(98 days)
No
The document describes a mechanical shoulder implant system and does not mention any software, algorithms, or AI/ML capabilities. The performance studies are focused on mechanical properties and range of motion, not algorithmic performance.
Yes
The device is a shoulder replacement system intended to provide increased mobility and relieve pain, which aligns with the purpose of a therapeutic device.
No
The device is a shoulder replacement system intended to provide increased mobility and relieve pain by replacing disabled shoulder joints. It is a therapeutic device, not a diagnostic one.
No
The device description clearly lists physical components made of materials like Titanium, CoCr, and UHMWPE, indicating it is a hardware medical device (a shoulder implant system).
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The AETOS Shoulder System is described as a collection of implants (humeral stem, head, glenoid, liner, baseplate, screws, etc.) made of materials like Titanium and CoCr. These are physical components designed to be surgically implanted into the body.
- Intended Use: The intended use is to replace shoulder joints disabled by various conditions, providing increased mobility and relieving pain. This is a therapeutic intervention, not a diagnostic test performed on samples.
The description clearly indicates a surgically implanted prosthetic device, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
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.
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), optional humeral spacer (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 joints
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)
Nonclinical Performance Data:
• Construct fatigue
• Dynamic glenoid loosening / dissociation per ASTM F2028
• Range of motion evaluation
• Scapular notching evaluation
• Construct disassembly evaluation
• Total humeral offset evaluation
Clinical Performance Data:
Clinical performance data were not necessary to demonstrate substantial equivalence of the subject device.
Key results: Bench testing supports that any minor dimensional differences between subject and predicate devices do not introduce or exacerbate any potential issues of safety and effectiveness.
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.
Smith & Nephew AETOS Shoulder System: K220847, Tornier, Inc. PERFORM Humeral System - Stem: K201315, LimaCorporate SMR TT Augmented Glenoid System: K200171
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.
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
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/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
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
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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)
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Section 5 - 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 | Patrick Hughes
Senior Regulatory Specialist
352-359-7940 |
| Date | June 5, 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 Devices | Smith & Nephew AETOS Shoulder System: K220847 (Primary)
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 | |
| Classification Panel | Orthopedic |
| 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), optional humeral spacer (Titanium), and
optional post extension (Titanium with Titanium plasma spray). |
| 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 | • Construct fatigue |
| | • Dynamic glenoid loosening / dissociation per ASTM F2028 |
| | • Range of motion evaluation |
| | • Scapular notching evaluation |
| | • Construct disassembly evaluation |
| | • Total humeral offset evaluation |
| Clinical Performance
Data | Clinical performance data were not necessary to demonstrate
substantial equivalence of the subject device. |
| Technological
Similarities and
Differences
Compared to
Predicate | The subject submission represents line extensions to the AETOS
Shoulder System as follows:
AETOS +15 Full Wedge Baseplates
AETOS +15 Full Wedge Baseplates have the same intended use as
predicate AETOS baseplates: to resurface glenoid bone as part of
reverse total shoulder arthroplasty. Like predicate AETOS baseplates,
AETOS +15 Full Wedge Baseplates are manufactured from Ti6Al4V
and have an unalloyed titanium plasma spray coating as well as screw and post features for uncemented fixation. Like all AETOS
baseplates, AETOS +15 Full Wedge Baseplates mate with compatible
glenospheres via peripheral taper. AETOS +15 Full Wedge
Baseplates have the same centered configuration, diameter, screw-
hole configuration, and post extension compatibility as predicate
augmented AETOS baseplates but differ in that they provide an
additional five degrees of augmentation. AETOS +15 Full Wedge
Baseplate components use packaging configurations and sterilization
processes identical to cited predicates.
AETOS 38mm +3mm Eccentric Glenospheres
AETOS 38mm +3mm Eccentric Glenospheres have the same
intended use as predicate AETOS glenospheres: to provide a
spherical surface for articulation with AETOS Shoulder System
humeral liners as part of a reverse shoulder implant construct. Like
predicate AETOS glenospheres, AETOS 38mm +3mm Eccentric
Glenospheres are manufactured from CoCrMo and attach to
compatible baseplates with a retainer and screw manufactured from
Ti6Al4V. AETOS 38mm +3mm Eccentric Glenospheres have the
same articulating radius, lateralization, and eccentricity as predicate
AETOS 42mm +3mm Eccentric Glenospheres but differ in that they
feature a smaller diameter. AETOS 38mm +3mm Eccentric
Glenospheres use packaging configurations and sterilization
processes identical to cited predicates.
AETOS Reverse Humeral Spacers
AETOS Reverse Humeral Spacers have the same intended use as
predicate and reference humeral spacers: to provide a method for
lateralizing reverse shoulder arthroplasty implant constructs on the
humeral side by introducing additional material between humeral stems and humeral liners. Like predicate Tornier PerFORM humeral |
| | spacers, AETOS Reverse Humeral Spacers are manufactured from
Ti-6Al-4V, provide 9mm of thickness, are available in two sizes, and
mate with compatible stems via Morse taper. AETOS Reverse
Humeral Spacers differ from predicate and reference devices in that
compatibility with humeral stems on the distal aspect and
compatibility with humeral liners on the proximal aspect require
connection geometry specific to their respective systems. Like
predicate Tornier PerFORM humeral spacers, AETOS Reverse
Humeral Spacers are provided sterile via gamma irradiation. |
| Conclusion | Substantial equivalence of the AETOS Shoulder System to cited
predicates can be demonstrated based on the following:
The subject and predicate devices have the same intended use
and similar or the same 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 minor dimensional differences
between subject and predicate devices do not introduce or exacerbate
any potential issues of safety and effectiveness. As a result Smith &
Nephew concludes the subject AETOS Shoulder System Line
Extensions are substantially equivalent to cited predicate devices. |
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