ONVOY Acetabular System

K213842 · Globus Medical, Inc. · LPH · Oct 3, 2022 · Orthopedic

Device Facts

• Record ID: K213842
• Device Name: ONVOY Acetabular System
• Applicant: Globus Medical, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Oct 3, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ONVOY™ Acetabular System is intended for use in reconstruction of the articulating surface of the acetabular portion of the hip that is severely disabled and/or very painful resulting from: 1. Non-inflammatory degenerative joint disease including osteoarthritis, and avascular necrosis, 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. 5. Revision of previously failed total hip arthroplasty. The ONVOY™ Acetabular System is used in conjunction with Globus/Stelkast hip systems. The acetabular components of this system are intended for cementless fixation.

Device Story

The ONVOY™ Acetabular System is a set of orthopedic implants used in total hip arthroplasty to reconstruct the acetabular articulating surface. The system comprises acetabular shells, liners, and bone screws. Shells are titanium alloy with a vacuum-sintered commercially pure titanium coating; liners are Vitamin E-stabilized ultra-high molecular weight polyethylene (UHMWPE); bone screws are titanium alloy. The device is used in conjunction with Globus/Stelkast femoral components. Surgeons implant the system via cementless fixation to restore hip function in patients with severe joint disease or following failed arthroplasty. The variety of sizes and configurations allows for anatomical matching. The device provides a stable articulating surface to reduce pain and restore mobility.

Clinical Evidence

Bench testing only. Mechanical testing performed per ASTM F1820, ASTM F2582, ISO 7206-12, ASTM F543, ASTM F3090, and ISO 21535. Bacterial endotoxin testing performed per ANSI/AAMI ST-72:2011. No clinical data provided.

Technological Characteristics

Materials: Titanium alloy, commercially pure titanium coating, Vitamin E-stabilized UHMWPE. Components: Acetabular shells (cluster hole design), liners (hooded/non-hooded), bone screws. Fixation: Cementless. Standards: ASTM F1820, ASTM F2582, ISO 7206-12, ASTM F543, ASTM F3090, ISO 21535, ANSI/AAMI ST-72:2011.

Indications for Use

Indicated for patients with severe hip disability or pain due to non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, proximal femur fractures (non-union, femoral neck, trochanteric), or revision of failed total hip arthroplasty.

Regulatory Classification

Identification

A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.

Predicate Devices

• StelKast Cross-Over Acetabular Shell and Liner (K122773)
• Smith & Nephew REFLECTION 3 Shell (K070756)
• StelKast ProForm Hip System (K950827)
• NovoSource NovoHip Total Hip System (K132158)
• Zimmer Trilogy Acetabular System (K934765)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Globus Medical Inc. Jennifer Antonacci Group Manager, Regulatory Affairs 2560 General Armistead Ave. Audubon, Pennsylvania 19403

#### Re: K213842

Trade/Device Name: ONVOY™ Acetabular System Regulation Number: 21 CFR 888.3358 Regulation Name: Hip Joint Metal/Polymer/Metal Semi-Constrained Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: LPH, MBL, OQG Dated: September 14, 2022 Received: September 14, 2022

#### Dear Jennifer Antonacci:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Limin Sun, 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

510(k) Number (if known) K213842

Device Name ONVOY™ Acetabular System

Indications for Use (Describe)

The ONVOY™ Acetabular System is intended for use in reconstruction of the articulating surface of the acetabular portion of the hip that is severely disabled and/or very painful resulting from:

1. Non-inflammatory degenerative joint disease including osteoarthritis, and avascular necrosis,

- 2. Rheumatoid arthritis.
3. Correction of functional deformity.

4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

5. Revision of previously failed total hip arthroplasty.

The ONVOY™ Acetabular System is used in conjunction with Globus/Stelkast hip systems. The acetabular components of this system are intended for cementless fixation.

| 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: ONVOY™ Acetabular System

| Company: | Globus Medical Inc.<br>2560 General Armistead Ave.<br>Audubon, PA 19403<br>610-930-1800 |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Jennifer Antonacci, Ph.D.<br>Group Manager, Regulatory Affairs |
| Date Prepared: | October 3, 2022 |
| Device Name: | ONVOY™ Acetabular System |
| Common Name: | Hip Prosthesis |
| Classification: | Per 21 CFR as follows:<br>§888.3358 Hip joint metal/polymer/metal semiconstrained<br>porous-coated uncemented prosthesis<br>Product Codes: LPH, MBL, OQG<br>Regulatory Class: II, Panel Code: 87 |

Primary Predicate: StelKast Cross-Over Acetabular Shell and Liner (K122773)

# Additional

Smith & Nephew REFLECTION 3 Shell (K070756) Predicates: StelKast ProForm Hip System (K950827) NovoSource NovoHip Total Hip System (K132158) Zimmer Trilogy Acetabular System (K934765)

# Purpose:

The purpose of this submission is to request clearance for new acetabular shells, liners and bone screws.

# Device Description:

The ONVOY™ Acetabular System consists of shells, liners, and bone screws that are used as part of a complete total hip system in conjunction with a femoral head and femoral stem in total hip arthroplasty. Implants are available in various configurations and sizes to fit a wide variety of patient anatomy. Shells are available in a cluster hole design, liners are available in hooded and non-hooded designs used in conjunction with the shells, and bone screws provide additional fixation when inserted through the shell.

ONVOY™ acetabular shells are manufactured from titanium alloy, with a commercially pure titanium vacuum sintered coating. The liners are manufactured from ultra-high molecular weight polyethylene (UHMWPE) with Vitamin E. Bone screws are manufactured from titanium alloy.

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# Indications for Use:

The ONVOY™ Acetabular System is intended for use in reconstruction of the articulating surface of the acetabular portion of the hip that is severely disabled and/or very painful resulting from:

- 1. Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, and avascular necrosis.
- 2. Rheumatoid arthritis.
- 3. Correction of functional deformity.
- 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques,
- 5. Revision of previously failed total hip arthroplasty.

The ONVOY™ Acetabular System is used in conjunction with Globus/StelKast hip systems. The acetabular components of this system are intended for cementless fixation.

## Performance Data:

Mechanical testing (push-out, and torque-out disassembly, impingement, deformation, screw testing, shell fatigue and range of motion) was conducted in accordance with ASTM F1820, ASTM F2582, ISO 7206-12, ASTM F543, ASTM F3090, and ISO 21535. Performance data demonstrate substantial equivalence to the predicate devices. Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011.

## Technological Characteristics:

Subject ONVOY™ implants have the same technological characteristics as the predicate devices including design, intended use, material composition, and range of sizes.

## Basis of Substantial Equivalence:

Subject ONVOY™ Acetabular System has been found to be substantially equivalent to the predicate devices with respect to technical characteristics, performance, and intended use. The information provided within this premarket notification supports substantial equivalence of the subject implants to the predicate devices.