AGILON XO Shoulder System

K222482 · Implantcast GmbH · KWT · Sep 28, 2022 · Orthopedic

Device Facts

• Record ID: K222482
• Device Name: AGILON XO Shoulder System
• Applicant: Implantcast GmbH
• Product Code: KWT · Orthopedic
• Decision Date: Sep 28, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3650
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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. 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 Story

AGILON XO Shoulder System is a modular shoulder prosthesis line extension; adds all-polyethylene cemented glenoid components to existing system. Components mate with previously cleared implantcast shoulder hardware. Used by orthopedic surgeons in clinical settings for total or hemi-shoulder arthroplasty. Surgeon selects specific implant configuration based on patient age, weight, bone quality, and joint deformity. Provides structural replacement for damaged or diseased shoulder joints; restores joint function and stability. System supports conversion between hemi, anatomic total, and inverse configurations during revision surgery.

Clinical Evidence

Bench testing only. Evaluations included dynamic evaluation of glenoid loosening or disassociation per ASTM F2028-17 and range of motion (ROM) assessment. Testing performed on worst-case components demonstrated performance equivalent to predicate devices.

Technological Characteristics

Modular shoulder prosthesis system. Stems designed for cementless fixation; glenoids designed for cemented fixation. Materials include polyethylene for glenoid components. Testing conducted per ASTM F2028-17 for glenoid loosening/disassociation. System is non-constrained, metal/polymer cemented prosthesis.

Indications for Use

Indicated for adults requiring total or hemi shoulder replacement due to non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), post-traumatic osteoarthritis, fractures, or rheumatoid arthritis. Specific indications for hemi-arthroplasty include humeral head fractures, head-splitting fractures, humeral head depression, chronic dislocation, and post-traumatic necrosis. CTA heads indicated for stable rotator cuff tear arthropathy with intact fornix humeri and subscapularis tendon. Inverse prosthesis indicated for rotator cuff tear arthropathy, chronic trauma, and humeral head decentering. Requires anatomically suitable joint and functional deltoid muscle.

Regulatory Classification

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).

Special Controls

*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.”

Predicate Devices

• Fx Solutions Humeris Shoulder (K163669)

Reference Devices

• AGILON XO Shoulder Replacement System (K191433)

Submission Summary (Full Text)

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# 510(K) SUMMARY

| Manufacturer: | implantcast GmbH<br>Lüneburger Schanze 26<br>21614 Buxtehude<br>Germany |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Ms. Juliane Höppner<br>Head of Regulatory Affairs<br>implantcast GmbH<br>Lüneburger Schanze 26<br>21614 Buxtehude<br>Germany<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Prepared By: | Mr. Dave McGurl<br>MCRA, LLC<br>803 7th Street NW, Floor 3<br>Washington, DC 20001<br>Phone: [phone]<br>[e-mail] |
| Date Prepared: | August 17, 2022 |
| Device Trade Name: | AGILON XO Shoulder System |
| Device Class and<br>Common Name: | Class II |
| Classification: | 21 CFR 888.3650: Prothesis, Shoulder, Non-Constrained,<br>Metal/Polymer Cemented |
| Product Codes: | KWT, PHX, HSD |
| Indications for Use: | The AGILON® XO Shoulder Replacement System<br>is indicated for use for total or hemi shoulder replacement<br>in cases of: |

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- 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<br>Equivalence: | The AGILON XO Shoulder System AGILON® XO Glenoid<br>Cemented components are substantially equivalent to the<br>glenoids of the legally marketed predicate device system, the<br>Fx Solutions Humeris Shoulder, with respect to design and<br>intended use. Additionally, the AGILON XO Glenoids<br>Cemented components are substantially equivalent to<br>components of the AGILON XO Shoulder Replacement<br>System reference device cleared in K191433. |
| Performance Testing: | All necessary testing has been performed for the "worst-case"<br>components of the AGILON XO Shoulder System to assure<br>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.

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### 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

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· 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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# 510(K) SUMMARY

| Manufacturer: | implantcast GmbH<br>Lüneburger Schanze 26<br>21614 Buxtehude<br>Germany |
|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Ms. Juliane Höppner<br>Head of Regulatory Affairs<br>implantcast GmbH<br>Lüneburger Schanze 26<br>21614 Buxtehude<br>Germany<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Prepared By: | Mr. Dave McGurl<br>MCRA, LLC<br>803 7th Street NW, Floor 3<br>Washington, DC 20001<br>Phone: [phone]<br>[e-mail] |
| Date Prepared: | August 17, 2022 |
| Device Trade Name: | AGILON XO Shoulder System |
| Device Class and<br>Common Name:<br>Classification: | Class II<br>21 CFR 888.3650: Prothesis, Shoulder, Non-Constrained,<br>Metal/Polymer Cemented |
| Product Codes: | KWT, PHX, HSD |
| Indications for Use: | The AGILON® XO Shoulder Replacement System<br>is indicated for use for total or hemi shoulder replacement<br>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<br>Equivalence: | The AGILON XO Shoulder System AGILON® XO Glenoid<br>Cemented components are substantially equivalent to the<br>glenoids of the legally marketed predicate device system, the<br>Fx Solutions Humeris Shoulder, with respect to design and<br>intended use. Additionally, the AGILON XO Glenoids<br>Cemented components are substantially equivalent to<br>components of the AGILON XO Shoulder Replacement<br>System reference device cleared in K191433. |
| Performance Testing: | All necessary testing has been performed for the "worst-case”<br>components of the AGILON XO Shoulder System to assure<br>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.