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:

Non-inflammatory degenerative joint disease including osteoarthritis, and avascular necrosis,
Rheumatoid arthritis.
Correction of functional deformity.
Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
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 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.

AI/ML Overview

This document is a 510(k) premarket notification from the FDA for a medical device called the ONVOY™ Acetabular System. A 510(k) submission is for demonstrating that a medical device is substantially equivalent to a legally marketed predicate device, not for proving that a device meets specific performance criteria beyond substantial equivalence. Therefore, the information typically requested in your prompt regarding acceptance criteria, specific studies to prove criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training data is not part of this type of regulatory submission.

This document confirms substantial equivalence through:

Indications for Use: The ONVOY™ Acetabular System has the same intended use as its predicate devices, which is for reconstructing the articulating surface of the acetabular portion of the hip in cases of non-inflammatory degenerative joint disease, rheumatoid arthritis, functional deformity, certain fractures, and revision of failed hip arthroplasty. It is used with Globus/StelKast hip systems and intended for cementless fixation.
Technological Characteristics: The subject implants possess the same technological characteristics as the predicate devices, including design, material composition (titanium alloy shells with commercially pure titanium vacuum sintered coating, UHMWPE liners with Vitamin E, and titanium alloy bone screws), and range of sizes.
Performance Data (Mechanical Testing): Mechanical testing was conducted in accordance with several ASTM and ISO standards (F1820, F2582, ISO 7206-12, F543, F3090, ISO 21535). These tests cover aspects like push-out, torque-out disassembly, impingement, deformation, screw testing, shell fatigue, and range of motion. The results of these tests "demonstrate substantial equivalence to the predicate devices."
Bacterial Endotoxin Testing (BET): BET was conducted in accordance with ANSI/AAMI ST-72:2011.

Therefore, it's not possible to provide the specific details you requested because a 510(k) summary focuses on demonstrating substantial equivalence to existing devices, rather than establishing and meeting novel acceptance criteria through independent performance studies. The document indicates that the performance data shows substantial equivalence, which is the "acceptance criteria" for a 510(k) submission itself.

Here's a breakdown based on the information provided and what is not provided in a 510(k) summary:

Information Requested	Provided in Document?	Details from Document
1. Table of Acceptance Criteria & Reported Device Performance	No*	The document states that "Performance data demonstrate substantial equivalence to the predicate devices." For a 510(k), demonstrating substantial equivalence is the acceptance criterion. Specific quantitative thresholds for various performance metrics would be assessed against the predicate device's established performance or relevant standards (e.g., ASTM/ISO). The document lists the types of mechanical tests performed (push-out, torque-out disassembly, impingement, deformation, screw testing, shell fatigue, range of motion) and standards (ASTM F1820, ASTM F2582, ISO 7206-12, ASTM F543, ASTM F3090, and ISO 21535), as well as Bacterial Endotoxin Testing (ANSI/AAMI ST-72:2011). However, the specific quantitative results of these tests and the precise acceptance criteria used to deem them "substantially equivalent" are not provided in this summary.
2. Sample Size for Test Set & Data Provenance	No	Not specified in a 510(k) summary. These details would be in the full submission, but generally pertain to engineering tests, not clinical data for an AI/diagnostic device.
3. Number of Experts & Qualifications for Ground Truth for Test Set	Not Applicable	This is a mechanical orthopedic device, not an AI/diagnostic device requiring expert interpretation of images or signals for ground truth.
4. Adjudication Method for Test Set	Not Applicable	This is a mechanical orthopedic device, not an AI/diagnostic device.
5. MRMC Comparative Effectiveness Study & Effect Size (Human + AI vs. Human only)	No	Not applicable. This is a medical device (hip prosthesis) and not an AI-assisted diagnostic or decision support tool.
6. Standalone Performance Done (Algorithm Only)	No	Not applicable. This is a medical device (hip prosthesis), not an algorithm.
7. Type of Ground Truth Used	Not Applicable	"Ground truth" in the context of this device would be established by physical measurements and test results according to specified standards, not typically by expert consensus or pathology in the way an AI diagnostic device would.
8. Sample Size for Training Set	No	Not applicable. This is a mechanical device, not an AI/ML algorithm that requires a training set.
9. How Ground Truth for Training Set Was Established	No	Not applicable.

In summary, this document is a regulatory approval notice based on demonstrating substantial equivalence to existing predicate devices through comprehensive mechanical and material testing, rather than presenting a study against novel, pre-defined acceptance criteria for a new type of performance claim (like an AI model's accuracy).

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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:

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

1. Rheumatoid arthritis.

Correction of functional deformity.
Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
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)
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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.2560 General Armistead Ave.Audubon, PA 19403610-930-1800
Contact:	Jennifer Antonacci, Ph.D.Group Manager, Regulatory Affairs
Date Prepared:	October 3, 2022
Device Name:	ONVOY™ Acetabular System
Common Name:	Hip Prosthesis
Classification:	Per 21 CFR as follows:§888.3358 Hip joint metal/polymer/metal semiconstrainedporous-coated uncemented prosthesisProduct Codes: LPH, MBL, OQGRegulatory 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:

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.
1. Rheumatoid arthritis.
1. Correction of functional deformity.
1. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques,
1. 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.

Regulation Number and Section

§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

(a)
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.(b)
Classification. Class II.