(75 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and biocompatibility of the implants, with no mention of AI or ML technology.
Yes
This device is a therapeutic device because its intended use is to provide internal bone fixation for fractures, arthrodesis, and reconstruction of bones, which are direct treatments for medical conditions.
No
Explanation: The ANTHEM® Fracture System is explicitly described as a system for "fixation of fractures, arthrodesis and reconstruction of bones," consisting of "plates, screws, and washers designed to be used for internal bone fixation." This indicates a therapeutic or surgical purpose rather than a diagnostic one.
No
The device description explicitly states that the ANTHEM® Fracture System is a family of plates, screws, and washers made from metallic materials, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the ANTHEM® Fracture System is for the "fixation of fractures, arthrodesis and reconstruction of bones." This describes a surgical implant used directly on the patient's body to treat a physical condition.
- Device Description: The device is described as a "family of plates, screws, and washers designed to be used for internal bone fixation." These are physical components implanted into the body.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided description does not mention any testing of biological samples or providing diagnostic information.
- Performance Studies: The performance studies mentioned focus on engineering analysis, screw performance, bacterial endotoxin testing, and biocompatibility of materials – all relevant to a surgical implant, not an IVD.
Therefore, the ANTHEM® Fracture System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ANTHEM® Fracture System is indicated for fixation of fractures, arthrodesis and reconstruction of bones for the appropriate size of the device to be used in adult patients, including the clavicle, scapula, humerus, radius, ulna, small bones (metacarpals, metatarsals, phalanges), wrist, pelvis, fibula, ankle, and foot. The clavicle hook plate may be used for dislocations of the acromioclavicular joint. Distal femur plates are indicated for diaphyseal, metaphyseal, epiphyseal, supracondylar, intra-articular, condylar, periprosthetic, and comminuted fractures, and for non-unions, Mini fragment plates are also indicated for fixation of fractures of the acetabulum, patella, and bone fragments, replantations and nonunion, and for non-load bearing stabilization and reduction of long bone fragments. Metaphyseal plates are indicated for non-load bearing stabilization of long bone fragments, and for fixation of bones including the radius and ulna.
In addition to adult patients, small fragment, proximal tibia, clavicle, metaphyseal, and distal fibula plates are indicated for use in infant, child, and adolescent pediatric subgroups and small stature plates are indicated for use in the diaphyseal areas of long bones in adolescent pediatric patients. Distal radius. distal tibia, metaphyseal, and mini fragment plates are indicated for use in adolescents (12-21 years of age). Plating can be used in patients with osteopenic bone.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC, HTN
Device Description
The ANTHEM® Fracture System is a family of plates, screws, and washers designed to be used for internal bone fixation. The ANTHEM® Distal Femur implants are designed for fractures of the distal femur, and are available in various sizes and configurations to accommodate patient anatomy. The ANTHEM® implants are manufactured from titanium, titanium alloy, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F136, F1295, F1472, F1537, F2229, F138 and F139.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Clavicle, scapula, humerus, radius, ulna, small bones (metacarpals, metatarsals, phalanges), wrist, pelvis, fibula, ankle, foot, femur, tibia, acetabulum, patella.
Indicated Patient Age Range
Adult patients, infant, child, and adolescent pediatric subgroups, adolescent pediatric patients, adolescents (12-21 years of age).
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)
An engineering analysis was conducted for the plates to demonstrate substantial equivalence to the predicate devices. Performance of the ANTHEM® Fracture System screws were evaluated in accordance with ASTM F543 and the FDA quidance Orthopedic Non-Spinal Metallic Bone Screws and Washers -Performance Criteria for Safety and Performance Based Pathway to demonstrate substantial equivalence to the predicate devices.
Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011. Biocompatibility of patient-contacting materials was demonstrated by using materials that meet applicable standards or are used in 510(k) cleared devices. In addition, the manufacturing methods are the same as those used in 510(k) cleared devices.
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
§ 888.3030 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
January 26, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Globus Medical Inc. Jennifer Antonacci Group Manager 2560 General Armistead Ave. Audubon, Pennsylvania 19403
Re: K213591
Trade/Device Name: ANTHEM® Fracture 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. HTN Dated: November 11, 2021 Received: November 12, 2021
Dear Jennifer Antonacci:
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
1
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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K213591
Device Name ANTHEM® Fracture System
Indications for Use (Describe)
The ANTHEM® Fracture System is indicated for fixation of fractures, arthrodesis and reconstruction of bones for the appropriate size of the device to be used in adult patients, including the clavicle, scapula, humerus, radius, ulna, small bones (metacarpals, metatarsals, phalanges), wrist, pelvis, fibula, ankle, and foot. The clavicle hook plate may be used for dislocations of the acromioclavicular joint. Distal femur plates are indicated for diaphyseal, metaphyseal, epiphyseal, supracondylar, intra-articular, condylar, periprosthetic, and comminuted fractures, and for non-unions, Mini fragment plates are also indicated for fixation of fractures of the acetabulum, patella, and bone fragments, replantations and nonunion, and for non-load bearing stabilization and reduction of long bone fragments. Metaphyseal plates are indicated for non-load bearing stabilization of long bone fragments, and for fixation of bones including the radius and ulna.
In addition to adult patients, small fragment, proximal tibia, clavicle, metaphyseal, and distal fibula plates are indicated for use in infant, child, and adolescent pediatric subgroups and small stature plates are indicated for use in the diaphyseal areas of long bones in adolescent pediatric patients. Distal radius. distal tibia, metaphyseal, and mini fragment plates are indicated for use in adolescents (12-21 years of age). Plating can be used in patients with osteopenic bone.
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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3
510(k) Summary: ANTHEM® Fracture System
| Company: | Globus Medical Inc.
2560 General Armistead Ave.
Audubon, PA 19403
610-930-1800 |
| ---------- | ----------------------------------------------------------------------------------------- |
|---|
- Contact: Jennifer Antonacci, Ph.D. Group Manager, Regulatory Affairs
- January 26, 2022 Date Prepared:
- ANTHEM® Fracture System Device Name:
- Common Name: Bone plates, screws, & washers
- Classification: Per 21 CFR as follows: §888.3030 Single/multiple component metallic bone fixation appliance and accessories (primary) §888.3040 Smooth or threaded metallic bone fixation fastener Product Code: HRS (primary), HWC, HTN Regulatory Class: II
Primary Predicate: ANTHEM® Fracture System (K202496)
Additional
Predicates: ANTHEM® Fracture System (K212433) Stryker AxSOS 3 (K172350)
Purpose:
The purpose of this submission is to request clearance for ANTHEM® Distal Femur plates, screws, and washers, as a line extension to the ANTHEM Fracture System.
Device Description:
The ANTHEM® Fracture System is a family of plates, screws, and washers designed to be used for internal bone fixation. The ANTHEM® Distal Femur implants are designed for fractures of the distal femur, and are available in various sizes and configurations to accommodate patient anatomy. The ANTHEM® implants are manufactured from titanium, titanium alloy, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F136, F1295, F1472, F1537, F2229, F138 and F139.
Indications for Use:
The ANTHEM® Fracture System is indicated for fixation of fractures, osteotomies, arthrodesis and reconstruction of bones for the appropriate size of the device to be used in adult patients, including the clavicle, scapula, humerus, radius, ulna,
4
small bones (metacarpals, metatarsals, phalanges), wrist, pelvis, femur, tibia, fibula, ankle, and foot. The clavicle hook plate may be used for dislocations of the acromioclavicular joint. Distal femur plates are indicated for diaphyseal, metaphyseal, epiphyseal, supracondylar, intra-articular, extra-articular, condylar, periprosthetic, and comminuted fractures, and for non-unions and malunions. Mini fragment plates are also indicated for fixation of fractures of the acetabulum, patella, and bone fragments, replantation, malunions and nonunion, and for nonload bearing stabilization and reduction of long bone fragments. Metaphyseal plates are indicated for non-load bearing stabilization and reduction of long bone fragments, and for fixation of bones including the radius and ulna.
In addition to adult patients, small fragment, mini fragment, proximal tibia, clavicle, metaphyseal, and distal fibula plates are indicated for use in infant, child, and adolescent pediatric subgroups and small stature adults. Distal femur plates are indicated for use in the diaphyseal and metaphyseal areas of long bones in adolescent pediatric patients. Distal radius, distal tibia, metaphyseal, and mini fragment plates are indicated for use in adolescents (12-21 years of age). Plating can be used in patients with osteopenic bone.
Performance Data:
An engineering analysis was conducted for the plates to demonstrate substantial equivalence to the predicate devices. Performance of the ANTHEM® Fracture System screws were evaluated in accordance with ASTM F543 and the FDA quidance Orthopedic Non-Spinal Metallic Bone Screws and Washers -Performance Criteria for Safety and Performance Based Pathway to demonstrate substantial equivalence to the predicate devices.
Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011. Biocompatibility of patient-contacting materials was demonstrated by using materials that meet applicable standards or are used in 510(k) cleared devices. In addition, the manufacturing methods are the same as those used in 510(k) cleared devices.
Technological Characteristics:
Subject ANTHEM® implants have similar technological characteristics as the predicate devices including overall design, intended use, material composition, function, and range of sizes.
Basis of Substantial Equivalence:
The subject ANTHEM® Fracture System has been found to be substantially equivalent to the predicate devices with respect to technical characteristics, performance, and intended use. The information provided supports substantial equivalence to the predicate devices.