(250 days)
Not Found
No
The document describes a mechanical implant system for shoulder replacement and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
Justification: The device, the AETOS Shoulder System, is intended to provide increased mobility and stability and to relieve pain in patients with various shoulder joint disabilities, such as arthritis and fractures. This clearly defines it as a therapeutic device aimed at treating or alleviating a medical condition.
No
The device is a shoulder replacement system and not used for diagnosing medical conditions. It is used to replace shoulder joints disabled by various conditions.
No
The device description and intended use clearly describe physical implant components (humeral stems, heads, glenoid components, humeral anchor) used in shoulder arthroplasty, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description and Intended Use: The AETOS Shoulder System is a surgical implant intended for the replacement of shoulder joints. It is a physical device implanted into the body to restore function and relieve pain.
- Lack of Specimen Analysis: The description and intended use do not mention the analysis of any biological specimens. The device itself is the treatment, not a tool for analyzing samples.
Therefore, the AETOS Shoulder System falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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 nonrepairable 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.
Product codes (comma separated list FDA assigned to the subject device)
PKC, KWS, KWT, HSD, PHX
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.
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
skeletally mature individuals
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)
Construct fatigue and corrosion resistance assessment Post-fatigue stability Static disengagement Dynamic stability / loosening Bone volume and contact analysis
Clinical performance data were not necessary to demonstrate substantial equivalence of the subject device.
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.
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.
Not Found
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.”
0
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"
1
(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).
2
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)
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.
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
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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 nonrepairable 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.
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 Division
7135 Goodlett Farms Parkway
Cordova, Tennessee 38016 |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment
Number | 3008744062 |
| Point of Contact | Cassidy Whipple
Senior Regulatory Specialist
737-270-8220 |
| 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 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) |
| Classification | Class II |
| Predicate
Devices | Smith & Nephew AETOS Shoulder System: K220847 (Primary)
Simpliciti Shoulder System: K143552 |
| Classification
Panel | Orthopedic |
| Device
Description /
Intended Use | 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. |
| Indications for
Use (System) | 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 glenoid
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 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 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. | |
| Nonclinical
Performance
Data | Construct fatigue and corrosion resistance assessment Post-fatigue stability Static disengagement Dynamic stability / loosening Bone volume and contact analysis |
| 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 Stemless
Humeral Prosthesis to cited predicates can be demonstrated based on the
following: The subject and predicate devices have the same intended use and
similar Indications for Use. The subject and predicate devices share similar functional and
technological characteristics via the same operational principles. The subject and predicate devices are made from the same
materials and packaged and sterilized using the same methods. Bench testing supports that any differences between subject and predicate
devices do not introduce or exacerbate any different questions of safety or
effectiveness. As a result Smith & Nephew concludes the subject AETOS
Shoulder System Line Extensions are substantially equivalent to cited
predicate device. |
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