(260 days)
No
The summary describes a knee replacement system focusing on materials, design, and mechanical testing, with no mention of AI/ML or related concepts like image processing, training/test sets, or performance metrics typically associated with AI/ML algorithms.
Yes
The device is a knee joint replacement system, which is a type of medical intervention designed to treat conditions like arthritis and replace damaged components, thereby providing a therapeutic effect by alleviating pain, restoring function, and improving quality of life for patients.
No
Explanation: The device is described as a knee implant system (femoral implants and tibial baseplates) used for surgical replacement in cases of arthritis or failed previous replacements. Its function is to replace damaged joint components, not to diagnose medical conditions.
No
The device description clearly details physical components (femoral implants, tibial baseplates) made of cast CoCrMo alloy with a TiNbN coating. The performance studies also focus on the mechanical properties and wear performance of these physical implants.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description clearly states that this device is a knee implant (femoral implants and tibial baseplates). These are surgically implanted devices used to replace damaged knee joints.
- Intended Use: The intended uses listed are for the surgical treatment of various knee conditions (arthritis, failed replacements, etc.). This involves direct intervention within the body, not testing of samples outside the body.
- Lack of IVD Characteristics: The description does not mention any components or processes related to sample collection, analysis of biological samples, or providing diagnostic information based on such analysis.
Therefore, this device is a surgical implant, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The indications for use are:
A. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis
B. Failed osteotomy or unicompartmental replacements
C. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists
D. The non-porous (uncoated, coated with CoCr beads without Titanium, and uncoated with a TiNbN overcoat) components may only be used with cement
E. The porous coated (CoCr beads with Titanium) components may be used with or without cement
Product codes
JWH
Device Description
The femoral implants are provided in left and right-side versions and designed to replicate the natural anatomy of the femur. They are available in a single variant only - CR, with sizes ranging from 1 to 6. The femoral implants have a R.P design, which offers surgeon an option for patients where a more minimal anatomic design is preferred. The femoral implants are manufactured using cast CoCrMo alloy (ASTM F75). A monolayer of TiNbN coating (thickness: 3 to 7 microns) is applied to the femoral implants.
The tibial baseplates are provided in left and right-side versions and designed to replicate the natural anatomy of the tibial baseplates are available in three variants – holed, pegged, and pegless, with sizes ranging from 0 to 6. The tibial baseplates are manufactured using cast CoCMo alloy (ASTM F75). A monolayer of TiNbN coating (thickness: 3 to 7 microns) is applied to the entire surface of the tibial baseplates.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical testing provided in the submission:
- TiNbN coating testing/statements by DOT America:
- Chemistry
- Physical properties: Coating thickness, Roughness
- Mechanical properties: Tensile bond strength, Tensile shear strength, Adhesive strength, Micro Hardness
- Other testing/statements: Figure Liquid Contact Angle TiNbN, Statement_Fixture Point_TiNbN, Test_Influence of PVD Coating on Base Material, Test Adhesive Strength of Bone Cement on PVD, Statement Artificial Aging TiNbN, Statement MRI TiNbN
- Wear performance of the subject and predicate devices under Mode 1 and Mode 3 conditions.
- Mechanical tests/analysis leveraged from predicate devices:
- Tibial Baseplate Fatigue Test
- Tibial Baseplate - Tibial Insert Locking Mechanism
- Range of Motion Analysis
Key Results:
- The TiNbN coating is considered biologically safe based on biocompatibility testing by DOT America (cytotoxicity, sensitization, irritation, acute systemic toxicity, and implantation).
- The subject devices have superior wear resistance than the predicate devices under both Mode 1 and Mode 3 conditions, based on wear testing per ISO 14243-1.
- The TiNbN coating does not affect the performance in the Tibial Baseplate Fatigue Test, Tibial Baseplate - Tibial Insert Locking Mechanism, and Range of Motion Analysis, allowing leveraging of predicate device data.
- Based on the nonclinical testing data, the subject devices are at least as safe and effective as the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K110950, K001456, K182251, K122239
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 14, 2025
Shalby Advanced Technologies Romil Sheth QA/RA Manager 1115 Windfield Way El Dorado Hills, California 95762
Re: K241180
Trade/Device Name: Consensus Knee System with TiNbN Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH Dated: November 18, 2024 Received: November 19, 2024
Dear Romil Sheth:
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.
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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 (QS) 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-regulatory
2
assistance/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,
Peter G.
Allen -S
Digitally signed by Peter G. Allen -S Date: 2025.01.14 00:18:23 -05'00'
For 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
Submission Number (if known)
Device Name
Consensus Knee System with TiNbN
Indications for Use (Describe)
The indications for use are:
A. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis
B. Failed osteotomy or unicompartmental replacements
C. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists
D. The non-porous (uncoated, coated with CoCr beads without Titanium, and uncoated with a TiNbN overcoat) components may only be used with cement
E. The porous coated (CoCr beads with Titanium) components may be used with or without cement
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) #: | K241180 |
|---|---|
| ----------- | --------- |
| 510(k) Summary | Prepared on: | 2025-01-07 | |
|---|---|---|---|
| ---------------- | -- | -------------- | ------------ |
| Contact Details | |||
|---|---|---|---|
| ----------------- | -- | -- | -- |
| 21 CFR 807.92(a)(1) | |||
|---|---|---|---|
| -- | -- | -- | --------------------- |
| Applicant Name | Shalby Advanced Technologies, Inc. dba Consensus Orthopedics |
|---|---|
| Applicant Address | 1115 Windfield Way El Dorado Hills CA 95762 United States |
| Applicant Contact Telephone | +1 2134002624 |
| Applicant Contact | Mr. Romil Sheth |
| Applicant Contact Email | rsheth@shalby.us |
| Device Name | 21 CFR 807.92(a)(2) | ||
|---|---|---|---|
| ------------- | -- | -- | --------------------- |
| Device Trade Name | Consensus Knee System with TiNbN |
|---|---|
| Common Name | Total knee prosthesis |
| Classification Name | prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer |
| Regulation Number | 21 CFR 888.3560 |
| Product Code(s) | JWH |
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | ||
|---|---|---|---|
| ------------------------------------ | -- | -- | --------------------- |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | |
|---|---|---|---|
| K110950, K001456 | Consensus Knee System (CKS) | JWH, MBH | |
| K182251, K122239 | EVOLUTION NitrX Medial-Pivot Knee, Foundation, Foundation | JWH |
| Device Description Summary | 21 CFR 807.92(a)(4) | ||
|---|---|---|---|
| ---------------------------- | -- | -- | --------------------- |
The femoral implants are provided in left and right-side versions and designed to replicate the natural anatomy of the femur. They are
available in a single variant only - CR, with sizes ranging from 1 to 6. The femoral implants have a R.P design, which offers surgeon an option for patients where a more minimal anatomic design is preferred. The femoral implants are manufactured using cast CoCrMo alloy (ASTM F75). A monolayer of TiNbN coating (thickness: 3 to 7 microns) is applied to the femoral implants.
The tibial baseplates are provided in left and right-side versions and designed to replicate the natural anatomy of the tibial baseplates are available in three variants – holed, pegged, and pegless, with sizes ranging from 0 to 6. The tibial baseplates are manufactured using cast CoCMo alloy (ASTM F75). A monolayer of TiNbN coating (thickness: 3 to 7 microns) is applied to the entire surface of the tibial baseplates.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
The indications for use are:
A. Primary intervention of rheumatoid arthritis, post-traumatic arthritis, or degenerative arthritis
B. Failed osteotomy or unicompartmental replacements
- C. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists
D. The non-porous (uncoated, coated without Titanium, and uncoated with a TiNbN overcoat) components may only be used with cement
5
E. The porous coated (CoCr beads with Titanium) components may be used with or without cement
Indications for Use Comparison
The subject devices have intended use and indications for use as the predicate devices.
The subject devices have the same design, except the TiNbN coating, as the predicate devices. The dimensions and tolerances for the subject devices are same as the predicate devices. The subject devices use the same substrate material, same sterilization method, and same shelf life as the predicate devices.
Technological Comparison
The subject devices have the same intended use, same indications for use, and similar technological characteristics as the predicate devices. The only difference in the technological characteristics is the TiNbN coating on subject devices, whereas the predicate devices are uncoated.
The questions of safety and effectiveness regarding the TiNbN coating are whether it is biocompatible and whether it impacts (negatively) the articulating surface wear (femoral insert). These questions are also applicable to the predicate devices, therefore, the TiNbN coating does not raise different questions of safety and effectiveness.
The subject devices are manufactured using the same substrate material, cast CoCr (ASTM F75), as the predicate devices. The subject devices use the same manufacturing process (including manufacturing contact materials) as the predicate devices, except, the TiNbN coating step. DOT America, the company which performs the TiNbN coating step for the subject devices, has conducted exhaustive biocompatibility testing for the TiNbN coating on CoCr material (cytotoxicity, sensitization, irritation, acute systemic toxicity, and implantation). Therefore, based on the substrate material/manufacturing process equivalency between the subject and predicate devices and the biocompatibility testing data from DOT America for the subject devices with the TiNbN coating are considered biologically safe.
The wear performance of the subject and predicate devices was evaluated under Mode 3 conditions per ISO 14243-1. Based on the results of the wear testing, the subject devices have a superior wear resistance than the predicate devices under both Mode 1 and Mode 3 conditions.
Further, the following reference devices are TiNbN coated by DOT America:
Foundation, Foundation - PS, 3D-Knee (K122239) EVOLUTION NitrX Medial-Pivot Knee (K182251)
Therefore, based on the above discussion, the subject devices are considered substantially equivalent to the predicate devices.
Non-Clinical and/or Clinical Tests Summary & Conclusions
Following nonclinical testing/statements have been provided in this submission. The TiNbN coating testing/statements are performed by DOT America. 1) TiNbN coating testing/statements o Chemistry o Physical properties @ Coating thickness & Roughness o Mechanical properties & Tensile bond strength 1 Tensile shear strength Adhesive strength & Micro Hardness o Other testing/statements 2 Figure Liquid Contact Angle TiNbN & Statement_Fixture Point_TiNbN മ Test_Influence of PVD Coating on Base Material 0 Test Adhesive Strength of Bone Cement on PVD & Statement Artificial Aging TiNbN 8 Statement MRI TiNbN 2) Wear performance of the subject and predicate devices under Mode 1 and Mode 3 conditions 3) The following mechanical tests/analysis were levers. The predicate devices are identical to the subject
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)
6
devices, except that the subject devices have the TiNbN coating on the surface. However, the TiNbN coating does not have any effect on these tests and hence, the testing performed of the predicate devices can be leveraged for the subject devices. o Tibial Baseplate Fatigue Test o Tibial Baseplate - Tibial Insert Locking Mechanism
o Range of Motion Analysis
The test reports, statements, and justification for using existing are attached to this section.
N/A
A significant number of tests were performed by DOT in support of ascertaining the safety and efficacy of the TiNbN coating. The wear performance of the subject and predicate devices was evaluated under Mode 3 conditions per ISO 14243-1. Based on the results of the wear testing, the subject devices have a superior wear resistance than the predicate devices under both Mode 1 and Mode 3 conditions. The tibial baseplate fatigue test, tibial insert locking mechanism test, and range of motion analysis for the predicate devices are leveraged for the subject devices. Based on the nondinical testing data, it can be concluded that the subject devices are at least as safe and effective as the predicate devices.