(57 days)
Not Found
No
The 510(k) summary describes a knee prosthesis system and its components, focusing on materials, mechanical properties, and intended use in surgical procedures. There is no mention of software, algorithms, image processing, or any other elements typically associated with AI/ML in medical devices. The performance studies are non-clinical and focus on wear behavior, mechanical testing, and biocompatibility.
Yes
The device is a knee prosthesis, replacing a damaged joint to alleviate pain and restore function, which clearly aligns with the definition of a therapeutic device.
No
This device is a knee prosthesis, which is an implant used in total knee arthroplasty procedures. It is a treatment device, not a diagnostic one.
No
The device description clearly outlines various physical components made of metallic alloys and UHMWPE, indicating it is a hardware medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes the device as a knee prosthesis for surgical implantation in total knee arthroplasty procedures. This is a surgical implant, not a device used to examine specimens derived from the human body for diagnostic purposes.
- Device Description: The description details the materials and components of a knee implant (femoral components, tibial trays, augmentations, etc.). This aligns with a surgical device, not an IVD.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health status
- Using reagents or assays
- Performing tests in a laboratory setting
The device is a medical device, specifically a surgical implant, used to replace a damaged knee joint.
N/A
Intended Use / Indications for Use
The Evolis/GMK knee prosthesis is designed for cemented use in total knee arthroplasty, 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, traumatoid arthritis or polyarthritis. · Avascular necrosis of 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 femoral components. In case a GMK Revision tibial tray is used, an extension stem must be implanted
The GMK® HINGE knee prosthesis is designed for cemented use in total knee arthroplasty when the preoperative diagnosis of the joint determines that the bone and stability situation of a constrained prosthesis. The GMK® HINGE knee system is indicated in the following cases: · Severely painful and/or disabled joint as a result of arthritis, rheumatoid arthritis or polyarthritis associated with bone loss and/or severe joint instability · Considerable loss of function of the knee joint · High-grade joint destruction requiring additional stabilization with stems and reconstruction of bone defects with metal augmentation - · Failure of a primary prosthesis (e.g. infection, loosening) - · Former revision arthroplasty - Post traumatic loss of joint configuration - · Avascular necrosis of femoral condyle. - Tibial augmentation are to be screwed to the tibial baseplate with both the two provided fixing screws. When a GMK® HINGE implant is used it is mandatory to implant both the femoral and tibial components with an extension stem.
Product codes (comma separated list FDA assigned to the subject device)
KRO, JWH
Device Description
The GMK Revision & Hinge Extension - TiNbN Coating is a Medacta GMK line extension to provide a larger product offering. The subject devices are designed for cemented use in total knee arthroplasty procedures. The GMK Revision & Hinge Extension - TiNbN Coating includes the following implants: - . GMK Revision Femoral Component TiNbN coated, Standard and Posterior Stabilized, Left and Right. Sizes from 1 to 6 - GMK Revision tibial tray TiNbN coated, Left and Right, Sizes from 1 to 6 - GMK Revision SC peg TiNbN coated, sizes from 10 to 26 mm - GMK Hinge Femoral Component TiNbN coated, Left and Right, Sizes from 1 to 6 ● - GMK Hinge tibial tray TiNbN coated, Left and Right, Sizes from 1 to 6 - GMK Hinge post extension TiNbN coated, sizes from 10 to 26 mm - Screwed tibial augmentations Ti6A14V, from 0 to 6 for thicknesses 5 and 10 and sizes from 1 to 6 for thicknesses 15 and 20 mm - Femoral posterior augmentations Ti6A14V, sizes from 1 to 6 thicknesses 4, 5, 8, and 10 . mm - Femoral distal augmentations Ti6A14V, sizes from 1 to 6 thicknesses 4, 8, 12, 16 and 20 mm The GMK Revision & Hinge - TiNbN Coating implants, both femoral components and Tibial trays, are manufactured from cobalt-chromium-molybdenum alloy (Co-Cr-Mo) according to ISO 5832-4:2014 Implants for Surgery - Metallic Materials-Part 4: Cobalt-Chromium-Molybdenum Casting Alloy with Titanium Niobium Nitride (TiNbN) coating. The external and internal bushes, inside the GMK Hinge - TiNbN Coating femoral component, are manufactured from Type 1 Ultra High Molecular Weight Polyethylene (UHMWPE) according to ISO 5834-2:2019 Implants for Surgery - Ultra-High-Molecular-Weight Polyethylene -Part 2: Moulded Forms. The GMK Revision SC peg & Hinge post extension, as well as the GMK hinge post and internal pivot inside the GMK Hinge - TiNbN Coating femoral component, are manufactured from cobaltchromium-molybdenum alloy (Co-Cr-Mo) according to ISO 5832-12:2019 Implants for Surgery -Metallic Materials-Part 12: Wrought cobalt-chromium-molybdenum Alloy with Titanium Niobium Nitride (TiNbN) coating. The GMK Revision & Hinge augmentations, both tibial and femoral, are manufactured from Ti6A14V per ISO 5832-3:2016 Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy.
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
Not Found
Intended User / Care Setting
Prescription Use
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)
Non-Clinical Studies: - . PERFORMANCE TESTING o TiNbN coated Femoral Components Wear Behavior Evaluation of modular tapered connection according to Medacta Test Protocol IL o 07.09.517, Medacta Test Report A.2 and Endolab Test Report 167.181121.20.87 Rev.0 Femoral Modular Connection (Femoral Components + Femoral Distal and Posterior о Augmentation) TiNbN Coating Excessive Ions Release O TiNbN coated Femoral Component Mechanical Performances o TiNbN coated Tibial Trays Mechanical Performances O TiNbN coated Tibial Trays Connection with the insert O Tibial Tray Modular Connection (Tibial Tray + Offset + Extension Stem) O Tibial Modular Connection (Revision Tibial Tray + Tibial Augmentation) O GMK Revision TiNbN coated SC Peg Mechanical Performances O GMK Hinge TiNbN coated Post Extension Mechanical Performances o Ti6A14V Femoral Augmentations Validation O O Posterior Wedge Screw Design Validation Report according to Test Protocol IL 07.09.566 0 Ti6Al4V Tibial Augmentation Validation - PYROGENICITY ● Bacterial Endotoxin Test (LAL test) was conducted according to European o Pharmacopoeia §2.6.14 (which is equivalent to USP chapter ) Pyrogen test according to USP chapter for pyrogenicity determination o The subject devices are not labeled as non-pyrogenic or pyrogen free o - BIOCOMPATIBILITY assessment ● Clinical Studies: - No clinical studies were conducted ●
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.
K102437, K103170, K123721, K130299, K163311, K172347, K202684
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
§ 888.3510 Knee joint femorotibial metal/polymer constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation or rotation in one or more planes and has components that are linked together or affined. This generic type of device includes prostheses composed of a ball-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a ball at the head of a column rising from the stemmed tibial component. The ball, the column, the tibial plateau, and the stem for fixation of the tibial component are made of an alloy, such as cobalt-chromium-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the femoral component's flat outer surface. The flat outer surface of the tibial component abuts both a reciprocal flat surface within the cavity of the femoral component and flanges on the femoral component designed to prevent distal displacement. The stem of the femoral component is made of an alloy, such as cobalt-chromium-molybdenum, but the socket of the component is made of ultra-high molecular weight polyethylene. The femoral component has metallic runners which align with the ultra-high molecular weight polyethylene tracks that press-fit into the metallic tibial component. The generic class also includes devices whose upper and lower components are linked with a solid bolt passing through a journal bearing of greater radius, permitting some rotation in the transverse plane, a minimal arc of abduction/adduction. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
March 2, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
Medacta International SA % Chris Lussier Senior Director, Quality and Regulatory Medacta USA 3973 Delp Street Memphis, Tennessee 83118
Re: K210010
Trade/Device Name: GMK Revision & Hinge Extension - TiNbN Coating Regulation Number: 21 CFR 888.3510 Regulation Name: Knee Joint Femorotibial Metal/Polymer Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: KRO, JWH Dated: December 30, 2020 Received: January 4, 2021
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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,
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
2
Indications for Use
510(k) Number (if known) K210010
Device Name
GMK Revision Extension - TiNbN Coating
Indications for Use (Describe)
The Evolis/GMK knee prosthesis is designed for cemented use in total knee arthroplasty, 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, traumatoid arthritis or polyarthritis. · Avascular necrosis of 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 femoral components. In case a GMK Revision tibial tray is used, an extension stem must be implanted
| 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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K210010
Device Name
GMK Hinge Extension - TiNbN Coating
Indications for Use (Describe)
The GMK® HINGE knee prosthesis is designed for cemented use in total knee arthroplasty when the preoperative diagnosis of the joint determines that the bone and stability situation of a constrained prosthesis. The GMK® HINGE knee system is indicated in the following cases:
· Severely painful and/or disabled joint as a result of arthritis, rheumatoid arthritis or polyarthritis associated with bone loss and/or severe joint instability
· Considerable loss of function of the knee joint
· High-grade joint destruction requiring additional stabilization with stems and reconstruction of bone defects with metal augmentation
- · Failure of a primary prosthesis (e.g. infection, loosening)
- · Former revision arthroplasty
- Post traumatic loss of joint configuration
- · Avascular necrosis of femoral condyle.
- Tibial augmentation are to be screwed to the tibial baseplate with both the two provided fixing screws.
When a GMK® HINGE implant is used it is mandatory to implant both the femoral and tibial components with an extension stem.
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
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, Director of Quality and Regulatory, Medacta USA Date Prepared: December 30, 2020 Date Revised: January 8, 2021
II. Device
| Device Proprietary Name: | GMK Revision & Hinge Extension - TiNbN Coating |
|---|---|
| Common or Usual Name: | Total Knee Prosthesis |
| Classification Name: | Knee joint femorotibial metal/polymer constrained cemented |
| prosthesis | |
| Knee joint patellofemorotibial polymer/metal/polymer semi- | |
| constrained cemented prosthesis | |
| Primary Product Code: | KRO |
| Secondary Product Code: | JWH |
| Regulation Number: | 21 CFR 888.3510 and 21 CFR 888.3560 |
| Device Classification | II |
III. Predicate Device
Substantial equivalence is claimed to the following devices:
- GMK Revision, K102437, Medacta International SA ●
- GMK Revision SC Liners, K103170, Medacta International SA ●
- GMK-Revision Extension, K123721, Medacta International SA ●
- GMK Hinge, K130299, Medacta International SA ●
- GMK Revision Femoral Distal Augmentations, K163311, Medacta International SA
- GMK Hinge and GMK Revision, K172347, Medacta International SA ●
- GMK Total Knee System TiNbN Coating, K202684, Medacta International SA ●
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IV. Device Description
The GMK Revision & Hinge Extension - TiNbN Coating is a Medacta GMK line extension to provide a larger product offering. The subject devices are designed for cemented use in total knee arthroplasty procedures. The GMK Revision & Hinge Extension - TiNbN Coating includes the following implants:
- . GMK Revision Femoral Component TiNbN coated, Standard and Posterior Stabilized, Left and Right. Sizes from 1 to 6
- GMK Revision tibial tray TiNbN coated, Left and Right, Sizes from 1 to 6
- GMK Revision SC peg TiNbN coated, sizes from 10 to 26 mm
- GMK Hinge Femoral Component TiNbN coated, Left and Right, Sizes from 1 to 6 ●
- GMK Hinge tibial tray TiNbN coated, Left and Right, Sizes from 1 to 6
- GMK Hinge post extension TiNbN coated, sizes from 10 to 26 mm
- Screwed tibial augmentations Ti6A14V, from 0 to 6 for thicknesses 5 and 10 and sizes from 1 to 6 for thicknesses 15 and 20 mm
- Femoral posterior augmentations Ti6A14V, sizes from 1 to 6 thicknesses 4, 5, 8, and 10 . mm
- Femoral distal augmentations Ti6A14V, sizes from 1 to 6 thicknesses 4, 8, 12, 16 and 20 mm
The GMK Revision & Hinge - TiNbN Coating implants, both femoral components and Tibial trays, are manufactured from cobalt-chromium-molybdenum alloy (Co-Cr-Mo) according to ISO 5832-4:2014 Implants for Surgery - Metallic Materials-Part 4: Cobalt-Chromium-Molybdenum Casting Alloy with Titanium Niobium Nitride (TiNbN) coating.
The external and internal bushes, inside the GMK Hinge - TiNbN Coating femoral component, are manufactured from Type 1 Ultra High Molecular Weight Polyethylene (UHMWPE) according to ISO 5834-2:2019 Implants for Surgery - Ultra-High-Molecular-Weight Polyethylene -Part 2: Moulded Forms.
The GMK Revision SC peg & Hinge post extension, as well as the GMK hinge post and internal pivot inside the GMK Hinge - TiNbN Coating femoral component, are manufactured from cobaltchromium-molybdenum alloy (Co-Cr-Mo) according to ISO 5832-12:2019 Implants for Surgery -Metallic Materials-Part 12: Wrought cobalt-chromium-molybdenum Alloy with Titanium Niobium Nitride (TiNbN) coating.
The GMK Revision & Hinge augmentations, both tibial and femoral, are manufactured from Ti6A14V per ISO 5832-3:2016 Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy.
V. Indications for Use
. GMK Revision
The Evolis/GMK knee prosthesis is designed for cemented use in total knee arthroplasty, 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.
- Avascular necrosis of femoral condyle. .
6
- . 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 tibial tray is used, an extension stem must be implanted.
● GMK Hinge
The GMK® HINGE knee prosthesis is designed for cemented use in total knee arthroplasty when the preoperative diagnosis of the joint determines that the bone and stability situation require the implantation of a constrained prosthesis.
The GMK® HINGE knee system is indicated in the following cases:
- . Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis or polyarthritis associated with bone loss and/or severe joint instability
- Considerable loss of function of the knee joint
- High-grade joint destruction requiring additional stabilization with stems and ● reconstruction of bone defects with metal augmentation
- Failure of a primary prosthesis (e.g. infection, loosening)
- Former revision arthroplasty
- . Post traumatic loss of joint configuration
- Avascular necrosis of femoral condyle.
Tibial augmentation are to be screwed to the tibial baseplate with both the two provided fixing screws.
When a GMK® HINGE implant is used it is mandatory to implant both the femoral and tibial components with an extension stem.
VI. Comparison of Technological Characteristics
The GMK Revision & Hinge Extension - TiNbN Coating and the predicate devices (K102437, K103170, K123721, K130299, K163311, K172347) share the following characteristics:
- indications for use;
- sizes: ●
- shape, design and dimensions (except for femoral posterior augmentation screw); ●
- fixation to the body and connections;
- substrate material (except for tibial and femoral augmentations); ●
- device usage:
- sterility:
- shelf life: and
- packaging.
7
The GMK Revision & Hinge Extension - TiNbN Coating differs from the predicate devices (K102437, K103170, K123721, K130299, K163311, K172347) in relation to:
- femoral posterior augmentations additional thicknesses;
- femoral posterior augmentation connection screw dimension; ●
- coating; and
- tibial and femoral augmentations material.
VII. Performance Data
Based on the risk analysis, testing was conducted according to written protocols. The following tests are being provided in support of a substantial equivalence determination:
Non-Clinical Studies:
- . PERFORMANCE TESTING
- o TiNbN coated Femoral Components Wear Behavior
- Evaluation of modular tapered connection according to Medacta Test Protocol IL o 07.09.517, Medacta Test Report A.2 and Endolab Test Report 167.181121.20.87 Rev.0
- Femoral Modular Connection (Femoral Components + Femoral Distal and Posterior о Augmentation)
- TiNbN Coating Excessive Ions Release O
- TiNbN coated Femoral Component Mechanical Performances o
- TiNbN coated Tibial Trays Mechanical Performances O
- TiNbN coated Tibial Trays Connection with the insert O
- Tibial Tray Modular Connection (Tibial Tray + Offset + Extension Stem) O
- Tibial Modular Connection (Revision Tibial Tray + Tibial Augmentation) O
- GMK Revision TiNbN coated SC Peg Mechanical Performances O
- GMK Hinge TiNbN coated Post Extension Mechanical Performances o
- Ti6A14V Femoral Augmentations Validation O
- O Posterior Wedge Screw Design Validation Report according to Test Protocol IL 07.09.566
- 0 Ti6Al4V Tibial Augmentation Validation
- PYROGENICITY ●
- Bacterial Endotoxin Test (LAL test) was conducted according to European o Pharmacopoeia §2.6.14 (which is equivalent to USP chapter )
- Pyrogen test according to USP chapter for pyrogenicity determination o
- The subject devices are not labeled as non-pyrogenic or pyrogen free o
- BIOCOMPATIBILITY assessment ●
8
Clinical Studies
- No clinical studies were conducted ●
VIII. Conclusion
Based on the above information, the GMK Revision & Hinge Extension - TiNbN Coating implants can be considered substantially equivalent to the identified predicate devices.
Substantial equivalence has been demonstrated through a comparison of intended use, design, and technological characteristics, as well as performance evaluations. The GMK Revision & Hinge Extension - TiNbN Coating implants are as safe and effective as the predicate devices (K102437, K103170, K123721, K130299, K163311, K172347 and K202684).