(269 days)
No
The device description and performance studies focus on mechanical properties and biocompatibility of plates and screws for fracture fixation, with no mention of AI or ML.
Yes
The device is described as a set of plate and screw components for Open Reduction Internal Fixation (ORIF) procedures of the proximal humerus, used to treat fractures, fracture dislocations, osteotomies, and non-unions. This directly indicates its therapeutic purpose of repairing and stabilizing bone structures.
No
Explanation: The device is described as a "Fracture System" and is indicated for "Open Reduction Internal Fixation (ORIF) procedures" for fractures and other bone conditions. This indicates it is a surgical implant for treatment, not a device used for diagnosis.
No
The device description explicitly states it is a set of plate and screw components, which are hardware. The performance studies also describe mechanical testing of these hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The device is intended for "Open Reduction Internal Fixation (ORIF) procedures of the proximal humerus" to treat fractures, fracture dislocations, osteotomies, and non-unions. This describes a surgical procedure performed on the patient's body to fix bones.
- Device Description: The device is described as a "set of plate and screw components" used for internal fixation. These are physical implants used in surgery.
- Lack of IVD Characteristics: An IVD is a medical device used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided text does not mention any such use or interaction with bodily specimens for diagnostic purposes.
The device is clearly an orthopedic surgical implant system.
N/A
Intended Use / Indications for Use
Exactech® Equinoxe® PHx® Fracture System:
The Exactech® Equinoxe® PHx® Fracture System is indicated for Open Reduction Internal Fixation (ORIF) procedures of the proximal humerus. Specific clinical indications for ORIF are as follows: fractures, fracture dislocations, osteotomies, and non-unions of the proximal humerus.
Exactech® EPIC Screws:
The 3.5mm diameter Exactech® EPIC Screws of the Epic Extremity Plate System (cleared under K153340) are also intended for use with the Exactech® Equinoxe® PHx® Fracture System for Open Reduction Internal Fixation procedures of the proximal humerus.
Product codes
HRS, HWC
Device Description
The Exactech® Equinoxe® PHx® Fracture System is a set of plate and screw components for use in Open Reduction Internal Fixation (ORIF) applications for fractures of the proximal humerus. The Exacteche Equinoxe® PHx® Fracture System includes various sizes of fracture plates and fixation screws and is to be used with the 3.5mm diameter Exactech® EPIC locking and non-locking style screws (cleared under K153340). The Exactech® Equinoxe® PHx® Fracture System with the Exactech® EPIC Screws are intended to be used for internal fixation of fractures, fracture dislocations, non-unions, and osteotomies of the proximal humerus.
The Exactech® EPIC Screws were previously cleared with the Epic Extremity Plate System with an indication for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. This is an indication change only for the 3.5mm EPIC locking and non-locking screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal humerus, humerus
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 following non-clinical testing and engineering analyses were performed to demonstrate that the Exactech® Equinoxe® PHx® Fracture System and the 3.5mm diameter Exactech EPIC Screws, as intended, are substantially equivalent to the identified predicate devices:
- Single cycle bend testing (ASTM F382)
- Cyclic fatigue bend testing (ASTM F382)
- Bend fatigue resistance testing of Exac-Loc™ Screw anchor feature (ASTM F384) .
- Bone screw performance testing (ASTM F543) ●
- . Biocompatibility
- Bacterial endotoxins ●
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K093978, K153340, K111352, K051412, K133668
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
September 25, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Exactech, Inc Valdimir Talley Regulatory Specialist 2320 NW 66th Ct. Gainesville, Florida 32653
Re: K223933
Trade/Device Name: Exactech® Equinoxe® PHx® Fracture System; Exactech® EPIC Screws 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: August 25, 2023 Received: August 25, 2023
Dear Mr. Talley:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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 mediation-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-S
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
2
Indications for Use
510(k) Number (if known) K223933
Device Name
Exactech® Equinoxe® PHx® Fracture System; Exactech® EPIC Screws
Indications for Use (Describe) Exactech® Equinoxe® PHx® Fracture System:
The Exactech® Equinoxe® PHx® Fracture System is indicated for Open Reduction Internal Fixation (ORIF) procedures of the proximal humerus. Specific clinical indications for ORIF are as follows: fractures, fracture dislocations, osteotomies, and non-unions of the proximal humerus.
Exactech® EPIC Screws:
The 3.5mm diameter Exactech® EPIC Screws of the Epic Extremity Plate System (cleared under K153340) are also intended for use with the Exactech® Equinox® PHx® Fracture System for Open Reduction Internal Fixation procedures of the proximal humerus.
| 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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3
K223933
Exactech® Equinoxe® PHx® Fracture System with Exactech® EPIC Screws Traditional 510(k) – 510(k) Summary
| Sponsor: | Exactech ®, Inc
2320 N.W. 66th Court
Gainesville, FL 32653 |
|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Phone: (352) 327-4824
Fax: (352) 378-2617 |
| | FDA Establishment Number 1038671 |
| Contact Person: | Valdimir Talley III
Regulatory Affairs Specialist |
| Date: | September 22, 2023 |
| Proprietary Name: | Exactech® Equinoxe® PHx® Fracture System
Exactech® EPIC Screws |
| Common Name: | Proximal Humeral Fracture Plate System |
| Regulation Number and
Classification Names: | 21 CFR 888.3030 (Primary) – Single/multiple component metallic bone
fixation appliances and accessories.
21 CFR 888.3040 – Smooth or threaded metallic bone fixation fastener |
| Device Class: | Class II |
| Product Codes: | HRS – Plate, Fixation, Bone
HWC – Screw, Fixation, Bone |
| Classification Panel: | Orthopedic |
Table 1. Legally Marketed Device to Which Substantial Equivalence Is Claimed:
| Predicate
Designation | 510(k)
Number | Trade or Proprietary Model Name | Manufacturer |
|--------------------------|------------------|---------------------------------------------------------------|----------------------------------------------------|
| Primary | K093978 | Exactech® Equinoxe® Proximal Humerus
Fracture Plate System | Exactech, Inc |
| Additional | K153340 | Epic Extremity Plate System | Exactech, Inc |
| Additional | K111352 | Talon™ DistalFix™ Proximal Femoral
Nail | Orthopedic Designs
North America, Inc.
(ODI) |
| Additional | K051412 | Humeral Head Plate with Angular
Stability | Implants for Trauma
Surgery (ITS) |
| Additional | K133668 | AFT™ GTF System | Shoulder Options |
4
K223933
Exactech® Equinoxe® PHx® Fracture System with Exactech® EPIC Screws Traditional 510(k) - 510(k) Summary
Device Description
The Exactech® Equinoxe® PHx® Fracture System is a set of plate and screw components for use in Open Reduction Internal Fixation (ORIF) applications for fractures of the proximal humerus. The Exacteche Equinoxe® PHx® Fracture System includes various sizes of fracture plates and fixation screws and is to be used with the 3.5mm diameter Exactech® EPIC locking and non-locking style screws (cleared under K153340). The Exactech® Equinoxe® PHx® Fracture System with the Exactech® EPIC Screws are intended to be used for internal fixation of fractures, fracture dislocations, non-unions, and osteotomies of the proximal humerus.
The Exactech® EPIC Screws were previously cleared with the Epic Extremity Plate System with an indication for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. This is an indication change only for the 3.5mm EPIC locking and non-locking screws.
Indications for Use
Exactech® Equinoxe® PHx® Fracture System:
The Exactech® Equinoxe® PHx® Fracture System is indicated for Open Reduction Internal Fixation (ORIF) procedures of the proximal humerus. Specific clinical indications for ORIF are as follows: fractures, fracture dislocations, osteotomies, and non-unions of the proximal humerus.
Exactech® EPIC Screws:
The 3.5mm diameter Exactech® EPIC Screws of the Epic Extremity Plate System (cleared under K153340) are also intended for use with the Exactech® Equinoxe® PHx® Fracture System for Open Reduction Internal Fixation procedures of the proximal humerus.
Summary of Device Characteristics Comparison
The rationale for substantial equivalence is based on consideration of the following device use, design characteristics and performance requirements:
Indications for Use
- The proposed and predicate devices have the same indications for use. ●
Materials
- The proposed and predicate devices are composed of similar, well-established, biocompatible ● materials.
Design Features
- . The proposed and predicate devices have the same or similar design features.
Sterilization
5
K223933
Exactech® Equinoxe® PHx® Fracture System with Exactech® EPIC Screws Traditional 510(k) - 510(k) Summary
- The proposed and predicate devices are provided non-sterile for single use, with the exception of the ● Exac-LocTM screw.
- The Exac-LocTM Screw is provided sterile for single use. ●
Performance Requirements
- . The proposed and predicate devices conform to recognized performance standards for multicomponent bone screw and plate fixation systems.
Non-Clinical Testing
The following non-clinical testing and engineering analyses were performed to demonstrate that the Exactech® Equinoxe® PHx® Fracture System and the 3.5mm diameter Exactech EPIC Screws, as intended, are substantially equivalent to the identified predicate devices:
- Single cycle bend testing (ASTM F382)
- Cyclic fatigue bend testing (ASTM F382)
- Bend fatigue resistance testing of Exac-Loc™ Screw anchor feature (ASTM F384) .
- Bone screw performance testing (ASTM F543) ●
- . Biocompatibility
- Bacterial endotoxins ●
Substantial Equivalence Conclusion
Based on consideration of indications for use, technological characteristics, and results of non-clinical testing, it was concluded that the Exactech® Equinoxe® PHx® Fracture System and the 3.5mm diameter Exactech EPIC Screws demonstrate substantial equivalence to the predicate devices.