submission.

{4}------------------------------------------------

{5}------------------------------------------------

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.