In Anatomic:
The AETOS Shoulder System (when used with the AETOS Humeral Meta Stems) is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and stability and to relieve pain.

The AETOS humeral stems (AETOS Humeral Meta Stems) and head may be used by themselves, as a hemiarthroplasty, if the natural dlenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement. When used with the AETOS Humeral Meta Stems, The AETOS Shoulder System is indicated for use as a replacement of shoulder joints disabled by:

Rheumatoid arthritis
· Non-inflammatory degenerative ioint disease
· Correction of functional deformity
· Fractures of the humeral head
· Traumatic arthritis
Revision of other devices if sufficient bone stock remains

The AETOS Shoulder System (when used with AETOS Stemless Humeral Prosthesis) is to be used only in patients with an intact or reconstructable rotator cuff.

When used with AETOS Stemless Humeral Prosthesis, the AETOS Shoulder System is indicated for anatomic total shoulder replacement of shoulder joints disabled by:

· Non-inflammatory degenerative joint disease
· Traumatic arthritis
Revision of other devices if sufficient bone stock remains

The coated humeral components are intended for uncemented use. The glenoid component is intended for cemented use only.

In Reverse:
The AETOS Shoulder System, when used with AETOS Humeral Meta Stems, is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear with pain disabled by:

Rheumatoid arthritis
· Non-inflammatory degenerative joint disease
· Correction of functional deformity
Fractures of the humeral head
Traumatic arthritis
· Revision of devices if sufficient bone stock remains

The humeral liner component is indicated for use in the AETOS Shoulder System as a primary reverse total shoulder replacement and for use when converting an anatomic AETOS Shoulder System into a reverse shoulder construct. This facilitates the conversion without the removal of the humeral stem during revision surgery for patients with a functional deltoid muscle. The component is permitted to be used in the conversion from anatomic to reverse if the humeral stem is well fixed, the patient has a functional deltoid muscle; the arthroplasty is associated with a massive and non-repairable rotator cuff tear.

The coated humeral stems are indicated for uncemented use. The coated glenoid base plate is intended for cementless application with the addition of screws for fixation.

Note: All implant components are single use.

Device Description

The AETOS Stemless Humeral Prosthesis subject to this submission is a humeral anchor intended for press-fit fixation as part of an implant construct in anatomic total shoulder arthroplasty for the treatment of skeletally mature individuals with degenerative diseases of the glenohumeral joint.

AI/ML Overview

This FDA submission (K240716) for the AETOS Shoulder System Stemless Humeral Prosthesis does not describe an AI/ML medical device. Therefore, it does not include information on acceptance criteria, reported device performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies that are typically associated with the evaluation of AI/ML software.

The submission focuses on the substantial equivalence of a new medical implant (a stemless humeral prosthesis) to previously cleared predicate devices. The evaluation criteria for this type of device are primarily based on non-clinical performance data, such as:

Construct fatigue and corrosion resistance assessment
Post-fatigue stability
Static disengagement
Dynamic stability / loosening
Bone volume and contact analysis

The document explicitly states: "Clinical performance data were not necessary to demonstrate substantial equivalence of the subject device." This confirms that a clinical study, which would typically involve human readers or an AI algorithm, was not conducted or required for this submission.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving device performance as it pertains to an AI/ML medical device, because this submission is for a physical orthopedic implant and does not involve AI/ML.

Summary

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November 20, 2024

Image /page/0/Picture/1 description: The image shows 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Smith & Nephew, Inc. Cassidy Whipple Senior Regulatory Affairs Specialist 7135 Goodlett Farms Parkway Cordova, Tennessee 38016

Re: K240716

Trade/Device Name: AETOS Shoulder System Stemless Humeral Prosthesis Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PKC, KWS, KWT, HSD, PHX Dated: October 22, 2024 Received: October 23, 2024

Dear Cassidy Whipple:

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.

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"

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(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 OS 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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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).

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Sincerely,

Digitally signed by Farzana Farzana Sharmin -S Sharmin -S Date: 2024.11.20
15:37:30 -05'00'

Farzana Sharmin, PhD Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K240716

Device Name

AETOS Shoulder System Stemless Humeral Prosthesis

Indications for Use (Describe)

In Anatomic:

The AETOS Shoulder System (when used with the AETOS Humeral Meta Stems) is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and stability and to relieve pain.

Rheumatoid arthritis
· Non-inflammatory degenerative ioint disease
· Correction of functional deformity
· Fractures of the humeral head
· Traumatic arthritis
· Revision of other devices if sufficient bone stock remains

The AETOS Shoulder System (when used with AETOS Stemless Humeral Prosthesis) is to be used only in patients with an intact or reconstructable rotator cuff.

When used with AETOS Stemless Humeral Prosthesis, the AETOS Shoulder System is indicated for anatomic total shoulder replacement of shoulder joints disabled by:

· Non-inflammatory degenerative joint disease
· Traumatic arthritis
Revision of other devices if sufficient bone stock remains

The coated humeral components are intended for uncemented use. The glenoid component is intended for cemented use only.

In Reverse:

The AETOS Shoulder System, when used with AETOS Humeral Meta Stems, is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear with pain disabled by:

Rheumatoid arthritis
· Non-inflammatory degenerative joint disease
· Correction of functional deformity
Fractures of the humeral head
Traumatic arthritis
· Revision of devices if sufficient bone stock remains

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The coated humeral stems are indicated for uncemented use. The coated glenoid base plate is intended for cementless application with the addition of screws for fixation.

Note: All implant components are single use.

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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510(k) Summary AETOS Shoulder System Line Extensions

Sponsor	Smith & Nephew, Inc.Orthopedic Division7135 Goodlett Farms ParkwayCordova, Tennessee 38016
EstablishmentNumber	3008744062
Point of Contact	Cassidy WhippleSenior Regulatory Specialist737-270-8220
Date	November 19, 2024
Trade Name	AETOS Shoulder System Stemless Humeral Prosthesis
Common Name	Shoulder Prosthesis
Product Code	PKC (primary), KWS, HSD, KWT, PHX
Regulation	1. Shoulder joint metal/polymer semi-constrained cementedprosthesis (21 CFR 888.3660)2. Shoulder Joint humeral (hemi-shoulder) metallic uncemented (21CFR 888.3690)3. Shoulder joint metal/polymer non-constrained cemented prosthesis(21 CFR 888.3650)
Classification	Class II
PredicateDevices	Smith & Nephew AETOS Shoulder System: K220847 (Primary)Simpliciti Shoulder System: K143552
ClassificationPanel	Orthopedic
DeviceDescription /Intended Use	The AETOS Stemless Humeral Prosthesis subject to this submission is ahumeral anchor intended for press-fit fixation as part of an implantconstruct in anatomic total shoulder arthroplasty for the treatment ofskeletally mature individuals with degenerative diseases of theglenohumeral joint.
Indications forUse (System)	In Anatomic:The AETOS Shoulder System (when used with the AETOS Humeral MetaStems) is to be used only in patients with an intact or reconstructablerotator cuff, where it is intended to provide increased mobility and stabilityand to relieve pain.
The AETOS humeral stems (AETOS Humeral Meta Stems) and head maybe used by themselves, as a hemiarthroplasty, if the natural glenoidprovides a sufficient bearing surface, or in conjunction with the glenoid, asa total replacement. When used with the AETOS Humeral Meta Stems,The AETOS Shoulder System is indicated for use as a replacement ofshoulder joints disabled by:
• Rheumatoid arthritis• Non-inflammatory degenerative joint disease• Correction of functional deformity• Fractures of the humeral head• Traumatic arthritis• Revision of other devices if sufficient bone stock remains
The AETOS Shoulder System (when used with AETOS Stemless HumeralProsthesis) is to be used only in patients with an intact or reconstructablerotator cuff.
When used with AETOS Stemless Humeral Prosthesis, the AETOSShoulder System is indicated for anatomic total shoulder replacement ofshoulder joints disabled by:
• Non-inflammatory degenerative joint disease• Traumatic arthritis• Revision of other devices if sufficient bone stock remains
The coated humeral components are intended for uncemented use. Theglenoid component is intended for cemented use only.
In Reverse:The AETOS Shoulder System, when used with AETOS Humeral MetaStems, is indicated for use as a replacement of shoulder joints for patientswith a functional deltoid muscle and with massive and non-repairablerotator cuff-tear with pain disabled by:
• Rheumatoid arthritis• Non-inflammatory degenerative joint disease• Correction of functional deformity• Fractures of the humeral head• Traumatic arthritis• Revision of devices if sufficient bone stock remains
The humeral liner component is indicated for use in the AETOS ShoulderSystem as a primary reverse total shoulder replacement and for use whenconverting an anatomic AETOS Shoulder System into a reverse shoulderconstruct. This facilitates the conversion without the removal of thehumeral stem during revision surgery for patients with a functional deltoid
muscle. The component is permitted to be used in the conversion fromanatomic to reverse if the humeral stem is well fixed, the patient has afunctional deltoid muscle; the arthroplasty is associated with a massiveand non-repairable rotator cuff tear.The coated humeral stems are indicated for uncemented use. The coatedglenoid base plate is intended for cementless application with the additionof screws for fixation.Note: All implant components are single use.
NonclinicalPerformanceData	Construct fatigue and corrosion resistance assessment Post-fatigue stability Static disengagement Dynamic stability / loosening Bone volume and contact analysis
ClinicalPerformanceData	Clinical performance data were not necessary to demonstrate substantialequivalence of the subject device.
Conclusion	Substantial equivalence of the AETOS Shoulder System StemlessHumeral Prosthesis to cited predicates can be demonstrated based on thefollowing: The subject and predicate devices have the same intended use andsimilar Indications for Use. The subject and predicate devices share similar functional andtechnological characteristics via the same operational principles. The subject and predicate devices are made from the samematerials and packaged and sterilized using the same methods. Bench testing supports that any differences between subject and predicatedevices do not introduce or exacerbate any different questions of safety oreffectiveness. As a result Smith & Nephew concludes the subject AETOSShoulder System Line Extensions are substantially equivalent to citedpredicate device.

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Regulation Number and Section

§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder 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 includes prostheses that have a humeral resurfacing 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 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”