(254 days)
Not Found
No
The document describes a modular shoulder replacement system and its components. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML. The focus is on the mechanical design and intended use of the physical implants.
Yes
Explanation: The device is a shoulder replacement system intended to treat various degenerative joint diseases, fractures, and arthropathies, which are conditions requiring therapeutic intervention to restore function and alleviate symptoms.
No
This device is a shoulder replacement system, which is a prosthetic implant used for surgical intervention, not for diagnosing medical conditions.
No
The device description clearly outlines physical components such as humeral heads, stems, glenoids, and instruments, indicating it is a hardware-based medical device for surgical implantation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The AGILON® XO Shoulder Replacement System is a surgical implant designed to replace the shoulder joint. Its intended use is for treating various conditions affecting the shoulder joint through surgical implantation.
- Lack of Specimen Analysis: The description and intended use do not involve the analysis of any biological specimens from the patient. The device is physically implanted into the body.
Therefore, the AGILON® XO Shoulder Replacement System falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The AGILON® XO Shoulder Replacement System is indicated for use for total or hemi shoulder replacement in cases of:
- · Non- inflammatory degenerative joint disease including osteoarthritis and avascular necrosis,
- · Post-traumatic osteoarthritis,
- · Fractures,
- · Rheumatoid arthritis.
The main indications for the implantation of an AGILON® hemi shoulder prosthesis are:
- · Multifragmental comminuted fractures of the humeral head,
- · 3- and 4-Fragment-fractures of the proximal humerus,
- · Head-splitting fractures,
- · Dislocated head-splitting fractures,
- · Humeral head depression with more than 40% of joint surface depressed,
- · Interlocking chronic dislocation with deep HILL-SACHS lesion,
- Fracture instability following internal fixation attempt in 3-fragment fractures (secondary dislocation, material loosening),
- · Posttraumatic humeral head necrosis,
- · Omarthrosis.
AGILON® CTA heads are destined for treatment of stable types of rotator cuff tear arthropathy. In order to achieve satisfactory results with the CTA heads the fornix humeri and the subscapularis tendon must be intact. A CTA cap is intended for the use as a hemi-arthroplasty, to treat a patient after an inverse shoulder has failed. It is not combined with a glenoid implant. It can be used in primary and revision cases.
The main indications for the implantation of an AGILON® inverse (reverse) shoulder prosthesis are:
- · Rotator cuff tear arthropathy,
- · Chronic trauma shoulder,
- · Decentering of the humeral head after implantation of a humeral head prosthesis.
Please note, that the patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary.
In case of revision surgery, the available bone stock has to be evaluated to allow for implantation of well-fixed stems. Conversion of the system, can be performed in revision cases as follows:
- · From Hemi Shoulder Arthroplasty to Anatomic Total Shoulder Arthroplasty
- From Hemi Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty
- · From Hemi Shoulder Arthroplasty to Inverse (Reverse) Total Shoulder Arthroplasty
- · From Inverse (Reverse) Total Shoulder Arthroplasty to Hemi Shoulder Arthroplasty as salvage procedure
- · From Inverse (Reverse) Total Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty as salvage procedure
- · From Anatomic Total Shoulder Arthroplasty to Inverse (Reverse) Total Shoulder Arthroplasty
- From Anatomic Total Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty
The device is intended for adults.
The AGILON® XO Shoulder Replacement System Titanium alloy stems are intended for cementless fixation.
The PE-glenoids of the AGILON® XO Shoulder Replacement System are intended for cemented fixation. The glenoids cementless are intended for cementless use with the addition of screws for fixation.
Product codes (comma separated list FDA assigned to the subject device)
KWT, HSD, PHX
Device Description
The AGILON® XO Shoulder Replacement System is a modular shoulder replacement system offering various components that can be combined to replace the shoulder joint with various options depending upon the size and of each patient. The components can be combined for use in a total (anatomic and reverse) or a hemi shoulder replacement:
Hemi Shoulder:
- Humeral Head Components (AGILON® XO Cap and AGILON® XO CTA Cap)
- Humeral Stems (Cementless)
Total Anatomic Shoulder:
- Humeral Head Components (AGILON® XO Cap)
- Glenoid Components (AGILON® PE-Glenoid, Cemented)
- Humeral Stems (Cementless)
Total Reverse Shoulder:
- Humeral Head Components (AGILON® Cap Inverse and AGILON® PE-Inlay) ●
- Glenoid and Glenosphere Components (AGILON® XO Glenoid Baseplate and AGILON® ● Glenosphere)
- Humeral Stems (Cementless)
Metaphyseal components (including a new line extension 145°), stem extension pieces, and component connection fixation screws are intended to be used for hemi and total (anatomic and reverse) shoulder configurations.
The subject system also includes device-specific reusable instruments for use with the subject implants, including an osteotomy guide, implant trials, and a humeral cutting block.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder joint
Indicated Patient Age Range
Adults
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)
All necessary testing had been performed for the "worst-case" components of the predicate AGILON® XO Shoulder Replacement System. Engineering analyses demonstrated the new 145° Metaphyseal component does not create a new worst-case for the system and no new performance testing was required for a determination of substantial equivalence.
The biocompatibility evaluation was completed per ISO 10993-1.
The cleaning, sterilization, shelf-life, packaging, and endotoxin testing were leveraged from the predicate AGILON® XO Shoulder Replacement System (K191433/K222482).
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.
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
§ 888.3650 Shoulder joint metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-Aluminum 4-Vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-Chromium-Molybdenum Casting Alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,”
(vii) F 1378-97 “Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”
0
February 16, 2024
Image /page/0/Picture/1 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font below.
Implantcast. GmbH % Sarah Pleaugh Associate Director Mcra, LLC 803 7th Street NW Third Floor Washington, District of Columbia 20001
Re: K231657
Trade/Device Name: AGILON® XO Shoulder Replacement System Regulation Number: 21 CFR 888.3650 Regulation Name: Shoulder joint metal/polymer non-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWT, HSD, PHX Dated: January 19, 2024 Received: January 19, 2024
Dear Sarah Pleaugh:
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products: and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Digitally signed by Joseph P. Joseph P. Russell -S Russell -S Date: 2024.02.16 12:02:30 -05'00'
for: Farzana Sharmin, PhD Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K231657
Device Name
AGILON® XO Shoulder Replacement System
Indications for Use (Describe)
The AGILON® XO Shoulder Replacement System is indicated for use for total or hemi shoulder replacement in cases of:
- · Non- inflammatory degenerative joint disease including osteoarthritis and avascular necrosis,
- · Post-traumatic osteoarthritis,
- · Fractures,
- · Rheumatoid arthritis.
The main indications for the implantation of an AGILON® hemi shoulder prosthesis are:
- · Multifragmental comminuted fractures of the humeral head,
- · 3- and 4-Fragment-fractures of the proximal humerus,
- · Head-splitting fractures,
- · Dislocated head-splitting fractures,
- · Humeral head depression with more than 40% of joint surface depressed,
- · Interlocking chronic dislocation with deep HILL-SACHS lesion,
- Fracture instability following internal fixation attempt in 3-fragment fractures (secondary dislocation, material loosening),
- · Posttraumatic humeral head necrosis,
- · Omarthrosis.
AGILON® CTA heads are destined for treatment of stable types of rotator cuff tear arthropathy. In order to achieve satisfactory results with the CTA heads the fornix humeri and the subscapularis tendon must be intact. A CTA cap is intended for the use as a hemi-arthroplasty, to treat a patient after an inverse shoulder has failed. It is not combined with a glenoid implant. It can be used in primary and revision cases.
The main indications for the implantation of an AGILON® inverse (reverse) shoulder prosthesis are:
- · Rotator cuff tear arthropathy,
- · Chronic trauma shoulder,
- · Decentering of the humeral head after implantation of a humeral head prosthesis.
Please note, that the patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary.
In case of revision surgery, the available bone stock has to be evaluated to allow for implantation of well-fixed stems. Conversion of the system, can be performed in revision cases as follows:
- · From Hemi Shoulder Arthroplasty to Anatomic Total Shoulder Arthroplasty
- From Hemi Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty
- · From Hemi Shoulder Arthroplasty to Inverse (Reverse) Total Shoulder Arthroplasty
- · From Inverse (Reverse) Total Shoulder Arthroplasty to Hemi Shoulder Arthroplasty as salvage procedure
- · From Inverse (Reverse) Total Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty as salvage procedure
- · From Anatomic Total Shoulder Arthroplasty to Inverse (Reverse) Total Shoulder Arthroplasty
- From Anatomic Total Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty
The device is intended for adults.
4
The AGILON® XO Shoulder Replacement System Titanium alloy stems are intended for cementless fixation.
The PE-glenoids of the AGILON® XO Shoulder Replacement System are intended for cemented fixation. The glenoids cementless are intended for cementless use with the addition of screws for 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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5
510(k) Summary
| Device Trade Name: | AGILON® XO Shoulder Replacement System | |
|---|---|---|
| Manufacturer: | implantcast, GmbH | |
| Lüneburger Schanze 26 | ||
| 21614 Buxtehude, Germany | ||
| Company Contact: | Juliane Höppner | |
| Title: Head of Regulatory & Clinical & Biological Affairs | ||
| Office: 49-4161-744-135 | ||
| Prepared by: | MCRA, LLC | |
| 803 7th Street, NW, 3rd Floor | ||
| Washington, DC 20001 | ||
| Office: 202.552.5800 | ||
| Date Prepared: | February 16, 2024 | |
| Classifications: | 21 CFR 888.3650, Shoulder joint metal/polymer non-constrained | |
| cemented prosthesis | ||
| 21 CFR 888.3690, Shoulder joint humeral (hemi-shoulder) metallic | ||
| uncemented prosthesis | ||
| 21 CFR 888.3660, Shoulder joint metal/polymer semi-constrained | ||
| cemented prosthesis | ||
| Class: | II | |
| Common Name: | Shoulder Prosthesis | |
| Product Codes: | KWT, HSD, PHX | |
| Primary Predicate: | AGILON® XO Shoulder Replacement System (K191433) | |
| Additional Predicate: | AGILON® XO Shoulder Replacement System (K222482) |
Indications For Use:
The AGILON® XO Shoulder Replacement System is indicated for use for total or hemi shoulder replacement in cases of:
- Non- inflammatory degenerative joint disease including osteoarthritis and avascular . necrosis,
- Post-traumatic osteoarthritis, .
- Fractures, ●
- Rheumatoid arthritis. ●
6
The main indications for the implantation of an AGILON® hemi shoulder prosthesis are:
- · Multifragmental comminuted fractures of the humeral head,
- · 3- and 4-Fragment-fractures of the proximal humerus,
- · Head-splitting fractures,
- · Dislocated head-splitting fractures,
- · Humeral head depression with more than 40% of joint surface depressed,
- · Interlocking chronic dislocation with deep HILL-SACHS lesion,
- · Fracture instability following internal fixation attempt in 3-fragment and 4-fragment fractures (secondary dislocation, material loosening),
- · Posttraumatic humeral head necrosis,
- · Omarthrosis.
AGILON® CTA heads are destined for treatment of stable types of rotator cuff tear arthropathy. In order to achieve satisfactory results with the CTA heads the fornix humeri and the subscapularis tendon must be intact. A CTA cap is intended for the use as a hemi-arthroplasty, to treat a patient after an inverse shoulder has failed. It is not combined with a glenoid implant. It can be used in primary and revision cases.
The main indications for the implantation of an AGILON® inverse (reverse) shoulder prosthesis are:
- Rotator cuff tear arthropathy,
- · Chronic trauma shoulder,
- · Decentering of the humeral head after implantation of a humeral head prosthesis.
Please note, that the patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary.
In case of revision surgery, the available bone stock has to be evaluated to allow for implantation of well-fixed stems. Conversion of the system, can be performed in revision cases as follows:
- · From Hemi Shoulder Arthroplasty to Anatomic Total Shoulder Arthroplasty
- From Hemi Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty
- From Hemi Shoulder Arthroplasty to Inverse (Reverse) Total Shoulder Arthroplasty
- · From Inverse (Reverse) Total Shoulder Arthroplasty to Hemi Shoulder Arthroplasty as salvage procedure
- · From Inverse (Reverse) Total Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty as salvage procedure
- · From Anatomic Total Shoulder Arthroplasty to Inverse (Reverse) Total Shoulder Arthroplasty
- From Anatomic Total Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty
The device is intended for adults.
The AGILON® XO Shoulder Replacement System Titanium alloy stems are intended for cementless fixation.
7
The PE-glenoids of the AGILON® XO Shoulder Replacement System are intended for cemented fixation. The glenoids cementless are intended for cementless use with the addition of screws for fixation.
Device Description:
The AGILON® XO Shoulder Replacement System is a modular shoulder replacement system offering various components that can be combined to replace the shoulder joint with various options depending upon the size and of each patient. The components can be combined for use in a total (anatomic and reverse) or a hemi shoulder replacement:
Hemi Shoulder:
- Humeral Head Components (AGILON® XO Cap and AGILON® XO CTA Cap)
- Humeral Stems (Cementless)
Total Anatomic Shoulder:
- Humeral Head Components (AGILON® XO Cap)
- Glenoid Components (AGILON® PE-Glenoid, Cemented)
- Humeral Stems (Cementless)
Total Reverse Shoulder:
- Humeral Head Components (AGILON® Cap Inverse and AGILON® PE-Inlay) ●
- Glenoid and Glenosphere Components (AGILON® XO Glenoid Baseplate and AGILON® ● Glenosphere)
- Humeral Stems (Cementless)
Metaphyseal components (including a new line extension 145°), stem extension pieces, and component connection fixation screws are intended to be used for hemi and total (anatomic and reverse) shoulder configurations.
The subject system also includes device-specific reusable instruments for use with the subject implants, including an osteotomy guide, implant trials, and a humeral cutting block.
Predicate Device:
implantcast submits the following information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, AGILON® XO Shoulder Replacement System is substantially equivalent in indications, design principles, and performance as compared to the predicate devices.
Performance Testing Summary:
All necessary testing had been performed for the "worst-case" components of the predicate AGILON® XO Shoulder Replacement System. Engineering analyses demonstrated the new 145° Metaphyseal component does not create a new worst-case for the system and no new performance testing was required for a determination of substantial equivalence.
The biocompatibility evaluation was completed per ISO 10993-1.
8
The cleaning, sterilization, shelf-life, packaging, and endotoxin testing were leveraged from the predicate AGILON® XO Shoulder Replacement System (K191433/K222482).
Substantial Equivalence:
The AGILON® XO Shoulder Replacement System is substantially equivalent to the predicate devices with respect to intended use, design, and fundamental scientific technology.
Conclusion:
The subject device and the predicate devices have intended use, have similar technological characteristics, and are made of the same materials. The subject and predicate devices are packaged and sterilized using the same materials and methods with the same shelf-life. The data included in this submission demonstrate substantial equivalence to the predicate devices for the new line extension components. AGILON® XO Shoulder Replacement System is as safe, as effective, and performs as well as, or better, than the predicate devices.