(58 days)
Not Found
No
The 510(k) summary describes a system of plates and screws for bone fixation. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the device description, intended use, or performance studies. The performance studies focus on mechanical testing and biocompatibility, not algorithmic performance.
Yes
The device is described as "internal bone fixation" for fractures, arthrodesis, and bone reconstruction, which are all therapeutic interventions.
No
The device is described as a system of plates and screws for internal bone fixation, used for treating fractures and other bone conditions, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states that the ANTHEM® Fracture System is a family of plates and screws, which are physical implants made from various metallic materials. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, the ANTHEM® Fracture System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the system is for the "fixation of fractures, arthrodesis and reconstruction of bones." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as "a family of plates and screws designed to be used for internal bone fixation." These are implants used within the body.
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. The ANTHEM® system does not perform this function.
The ANTHEM® Fracture System is a surgical implant used for orthopedic procedures.
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 clavice hook plate may be used for dislocations of the acromioclavicular joint. Mini fragment plates are also indicated for fixation of fractures of the acetabulum, patella, and bone fragments, replantation, malunions and for non-load 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, 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 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
Device Description
The ANTHEM® Fracture System is a family of plates and screws designed to be used for internal bone fixation. The implants are available in various sizes and shapes to accommodate patient anatomy, and may be contoured or straight, with various lengths and types of screws. ANTHEM® implants are manufactured from titanium, titanium allov, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F67, 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, acetabulum, patella, long bone, proximal tibia, distal fibula, distal radius
Indicated Patient Age Range
adult patients, infant, child, and adolescent pediatric subgroups, small stature adults, 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)
Performance of the ANTHEM® Fracture System plates and screws were evaluated in accordance with ASTM F382 and ASTM F543. An engineering analysis was conducted for the plates and screws to demonstrate substantial equivalence to the predicate devices.
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
October 1 , 2021
Globus Medical Inc. Jennifer Antonacci Group Manager, Regulatory Affairs 2560 General Armistead Ave. Audubon, Pennsylvania 19403
Re: K212433
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 Dated: August 3, 2021 Received: August 4, 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, M.P.H. 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
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Indications for Use
510(k) Number (if known) K212433
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 clavice hook plate may be used for dislocations of the acromioclavicular joint. Mini fragment plates are also indicated for fixation of fractures of the acetabulum, patella, and bone fragments, replantation, malunions and for non-load 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, 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 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 |
| Date Prepared: | September 30, 2021 |
| Device Name: | ANTHEM® Fracture System |
| Common Name: | Bone plates & screws |
| 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
Regulatory Class: II |
Primary Predicate: ANTHEM® Fracture System (K180554)
Additional Predicates:
ANTHEM® Fracture System (K202496)
Purpose:
The purpose of this submission is to request clearance for new implants and changes to ANTHEM® Mini Fragment plates and screws.
Device Description:
The ANTHEM® Fracture System is a family of plates and screws designed to be used for internal bone fixation. The implants are available in various sizes and shapes to accommodate patient anatomy, and may be contoured or straight, with various lengths and types of screws. ANTHEM® implants are manufactured from titanium, titanium allov, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F67, 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, small bones (metacarpals, metatarsals, phalanges), wrist, pelvis, fibula, ankle, and foot. The clavicle hook plate may be used for dislocations of the acromioclavicular joint. Mini
4
fragment plates are also indicated for fixation of fractures of the acetabulum, patella, and bone fragments, replantation, malunions and nonunion, and for non-load 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, 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 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:
Performance of the ANTHEM® Fracture System plates and screws were evaluated in accordance with ASTM F382 and ASTM F543. An engineering analysis was conducted for the plates and screws to demonstrate substantial equivalence to the predicate devices.
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. The subject implants include minor design modifications and new non-locking straight plates. New material specifications for existing plates and screws are in accordance with the same material standards.
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.