(298 days)
Not Found
No
The summary describes a mechanical implant system for hip replacement and does not mention any software, algorithms, or AI/ML capabilities.
Yes.
The device is intended for reconstruction of the articulating surface of the acetabular portion of the hip that is severely disabled and/or very painful resulting from various conditions, which aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
The device is an acetabular system intended for surgical reconstruction of the hip, which is a therapeutic rather than diagnostic function.
No
The device description explicitly states that the ONVOY™ Acetabular System consists of physical components like shells, liners, and bone screws made from materials like titanium alloy and UHMWPE. This indicates it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for reconstructing the hip joint. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details physical components (shells, liners, screws) made of materials like titanium and polyethylene, designed for surgical implantation. This is consistent with a medical device, not an IVD which typically involves reagents, instruments, or software used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition based on in vitro testing.
Therefore, the ONVOY™ Acetabular System is a medical device (specifically, a surgical implant), not an In Vitro Diagnostic device.
N/A
Intended Use / 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:
- 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.
Product codes (comma separated list FDA assigned to the subject device)
LPH, MBL, OQG
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
acetabular portion of the hip
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K122773, K070756, K950827, K132158, K934765
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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
2
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,
-
- 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) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary: ONVOY™ Acetabular System
| Company: | Globus Medical Inc.
2560 General Armistead Ave.
Audubon, PA 19403
610-930-1800 |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 semiconstrained
porous-coated uncemented prosthesis
Product Codes: LPH, MBL, OQG
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.
4
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:
-
- Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, 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.
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.