(86 days)
No
The device description explicitly states that there is "no change to the fundamental scientific technology" of the predicate devices and the modification is solely the addition of a TiN coating. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes.
The device is a knee replacement system intended to treat various debilitating joint conditions, which aligns with the definition of a therapeutic device designed to alleviate or cure a diseased or injured body part.
No
This device is a total knee replacement system, intended for primary or revision total knee replacement due to various conditions like degenerative joint disease or rheumatoid arthritis. It is an implantable medical device, not a diagnostic tool.
No
The device description clearly states it is a knee replacement system, which is a physical implant, and the 510(k) is for a coating applied to metal components of this implant.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "primary or revision total knee replacement" and is "intended for cemented single use implantation." This describes a surgical implant used within the body, not a device used to test samples outside the body (in vitro).
- Device Description: The description focuses on the physical components of the knee replacement and the addition of a coating to those components. It doesn't mention any reagents, test strips, or analytical processes typically associated with IVDs.
- Performance Studies: The performance studies described are related to the physical properties of the coating and the device (chemical composition, thickness, hardness, adhesion, wear resistance, LAL testing for endotoxins), not diagnostic accuracy or analytical performance.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
Therefore, this device is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The OMNI TiN Coated Apex Knee™ System is intended for use as a primary or revision total knee replacement. This knee replacement system is intended for cemented single use implantation. This prosthesis may be used for the following conditions, as appropriate:
- Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
- Rheumatoid arthritis;
- Correction of functional deformity;
- Revision procedures where other treatments or devices have failed;
The Apex Knee™ Modular Tibial Augments with TiN coating are intended to be bolted to the TiN coated Tibia Baseplate and cemented to the prepared tibia. The Apex Knee Revision Femur System Augments are intended to be bolted to the TiN coated femoral component and cemented to the prepared femur.
Product codes
JWH
Device Description
The change that is the subject of this 510(k) is to add a thin coating of Titanium Nitride (TiN) to all surfaces of all CoCrMo substrate metal components (Femoral(s), Tibial Baseplate(s), and Revision Tibia Augments) as listed in the above Predicates. The purpose of the TiN coating is to substantially reduce release of CoCrMo metal ions into body fluids, bone or soft tissues.
There is no change to the fundamental scientific technology of the referenced OMNI Predicate Knee Systems (5) with the modifications in this 510(k) submission. This includes no changes to the substrate materials, design, sterilization, packaging, or method(s) of manufacture.
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 Testing:
Testing was conducted for the TiN Coating: Chemical Composition, Thickness, Hardness, Adhesion Strength to the CoCrMo substrate material, Surface Roughness and Wear Resistance Mode 1 and Mode 3.
LAL testing has been conducted, product will not be released if 20 EU/per device is exceeded.
Clinical Testing:
No clinical studies were performed.
Key Metrics
Not Found
Predicate Device(s)
K163332, K163167, K110950, K122239, K020114, K143443, K143106, K120955, K101815
Reference Device(s)
Not Found
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
September 25, 2019
OMNI life science, Inc. Ms. Christina Rovaldi Manager. Regulatory Affairs 480 Paramount Drive Raynham, Massachusetts 02767
Re: K191765
Trade/Device Name: OMNI TiN Coated Apex KneeTM System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH Dated: June 28, 2019 Received: July 1, 2019
Dear Ms. Christina Rovaldi:
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 CAPT Raquel Peat, PhD, MPH, USPHS Director 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) K191765
Device Name OMNI TiN Coated APEX Knee™ System
Indications for Use (Describe)
The OMNI TiN Coated Apex Knee™ is intended for use as a primary or revision total knee replacement. This knee replacement system is intended for cemented single use implantation. This prosthesis may be used for the following conditions, as appropriate:
- · Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
- · Rheumatoid arthritis;
- · Correction of functional deformity;
- · Revision procedures where other treatments or devices have failed;
The Apex Knee™ Modular Tibial Augments with TiN coating are intended to be bolted to the TiN coated Tibia Baseplate and cemented to the prepared tibia. The Apex Knee Revision Femur System Augments are intended to be bolted to the TiN coated femoral component and cemented to the prepared femur.
| 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)
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510(k) SUMMARY
OMNI TiN Coated APEX Knee™ System
Date: June 21, 2019
- Submitter: OMNIIife science™, Inc. 480 Paramount Dr. Raynham, MA 02767
- Contact: Christina Rovaldi Manager, Regulatory Affairs OMNI
Phone: (774) 226-1857 Email: crovaldi@omnils.com
| 1. Device Name: | |
|---|---|
| Proprietary Name: | OMNI TiN Coated APEX Knee™ System |
| Common Name: | Knee prosthesis, cemented/un-cemented |
| Classification: | Class II - per 21 CFR §888.3560 prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer |
| Product Codes: | JWH |
2. Indications for Use:
The OMNI TiN Coated Apex Knee™ System is intended for use as a primary or revision total knee replacement. This knee replacement system is intended for cemented single use implantation. This prosthesis may be used for the following conditions, as appropriate:
- Non-inflammatory degenerative ioint including ● disease. osteoarthritis and avascular necrosis;
- Rheumatoid arthritis; ●
- Correction of functional deformity: ●
- Revision procedures where other treatments or devices have failed; .
The Apex Knee™ Modular Tibia System Tibial Augments with TiN coating are intended to be bolted to the TiN coated Tibia Baseplate and cemented to the prepared tibia. The Apex Knee Revision Femur System Augments are intended to be bolted to the TiN coated femoral component and cemented to the prepared femur.
3. Description:
The change that is the subject of this 510(k) is to add a thin coating of Titanium Nitride (TiN) to all surfaces of all CoCrMo substrate metal components (Femoral(s), Tibial Baseplate(s), and Revision Tibia Augments) as listed in the above Predicates. The purpose of the TiN coating is to substantially reduce release of CoCrMo metal ions into body fluids, bone or soft tissues.
There is no change to the fundamental scientific technology of the referenced OMNI Predicate Knee Systems (5) with the modifications in this 510(k) submission. This includes no changes to the substrate materials, design, sterilization, packaging, or method(s) of manufacture.
4
4. Predicate Devices:
Primary Predicate: OMNI life science™ - Apex Revision Knee System, K163332 Additional Predicate: Consensus Orthopedics - CKS Plus Knee System, K163167, K110950 Additional Predicate: DJO Surgical - Foundation Knee -Armor Coat-System, K122239, K020114 Additional Predicate: Aesculap Implant Systems - VEGA, Columbus, Additional Predicate: EnduRo Knee -Advanced Surface Technology-System(s), K143443, K143106, K120955, K101815
5. Comparable Features to the Predicate Device(s):
Features comparable to the Predicate Devices include: indications for cemented use, dimensions, substrate materials, packaging, sterilization, surgical implantation technique, instrumentation and intended use.
6. Non-Clinical Testing:
Testing was conducted for the TiN Coating: Chemical Composition, Thickness, Hardness, Adhesion Strength to the CoCrMo substrate material, Surface Roughness and Wear Resistance Mode 1 and Mode 3.
LAL testing has been conducted, product will not be released if 20 EU/per device is exceeded.
7. Clinical Testing:
No clinical studies were performed.
8. Conclusions:
The OMNI TiN Coated APEX Knee™ System is substantially equivalent to the Predicate Devices.