(45 days)
Not Found
No
The device description and intended use clearly define a system of physical plates and screws 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 described as a system of plates and screws for internal bone fixation to treat fractures and deformities, which falls under orthopedic surgical devices rather than therapeutic devices aimed at treating systemic conditions or diseases.
No
The ANTHEM™ Fracture System is described as a family of plates and screws for internal bone fixation (fractures, arthrodesis, reconstruction), which indicates a therapeutic rather than a diagnostic purpose.
No
The device description explicitly states it is a family of plates and screws, which are physical implants made from medical-grade materials. This indicates it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The ANTHEM™ Fracture System is described as a family of plates and screws used for internal bone fixation. Its intended use is for the fixation of fractures, arthrodesis, and reconstruction of bones. This involves surgically implanting the device directly into the body to stabilize bones.
The device's function is entirely mechanical and structural, used within the body to support and fix bones. It does not analyze biological samples taken from the body.
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.
Small fragment, proximal tibia, clavicle and distal fibula plates may be used in all pediatric subgroups (except neonates) and small stature adults. Distal radius plates may be used in adolescents (12-21 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, sterile and non-sterile, with locking and non-locking screws. ANTHEM™ implants are manufactured from medical grade titanium alloy, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM 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, and foot (as stated in the initial Indications for Use)
clavicle, scapula, humerus, radius, ulna, small bones (metacarpals, metatarsals, phalanges), wrist, pelvis, femur, tibia, fibula, ankle, and foot (as stated in the 510(k) Summary Indications for Use)
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)
Performance of the ANTHEM™ Fracture System plates and screws was evaluated in accordance with ASTM F543 and ASTM F382. An engineering analysis was conducted for the plates and screws to demonstrate substantial equivalence to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K163361, K101536, K111540, K101536, K061753, K012655, K130116, K140259, K083286, K071563, K092015, K133440
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which 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.
November 13, 2017
Globus Medical Inc. Kelly Baker Senior Vice President, Regulatory and Clinical Affairs 2560 General Armistead Ave. Audubon, Pennsylvania 19403
Re: K173166
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 28, 2017 Received: September 29, 2017
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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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,
Mark N. Melkerson -S
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) K173166
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.
Small fragment, proximal tibia, clavicle and distal fibula plates may be used in all pediatric subgroups (except neonates) and small stature adults. Distal radius plates may be used in adolescents (12-21 years of age). Plating may be used in patients with osteopenic bone
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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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
- Date Prepared: September 28, 2017
- Device Name: ANTHEM™ Fracture System
- 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)
Additional
Predicates: Clavicle Plates
Synthes 2.7/3.5mm VA-LCP Anterior Clavicle Plates (K101536) Synthes 3.5mm LCP Clavicle Plates (K111540) Synthes 2.7/3.5mm VA-LCP Anterior Clavicle Plates (K101536) Synthes Clavicle Hook Plates (K061753) Acumed Congruent Bone Plates (K012655) Stryker VariAx Clavicle Plates (K130116) Stryker VariAx Clavicle Hook Plates (K140259) Orthopediatrics PediLoc Locking Plate System (K083286)
Proximal Tibial Plates Smith & Nephew PERI-LOC VLP Proximal Tibia Plates (K071563) Smith & Nephew PERI-LOC Periarticular Locked Plates (K092015) Stryker AxSOS 3 Ti Locking Plates (K133440)
Purpose:
The purpose of this submission is to request clearance of ANTHEM™ Clavicle Plates, ANTHEM™ Proximal Tibial Plates and line extensions to cleared ANTHEM™ Plates.
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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, sterile and non-sterile, with locking and non-locking screws. ANTHEM™ implants are manufactured from medical grade titanium alloy, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM 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.
Small fragment, proximal tibia, clavicle and distal fibula plates may be used in all pediatric subgroups (except neonates) and small stature adults. Distal radius plates may be used in adolescents (12-21 years of age). Plating may be used in patients with osteopenic bone.
Performance Data:
Performance of the ANTHEM™ Fracture System plates and screws was evaluated in accordance with ASTM F543 and ASTM F382. An engineering analysis was conducted for the plates and screws to demonstrate substantial equivalence to the predicate devices.
Technoloqical Characteristics:
ANTHEM™ implants have the same technological characteristics as the predicate devices including design, intended use, material composition, 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.