(245 days)
Not Found
No
The device description and performance studies focus solely on the mechanical properties and materials of a plate and screw system for bone fixation. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is an implantable plate and screw system used for surgical procedures on the calcaneus, which is a structural component for bone fixation rather than directly providing therapy.
No
The device description and intended use indicate it is an implantable plate and screw system for surgical fixation during osteotomies and other orthopedic procedures, not for diagnosing conditions.
No
The device description explicitly details physical components such as plates, screws, and accessory instruments made of Ti-6Al-4V ELI, which are hardware. The performance studies also focus on the mechanical properties of these hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical implant system for bone procedures (osteotomies, fusions, etc.) in the calcaneus. This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The device is described as a plate and screw system made of titanium, designed for surgical implantation. This is consistent with a medical device used for structural support and fixation, not for analyzing samples from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) from the human body to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) for surgical repair.
N/A
Intended Use / Indications for Use
The Nextremity Solutions CalcShift™ Displacement Calcaneal Osteotomy System is indicated for osteotomies, nonunions, malunions, revisions, fusions, and reconstruction of the calcaneus requiring a medial or lateral displacement osteotomy.
Product codes
HRS, HWC
Device Description
The CalcShift Displacement Calcaneal Osteotomy System is a foot and ankle plate and screw system consisting of a plate and screw implants. The plate is 1.6mm thick, 19.75mm long, and 11.5mm wide. The plate has 4 screw holes. The system provides locking and non-locking screws that are 3.5mm in diameter and range in length from 10mm to 70mm. The system includes cannulated compression screws and cannulated stability screws that are 5.0mm in diameter and range from 30mm to 100mm in length. The plate and screws are provided sterile. The plates and screws are manufactured from Ti-6Al-4V ELI conforming to ASTM F136.
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
calcaneus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
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
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached 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 date May 20, 2022. The date is written in a clear, legible font. The month is spelled out, followed by the day and year, separated by commas.
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Nextremity Solutions, Inc. Elise Fox Quality and Regulatory Specialist 1195 Polk Drive Warsaw, Indiana 46582
Re: K212979
Trade/Device Name: CalcShift™ Displacement Calcaneal Osteotomy System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS. HWC Dated: April 14, 2022 Received: April 15, 2022
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.
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
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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, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212979
Device Name
CalcShift™ Displacement Calcaneal Osteotomy System
Indications for Use (Describe)
The Nextremity Solutions CalcShift™ Displacement Calcaneal Osteotomy System is indicated for osteotomies, nonunions, malunions, revisions, fusions, and reconstruction of the calcaneus requiring a medial or lateral displacement osteotomy.
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)
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| 510(k) Summary | |
|---|---|
| Prepared: | May 17, 2022 |
| Submitter: | Nextremity Solutions, Inc. |
| 1195 Polk Drive | |
| Warsaw, IN 46582 | |
| Contact: | Elise Fox |
| Quality and Regulatory Specialist | |
| elise.fox@medartis.com | |
| Phone: 574-376-2062 | |
| FAX: 574-966-1396 | |
| Proprietary Name: | CalcShift™ Displacement Calcaneal Osteotomy System |
| Common Name: | Bone Plate and Screw System |
| Classifications: | 21 CFR §888.3030: Single/Multiple Component Metallic Bone |
| Fixation Appliances And Accessories; Class II (Primary) | |
| 21 CFR §888.3040: Smooth or Threaded Metallic Bone Fixation | |
| Fastener; Class II | |
| Product Codes: | 87 / HRS, 87 / HWC |
Substantially Equivalent Devices:
- Wright Medical Technology, Ortholoc 3Di Midfoot/Flatfoot System, K121651- Primary . Predicate
- Nextremity Solutions, Stratum Foot Plating System, K182201-Additional Predicate .
- Zimmer Biomet, TiMAX™ Cannulated Screw System (Cleared as Biomet Cannulated . Screw System), K140891-Additional Predicate
Device Description:
The CalcShift Displacement Calcaneal Osteotomy System is a foot and ankle plate and screw system consisting of a plate and screw implants. The plate is 1.6mm thick, 19.75mm long, and 11.5mm wide. The plate has 4 screw holes. The system provides locking and non-locking screws that are 3.5mm in diameter and range in length from 10mm to 70mm. The system includes cannulated compression screws and cannulated stability screws that are 5.0mm in diameter and range from 30mm to 100mm in length. The plate and screws are provided sterile. The plates and screws are manufactured from Ti-6Al-4V ELI conforming to ASTM F136.
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The system is provided with a set of accessory instruments designed for preparation of the implant site and insertion of the implants into bone.
Indications for Use:
The Nextremity Solutions CalcShift Displacement Calcaneal Osteotomy System is indicated for osteotomies, non-unions, malunions, revisions, and reconstruction of the calcaneus requiring a medial or lateral displacement osteotomy.
Summary of Technologies/Substantial Equivalence:
The CalcShift Displacement Calcaneal Osteotomy 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 CalcShift Displacement Calcaneal Osteotomy System, axial pullout strength, torque to failure tests, and insertion/removal torque were performed on worst case screws in accordance with ASTM F543-17. Static 4-point bend tests and dynamic 4-point bend tests were performed on the CalcShift plate according to ASTM F382. These tests confirmed that the strength of the CalcShift Displacement Calcaneal Osteotomy 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 CalcShift Displacement Calcaneal Osteotomy System to the predicate device.
Conclusions/Substantial Equivalence:
The CalcShift Displacement Calcaneal Osteotomy 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 different types of safety and effectiveness questions.