(85 days)
No
The device description and performance studies focus on the mechanical properties and fixation capabilities of the implant, with no mention of AI or ML.
No.
The device is a surgical implant designed for internal fixation during bone fusion, which is used to physically stabilize bones, not to treat a disease or medical condition in a therapeutic sense.
No
The device is described as an internal fixation system used for surgical fusion of bones, not for identifying or diagnosing a condition.
No
The device description clearly states it consists of physical components (post, screws, post plug screw) made of Ti-6Al-4V alloy and includes accessory instruments for implantation. This is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "internal fixation for First Metatarsocuneiform arthrodesis". This describes a surgical procedure to fuse bones, not a test performed on biological samples outside the body to diagnose a condition.
- Device Description: The device is a "three-part construct" consisting of a post and screws made of titanium alloy. These are physical implants used in surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any diagnostic testing. The performance studies focus on mechanical strength and bacterial endotoxin levels, which are relevant to surgical implants, not diagnostic tests.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device is a surgical implant used for structural support during bone fusion.
N/A
Intended Use / Indications for Use
The Nextremity Solutions InCore® Lapidus System is a three-part construct intended for internal fixation for First Metatarsocuneiform arthrodesis (also known as Lapidus or First Tarsometatarsal Fusion).
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The InCore® Lapidus System consists of a post and two headless compression screws. Posts are available in 28mm and 32mm lengths and in right and left orientations. Screws are available in a 3.5mm diameter and lengths of 24 to 60mm. The post is inserted into the medial cuneiform and compression screws are inserted into the first metatarsal and into the post to maintain apposition of the bones during fusion. A post plug screw is threaded into the top of the post after all components have been implanted to prevent tissue ingrowth into the post and facilitate removal, if needed. All implants are manufactured from color anodized Ti-6Al-4V alloy conforming to ASTM F-136. The system is provided with a set of accessory instruments designed for preparation of the implant site and insertion of the implants into bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
First Metatarsocuneiform
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)
Non-Clinical Testing: To evaluate the strength of the InCore® Lapidus System and components, axial pull-out strength, torque to failure and 3 point bend tests were performed on worst case compression screws. Torque to failure, static 3 point bend and dynamic 3 point bend tests were performed on worst case constructs. These tests confirmed that the strength of the InCore® Lapidus System is substantially equivalent to predicate devices with similar indications and is adequate for its intended use. In addition, bacterial endotoxin levels were measured using LAL testing.
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.
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/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration. The Department of Health & Human Services logo is on the left, and the U.S. Food & Drug Administration logo is on the right. The FDA logo is blue and white and includes the words "FDA U.S. FOOD & DRUG ADMINISTRATION".
April 25, 2018
Nextremity Solutions, Inc. Greg Denham Project Leader, Product Development 210 North Buffalo Street Warsaw, Indiana 46580
Re: K180257
Trade/Device Name: InCore® Lapidus System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: January 29, 2018 Received: January 30, 2018
Dear Greg Denham:
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 (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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
K180257
Device Name
InCore® Lapidus System
Indications for Use (Describe)
The Nextremity Solutions InCore® Lapidus System is a three-part construct intended for internal fixation for First Metatarsocuneiform arthrodesis (also known as Lapidus or First Tarsometatarsal Fusion).
Type of Use (Select one or both, as applicable)
区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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| 510(k) Summary | |
|---|---|
| Prepared: | April 8, 2018 |
| Submitter: | Nextremity Solutions, Inc. |
| 210 North Buffalo Street | |
| Warsaw, IN 46580 | |
| Contact: | Greg Denham |
| Project Leader, Product Development | |
| greg.denham@nextremity.com | |
| Phone: 732-383-7901 | |
| FAX: 574-966-1396 | |
| Proprietary Name: | InCore® Lapidus System |
| Common Name: | Bone Screw System |
| Classification: | 21 CFR §888.3040: Smooth or Threaded Metallic Bone Fixation Fastener; |
| Class II | |
| Product Code: | HWC |
| Substantially | |
| Equivalent Devices: | Extremity Medical Screw and Washer System (IO FiX), K121349 – Primary Predicate Phalanx Innovations OsteoBullet Compression Screw, K160304 |
Nextremity Solutions Axi+Line Proximal Bunion Correction System, � K152548 - Reference Predicate
Device Description:
The InCore® Lapidus System consists of a post and two headless compression screws. Posts are available in 28mm and 32mm lengths and in right and left orientations. Screws are available in a 3.5mm diameter and lengths of 24 to 60mm. The post is inserted into the medial cuneiform and compression screws are inserted into the first metatarsal and into the post to maintain apposition of the bones during fusion. A post plug screw is threaded into the top of the post after all components have been implanted to prevent tissue ingrowth into the post and facilitate removal, if needed. All implants are manufactured from color anodized Ti-6Al-4V alloy conforming to ASTM F-136.
4
The system is provided with a set of accessory instruments designed for preparation of the implant site and insertion of the implants into bone.
Intended Use / Indications:
The Nextremity Solutions InCore® Lapidus System is a three-part construct intended for internal fixation for First Metatarsocuneiform arthrodesis (also known as Lapidus or First Tarsometatarsal Fusion).
Summary of Technologies, Similarities/Differences:
The InCore® Lapidus System is similar to the predicate devices in regards to its intended use and indications, material, design, sizes, and mechanical properties. Differences between the subject device system and the predicate device systems include a targeting guide and sub-cortical interlocking components. These differences do not rase new types of safety and effectiveness questions.
Non-Clinical Testing:
To evaluate the strength of the InCore® Lapidus System and components, axial pull-out strength, torque to failure and 3 point bend tests were performed on worst case compression screws. Torque to failure, static 3 point bend and dynamic 3 point bend tests were performed on worst case constructs. These tests confirmed that the strength of the InCore® Lapidus System is substantially equivalent to predicate devices with similar indications and is adequate for its intended use. In addition, bacterial endotoxin levels were measured using LAL testing.
Clinical Testing:
Clinical testing was not necessary to demonstrate substantial equivalence of the InCore® Lapidus System to the predicate device.
Conclusions / Substantial Equivalence:
Differences between the subject device system and the predicate device systems do not raise new types of safety and effectiveness questions. The InCore® Lapidus System is substantially equivalent to the predicate devices in regards to its intended use, material, design, sizes and mechanical properties.