OMNI TiN Coated Apex Knee™ System

K191765 · Omni Life Science, Inc. · JWH · Sep 25, 2019 · Orthopedic

Device Facts

• Record ID: K191765
• Device Name: OMNI TiN Coated Apex Knee™ System
• Applicant: Omni Life Science, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Sep 25, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

OMNI TiN Coated Apex Knee System is a total knee replacement prosthesis; consists of CoCrMo metal components (femoral, tibial baseplate, revision augments) with a Titanium Nitride (TiN) surface coating. TiN coating applied to reduce metal ion release into surrounding tissues. Device intended for cemented, single-use implantation in primary or revision knee arthroplasty. Operated by orthopedic surgeons in clinical/OR settings. Surgeon implants device to restore joint function and alleviate pain associated with degenerative or inflammatory joint disease. No changes to substrate materials, design, or surgical technique compared to predicate systems.

Clinical Evidence

No clinical studies were performed. Substantial equivalence is supported by non-clinical bench testing, including chemical composition, coating thickness, hardness, adhesion strength, surface roughness, and wear resistance (Mode 1 and Mode 3). LAL testing for endotoxins was conducted.

Technological Characteristics

CoCrMo substrate components with Titanium Nitride (TiN) surface coating. Semi-constrained patellofemorotibial prosthesis. Cemented fixation. Modular tibial and femoral augments. Sterilization and packaging unchanged from predicate devices.

Indications for Use

Indicated for primary or revision total knee replacement in patients requiring cemented implantation for non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity correction, or revision of failed prior treatments.

Regulatory Classification

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).

Predicate Devices

• Apex Revision Knee System (K163332)
• CKS Plus Knee System (K163167, K110950)
• Foundation Knee -Armor Coat-System (K122239, K020114)
• VEGA, Columbus (Aesculap Implant Systems)
• EnduRo Knee -Advanced Surface Technology-System(s) (K143443, K143106, K120955, K101815)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# 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: [phone] Email: [e-mail]

| 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.

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## 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.