(101 days)
No
The summary describes a traditional knee implant system and its materials, with no mention of AI, ML, image processing, or data-driven decision-making.
Yes
The device is a total knee replacement system used to treat severely disabled and/or very painful joints due to conditions like osteoarthritis, osteonecrosis, and rheumatoid arthritis, which are therapeutic interventions.
No
Explanation: The provided text describes the ACTIFY Total Knee System and ACTIFY 3D Total Knee System as implants for total knee replacement, indicating their use in treatment and reconstruction, not for identifying or diagnosing a condition.
No
The device description explicitly details physical implants made of metal alloys and polyethylene, which are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The ACTIFY™ Total Knee System and ACTIFY™ 3D Total Knee System are described as implants used in total knee arthroplasty. These are physical devices surgically implanted into the body to replace a damaged knee joint.
- Intended Use: The intended use is for the reconstruction of severely disabled and/or very painful joints and total knee replacement due to various conditions. This is a surgical procedure, not a diagnostic test performed on a sample.
The information clearly indicates that this is a surgical implant device, not a diagnostic test performed outside the body.
N/A
Intended Use / Indications for Use
ACTIFY™ Total Knee System and ACTIFY™ 3D Total Knee System are indicated for single use only in sketally mature individuals undergoing reconstruction of severely disabled and/or very painful joints.
ACTIFY™ Total Knee System and ACTIFY™ 3D Total Knee System are indicated for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and/or post-traumatic degenerative problems, and revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.
ACTIFY™ Total Knee System is indicated for cemented use only, except for the porous femoral component which is indicated for both cemented and uncemented use.
ACTIFYTM 3D Total Knee System is indicated for cemented and uncemented use.
Product codes (comma separated list FDA assigned to the subject device)
JWH, MBH, OIY
Device Description
The ACTIFY™ 3D Total Knee System and ACTIFY™ Total Knee System implants consist of modular femoral, tibial, and patellar implants that are used as part of a complete knee system in total knee arthroplasty. Implants are available in various configurations and sizes to fit a wide variety of patient anatomy. Femoral components and tibial inserts are available in posterior-stabilized (PS) and cruciate-retaining (CR) designs.
Femurs are manufactured from cobalt chromium alloy (CoCr) with a CoCr coating. Tibial inserts and patella implants are manufactured from ultrahigh molecular weight polyethylene (UHMWPE) with and without Vitamin E. ACTIFY™ 3D Total Knee tibia trays and the patella metal base are additively manufactured from titanium alloy powder per ASTM F3001. ACTIFY™ Total Knee tibia trays are manufactured from titanium alloy per ASTM F136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee Joint
Indicated Patient Age Range
skeletally mature individuals
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 (tray fatigue, A-P shear, shear, and tensile) was conducted in accordance with the "Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses - Class II Special Controls Guidance Document for Industry and FDA Staff," January 16, 2003, ASTM F2083, ASTM F1800, ASTM F1044, ASTM F1147, and ASTM F1672. Performance data demonstrate substantial equivalence to the predicate devices. Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011.
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.
Stryker Triathlon Total Knee System (K173849), GENflex2® Total Knee System (K162222), GENflex2® Total Knee System - Ultra-Congruent CR Tibial Insert (K173875), Proven Cemented Semi-Constrained Total Knee System (K122883, K980276)
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.
HEDRON® Cervical & Lumbar Spacers, SABLE® Expandable Spacer (K222270), EXp Acetabular Shell Liner (K094035)
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
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows 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.
June 20, 2024
Globus Medical, Inc Jennifer Antonacci Senior Group Manager, Regulatory Affairs Valley Forge Business Center 2560 General Armistead Ave Audubon, Pennsylvania 19403
Re: K240669
Trade/Device Name: ACTIFY™ 3D Total Knee System ACTIFY™ Total Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH, MBH, OIY Dated: May 20, 2024 Received: May 21, 2024
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
2
Sincerely,
Lixin Liu -S
Lixin Liu, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K240669
Device Name ACTIFY™ 3D Total Knee System ACTIFY™ Total Knee System
Indications for Use (Describe)
ACTIFY™ Total Knee System and ACTIFY™ 3D Total Knee System are indicated for single use only in sketally mature individuals undergoing reconstruction of severely disabled and/or very painful joints.
ACTIFY™ Total Knee System and ACTIFY™ 3D Total Knee System are indicated for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and/or post-traumatic degenerative problems, and revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.
ACTIFY™ Total Knee System is indicated for cemented use only, except for the porous femoral component which is indicated for both cemented and uncemented use.
ACTIFYTM 3D Total Knee System is indicated for cemented and uncemented use.
| 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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510(k) Summary: ACTIFY™ 3D Total Knee System ACTIFY™ Total Knee System
| Company: | Globus Medical Inc.
2560 General Armistead Ave.
Audubon, PA 19403
610-930-1800 |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Jennifer Antonacci, Ph.D.
Senior Group Manager, Regulatory Affairs |
| Date Prepared: | June 20, 2024 |
| Device Name: | ACTIFYTM 3D Total Knee System
ACTIFYTM Total Knee System |
| Common Name: | Total Knee Joint Replacement |
| Classification: | Per 21 CFR as follows:
§888.3560 Knee joint patellofemorotibial
polymer/metal/polymer semi-constrained
cemented prosthesis
§888.3565 Knee joint patellofemorotibial metal/polymer
porous-coated uncemented prosthesis
Product Codes: JWH, MBH, OIY
Regulatory Class: II, Panel Code: 87 |
| Primary Predicate: | Stryker Triathlon Total Knee System (K173849) |
| Secondary
Predicates: | GENflex2® Total Knee System (K162222)
GENflex2® Total Knee System - Ultra-Congruent CR Tibial
Insert (K173875)
Proven Cemented Semi-Constrained Total Knee System
(K122883, K980276) |
| Reference
Devices: | HEDRON® Cervical & Lumbar Spacers, SABLE® Expandable
Spacer (K222270)
EXp Acetabular Shell Liner (K094035) |
Purpose:
The purpose of this submission is to request clearance for new ACTIFY™ 3D Total Knee System femur, tibia, and patella total knee implants, and expanded indications for cleared GENflex2® implants. GENflex2® implants will be marketed under the ACTIFY™ trade name as the ACTIFY™ Total Knee System.
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Device Description:
The ACTIFY™ 3D Total Knee System and ACTIFY™ Total Knee System implants consist of modular femoral, tibial, and patellar implants that are used as part of a complete knee system in total knee arthroplasty. Implants are available in various configurations and sizes to fit a wide variety of patient anatomy. Femoral components and tibial inserts are available in posterior-stabilized (PS) and cruciate-retaining (CR) designs.
Femurs are manufactured from cobalt chromium alloy (CoCr) with a CoCr coating. Tibial inserts and patella implants are manufactured from ultrahigh molecular weight polyethylene (UHMWPE) with and without Vitamin E. ACTIFY™ 3D Total Knee tibia trays and the patella metal base are additively manufactured from titanium alloy powder per ASTM F3001. ACTIFY™ Total Knee tibia trays are manufactured from titanium alloy per ASTM F136.
Indications for Use:
ACTIFY™ Total Knee System and ACTIFY™ 3D Total Knee System are indicated for single use only in skeletally mature individuals undergoing reconstruction of severely disabled and/or very painful joints.
ACTIFY™ Total Knee System and ACTIFY™ 3D Total Knee System are indicated for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and/or post-traumatic degenerative problems, and revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.
ACTIFY™ Total Knee System is indicated for cemented use only, except for the porous femoral component which is indicated for both cemented and uncemented use.
ACTIFY™ 3D Total Knee System is indicated for cemented and uncemented use.
Substantial Equivalence Discussion:
ACTIFY™ 3D Total Knee System and ACTIFY™ Total Knee System implants have similar technological characteristics as the predicate devices including design (articular geometry, locking mechanism, material thickness), intended use, material composition, function, and range of sizes. The subject ACTIFY™ 3D and ACTIFY™ femurs differ in porous coating properties, and the ACTIFY™ 3D tibial inserts and trays have an additional mating feature compared to the predicates. These differences are minor and do not raise any new concerns of safety or effectiveness for the subject ACTIFY™ 3D Total Knee System and ACTIFY™ Total Knee System for the intended indications for use.
Performance Data:
Mechanical testing (tray fatigue, A-P shear, shear, and tensile) was conducted in accordance with the "Knee Joint Patellofemorotibial and Femorotibial
6
Metal/Polymer Porous-Coated Uncemented Prostheses - Class II Special Controls Guidance Document for Industry and FDA Staff," January 16, 2003, ASTM F2083, ASTM F1800, ASTM F1044, ASTM F1147, and ASTM F1672. Performance data demonstrate substantial equivalence to the predicate devices. Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011.
Conclusion:
ACTIFY™ 3D Total Knee System and ACTIFY™ Total Knee System implants have been found to be substantially equivalent to the predicate devices with respect to technical characteristics, performance, and intended use. The information provided within this premarket notification supports substantial equivalence of the subject implants to the predicate devices.