(57 days)
No
The summary describes a knee prosthesis implant and its components, focusing on materials, manufacturing process, and mechanical testing. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
Yes
The device is a knee prosthesis indicated for conditions like arthritis and avascular necrosis, aiming to alleviate pain and restore joint function, which aligns with the definition of a therapeutic device.
No
The device is a knee prosthesis, specifically a tibial baseplate, used in total knee arthroplasty to replace a damaged joint, not to diagnose a condition.
No
The device description explicitly states it is a sterile, individually packaged implant manufactured using a Direct Metal Laser Sintering (DMLS) process with titanium alloy powder. This describes a physical hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for total knee arthroplasty. This is a medical device used in vivo (within the body) to replace a damaged joint.
- Device Description: The description details a sterile, individually packaged implant made of titanium alloy, designed for cemented use in surgery.
- Performance Studies: The performance studies focus on mechanical properties, biocompatibility, and shelf-life of the implant itself, not on analyzing biological samples for diagnostic purposes.
- Lack of IVD characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), providing diagnostic information, or being used in a laboratory setting.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a therapeutic device used to replace a damaged body part.
N/A
Intended Use / Indications for Use
The GMK® knee prosthesis is designed for cemented application in total knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components.
The GMK 3D Metal® Tibial Baseplate is indicated for cemented application if there is evidence of sufficient sound bone to seat and support the components.
This knee replacement system is indicated in the following cases:
- · Severely painful and/or disabled joint as a result of arthritis, rheumatoid arthritis or polyarthritis
- · Collagen disorders, and avascular necrosis of the femoral condyle
- · Post traumatic loss of joint configuration
- Primary implantation failure
Tibial wedges cemented are to be attached to the tibial baseplate with both the fixing cylinders and bone cement. The screwed tibial augments are for screwed fixation to the tibial baseplate. In case a semi-constrained liner is used, an extension stem must be implanted both on the tibial and on the femoral components. In case a GMK Revision or GMK Sphere Revision tibial tray is used, an extension stem must be implanted.
It is not possible to implant tibial wedges and extens with the GMK 3D Metal® Tibial Baseplate.
Limitations for use for GMK SPHERE/GMK SPHERIKA used with kinematic alignment
GMK® Sphere and GMK® SpheriKA can be implanted in kinematic alignment. In this case, this knee replacement system is indicated for:
- · Severely painful and/or disabled joint as a result of arthritis, rheumatic arthritis or polyarthritis
- · Collagen disorders, and/or avascular necrosis of the femoral condyle
- · Moderate valgus, varus, or flexion deformities
Product codes
MBH, JWH
Device Description
The GMK 3D Metal Tibial Tray is a line extension to Medacta GMK Total Knee System.
The subject devices are sterile, individually packaged implants designed for cemented use in Total Knee Arthroplasty procedures.
The GMK 3D Metal Tibial Tray is available in eleven sizes plus two bridge versions with right and left configuration.
The subject devices are manufactured using a Direct Metal Laser Sintering (DMLS) process with titanium alloy powder (Ti-6Al-4V) according to ASTM F2924-14.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
Indicated Patient Age Range
Not Found
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
Non-Clinical Studies:
- DESIGN VALIDATION
- 3D Metal Tibia Tray Anthropometric Study
- Design Validation wetlab
- PERFORMANCE TESTING
- Stereological evaluation according to ASTM F1854-15
- Tension test on 3D metal honeycomb trabecular structure according to ASTM F1147 05(2017)e1
- Static shear test on 3D metal honeycomb trabecular structure according to ASTM F1044 05(2017)e1
- Dynamic shear test on 3D metal honeycomb trabecular structure according to ASTM F1160 14(2017)e1
- Taber abrasion resistance test on 3D metal honeycomb trabecular structure according to ASTM F1978-18
- GMK 3D Metal Tibial Tray cementation study
- GMK 3D Metal Tibial Tray Dynamic endurance fatigue test according to ASTM F1800-19e1
- PYROGENICITY
- Bacterial endotoxin test (LAL test) according to European Pharmacopoeia §2.6.14 (which is equivalent to USP chapter )
- Pyrogen test according to USP chapter for pyrogenicity determination
- BIOCOMPATIBILITY evaluation
- SHELF-LIFE evaluation
Clinical Studies:
- No clinical studies were conducted.
Key results: Based on the comparison of technological characteristics and performance data provided within this submission, the data supports the substantial equivalence of the GMK 3D Metal Tibial Tray to the identified predicate devices.
Key Metrics
Not Found
Predicate Device(s)
K123486, K090988, K121416, K211004, K201343
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.
0
August 23, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health and Human Services, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in three lines, with "FDA" being the largest and boldest, followed by "U.S. FOOD & DRUG" and then "ADMINISTRATION".
Medacta International S.A. % Chris Lussier Senior Director, Quality, Regulatory and Clinical Research Medacta USA 3973 Delp Street Memphis, Tennessee 38118
Re: K221850
Trade/Device Name: GMK 3D Metal Tibial Tray Regulation Number: 21 CFR 888.3565 Regulation Name: Knee Joint Patellofemorotibial Metal/Polymer Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: MBH. JWH Dated: June 24, 2022 Received: June 27, 2022
Dear Chris Lussier:
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,
For: Ting Song, Ph.D., R.A.C. 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) K221850
Device Name GMK 3D Metal Tibial Tray
Indications for Use (Describe)
The GMK® knee prosthesis is designed for cemented application in total knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components.
The GMK 3D Metal® Tibial Baseplate is indicated for cemented application if there is evidence of sufficient sound bone to seat and support the components.
This knee replacement system is indicated in the following cases:
- · Severely painful and/or disabled joint as a result of arthritis, rheumatoid arthritis or polyarthritis
- · Collagen disorders, and avascular necrosis of the femoral condyle
- · Post traumatic loss of joint configuration
- Primary implantation failure
Tibial wedges cemented are to be attached to the tibial baseplate with both the fixing cylinders and bone cement. The screwed tibial augments are for screwed fixation to the tibial baseplate. In case a semi-constrained liner is used, an extension stem must be implanted both on the tibial and on the femoral components. In case a GMK Revision or GMK Sphere Revision tibial tray is used, an extension stem must be implanted.
It is not possible to implant tibial wedges and extens with the GMK 3D Metal® Tibial Baseplate.
Limitations for use for GMK SPHERE/GMK SPHERIKA used with kinematic alignment
GMK® Sphere and GMK® SpheriKA can be implanted in kinematic alignment. In this case, this knee replacement system is indicated for:
- · Severely painful and/or disabled joint as a result of arthritis, rheumatic arthritis or polyarthritis
- · Collagen disorders, and/or avascular necrosis of the femoral condyle
- · Moderate valgus, varus, or flexion deformities
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(k) Summary
I. Submitter
Medacta International SA Strada Regina 6874 Castel San Pietro (CH) Switzerland Phone (+41) 91 696 60 60 Fax (+41) 91 696 60 66
Contact Person: Stefano Baj, Regulatory and Compliance Director, Medacta International SA Applicant Correspondent: Chris Lussier, Senior Director Quality, Regulatory, and Clinical Research, Medacta USA Date Prepared: June 24, 2022 Date Revised: August 23, 2022
II. Device
| Device Proprietary Name: | GMK 3D Metal Tibial Tray |
|---|---|
| Common or Usual Name: | Total Knee Joint Replacement |
| Classification Name: | Knee joint patellofemorotibial metal/polymer porous-coated |
| uncemented prosthesis | |
| Primary Product Code | MBH |
| Secondary Product Code: | JWH |
| Regulation Number: | 21 CFR 888.3565, 21 CFR 888.3560 |
| Device Classification | II |
III. Predicate Device
Substantial equivalence is claimed to the following devices:
Primary predicate device:
-
Triathlon Tritanium Tibia Baseplate, Stryker, K123486
Additional predicate devices: -
GMK Total Knee System, K090988, Medacta International SA
-
GMK Sphere, K121416, Medacta International SA
-
GMK Spherika Femurs and Fixed Tibial Trays Plus, K211004, Medacta International SA
-
A Triathlon Total Knee System, K201343, Howmedica Osteonics Corp. dba Stryker Orthopaedics
Reference device:
-
Mpact 3D Metal DMLS, K202568, Medacta International SA
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Device Description IV.
The GMK 3D Metal Tibial Tray is a line extension to Medacta GMK Total Knee System.
The subject devices are sterile, individually packaged implants designed for cemented use in Total Knee Arthroplasty procedures.
The GMK 3D Metal Tibial Tray is available in eleven sizes plus two bridge versions with right and left configuration.
The subject devices are manufactured using a Direct Metal Laser Sintering (DMLS) process with titanium alloy powder (Ti-6Al-4V) according to ASTM F2924-14.
V. Indications for Use
The GMK® knee prosthesis is designed for cemented application in total knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components.
The GMK 3D Metal® Tibial Baseplate is indicated for cemented application if there is evidence of sufficient sound bone to seat and support the components.
This knee replacement system is indicated in the following cases:
- Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid ● arthritis or polyarthritis
- Collagen disorders, and avascular necrosis of the femoral condyle
- Post traumatic loss of joint configuration
- Primary implantation failure ●
Tibial wedges cemented are to be attached to the tibial baseplate with both the fixing cylinders and bone cement. The screwed tibial augments are for screwed fixation to the tibial baseplate. In case a semiconstrained liner is used, an extension stem must be implanted both on the femoral components. In case a GMK Revision or GMK Sphere Revision tibial tray is used, an extension stem must be implanted.
It is not possible to implant tibial wedges and extens with the GMK 3D Metal® Tibial Baseblate.
Limitations for use for GMK SPHERE/GMK SPHERIKA used with kinematic alignment
GMK® Sphere and GMK® SpheriKA can be implanted in kinematic alignment. In this case, this knee replacement system is indicated for:
- Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid ● arthritis or polyarthritis
- Collagen disorders, and/or avascular necrosis of the femoral condyle ●
- . Moderate valgus, varus, or flexion deformities
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VI. Comparison of Technological Characteristics
The subject devices are substantially equivalent to the predicate. Triathlon Tritanium Tibia Baseplate (K123486), with regards to the following characteristics:
- Primary stability;
- Materials: ●
- Biocompatibility; ●
- Device usage: ●
- Packaging; ●
- Shelf-life; and .
- Sterilization.
The subject implants differ from the predicate device, Triathlon Tibia Baseplate (K123486) as follows:
- o Design:
- Sizes:
- Secondary stability. ●
Discussion
Medacta International SA has not made any change to the materials, device usage, biocompatibility, sterility, shelf life, and packaging of the subject devices respect to the predicate devices.
Based on the comparison of technological characteristics and performance data provided within this submission, the data supports the substantial equivalence of the GMK 3D Metal Tibial Tray to the identified predicate devices.
VII. Performance Data
Based on the risk analysis, design validation and performance testing were conducted to written protocols. The following validation and tests are being provided in support of the substantial equivalence determination:
Non-Clinical Studies
- DESIGN VALIDATION ●
- 3D Metal Tibia Tray Anthropometric Study O
- Design Validation wetlab o
- PERFORMANCE TESTING ●
- Stereological evaluation according to ASTM F1854-15 o
- Tension test on 3D metal honeycomb trabecular structure according to ASTM F1147 o 05(2017)e1
- Static shear test on 3D metal honeycomb trabecular structure according to ASTM F1044 o 05(2017)e1
7
- Dynamic shear test on 3D metal honeycomb trabecular structure according to ASTM F1160o 14(2017)e1
- Taber abrasion resistance test on 3D metal honeycomb trabecular structure according to O ASTM F1978-18
- GMK 3D Metal Tibial Tray cementation study o
- GMK 3D Metal Tibial Tray Dynamic endurance fatigue test according to ASTM F1800-19e1 o
- PYROGENICITY ●
- Bacterial endotoxin test (LAL test) according to European Pharmacopoeia §2.6.14 (which is о equivalent to USP chapter )
- Pyrogen test according to USP chapter for pyrogenicity determination o
- o The subject devices are not labeled as non-pyrogenic or pyrogen free.
- BIOCOMPATIBILITY evaluation ●
- SHELF-LIFE evaluation
Clinical Studies:
- No clinical studies were conducted. ●
VIII. Conclusion
The information provided above supports that the GMK 3D Metal Tibial Tray are substantially equivalent to the predicate devices.