The Lync® intramedullary implants are indicated for small bone reconstruction limited to inter-digital fusion of fingers and toes and small bone fusion.

Device Description

Lync® intramedullary implants are single-use bone fixation devices intended to be permanently implanted. Lync® intramedullary implants are made of unalloyed titanium.

AI/ML Overview

The provided text is a 510(k) Summary for the Lync® intramedullary implant by Novastep, which is a medical device. This document does not pertain to an AI/ML device, but rather a physical implant. Therefore, the requested information (acceptance criteria, study details, sample sizes, expert involvement, adjudication, MRMC, standalone performance, ground truth, training set details) is not applicable or cannot be extracted from this type of regulatory submission.

The document discusses the substantial equivalence of the Lync® intramedullary implant to predicate devices based on mechanical characteristics, material, intended use, and indications for use. It references compliance with ASTM F564-10 for metallic bone staples and ISO 5832-2 for unalloyed titanium. Biocompatibility was evaluated according to ISO 10993-1.

Key points from the document regarding device testing:

Mechanical characteristics: Tested according to ASTM F564-10 Sections A1, A2, and A4 (Standard Specification and Test Methods for Metallic Bone Staples). These tests would likely involve static bending, dynamic bending, and pull-out resistance.
Material: Conforms to ISO 5832-2 (Implants For Surgery - Metallic Materials – Part 2: Unalloyed Titanium).
Biocompatibility: Evaluated in accordance with ISO 10993-1.

Since this is a 510(k) submission for a non-AI medical device, a direct mapping to the requested AI/ML specific criteria (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone algorithm performance, training set details) is not possible. The document explicitly states: "Clinical studies were not required for this submission" and "Animal studies were not required for this submission." The basis for clearance is demonstrating substantial equivalence to legally marketed predicate devices through comparison of technological characteristics, materials, and mechanical performance.

Summary

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

February 19, 2015

Novastep Mr. Gilles Audic QA/RA Director Espace Performance Alphasis - Batiment C1-C2 35769 Saint Gregoire France

Re: K143049

Trade/Device Name: Lync® intramedullary implant Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY Dated: January 27, 2015 Received: January 30, 2015

Dear Mr. Audic:

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

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Page 2 - Mr. Gilles Audic

(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 (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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Lori A. Wiggins -S

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

Enclosure

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Expiration Date: January 31, 2017

See PRA Statement below.

Form Approved: OMB No. 0910-0120

Indications for Use

510(k) Number (if known) K143049

Device Name Lync® intramedullary implant

Indications for Use (Describe)

The Lync® intramedullary implants are indicated for small bone reconstruction limited to inter-digital fusion of fingers and toes and small bone fusion.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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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:

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Image /page/3/Picture/1 description: The image shows the logo for "novastep". The logo consists of a stylized, abstract shape on the left, followed by the word "novastep" in a sans-serif font. The entire logo is in a muted pink color. There is a registered trademark symbol to the right of the word "novastep".

"510(k) Summary" as required by section 807.92(c)

Submitter	NOVASTEP
	Espace performance Alphasis
	Bâtiment C1-C2
	35769 SAINT GREGOIRE
	France
	Phone : + 33 (0)2 99 33 86 50
	Fax :+ 33 (0)9 70 29 18 95
Contact person	Mister Gilles AUDIC
	QA / RA Director
	Cell phone:+33 (0)6 30 93 96 08
	e-mail: gilles.audic@novastep-ortho.com
Preparation date	February 3rd 2015

Trade name	Lync® intramedullary implant
Common Name	Intramedullary implant
Classification Name	Smooth or threaded metallic fixation fastener (21CFR 888.3040, productcode HTY)
Regulatory class	II

Legally marketed predicate devices	510(k) number:This 510K submission uses a main predicate (in term of intended use, indication for use, mechanical characteristics technological characteristics & design):K070598 / K112197 K112197 is a re-submission of K070598 after Memometal Smart Toe® intramedullary bone fastener line extension.	510(k) number:	This 510K submission uses a main predicate (in term of intended use, indication for use, mechanical characteristics technological characteristics & design):	K070598 / K112197	K112197 is a re-submission of K070598 after Memometal Smart Toe® intramedullary bone fastener line extension.
510(k) number:
This 510K submission uses a main predicate (in term of intended use, indication for use, mechanical characteristics technological characteristics & design):
K070598 / K112197
K112197 is a re-submission of K070598 after Memometal Smart Toe® intramedullary bone fastener line extension.

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Image /page/4/Picture/1 description: The image shows the word "novastep" in a stylized font. The word is in a pink color, and there is a symbol to the left of the word. There is also a registered trademark symbol to the right of the word.

	Device name: Memometal Intramedullary bone fastener, models SmartToe / X-Fuse
	Original applicant: Memometal Technologies.
	And a second predicate (only for the material):
	K102072
	Device name: Memometal implants (K-Snap & Ti-Fuse)
	Original applicant: Memometal Technologies
Description	Lync® intramedullary implants are single-use bone fixation devicesintended to be permanently implanted. Lync® intramedullary implantsare made of unalloyed titanium.
Intended use	The Lync® intramedullary implants are intended for small bonereconstruction limited to inter-digital fusion of fingers and toes and smallbone fusion.
Comparison of thetechnologicalcharacteristics with thepredicate device	The new devices Lync® intramedullary implants have similar technologicalcharacteristics in terms of mechanical characteristics (ASTM F564-10Sections A1, A2 and A4 Standard Specification and Test Methods forMetallic Bone Staples) and thus are believed to be substantiallyequivalent to the predicate device Memometal Intramedullary bonefastener, models Smart Toe / X-Fuse (K070598 / K112197).
	The new devices Lync® intramedullary implants have similar technologicalcharacteristics in terms of material (ISO5832-2 Implants For Surgery -Metallic Materials – Part 2: Unalloyed Titanium) and thus are believed tobe substantially equivalent to the predicate device Memometal implants(K-Snap & Ti Fuse) (K102072).
Performance data	The biocompatibility evaluation for new devices Lync® intramedullaryimplants was conducted in accordance with Blue Book Memorandum#G95-1 "Use of International Standard ISO-10993, 'Biological Evaluationof Medical Devices Part 1: Evaluation and Testing" and InternationalStandard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1:Evaluation and Testing Within a Risk Management Process" as recognizedby FDA.
	The new devices Lync® intramedullary implants have similar technologicalcharacteristics in terms of design and mechanical characteristics (staticbending, dynamic bending and pull-out resistance) and thus are believedto be substantially equivalent to the predicate device Memometal
	Intramedullary bone fastener, models Smart Toe / X-Fuse (K070598 /K112197).
Indication for use	The Lync® intramedullary implants are indicated for small bonereconstruction limited to inter-digital fusion of fingers and toes and smallbone fusion.
Clinical studies	Clinical studies were not required for this submission
Animal studies	Animal studies were not required for this submission
Conclusion	The Lync® intramedullary implants are substantially equivalent to theirpredicate devices Memometal Intramedullary bone fastener, modelsSmart Toe / X-Fuse (K070598 / K112197), in terms of intended use andindications for use, design and function and to Memometal implants (K-Snap & Ti Fuse) (K102072) in terms of material. Any minor differencesbetween these devices do not raise new questions of safety andeffectiveness.

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Image /page/5/Picture/1 description: The image shows the logo for "novastep". The logo consists of a stylized, abstract shape to the left of the word "novastep", which is written in a sans-serif font. A circled "R" symbol is present to the upper right of the word "novastep", indicating that the logo is a registered trademark. The logo is a muted pink color.

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.