(235 days)
Not Found
No
The 510(k) summary describes a system of plates and screws for bone fixation and mentions only mechanical testing and engineering analysis, with no indication of AI/ML technology.
Yes
The device is described as a "Fracture System" and is indicated for "fixation of fractures, arthrodesis and reconstruction of bones," which are therapeutic actions to treat a medical condition.
No
The device is described as a "family of plates and screws designed to be used for internal bone fixation" for fractures, arthrodesis, and reconstruction. This indicates a therapeutic or surgical function, not a diagnostic one.
No
The device description explicitly states that the ANTHEM® Fracture System is a family of plates and screws made from various metallic materials, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The ANTHEM® Fracture System is described as a family of plates and screws designed for internal bone fixation. This means it is surgically implanted into the body to stabilize fractures.
- Intended Use: The intended use clearly states it is for "fixation of fractures, arthrodesis and reconstruction of bones." This is a structural and mechanical function within the body, not a diagnostic test performed on a specimen outside the body.
The information provided about the device's materials, mechanical testing, and anatomical sites of use further confirms its nature as an orthopedic implant, not an IVD.
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 fragments, replantation, malunions, and for non-load bearing stabilization and reduction of long bone fragments.
Small fragment, mini fragment, proximal tibia, clavicle and distal fibula plates may be used in all pediatric subgroups (except neonates) and small stature adults. Distal radius and mini fragment plates may be used in adolescents (12-2 years of age). Plating may be used in patients with osteopenic bone.
Product codes
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 locking and non-locking screws. ANTHEM® implants are manufactured from titanium, titanium alloy, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F67, F136, F1295, F1472, F1537, F2229, F138 and F139. All implants are for single use only.
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, femur, tibia.
Indicated Patient Age Range
Adult patients, all pediatric subgroups (except neonates), 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)
Mechanical testing (static and dynamic bending, insertion/removal, axial pullout, static torsion, and cantilever bend) of the ANTHEM® Fracture System plates and screws was evaluated in accordance with ASTM F382, F543, and F2193. An engineering analysis was conducted for the plates and screws to demonstrate substantial equivalence to the predicate devices. Performance data demonstrate substantial equivalence to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K163361, K173166, K063049, K090047, K140814, K993106, K090675, K100776
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
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Globus Medical Inc. Kelly Baker Senior Vice President, Regulatory and Clinical Affairs 2560 General Armistead Avenue Valley Forge Business Center Audubon, Pennsylvania 19403
October 22, 2018
Re: K180554
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: September 18, 2018 Received: September 19, 2018
Dear Kelly Baker:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jesse Muir -S 2018.10.22 10:36:32 -04'00'
For: Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K180554
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 fragments, replantation, malunions, and for non-load bearing stabilization and reduction of long bone fragments.
Small fragment, mini fragment, proximal tibia, clavicle and distal fibula plates may be used in all pediatric subgroups (except neonates) and small stature adults. Distal radius and mini fragment plates may be used in adolescents (12-2 years of age). Plating may 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: Kelly J. Baker, Ph.D. Senior Vice President, Regulatory and Clinical Affairs
- September 18, 2018 Date Prepared:
- ANTHEM® Fracture System Device Name:
- Common Name: Bone plate & screws
Classification: Per 21 CFR as follows: §888.3030 Single/multiple component metallic bone fixation appliance and accessories §888.3040 Smooth or threaded metallic bone fixation fastener Product Code: HRS, HWC Regulatory Class: II
Primary Predicate: ANTHEM® Fracture System (K163361, K173166)
Additional
Predicates: Mini Fragment Plates Synthes Modular Mini Fragment LCP System (K063049) Synthes 1.5mm Mini Fragment LCP System (K090047) Smith & Nephew EVOS Mini-Fragment Plating System (K140814) Smith & Nephew Bone Plate System (K993106) Smith & Nephew VLP (K090675) Synthes Forefoot/Midfoot System (K100776)
Purpose:
The purpose of this submission is to request clearance of ANTHEM® Mini Fragment Plates.
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 locking and non-locking screws. ANTHEM® implants are manufactured from titanium, titanium alloy, cobalt chromium molybdenum alloy, or stainless steel, as
4
specified in ASTM F67, F136, F1295, F1472, F1537, F2229, F138 and F139. All implants are for single use only.
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, femur, tibia, fibula, ankle, and foot. The clavicle 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 nonunions, and for non-load bearing stabilization and reduction of long bone fragments.
Small fragment, mini fragment, proximal tibia, clavicle and distal fibula plates may be used in all pediatric subgroups (except neonates) and small stature adults. Distal radius and mini fragment plates may be used in adolescents (12-21 years of age). Plating may be used in patients with osteopenic bone.
Performance Data:
Mechanical testing (static and dynamic bending, insertion/removal, axial pullout, static torsion, and cantilever bend) of the ANTHEM® Fracture System plates and screws was evaluated in accordance with ASTM F382, F543, and F2193. An engineering analysis was conducted for the plates and screws to demonstrate substantial equivalence to the predicate devices. Performance data demonstrate substantial equivalence to the predicate device.
No further sterilization or biocompatibility evaluation and/or testing were required for this submission. Previous sterilization and biocompatibility testing applies to the subject devices.
Technoloqical Characteristics:
Subject ANTHEM® implants have the same technological characteristics as the predicate devices including 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.