(119 days)
Not Found
No
The summary describes a mechanical bone fixation device made of titanium and focuses on biocompatibility and mechanical performance testing. There is no mention of AI, ML, image processing, or any software-based functionality that would suggest the use of these technologies.
Yes
The device is described as an "intramedullary implant" used for "small bone reconstruction" and "small bone fusion," which are therapeutic interventions.
No.
Explanation: The device is described as an "intramedullary implant" and "bone fixation device" used for "small bone reconstruction" and "fusion." Its function is structural support and fixation, not diagnosis.
No
The device description clearly states that the Lync® intramedullary implants are physical, single-use bone fixation devices made of unalloyed titanium, intended for permanent implantation. This indicates a hardware medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "small bone reconstruction limited to inter-digital fusion of fingers and toes and small bone fusion." This describes a surgical procedure involving the physical implantation of a device to fix bones.
- Device Description: The device is described as "single-use bone fixation devices intended to be permanently implanted." This further confirms its role as a physical implant used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The Lync® intramedullary implants are indicated for small bone reconstruction limited to inter-digital fusion of fingers and toes and small bone fusion.
Product codes (comma separated list FDA assigned to the subject device)
HTY
Device Description
Lync® intramedullary implants are single-use bone fixation devices intended to be permanently implanted. Lync® intramedullary implants are made of unalloyed titanium.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Small bone (fingers and toes)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The biocompatibility evaluation for new devices Lync® intramedullary implants was conducted in accordance with Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process" as recognized by FDA.
The new devices Lync® intramedullary implants have similar technological characteristics in terms of mechanical characteristics (ASTM F564-10 Sections A1, A2 and A4 Standard Specification and Test Methods for Metallic Bone Staples) and thus are believed to be substantially equivalent to the predicate device Memometal Intramedullary bone fastener, models Smart Toe / X-Fuse (K070598 / K112197).
The new devices Lync® intramedullary implants have similar technological characteristics in terms of design and mechanical characteristics (static bending, dynamic bending and pull-out resistance) and thus are believed to be substantially equivalent to the predicate device Memometal Intramedullary bone fastener, models Smart Toe / X-Fuse (K070598 / K112197).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles facing to the right. The profiles are black and the background is white.
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
1
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)
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."
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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, product |
| code 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 / K112197K112197 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 Smart
Toe / 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 devices
intended to be permanently implanted. Lync® intramedullary implants
are made of unalloyed titanium. |
| Intended use | The Lync® intramedullary implants are intended for small bone
reconstruction limited to inter-digital fusion of fingers and toes and small
bone fusion. |
| Comparison of the
technological
characteristics with the
predicate device | The new devices Lync® intramedullary implants have similar technological
characteristics in terms of mechanical characteristics (ASTM F564-10
Sections A1, A2 and A4 Standard Specification and Test Methods for
Metallic Bone Staples) and thus are believed to be substantially
equivalent to the predicate device Memometal Intramedullary bone
fastener, models Smart Toe / X-Fuse (K070598 / K112197). |
| | The new devices Lync® intramedullary implants have similar technological
characteristics in terms of material (ISO5832-2 Implants For Surgery -
Metallic Materials – Part 2: Unalloyed Titanium) and thus are believed to
be substantially equivalent to the predicate device Memometal implants
(K-Snap & Ti Fuse) (K102072). |
| Performance data | The biocompatibility evaluation for new devices Lync® intramedullary
implants was conducted in accordance with Blue Book Memorandum
#G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation
of Medical Devices Part 1: Evaluation and Testing" and International
Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1:
Evaluation and Testing Within a Risk Management Process" as recognized
by FDA. |
| | The new devices Lync® intramedullary implants have similar technological
characteristics in terms of design and mechanical characteristics (static
bending, dynamic bending and pull-out resistance) and thus are believed
to 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 bone
reconstruction limited to inter-digital fusion of fingers and toes and small
bone 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 their
predicate devices Memometal Intramedullary bone fastener, models
Smart Toe / X-Fuse (K070598 / K112197), in terms of intended use and
indications for use, design and function and to Memometal implants (K-
Snap & Ti Fuse) (K102072) in terms of material. Any minor differences
between these devices do not raise new questions of safety and
effectiveness. |
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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.