(42 days)
AGILON XO Shoulder Replacement System (K191433)
No
The document describes a shoulder replacement system and its components, focusing on materials, indications for use, and mechanical performance testing. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is a shoulder replacement system intended to treat various degenerative joint diseases, fractures, and arthropathy, which is a therapeutic purpose.
No
This device is described as a shoulder replacement system, which is an implant used for an intervention (replacement of joints) rather than for diagnosing a condition.
No
The device description clearly states it is a shoulder replacement system, which involves physical implants (hardware). The submission is for a line extension of cemented glenoids, which are also hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing parts of the shoulder joint due to various conditions like osteoarthritis, fractures, and rheumatoid arthritis. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is described as a "Shoulder Replacement System" consisting of components like glenoids and stems, intended to be implanted.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) as a surgical implant.
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 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 in revision cases after an inverse shoulder has failed. It is not combined with a glenoid implant. It can also be used in primary 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.
AGILON® retentive caps invers are indicated in case of shoulder joint instability if the joint cannot be stabilized with a regular AGILON® cap inverse in combination with a Glenosphere. Warning: The use of the AGILON® retentive caps invers entails a decrease of the Range of Motion of the prosthesis. The surgeon has to balance conscientiously the advantage of stabilization and the increased risk of scapula impingement.
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 surgeon decides which version of prosthesis for the individual patient is used. This decision depends on several factors, such as the age and the patient's weight, bone quality, shape of the bone and deformation of the joint.
Product codes
KWT, PHX, HSD
Device Description
The purpose of this Traditional 510(k) is introduce into interstate commerce in the United States the ALIGON® XO Glenoid Cemented components to the AGILON XO Shoulder System. The components are a line extension to the previously cleared AGILON XO Shoulder Replacement System which add all polyethylene cemented glenoids to the current system. The components introduced with this submission are intended to mate with other previously cleared implantcast shoulder components to make a complete prosthesis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder
Indicated Patient Age Range
The device is intended for 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 has been performed for the "worst-case" components of the AGILON XO Shoulder System to assure substantial equivalence to its predicate and to demonstrate the subject devices perform as intended. All testing was performed on test units representative of or worst-case compared to the finished device. The following evaluations were conducted to characterize the devices:
- Dynamic Evaluation of Glenoid Loosening or Disassociation (ASTM F2028-17)
- Range of Motion (ROM) Evaluation
Conclusions: The AGILON XO Shoulder System subject to this submission possess the same intended use and technological characteristics as the predicate device system components. All performance testing conducted for the AGILON XO Shoulder System met the predetermined acceptance criteria or were otherwise considered acceptable. As such, the AGILON XO Shoulder System components are substantially equivalent to the predicate device for the intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Fx Solutions Humeris Shoulder (K163669)
Reference Device(s)
AGILON XO Shoulder Replacement System (K191433)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(K) SUMMARY
| Manufacturer: | implantcast GmbH
Lüneburger Schanze 26
21614 Buxtehude
Germany |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Ms. Juliane Höppner
Head of Regulatory Affairs
implantcast GmbH
Lüneburger Schanze 26
21614 Buxtehude
Germany
Phone: +49 4161 744 135
Fax: +49 4161 744 200
Email: j.hoeppner@implantcast.de |
| Prepared By: | Mr. Dave McGurl
MCRA, LLC
803 7th Street NW, Floor 3
Washington, DC 20001
Phone: 202.552.5797
dmcgurl@mcra.com |
| Date Prepared: | August 17, 2022 |
| Device Trade Name: | AGILON XO Shoulder System |
| Device Class and
Common Name: | Class II |
| Classification: | 21 CFR 888.3650: Prothesis, Shoulder, Non-Constrained,
Metal/Polymer Cemented |
| Product Codes: | KWT, PHX, HSD |
| Indications for Use: | The AGILON® XO Shoulder Replacement System
is indicated for use for total or hemi shoulder replacement
in cases of: |
1
- 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 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 in revision cases after an inverse shoulder has failed. It is not combined with a glenoid implant. It can also be used in primary 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.
AGILON® retentive caps invers are indicated in case of shoulder joint instability if the joint cannot be stabilized with
2
a regular AGILON® cap inverse in combination with a Glenosphere. Warning: The use of the AGILON® retentive caps invers entails a decrease of the Range of Motion of the prosthesis. The surgeon has to balance conscientiously the advantage of stabilization and the increased risk of scapula impingement.
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 surgeon decides which version of prosthesis for the individual patient is used. This decision depends on several factors, such as the age and the patient's weight, bone quality, shape of the bone and deformation of the joint.
The device is intended for adults.
The stems of the AGILON® XO Shoulder Replacement System are intended for cementless fixation. The glenoids of the AGILON® XO Shoulder Replacement System are intended for cemented fixation.
- Device Description: The purpose of this Traditional 510(k) is introduce into interstate commerce in the United States the ALIGON® XO Glenoid Cemented components to the AGILON XO Shoulder System. The components are a line extension to the previously cleared AGILON XO Shoulder Replacement System which add all polyethylene cemented glenoids to the current system. The components introduced with this submission are intended to mate with other previously cleared
3
implantcast shoulder components to make a complete prosthesis.
| Predicate Device: | - Fx Solutions Humeris Shoulder (K163669) |
|---|---|
| Reference Device: | - AGILON XO Shoulder Replacement System (K191433) |
| Substantial | |
| Equivalence: | The AGILON XO Shoulder System AGILON® XO Glenoid |
| Cemented components are substantially equivalent to the | |
| glenoids of the legally marketed predicate device system, the | |
| Fx Solutions Humeris Shoulder, with respect to design and | |
| intended use. Additionally, the AGILON XO Glenoids | |
| Cemented components are substantially equivalent to | |
| components of the AGILON XO Shoulder Replacement | |
| System reference device cleared in K191433. | |
| Performance Testing: | All necessary testing has been performed for the "worst-case" |
| components of the AGILON XO Shoulder System to assure | |
| substantial equivalence to its predicate and to demonstrate the |
subject devices perform as intended. All testing was performed on test units representative of or worst-case compared to the finished device. The following evaluations were conducted to characterize the devices:
- . Dynamic Evaluation of Glenoid Loosening or Disassociation (ASTM F2028-17)
- . Range of Motion (ROM) Evaluation
- The AGILON XO Shoulder System subject to this submission Conclusions: possess the same intended use and technological characteristics as the predicate device system components. All performance testing conducted for the AGILON XO Shoulder System met the predetermined acceptance criteria or were otherwise considered acceptable. As such, the AGILON XO Shoulder System components are substantially equivalent to the predicate device for the intended use.
4
Indications for Use
510(k) Number (if known) K222482
Device Name AGILON XO Shoulder System
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 in revision cases after an inverse shoulder has failed. It is not combined with a glenoid implant. It can also be used in primary 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.
AGILON® retentive caps invers are indicated in case of shoulder joint instability if the joint cannot be stabilized with a regular AGILON® cap inverse in combination with a Glenosphere. Warning: The use of the AGILON® retentive caps invers entails a decrease of the Range of Motion of the prosthesis. The surgeon has to balance conscientiously the advantage of stabilization and the increased risk of scapula impingement.
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
5
· From Anatomic Total Shoulder Arthroplasty to Inverse (Reverse) Total Shoulder Arthroplasty
- · From Anatomic Total Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty
The surgeon decides which version of prosthesis for the individual patient is used. This decision depends on several factors, such as the age and the patient's weight, bone quality, shape of the bone and deformation of the joint.
The device is intended for adults.
The stems of the AGILON® XO Shoulder Replacement System are intended for cementless fixation. The glenoids of the AGILON® XO Shoulder Replacement System are intended for cemented fixation.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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6
510(K) SUMMARY
| Manufacturer: | implantcast GmbH
Lüneburger Schanze 26
21614 Buxtehude
Germany |
|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Ms. Juliane Höppner
Head of Regulatory Affairs
implantcast GmbH
Lüneburger Schanze 26
21614 Buxtehude
Germany
Phone: +49 4161 744 135
Fax: +49 4161 744 200
Email: j.hoeppner@implantcast.de |
| Prepared By: | Mr. Dave McGurl
MCRA, LLC
803 7th Street NW, Floor 3
Washington, DC 20001
Phone: 202.552.5797
dmcgurl@mcra.com |
| Date Prepared: | August 17, 2022 |
| Device Trade Name: | AGILON XO Shoulder System |
| Device Class and
Common Name:
Classification: | Class II
21 CFR 888.3650: Prothesis, Shoulder, Non-Constrained,
Metal/Polymer Cemented |
| Product Codes: | KWT, PHX, HSD |
| Indications for Use: | The AGILON® XO Shoulder Replacement System
is indicated for use for total or hemi shoulder replacement
in cases of: |
7
- 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 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 in revision cases after an inverse shoulder has failed. It is not combined with a glenoid implant. It can also be used in primary 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.
AGILON® retentive caps invers are indicated in case of shoulder joint instability if the joint cannot be stabilized with
8
a regular AGILON® cap inverse in combination with a Glenosphere. Warning: The use of the AGILON® retentive caps invers entails a decrease of the Range of Motion of the prosthesis. The surgeon has to balance conscientiously the advantage of stabilization and the increased risk of scapula impingement.
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 surgeon decides which version of prosthesis for the individual patient is used. This decision depends on several factors, such as the age and the patient's weight, bone quality, shape of the bone and deformation of the joint.
The device is intended for adults.
The stems of the AGILON® XO Shoulder Replacement System are intended for cementless fixation. The glenoids of the AGILON® XO Shoulder Replacement System are intended for cemented fixation.
- Device Description: The purpose of this Traditional 510(k) is introduce into interstate commerce in the United States the ALIGON® XO Glenoid Cemented components to the AGILON XO Shoulder System. The components are a line extension to the previously cleared AGILON XO Shoulder Replacement System which add all polyethylene cemented glenoids to the current system. The components introduced with this submission are intended to mate with other previously cleared
9
implantcast shoulder components to make a complete prosthesis.
| Predicate Device: | Fx Solutions Humeris Shoulder (K163669) |
|---|---|
| Reference Device: | AGILON XO Shoulder Replacement System (K191433) |
| Substantial | |
| Equivalence: | The AGILON XO Shoulder System AGILON® XO Glenoid |
| Cemented components are substantially equivalent to the | |
| glenoids of the legally marketed predicate device system, the | |
| Fx Solutions Humeris Shoulder, with respect to design and | |
| intended use. Additionally, the AGILON XO Glenoids | |
| Cemented components are substantially equivalent to | |
| components of the AGILON XO Shoulder Replacement | |
| System reference device cleared in K191433. | |
| Performance Testing: | All necessary testing has been performed for the "worst-case” |
| components of the AGILON XO Shoulder System to assure | |
| substantial equivalence to its predicate and to demonstrate the |
subject devices perform as intended. All testing was performed on test units representative of or worst-case compared to the finished device. The following evaluations were conducted to characterize the devices:
- . Dynamic Evaluation of Glenoid Loosening or Disassociation (ASTM F2028-17)
- . Range of Motion (ROM) Evaluation
- The AGILON XO Shoulder System subject to this submission Conclusions: possess the same intended use and technological characteristics as the predicate device system components. All performance testing conducted for the AGILON XO Shoulder System met the predetermined acceptance criteria or were otherwise considered acceptable. As such, the AGILON XO Shoulder System components are substantially equivalent to the predicate device for the intended use.