(286 days)
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.
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).
The provided text is a 510(k) Summary for the AETOS Shoulder System. It details the device's description, indications for use, and a summary of nonclinical performance data. However, it explicitly states that "Clinical performance data were not necessary to demonstrate substantial equivalence of the subject device."
Therefore, I cannot provide information on acceptance criteria and a study that proves the device meets these criteria in the context of clinical performance, as no such clinical study was deemed necessary or performed for this 510(k) submission.
The document focuses on nonclinical performance data to establish substantial equivalence to predicate devices. Here's what can be extracted regarding the nonclinical evaluation:
1. A table of acceptance criteria and the reported device performance:
The document does not provide a table with explicit acceptance criteria (e.g., "Must withstand X N of force") and specific reported device performance values (e.g., "Device withstood Y N of force"). Instead, it lists the types of nonclinical testing performed to demonstrate substantial equivalence. The implication is that the performance in these tests was considered acceptable compared to the predicate devices and relevant standards.
| Acceptance Criteria (Inferred from testing) | Reported Device Performance |
|---|---|
| Full Construct Fatigue Testing (Anatomic and Reverse Configurations) | Not explicitly detailed; deemed acceptable for substantial equivalence. |
| Taper Axial Testing (Humeral Head, Glenosphere) | Not explicitly detailed; deemed acceptable for substantial equivalence. |
| Taper Torsional Testing (Humeral Head, Glenosphere) | Not explicitly detailed; deemed acceptable for substantial equivalence. |
| Anatomic Glenoid Pull-out Testing | Not explicitly detailed; deemed acceptable for substantial equivalence. |
| Anatomic Glenoid Loosening Testing | Not explicitly detailed; deemed acceptable for substantial equivalence. |
| Humeral Liner Axial Disassembly Testing | Not explicitly detailed; deemed acceptable for substantial equivalence. |
| Humeral Liner Torsional Disassembly Testing | Not explicitly detailed; deemed acceptable for substantial equivalence. |
| Humeral Liner Lever-out Testing | Not explicitly detailed; deemed acceptable for substantial equivalence. |
| Screw Testing (Torsional Properties, Axial Pullout) | Not explicitly detailed; deemed acceptable for substantial equivalence. |
| Reverse Glenoid Dynamic Loosening Testing | Not explicitly detailed; deemed acceptable for substantial equivalence. |
| Post Extension Corrosion Testing | Not explicitly detailed; deemed acceptable for substantial equivalence. |
| Scapular Notching Risk Evaluation | Not explicitly detailed; deemed acceptable for substantial equivalence. |
| Range of Motion Evaluation | Not explicitly detailed; deemed acceptable for substantial equivalence. |
| Wear Assessment | Not explicitly detailed; deemed acceptable for substantial equivalence. |
2. Sample sized used for the test set and the data provenance:
- Sample Size: Not specified in the provided text for any of the nonclinical tests.
- Data Provenance: The tests are nonclinical (bench testing) and were performed by the manufacturer, Smith & Nephew, Inc. No country of origin for the data or whether it was retrospective/prospective is given, as these are typically not relevant for bench testing in the same way they are for clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as there was no clinical study, and thus no "ground truth" established by experts in a diagnostic context. The "ground truth" for the nonclinical tests would be the measurement results against engineering specifications or established standards.
4. Adjudication method for the test set:
This information is not applicable as there was no clinical study requiring adjudication of expert interpretations.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical performance data were not necessary to demonstrate substantial equivalence of the subject device."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable as the AETOS Shoulder System is a physical orthopedic implant, not an AI algorithm or software device.
7. The type of ground truth used:
For the nonclinical (bench) testing, the "ground truth" would be the engineering specifications, material science properties, and performance standards relevant to orthopedic implants, against which the device's performance in mechanical and material tests was evaluated for substantial equivalence to predicates.
8. The sample size for the training set:
This information is not applicable as this is a physical medical device, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established:
This information is not applicable for the same reason as above.
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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
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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 Division7135 Goodlett Farms ParkwayCordova, Tennessee 38016 |
|---|---|
| Establishment Number | 3008744062 |
| Point of Contact | Cassidy Lemkau (Whipple)Senior Regulatory Specialist512-466-1130 |
| Date | January 3, 2023 |
| Trade Name | AETOS Shoulder System |
| Common Name | Shoulder Prosthesis |
| Product Code | 1. KWS2. HSD3. KWT4. 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), K151293Tornier, Inc. Aequalis PerFORM Reversed, Aequalis PerFORM + Reversed Glenoid: K161742Tornier, Inc. Aequalis PerFORM + Shoulder System: K160975PROMOS Reverse Shoulder System: K081016 |
| Titan Modular Total Shoulder System Fin-Lock Glenoid: K152047 | |
| Equinoxe Reverse Shoulder System: K063569 | |
| Titan Reverse Shoulder System: K181999, K190588, | |
| ReferenceDevice | 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 | |
| ClassificationPanel | Orthopedic/87 |
| DeviceDescription | The AETOS Shoulder System consists of: |
| In an anatomic configuration: A humeral stem (Titanium) with a plasmaspray coating (Titanium), a compatible humeral head (CoCr) with acompatible glenoid (UHMWPE). The AETOS Shoulder System stem andhead may be used by themselves for hemiarthroplasty. | |
| In a reverse configuration: A humeral stem (Titanium) with a plasma spraycoating (Titanium), a compatible liner (UHMWPE), glenoid baseplate(Titanium with Titanium plasma spray), glenosphere (CoCr with Titaniumretaining component), peripheral screws (Titanium), center screw(Titanium), and optional post extension (Titanium with Titanium plasmaspray). | |
| Intended Use/Indications forUse | Intended Use |
| The AETOS Shoulder System is intended for:• Replacement of shoulder joints in primary anatomic or primary reversearthroplasty.• Replacement of shoulder joint devices in revision cases if sufficientbone stock is present.• The AETOS Shoulder System also allows for conversions fromanatomic to reverse in case of revision. | |
| Indications for UseIn Anatomic:The stem and head may be used by themselves, as a hemiarthroplasty, if thenatural glenoid provides a sufficient bearing surface, or in conjunction withthe glenoid, as a total replacement. | |
| The AETOS Shoulder System is to be used only in patients with an intact orreconstructable rotator cuff, where it is intended to provide increasedmobility and stability and to relieve pain. The AETOS Shoulder System isindicated 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 glenoidcomponent is intended for cemented use only. | |
| In Reverse: | |
| The AETOS Shoulder System is indicated for use as a replacement ofshoulder joints for patients with a functional deltoid muscle and withmassive 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 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 the humeralstem during revision surgery for patients with a functional deltoid muscle.The component is permitted to be used in the conversion from anatomic toreverse if the humeral stem is well fixed, the patient has a functional deltoidmuscle; the arthroplasty is associated with a massive and non-repairablerotator cuff tear. | |
| The coated humeral stem is indicated for uncemented use. The coatedglenoid baseplate is intended for cementless application with the addition ofscrews for fixation. | |
| Note: All implant components are single use. | |
| NonclinicalPerformanceData | 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 |
| ClinicalPerformanceData | 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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§ 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.”