AETOS Shoulder System

K230572 · Smith & Nephew, Inc. · KWS · Jun 7, 2023 · Orthopedic

Device Facts

• Record ID: K230572
• Device Name: AETOS Shoulder System
• Applicant: Smith & Nephew, Inc.
• Product Code: KWS · Orthopedic
• Decision Date: Jun 7, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AETOS Shoulder System is intended for: Replacement of shoulder joints in primary anatomic or primary reverse arthroplasty. Replacement of shoulder joint devices in revision cases if sufficient bone stock is present. The AETOS Shoulder System also allows for conversions from anatomic to reverse in case of revision.

Device Story

AETOS Shoulder System is a modular shoulder prosthesis for anatomic or reverse total shoulder arthroplasty and hemiarthroplasty. Anatomic configuration includes titanium humeral stem, CoCr humeral head, and UHMWPE glenoid. Reverse configuration includes titanium humeral stem, UHMWPE liner, titanium glenoid baseplate, CoCr glenosphere, and titanium screws/spacers. Used in clinical settings by orthopedic surgeons. Device replaces diseased or damaged shoulder joints to relieve pain and restore mobility. Line extensions include +15 full wedge baseplates, 38mm +3mm eccentric glenospheres, and reverse humeral spacers. Implants are single-use. Surgeons select components based on patient anatomy and pathology; components are implanted via cemented (glenoid) or uncemented (humeral stem/baseplate) fixation. Benefits include pain relief, improved joint function, and ability to convert anatomic to reverse constructs without removing well-fixed humeral stems.

Clinical Evidence

No clinical data was necessary to demonstrate substantial equivalence. Evidence is based on bench testing, including construct fatigue, dynamic glenoid loosening/dissociation (ASTM F2028), range of motion, scapular notching, construct disassembly, and total humeral offset evaluations.

Technological Characteristics

Modular shoulder prosthesis. Materials: Ti6Al4V, CoCrMo, UHMWPE. Features: plasma spray titanium coating for uncemented fixation, Morse taper connections, peripheral/center screw fixation. Dimensions vary by size/augmentation. Sterilization: gamma irradiation. No software or electronic components.

Indications for Use

Indicated for patients with shoulder joint disability due to rheumatoid arthritis, non-inflammatory degenerative joint disease, functional deformity, humeral head fractures, traumatic arthritis, or revision of other devices with sufficient bone stock. Anatomic use requires intact/reconstructable rotator cuff. Reverse use requires functional deltoid muscle and massive, non-repairable rotator cuff tear.

Regulatory Classification

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).

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 “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.”

Predicate Devices

• Smith & Nephew AETOS Shoulder System (K220847)
• Tornier, Inc. PERFORM Humeral System - Stem (K201315)
• LimaCorporate SMR TT Augmented Glenoid System (K200171)

Reference Devices

• Encore AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small Hemi-Adapter, AltiVate Reverse, Small Socket Insert (K172351)
• Zimmer Trabecular Metal Reverse Shoulder System (K052906)
• Univers Revers Shoulder Prosthesis System (K130129)
• LimaCorporate Bone Screws dia. 5,0 mm (K210717)
• LimaCorporate SMR 40mm Glenosphere (K142139)
• Titan Reverse Shoulder System (K130050)
• Titan Reverse Shoulder System (K181999)
• Titan Modular Total Shoulder System Fin-Lock Glenoid (K152047)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 7, 2023

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

Re: K230572

Trade/Device Name: AETOS Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS, HSD, KWT, PHX Dated: May 10, 2023 Received: May 10, 2023

Dear Patrick Hughes:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

{1}------------------------------------------------

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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Image /page/1/Figure/4 description: The image shows a digital signature. The signature is from Joseph P. Russell. The date of the signature is 2023.06.07 15:52:32 -04'00'. The image also includes the word 'Sincerely,'.

For: Farzana Sharmin, Ph.D. Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K230572

Device Name AETOS Shoulder System

### Indications for Use (Describe)

In Anatomic:

The stem and head may be used by themselves, as a hemiathroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement.

The AETOS Shoulder System is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and to relieve pain. The AETOS Shoulder System is indicated for use as a replacement of shoulder 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 coated humeral component is intended for uncement is intended for cement is intended for cemented use only.

In Reverse:

The AETOS Shoulder System 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 stem is indicated for uncemented use. The coated glenoid baseplate 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)

{3}------------------------------------------------

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

# Section 5 - 510(k) Summary AETOS Shoulder System Line Extensions

| Sponsor | Smith & Nephew, Inc.<br>Orthopedic Division<br>7135 Goodlett Farms Parkway<br>Cordova, Tennessee 38016 |
|------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Number | 3008744062 |
| Point of Contact | Patrick Hughes<br>Senior Regulatory Specialist<br>352-359-7940 |
| Date | June 5, 2023 |
| Trade Name | AETOS Shoulder System |
| Common Name | Shoulder Prosthesis |
| Product Code | 1. KWS<br>2. HSD<br>3. KWT<br>4. PHX |
| Regulation | 1. Shoulder joint metal/polymer semi-constrained cemented<br>prosthesis (21 CFR 888.3660)<br>2. Shoulder joint humeral (hemi-shoulder) metallic uncemented (21<br>CFR 888.3690)<br>3. Shoulder joint metal/polymer non-constrained cemented<br>prosthesis (21 CFR 888.3650)<br>4. Shoulder joint metal/polymer semi-constrained cemented<br>prosthesis (21 CFR 888.3660) |
| Classification | Class II |
| Predicate Devices | Smith & Nephew AETOS Shoulder System: K220847 (Primary)<br>Tornier, Inc. PERFORM Humeral System - Stem: K201315<br>LimaCorporate SMR TT Augmented Glenoid System: K200171 |
| Reference Devices | Encore AltiVate Reverse Humeral Stem, AltiVate Reverse Small<br>Spacer, Altivate Reverse, Small Hemi-Adapter, AltiVate Reverse,<br>Small Socket Insert: K172351<br>Zimmer Trabecular Metal Reverse Shoulder System: K052906<br>Univers Revers Shoulder Prosthesis System: K130129 |
| LimaCorporate Bone Screws dia. 5,0 mm: K210717 | |
| LimaCorporate SMR 40mm Glenosphere: K142139 | |
| Titan Reverse Shoulder System: K130050 | |
| Titan Reverse Shoulder System: K181999 | |
| Titan Modular Total Shoulder System Fin-Lock Glenoid: K152047 | |
| Classification Panel | Orthopedic |
| Device Description | The AETOS Shoulder System consists of:<br><br>In an anatomic configuration: A humeral stem (Titanium) with a<br>plasma spray coating (Titanium), a compatible humeral head (CoCr)<br>with a compatible glenoid (UHMWPE). The AETOS Shoulder<br>System stem and head may be used by themselves for<br>hemiarthroplasty.<br><br>In a reverse configuration: A humeral stem (Titanium) with a plasma<br>spray coating (Titanium), a compatible liner (UHMWPE), glenoid<br>baseplate (Titanium with Titanium plasma spray), glenosphere (CoCr<br>with Titanium retaining component), peripheral screws (Titanium),<br>center screw (Titanium), optional humeral spacer (Titanium), and<br>optional post extension (Titanium with Titanium plasma spray). |
| Intended Use/ | The AETOS Shoulder System is intended for:<br>Replacement of shoulder joints in primary anatomic or primary reverse arthroplasty. Replacement of shoulder joint devices in revision cases if sufficient bone stock is present. The AETOS Shoulder System also allows for conversions from anatomic to reverse in case of revision. |
| Indications for Use | In Anatomic:<br>The stem and head may be used by themselves, as a hemiarthroplasty,<br>if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement.<br><br>The AETOS Shoulder System 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 Shoulder System is indicated for use as a replacement of shoulder joints disabled by:<br>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 coated humeral component is intended for uncemented use. The<br>glenoid component is intended for cemented use only. |
| | In Reverse:<br>The AETOS Shoulder System is indicated for use as a replacement of<br>shoulder joints for patients with a functional deltoid muscle and with<br>massive and non-repairable rotator cuff-tear with pain disabled by: |
| | • Rheumatoid arthritis |
| | • Non-inflammatory degenerative joint disease…