(81 days)
Not Found
No
The device description and performance studies focus on mechanical properties and surgical instrumentation, with no mention of AI or ML.
Yes
The device is an implant designed for the reduction and internal fixation of arthrodeses, osteotomies, and nonunions of bones and joints of the foot, specifically for subtalar joint arthrodesis, which directly treats a medical condition.
No
The device is described as an internal fixation system for bones and joints of the foot, specifically for arthrodeses, osteotomies, and nonunions, which means it is a therapeutic/surgical device, not a diagnostic one.
No
The device description clearly states it consists of physical components (post, screws, instruments, targeting guide) made of Ti-6Al-4V alloy, which are implanted into the body. This is a hardware 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 "reduction and internal fixation of arthrodeses, osteotomies, and nonunions of the bones and joints of the foot." This describes a surgical implant used to stabilize bones, not a test performed on biological samples to diagnose or monitor a condition.
- Device Description: The device is a "post and two headless compression screws" made of Ti-6Al-4V alloy, along with surgical instruments. This is a physical implant and surgical tool system.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
The device is clearly a surgical implant system for orthopedic procedures in the foot.
N/A
Intended Use / Indications for Use
The Nextremity Solutions InCore® Subtalar System is intended for reduction and internal fixation of arthrodeses, osteotomies, and nonunions of the bones and joints of the foot. The three-part construct is specifically intended for internal fixation for Subtalar Joint Arthodesis (also known as Subtalar Joint Fusion).
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The InCore® Subtalar System consists of a post and two headless compression screws. Posts are available with an 8.0 mm diameter, in an 28mm length, and in right and left orientations. Screws are available in a 5.5 mm diameter and lengths of 50 to 120mm. The post is inserted into the talus and compression screws are inserted into the calcaneus 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, including an implant specific targeting guide, 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
bones and joints of the foot, Subtalar Joint
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: Endotoxin testing was performed using the Limulus Amebocyte Lysate (LAL) method according to AAMI ST72, USP 161 and USP 85. Results met the Endotoxin limit of ≤20 EU per device. To evaluate the strength of the InCore® Subtalar System and components, torque to failure was performed on worst case compression screws and worst case constructs per ASTM F543. Static three-point bend and dynamic three-point bend tests were performed on worst case constructs per ASTM F382 and ASTM F1264. These tests confirmed that the strength of the InCore® Subtalar System is substantially equivalent to predicate devices with similar indications and is adequate for its intended use.
Clinical Testing: Clinical testing was not necessary to demonstrate substantial equivalence of the InCore® Subtalar System to the predicate device.
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
December 21, 2021
Nextremity Solutions, Inc. Elise Fox Quality and Regulatory Specialist 1195 Polk Drive Warsaw, Indiana 46582
Re: K213301
Trade/Device Name: InCore® Subtalar System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: September 30, 2021 Received: October 1, 2021
Dear Elise Fox:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Shumaya Ali, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
InCore® Subtalar System
Indications for Use (Describe)
The Nextremity Solutions InCore® Subtalar System is intended for reduction and internal fixation of arthrodeses, osteotomies, and nonunions of the bones and joints of the three-part construct is specifically intended for internal fixation for Subtalar Joint Arthodesis (also known as Subtalar Joint Fusion).
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary - K213301
| Prepared: | September 30, 2021 |
|---|---|
| Submitter: | Nextremity Solutions, Inc. |
| 1195 Polk Drive | |
| Warsaw, IN 46582 | |
| Contact: | Elise Fox |
| Quality and Regulatory Specialist | |
| elise.fox@nextremity.com | |
| Phone: 574-376-2062 | |
| FAX: 574-966-1396 | |
| Proprietary Name: | InCore® Subtalar 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:
- Zimmer Biomet, TiMAX™ Cannulated Screw System (Cleared as Biomet Cannulated ● Screw System), K140891-Primary Predicate
- Nextremity Solutions, Stratum Foot Plating System, K182201-Additional Predicate .
Device Description:
The InCore® Subtalar System consists of a post and two headless compression screws. Posts are available with an 8.0 mm diameter, in an 28mm length, and in right and left orientations. Screws are available in a 5.5 mm diameter and lengths of 50 to 120mm. The post is inserted into the talus and compression screws are inserted into the calcaneus 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, including an implant specific targeting guide, designed for preparation of the implant site and insertion of the implants into bone.
4
Intended Use / Indications:
The Nextremity Solutions InCore® Subtalar System is intended for reduction and internal fixation of arthrodeses, osteotomies, and nonunions of the bones and joints of the foot. The three-part construct is specifically intended for internal fixation for Subtalar Joint Arthodesis (also known as Subtalar Joint Fusion).
Summary of Technologies/Substantial Equivalence:
The InCore® Subtalar System is substantially equivalent to the predicate devices regarding the intended use and indications, material, design, sizes, and mechanical properties. Differences between the subject device system and the predicate device systems do not raise new types of safety and effectiveness questions.
Non-Clinical Testing:
Endotoxin testing was performed using the Limulus Amebocyte Lysate (LAL) method according to AAMI ST72, USP 161 and USP 85. Results met the Endotoxin limit of ≤20 EU per device. To evaluate the strength of the InCore® Subtalar System and components, torque to failure was performed on worst case compression screws and worst case constructs per ASTM F543. Static three-point bend and dynamic three-point bend tests were performed on worst case constructs per ASTM F382 and ASTM F1264. These tests confirmed that the strength of the InCore® Subtalar System is substantially equivalent to predicate devices with similar indications and is adequate for its intended use.
Clinical Testing:
Clinical testing was not necessary to demonstrate substantial equivalence of the InCore® Subtalar System to the predicate device.
Conclusions/Substantial Equivalence:
The InCore® Subtalar System is substantially equivalent to the predicate devices regarding its intended use, material, design, sizes, and mechanical properties. Differences between the subject device system and the predicate device systems do not raise new types of safety and effectiveness questions.