(286 days)
No
The summary describes a mechanical shoulder implant system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The “Intended Use / Indications for Use” section explicitly states that the device is intended for the "Replacement of shoulder joints" and to "provide increased mobility and stability and to relieve pain" in patients with various conditions such as "Rheumatoid arthritis" and "Fractures of the humeral head," which are therapeutic goals.
No
The device description indicates it is an implantable shoulder system used for replacement in arthroplasty, which is a therapeutic intervention, not a diagnostic tool.
No
The device description explicitly lists multiple hardware components made of materials like Titanium, CoCr, and UHMWPE, indicating it is a physical implant system, not software.
Based on the provided text, the AETOS Shoulder System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the device is for the "Replacement of shoulder joints" in various arthroplasty procedures. This is a surgical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the physical components of the implant (stems, heads, glenoids, screws, etc.) made of materials like Titanium and CoCr. These are implantable medical devices, not reagents or instruments used for analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
- Reagents, calibrators, or controls
The AETOS Shoulder System is a surgical implant intended to replace damaged shoulder joints.
N/A
Intended Use / Indications for Use
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.
Indications for Use
In Anatomic:
The stem and head may be used by themselves, as a hemiarthroplasty, 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 stability 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 uncemented use. The glenoid component 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.
Product codes (comma separated list FDA assigned to the subject device)
KWS, HSD, KWT, PHX
Device Description
The AETOS Shoulder System consists of:
In an anatomic configuration: A humeral stem (Titanium) with a plasma spray coating (Titanium), a compatible humeral head (CoCr) with a compatible glenoid (UHMWPE). The AETOS Shoulder System stem and head may be used by themselves for hemiarthroplasty.
In a reverse configuration: A humeral stem (Titanium) with a plasma spray coating (Titanium), a compatible liner (UHMWPE), glenoid baseplate (Titanium with Titanium plasma spray), glenosphere (CoCr with Titanium retaining component), peripheral screws (Titanium), center screw (Titanium), and optional post extension (Titanium with Titanium plasma spray).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder joint
Indicated Patient Age Range
Not Found
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)
The AETOS Shoulder System has undergone the following testing: Full Construct Fatigue Testing (Anatomic and Reverse Configurations) Taper Axial Testing (Humeral Head, Glenosphere) Taper Torsional Testing (Humeral Head, Glenosphere) Anatomic Glenoid Pull-out Testing Anatomic Glenoid Loosening Testing Humeral Liner Axial Disassembly Testing Humeral Liner Torsional Disassembly Testing Humeral Liner Lever-out Testing Screw Testing (Torsional Properties, Axial Pullout) Reverse Glenoid Dynamic Loosening Testing Post Extension Corrosion Testing Scapular Notching Risk Evaluation Range of Motion Evaluation Wear Assessment.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K122698, K151293, K161742, K160975, K081016, K152047, K063569, K181999, K190588
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K142413, K100448, K130050, K121543, K181611
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3660 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.”
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Image /page/0/Picture/10 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Smith & Nephew, Inc. Cassidy Lemkau Senior Regulatory Affairs Specialist 7135 Goodlett Farms Parkway Cordova, Tennessee 38016
Re: K220847
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: December 5, 2022 Received: December 5, 2022
Dear Cassidy Lemkau:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
January 3, 2023
1
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 (OS) 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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Digitally signed by Farzana Farzana Sharmin -S Sharmin -S Date: 2023.01.03 18:03:53 -05'00'
For Victoria Lilling, M.D. 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
510(k) Number (if known) K220847
Device Name AETOS Shoulder System
Indications for Use (Describe)
In Anatomic:
The stem and head may be used by themselves, as a hemiarthroplasty, 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 uncemented use. The glenoid component 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 base plate is intended for cementless application with the addition of screws for fixation.
Note: All implant components are single use.
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Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
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510(k) Summary AETOS Shoulder System
| Sponsor | Smith & Nephew, Inc.
Orthopedic Division
7135 Goodlett Farms Parkway
Cordova, Tennessee 38016 |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Number | 3008744062 |
| Point of Contact | Cassidy Lemkau (Whipple)
Senior Regulatory Specialist
512-466-1130 |
| Date | January 3, 2023 |
| Trade Name | AETOS Shoulder System |
| Common Name | Shoulder Prosthesis |
| Product Code | 1. KWS
2. HSD
3. KWT
4. PHX |
| Regulation | 1. Shoulder joint metal/polymer semi-constrained cemented prosthesis (21 CFR 888.3660)
2. Shoulder Joint humeral (hemi-shoulder) metallic uncemented (21 CFR 888.3690)
3. Shoulder joint metal/polymer non-constrained cemented prosthesis (21 CFR 888.3650)
4. Shoulder joint metal/polymer semi-constrained cemented prosthesis (21 CFR 888.3660) |
| Classification | Class II |
| Predicate Device | Tornier SAS Aequalis Ascend Flex Shoulder System: K122698 (Primary), K151293
Tornier, Inc. Aequalis PerFORM Reversed, Aequalis PerFORM + Reversed Glenoid: K161742
Tornier, Inc. Aequalis PerFORM + Shoulder System: K160975
PROMOS Reverse Shoulder System: K081016 |
| | Titan Modular Total Shoulder System Fin-Lock Glenoid: K152047 |
| | Equinoxe Reverse Shoulder System: K063569 |
| | Titan Reverse Shoulder System: K181999, K190588, |
| Reference
Device | Titan Modular Total Shoulder System: K142413, K100448 |
| | Titan Reverse Shoulder System: K130050 |
| | Zimmer Trabecular Metal Reverse Shoulder System: K121543 |
| | Zimmer Comprehensive Reverse Shoulder System: K181611 |
| Classification
Panel | Orthopedic/87 |
| Device
Description | The AETOS Shoulder System consists of: |
| | In an anatomic configuration: A humeral stem (Titanium) with a plasma
spray coating (Titanium), a compatible humeral head (CoCr) with a
compatible glenoid (UHMWPE). The AETOS Shoulder System stem and
head may be used by themselves for hemiarthroplasty. |
| | In a reverse configuration: A humeral stem (Titanium) with a plasma spray
coating (Titanium), a compatible liner (UHMWPE), glenoid baseplate
(Titanium with Titanium plasma spray), glenosphere (CoCr with Titanium
retaining component), peripheral screws (Titanium), center screw
(Titanium), and optional post extension (Titanium with Titanium plasma
spray). |
| Intended Use/
Indications for
Use | 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. |
| | Indications for Use
In Anatomic:
The stem and head may be used by themselves, as a hemiarthroplasty, 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 stability 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 uncemented use. The glenoid
component 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. | |
| Nonclinical
Performance
Data | The AETOS Shoulder System has undergone the following testing:
Full Construct Fatigue Testing (Anatomic and Reverse Configurations) Taper Axial Testing (Humeral Head, Glenosphere) Taper Torsional Testing (Humeral Head, Glenosphere) Anatomic Glenoid Pull-out Testing Anatomic Glenoid Loosening Testing Humeral Liner Axial Disassembly Testing Humeral Liner Torsional Disassembly Testing Humeral Liner Lever-out Testing Screw Testing (Torsional Properties, Axial Pullout) Reverse Glenoid Dynamic Loosening Testing Post Extension Corrosion Testing Scapular Notching Risk Evaluation Range of Motion Evaluation Wear Assessment |
| Clinical
Performance
Data | Clinical performance data were not necessary to demonstrate substantial equivalence of the subject device. |
| Conclusion | Substantial equivalence of the AETOS Shoulder System to cited predicates can be demonstrated based on the following: The subject and predicate devices have similar intended use and indications for use. The subject and predicate devices share similar functional and technological characteristics via the same operational principles. Per this comparison and the results of bench testing it can be concluded any differences between the subject and predicate devices do not raise different questions of safety and effectiveness. Therefore, the AETOS Shoulder System is substantially equivalent to the cited predicates |
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