(54 days)
No
The summary describes a line extension of existing partial knee and patellofemoral joint replacement systems, focusing on material composition, sizes, and mechanical performance testing. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities.
Yes
The device is a partial knee arthroplasty system, which is used to replace damaged parts of the knee joint. This procedure is performed to alleviate pain and restore function, thereby treating a medical condition and improving the patient's health.
No
The device is an implantable partial knee arthroplasty system, designed for cemented use in partial knee replacements. It is a treatment device, not one used for diagnosis.
No
The device description clearly states that the MOTO™ Partial Knee & MOTO™ PFJ Systems are sterile implantable devices made of physical materials (cobalt-chromium-molybdenum alloy and E-Cross UHMWPE). The performance studies also focus on mechanical and biological properties of these physical components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a surgical implant for partial knee replacement. It is used in vivo (within the body) to treat conditions affecting the knee joint.
- Device Description: The description details the components of a knee implant (femoral components, tibial inserts, patellofemoral joint, patella) made from materials like cobalt-chromium-molybdenum alloy and UHMWPE. These are materials used for surgical implants, not for testing biological samples in vitro.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
- Performance Studies: The performance studies described are focused on the mechanical properties, wear behavior, biocompatibility, and shelf-life of the implant itself, not on the accuracy or reliability of a diagnostic test.
Therefore, based on the provided information, the MOTO™ Partial Knee System and MOTO™ PFJ System are surgical implants, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
o MOTO™ Partial Knee System
The MOTO™ Partial Knee System is designed for cemented use in partial knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components. Partial replacement of the articulating surfaces of the knee is indicated when only one compartment of the joint is affected due to the compartmental primary degenerative or posttraumatic decenerative disease, previous tibial condule or plateau fractures, deformity or revious arthroplasty.
o MOTO™ PFJ System
The MOTO™ PFJ is designed for cemented use in partial knee arthroplasty, if there is evidence of enough sound bone to seat and support the components. Patellofemoral replacement is indicated in the following cases:
- · Osteoarthritis, post-traumatic arthritis, severe chondrocalcinosis of the patellofemoral joint.
- · Previously failed surgical attempts (i.e. arthroscopy, lateral release, tibial tubercle elevation, cartilage transplantation).
- · History of patellar dislocation or fracture, resulting in cartilage degeneration of the patellofemoral joint.
- · Degeneration induced by dysplasia.
If the surgeon evaluates an unequivocal indication for replacement of the patellofemoral joint, with or without a patella resurfacing, which outweighs the risks associated with the surgery, PFJ replacement may be considered, particularly for young patients.
Product codes (comma separated list FDA assigned to the subject device)
HSX, KRR, JWH, NPJ
Device Description
The purpose of this submission is to gain clearance for the MOTO™ Partial Knee & MOTO™ PFJ Systems Extension and to extend the compatibility of the already cleared MOTO Patella. Specifically, both the new MOTO Patella and the already cleared one (K200122) may be used in the following combinations:
- . with the MOTO PFJ
- with the MOTO PFJ and with the MOTO Partial Knee System (K162084, K183029), GMK UNI ● (K162084).
- alone (without MOTO PFJ) with the GMK Primary or GMK Sphere devices (K090988, ● K120790, K121416, K122232, K140826, K142069 and K202684) or GMK Spherika (K211004).
The MOTO™ Partial Knee & MOTO™ PFJ Systems is a line extension to provide a larger product offering. The subject devices are sterile implantable devices designed for cemented use in partial knee arthroplasty procedures. The MOTO™ Partial Knee & MOTO™ PFJ Systems extension includes:
- Medial femoral components TiNbN coated, left medial, sizes from 1 to 10; ●
- Lateral femoral components TiNbN coated, sizes from 1 to 7; ●
- Medial tibial inserts fixed E-cross, left medial and right medial, sizes from 1 to 8 and 6 thicknesses ● from 8 to 14;
- . Lateral tibial inserts fixed E-cross, sizes from 1 to 8 and 6 thicknesses from 8 to 14;
- . Patello Femoral Joint TiNbN coated, left and right, sizes from 1 to 6;
- MOTO Patella E-cross, 6 sizes. ●
The subject femoral components, as well as the patello femoral joint, are manufactured from cobalt-chromium-molybdenum alloy (Co-Cr-Mo) according to ISO 5832-4 with Titanium Nitride (TiNbN) coating.
The subject tibial inserts, as well as the MOTO patella, are made of E-Cross (Vitamin-E Highly Crosslinked UHMWPE).
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
Surgeon evaluated for PFJ replacement, "particularly for young patients."
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
- TiNbN coated MOTO Femoral component Mechanical performances
- TiNbN coated MOTO Femoral component Wear behavior
- TiNbN coating Excessive Ions release
- TiNbN coated PFJ implant Mechanical performances
- TiNbN coated PFJ implant Wear behavior
- E-Cross MOTO medial and lateral tibial inserts Wear behavior. ROM and constraints rationale
- MOTO Partial knee system E-Cross medial and lateral tibial inserts: static ML SHEAR and AP draw test of the insert-tray clipping system according to ASTM F2083
- MOTO E-Cross tibial inserts Contact pressures and areas according to ASTM F2083
- Contact pressure and areas: MOTO Patella articulating on GMK-Sphere & GMK-Primary femoral component
- Constraint comparison within Medacta MOTO Patella & Medacta EVOLIS Patella in terms of jump height
- E-Cross MOTO Patella Wear behavior, ROM and constraints rationale
- Constraints equivalence of GMK Resurfacing and MOTO Patella articulating with GMK Spherika femoral component and GMK Spherika anatomical femoral component and the predicated device
- Contact areas equivalence of GMK Resurfacing and MOTO Patella articulating with GMK Spherika femoral component and GMK Spherika anatomical femoral component and the predicated device
- 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
- The subject devices are not labeled as non-pyrogenic or pyrogen free.
- BIOCOMBATIBILITY evaluation
- SHELF-LIFE evaluation
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.
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.
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
§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
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November 16, 2021
Medacta USA % Chris Lussier Senior Director, Quality and Regulatory 3973 Delp Street Memphis, Tennessee 38118
Re: K213071
Trade/Device Name: MOTO™ Partial Knee & MOTO PFJ Systems Extension Regulation Number: 21 CFR 888.3520 Regulation Name: Knee Joint Femorotibial Metal/Polymer Non-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: HSX, KRR, JWH, NPJ Dated: November 11, 2021 Received: November 12, 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
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,
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)
Device Name
MOTO™ Partial Knee & MOTO PFJ Systems Extension
Indications for Use (Describe)
o MOTO™ Partial Knee System
The MOTO™ Partial Knee System is designed for cemented use in partial knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components. Partial replacement of the articulating surfaces of the knee is indicated when only one compartment of the joint is affected due to the compartmental primary degenerative or posttraumatic decenerative disease, previous tibial condule or plateau fractures, deformity or revious arthroplasty.
o MOTO™ PFJ System
The MOTO™ PFJ is designed for cemented use in partial knee arthroplasty, if there is evidence of enough sound bone to seat and support the components. Patellofemoral replacement is indicated in the following cases:
- · Osteoarthritis, post-traumatic arthritis, severe chondrocalcinosis of the patellofemoral joint.
- · Previously failed surgical attempts (i.e. arthroscopy, lateral release, tibial tubercle elevation, cartilage transplantation).
- · History of patellar dislocation or fracture, resulting in cartilage degeneration of the patellofemoral joint.
- · Degeneration induced by dysplasia.
If the surgeon evaluates an unequivocal indication for replacement of the patellofemoral joint, with or without a patella resurfacing, which outweighs the risks associated with the surgery, PFJ replacement may be considered, particularly for young patients.
| 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
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 of Quality and Regulatory, Medacta USA Date Prepared: September 22, 2021 Date Revised: November 12, 2021
II. Device
| Device Proprietary Name: | MOTO™ Partial Knee & MOTO PFJ Systems Extension |
|---|---|
| Common or Usual Name: | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, |
| Metal/Polymer | |
| Classification Name: | Knee joint femorotibial metal/polymer non-constrained |
| cemented prosthesis | |
| Primary Product Code | HSX |
| Secondary Product Code: | KRR, JWH, NPJ |
| Regulation Number: | 21 CFR 888.3520, 21 CFR 888.3540 and 21 CFR 888.3560 |
| Device Classification | II |
III. Predicate Device
Substantial equivalence is claimed to the following devices:
Primary predicate device
-
MOTO™ Partial Knee System, K162084, Medacta International SA
Additional predicate devices -
MOTO™ Lateral Partial Knee System, K183029, Medacta International SA
-
MOTO™ PFJ System, K200122, Medacta International SA
Additional reference devices
-
GMK Sphere E-cross, K202022, Medacta International SA
-
GMK Total Knee System TiNbN Coating, K202684, Medacta International SA
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IV. Device Description
The purpose of this submission is to gain clearance for the MOTO™ Partial Knee & MOTO™ PFJ Systems Extension and to extend the compatibility of the already cleared MOTO Patella. Specifically, both the new MOTO Patella and the already cleared one (K200122) may be used in the following combinations:
- . with the MOTO PFJ
- with the MOTO PFJ and with the MOTO Partial Knee System (K162084, K183029), GMK UNI ● (K162084).
- alone (without MOTO PFJ) with the GMK Primary or GMK Sphere devices (K090988, ● K120790, K121416, K122232, K140826, K142069 and K202684) or GMK Spherika (K211004).
The MOTO™ Partial Knee & MOTO™ PFJ Systems is a line extension to provide a larger product offering. The subject devices are sterile implantable devices designed for cemented use in partial knee arthroplasty procedures. The MOTO™ Partial Knee & MOTO™ PFJ Systems extension includes:
- Medial femoral components TiNbN coated, left medial, sizes from 1 to 10; ●
- Lateral femoral components TiNbN coated, sizes from 1 to 7; ●
- Medial tibial inserts fixed E-cross, left medial and right medial, sizes from 1 to 8 and 6 thicknesses ● from 8 to 14;
- . Lateral tibial inserts fixed E-cross, sizes from 1 to 8 and 6 thicknesses from 8 to 14;
- . Patello Femoral Joint TiNbN coated, left and right, sizes from 1 to 6;
- MOTO Patella E-cross, 6 sizes. ●
The subject femoral components, as well as the patello femoral joint, are manufactured from cobaltchromium-molybdenum alloy (Co-Cr-Mo) according to ISO 5832-4 with Titanium Nitride (TiNbN) coating.
The subject tibial inserts, as well as the MOTO patella, are made of E-Cross (Vitamin-E Highly Crosslinked UHMWPE).
Indications for Use V.
MOTO™ Partial Knee System
The MOTOM Partial Knee System is designed for cemented use in partial knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components. Partial replacement of the articulating surfaces of the knee is indicated when only one compartment of the joint is affected due to the compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty.
o MOTO™ PFJ System
The MOTO™ PFJ is designed for cemented use in partial knee arthroplasty, if there is evidence of enough sound bone to seat and support the components. Patellofemoral replacement is indicated in the following cases:
5
- . Osteoarthritis, post-traumatic arthritis, severe chondrocalcinosis of the patellofemoral joint.
- Previously failed surgical attempts (i.e. arthroscopy, lateral release, tibial tubercle elevation, ● cartilage transplantation).
- History of patellar dislocation or fracture, resulting in cartilage degeneration of the patellofemoral . joint.
- Degeneration induced by dysplasia. ●
If the surgeon evaluates an unequivocal indication for replacement of the patellofemoral joint, with or without a patella resurfacing, which outweighs the risks associated with the surgery, PFJ replacement may be considered, particularly for young patients.
Comparison of Technological Characteristics VI.
The MOTO™ Partial Knee & MOTO™ PFJ Systems Extension implants and the predicate devices (K162084, K183029 and K200122) share the following characteristics:
- indications for use; ●
- sizes: ●
- shape and design: ●
- fixation and stability;
- biocompatibility; ●
- . device usage:
- sterility; ●
- shelf-life; and ●
- packaging.
The MOTO™ Partial Knee & MOTO™ PFJ Systems Extension implants differ from the predicate devices (K162084, K183029 and K200122) as follow:
- MOTO tibial inserts and MOTO Patella material; and .
- femoral components and MOTO PFJ coating. .
Discussion
Medacta International SA has not made any change to the indications for use, sizes, general design and shape, fixation and stability features, 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 MOTO™ Partial Knee & MOTO™ PFJ Systems Extension implants to the identified predicate devices.
VII. Performance Data
Based on the risk analysis, performance testing were conducted to written protocols. The following tests and rationales are provided in support of the substantial equivalence determination: Non-Clinical Studies
6
- PERFORMANCE TESTING .
- TiNbN coated MOTO Femoral component Mechanical performances о
- TiNbN coated MOTO Femoral component Wear behavior o
- TiNbN coating Excessive Ions release o
- TiNbN coated PFJ implant Mechanical performances o
- TiNbN coated PFJ implant Wear behavior O
- E-Cross MOTO medial and lateral tibial inserts Wear behavior. ROM and constraints O rationale
- MOTO Partial knee system E-Cross medial and lateral tibial inserts: static ML SHEAR and O AP draw test of the insert-tray clipping system according to ASTM F2083
- MOTO E-Cross tibial inserts Contact pressures and areas according to ASTM F2083 о
- Contact pressure and areas: MOTO Patella articulating on GMK-Sphere & GMK-Primary o femoral component
- Constraint comparison within Medacta MOTO Patella & Medacta EVOLIS Patella in terms O of jump height
- E-Cross MOTO Patella Wear behavior, ROM and constraints rationale o
- Constraints equivalence of GMK Resurfacing and MOTO Patella articulating with GMK o Spherika femoral component and GMK Spherika anatomical femoral component and the predicated device
- Contact areas equivalence of GMK Resurfacing and MOTO Patella articulating with GMK о Spherika femoral component and GMK Spherika anatomical femoral component and the predicated device
- PYROGENICITY ●
- Bacterial endotoxin test (LAL test) according to European Pharmacopoeia $2.6.14 (which is o equivalent to USP chapter )
- o Pyrogen test according to USP chapter for pyrogenicity determination
- The subject devices are not labeled as non-pyrogenic or pyrogen free. o
- BIOCOMBATIBILITY evaluation .
- SHELF-LIFE evaluation ●
Clinical Studies:
- No clinical studies were conducted. ●
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VIII. Conclusion
The information provided above supports that the MOTO™ Partial Knee & MOTO™ PFJ Systems Extension implants are substantially equivalent to the predicate devices.