(180 days)
Not Found
No
The document describes a mechanical implant and its performance studies, with no mention of AI or ML capabilities.
Yes
The device is a modular humeral component intended for use as a total-shoulder arthroplasty long-term implant to treat conditions like osteoarthritis and posttraumatic arthrosis, thus acting as a therapeutic intervention by replacing damaged bone and restoring function.
No
The device is a modular humeral component designed to be used as a total-shoulder arthroplasty long-term implant, replacing the proximal humeral bone, indicating it is a prosthetic implant, not a diagnostic device.
No
The device description clearly states it is a modular humeral component (consisting of a humeral anchor and a head) designed to be used as a total-shoulder arthroplasty long-term implant, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The Sidus Stem-Free Shoulder is a surgical implant designed to replace the proximal humeral bone. It is a physical device implanted into the body.
- Intended Use: The intended use is for treating conditions like osteoarthritis and posttraumatic arthrosis by replacing the shoulder joint. This is a surgical intervention, not a diagnostic test performed on a specimen.
- Lack of IVD Indicators: The description does not mention any analysis of biological samples, laboratory procedures, or diagnostic information derived from such analysis.
Therefore, the Sidus Stem-Free Shoulder is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Indications for Use of the Sidus Stem-Free Shoulder are:
- Osteoarthritis;
- Posttraumatic arthrosis;
- Focal avascular necrosis of the humeral head;
- Previous surgeries of the shoulder that do not compromise the fixation.
The Sidus Stem-Free Shoulder components (Anchors and Humeral Heads) are intended for cementless use.
Product codes (comma separated list FDA assigned to the subject device)
PKC
Device Description
The Sidus Stem-Free Shoulder is a modular humeral component (consisting of a humeral anchor and a head) designed to be used as a total- shoulder arthroplasty long-term implant. Both humeral anchor and humeral head components are available in multiple sizes.
The Sidus Stem-Free Shoulder replaces the proximal humeral bone, including the articulating surface, using an anatomical reconstruction surgical technique philosophy. The Sidus Stem-Free humeral anchor fixes within the proximal humeral bone via an uncemented interference press-fit. The Sidus Stem-Free humeral head mates to the Sidus Stem-Free humeral anchor via a Morse taper with the male taper on the humeral anchor and female taper on the humeral head.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, humeral head
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)
Non-Clinical Tests:
Non-clinical testing demonstrated that the Sidus Stem-Free Shoulder meets performance requirements as defined by Design Control activities and is substantially equivalent to the predicate devices in terms of safety and efficacy.
- Literature review to ensure appropriate materials are used: Identified the most appropriate synthetic materials used to simulate the proximal humerus. Acceptable.
- Literature review of joint loading conditions: Identified the most appropriate loading conditions against which to evaluate the long-term performance of humeral implants. Acceptable.
- Analysis of acceptable implant geometry: Assessed the geometry of the proximal humerus, fit of the implant and the cancellous bone material of the humerus. Acceptable.
- Finite Element Analysis (FEA) – Stress Analysis: Used FEA to identify worst case conditions in-vivo. Acceptable.
- Mechanical Testing - Fatigue: Verified sufficient fatigue strength. Acceptable.
- Finite Element Analysis (FEA) - Initial stability: Evaluated with FEA the initial fixation. Acceptable.
- Mechanical Testing - Primary Stability Testing: Determined the influence of bone quality and implant size on implant displacement. Acceptable.
- Mechanical Testing - Primary Stability with Cadaveric Testing: Verified primary stability in worst case physical testing in cadaveric bone. Acceptable.
- Magnetic Resonance Imaging (MRI) Analysis: Verified component can be used safely in a MRI environment. Acceptable.
Clinical Tests:
A Multicenter Investigational Device Exemption (IDE) Trial of the Sidus Stem-Free Shoulder Investigational was conducted in the United States and Canada to demonstrate the safety and effectiveness of the Sidus Stem-Free Shoulder. The results of this clinical study were compared to a Clinical Performance Goal using the stemmed Bigliani/Flatow prosthesis (Sidus IDE historical control). The Clinical Performance Goal for was established at 85.42% based on the historical performance of the Bigliani/Flatow Shoulder. The exact binomial confidence interval of the estimate is 72.24%. 93.93% (lower bound, upper bound).
- Sidus IDE Study: Sample Size: 71, N of Success: 66, No of Failure: 5, Percent of Success (PS): 93.0%, 95% Exact CI of PS: (84.3%, 97.7%).
- Historical Control Study: Sample Size: 48, N of Success: 41, No of Failure: 7, Percent of Success (PS): 85.4%, 95% Exact CI of PS: (72.24%, 93.93).
Key results: 93.0% of subjects in the Sidus IDE analysis were considered a success based on composite clinical success criteria at 2 years (ASES overall score improvement of at least 30 points from baseline, radiographic success, no device-related SAE, no reoperation or revision). 98.5% of Sidus IDE patients had over a 30 point improvement on the ASES score from preoperative. The study yielded 95.8% survivorship. 98.5% of patients completing two year visits successfully passed the radiographic success criteria.
A second Sidus study was conducted in Europe, Sidus Stem-Free Shoulder: A Multicenter, Prospective, Non-Controlled Post-Market Clinical Follow-up Study (PMCF), to further confirm performance of the device.
- PMCF Study: Sample Size: 43, N of Success: 38, N of Failure: 5, Percent of Success (PS): 88.4%, Exact CI of PS: (74.9%, 96.1%).
Key results: 88.4% of subjects were considered a success when measured against the same Clinical Performance Goal as the IDE study.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Composite clinical success criteria included: ASES overall score improvement of at least 30 points from baseline, Radiographic success (No progressive radiolucencies of the humeral component > 2 mm, and No progressive migration or subsidence of the humeral component >= 5 mm), No device-related serious adverse events (SAE), No reoperation or revision of the study implants.
Percent of Success (PS) was reported.
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
December 18, 2017
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Zimmer GmbH Dalene Binkley Project Manager, Regulatory Affairs 1800 West Center Street Warsaw, Indiana 46580
Re: K171858
Trade/Device Name: Sidus Stem-Free Shoulder Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: PKC Dated: November 7, 2017 Received: November 8, 2017
Dear Dalene Binkley:
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. 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 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Katherine D. Kavlock -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K171858
Device Name Sidus Stem-Free Shoulder
Indications for Use (Describe)
The Indications for Use of the Sidus Stem-Free Shoulder are:
- Osteoarthritis;
- Posttraumatic arthrosis;
- Focal avascular necrosis of the humeral head;
- Previous surgeries of the shoulder that do not compromise the fixation.
The Sidus Stem-Free Shoulder components (Anchors and Humeral Heads) are intended for cementless 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the Sidus™ Stem-Free Shoulder 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.
| Sponsor: | Zimmer GmbH
Sulzer Allee 8
CH-8404 Winterthur, Switzerland | | | | | | |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|-----------------------------------------------------|-----------------------------------------|---------------------------------|-------------------------------------------------------------------------------------------|--------------|
| Contact Person: | Dalene T. Binkley
Project Manager, Extremities Regulatory Affairs
Telephone: (574) 372-6789 | | | | | | |
| Date: | December 15, 2017 | | | | | | |
| Subject Device: | Trade Name: Sidus Stem-Free Shoulder
Common Name: Shoulder Prosthesis | | | | | | |
| | Classification Name:
PKC - Shoulder joint metal/polymer semi-constrained
cemented prosthesis (21 CFR § 888.3660) | | | | | | |
| Predicate Device(s): | K143552
(cleared 3/4/2015)Primary Predicate:
Simpliciti Shoulder
SystemWright Medical
(formerly
Tornier)K982981
(cleared 12/17/1998)Bigliani/Flatow Shoulder
Size 6mm x 60mm and
Standard (concentric)
Humeral HeadsZimmer, Inc. | K143552
(cleared 3/4/2015) | Primary Predicate:
Simpliciti Shoulder
System | Wright Medical
(formerly
Tornier) | K982981
(cleared 12/17/1998) | Bigliani/Flatow Shoulder
Size 6mm x 60mm and
Standard (concentric)
Humeral Heads | Zimmer, Inc. |
| K143552
(cleared 3/4/2015) | Primary Predicate:
Simpliciti Shoulder
System | Wright Medical
(formerly
Tornier) | | | | | |
| K982981
(cleared 12/17/1998) | Bigliani/Flatow Shoulder
Size 6mm x 60mm and
Standard (concentric)
Humeral Heads | Zimmer, Inc. | | | | | |
| Purpose and Device Description: | The Sidus Stem-Free Shoulder is a modular humeral
component (consisting of a humeral anchor and a head)
designed to be used as a total- shoulder arthroplasty long-
term implant. Both humeral anchor and humeral head | | | | | | |
components are available in multiple sizes.
4
The Sidus Stem-Free Shoulder replaces the proximal humeral bone, including the articulating surface, using an anatomical reconstruction surgical technique philosophy. The Sidus Stem-Free humeral anchor fixes within the proximal humeral bone via an uncemented interference press-fit. The Sidus Stem-Free humeral head mates to the Sidus Stem-Free humeral anchor via a Morse taper with the male taper on the humeral anchor and female taper on the humeral head.
Significant Physical and Performance Characteristics: (1) Device Design: The Sidus Stem-Free Shoulder humeral anchor major design features include four fins, a baseplate and a male Morse taper. The Sidus Stem-Free Shoulder humeral head major design features include the articulation surface and a female Morse taper. (2) Material Used: The Sidus Stem-Free Shoulder humeral anchor is made of a titanium alloy. The Sidus Stem-Free Shoulder humeral head is made of a cobalt chromium alloy.
(3) Physical Properties: The Sidus Stem-Free Shoulder humeral anchor is rough blasted on the four fins. The Sidus Stem-Free Shoulder humeral head is highly polished on the articulation surface.
The Indications for Use of the Sidus Stem-Free Shoulder are:
- Osteoarthritis:
- Posttraumatic arthrosis;
- Focal avascular necrosis of the humeral head;
- Previous surgeries of the shoulder that do not compromise the fixation.
The Sidus Stem-Free Shoulder components (Anchors and Humeral Heads) are intended for cementless use.
The Sidus Stem-Free Shoulder has the same intended use and fundamental scientific technology as its predicate devices. The technological characteristics (material, sizing, indications, coating, packaging, shelf life, and sterilization) of the Sidus Stem-Free Shoulder are substantially equivalent to the predicate device. The design differences have been demonstrated through clinical and non-clinical performance data do not raise new issues of safety or effectiveness.
Intended Use and Indications for Use:
Summary of Technological Characteristics:
5
| Property or
Characteristic | Proposed Device | Primary Predicate
Device | Predicate Device |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FDA Product
Code(s) | Sidus Stem-Free
Shoulder | Simpliciti Shoulder
System (K143552) | Bigliani/Flatow
Shoulder (K982981) |
| Intended Use | Intended for Total
Arthroplasty of the
Shoulder | PKC | HSD, KWS and KWT |
| Indications for
Use | Intended for Total
Arthroplasty of the
Shoulder
The Indications for Use
of the Sidus Stem-Free
Shoulder are:
- Osteoarthritis;
- Posttraumatic arthrosis;
- Focal avascular
necrosis of the humeral
head; - Previous surgeries of
the shoulder that do not
compromise the fixation.
The Sidus Stem-Free
Shoulder components
(Anchors and Humeral
Heads) are intended for
cementless use. | Intended for Total
Arthroplasty of the
Shoulder
The Simpliciti
Shoulder System is
indicated for severely
painful and/or disabled
joint resulting from
osteoarthritis and
traumatic arthritis.
The metaphyseal
humeral stems are
indicated for press-fit,
un-cemented use.
The glenoid
components are
indicated for cemented
use only and are
indicated only for use
with bone cement.
This device is for
single use. | Intended for Total or
Hemi Arthroplasty of
the Shoulder
Prosthetic replacement
with this device may be
indicated for the
treatment of severe pain
or significant disability
in degenerative,
rheumatoid, or
traumatic disease of the
glenohumeral joint;
ununited humeral head
fractures of long
duration; irreducible 3-
and 4- part proximal
humeral fractures;
avascular necrosis of the
humeral head; or other
difficult clinical
management problems
where arthrodesis or
resectional arthroplasty
is not acceptable. The
assembled humeral
component may be used
alone for
hemiarthroplasty or
combined with the
glenoid component for
total shoulder
arthroplasty. Humeral
heads with heights of 27
mm or greater may be
used for difficult
clinical management
problems involving |
| FDA Product
Code(s) | PKC | PKC | HSD, KWS and KWT |
| Intended Use | Intended for Total
Arthroplasty of the
Shoulder | Intended for Total
Arthroplasty of the
Shoulder | Intended for Total or
Hemi Arthroplasty of
the Shoulder |
| Indications for
Use | The Indications for Use
of the Sidus Stem-Free
Shoulder are:
- Osteoarthritis;
- Posttraumatic arthrosis;
- Focal avascular
necrosis of the humeral
head; - Previous surgeries of
the shoulder that do not
compromise the fixation.
The Sidus Stem-Free
Shoulder components
(Anchors and Humeral
Heads) are intended for
cementless use. | The Simpliciti
Shoulder System is
indicated for severely
painful and/or disabled
joint resulting from
osteoarthritis and
traumatic arthritis.
The metaphyseal
humeral stems are
indicated for press-fit,
un-cemented use.
The glenoid
components are
indicated for cemented
use only and are
indicated only for use
with bone cement.
This device is for
single use. | Prosthetic replacement
with this device may be
indicated for the
treatment of severe pain
or significant disability
in degenerative,
rheumatoid, or
traumatic disease of the
glenohumeral joint;
ununited humeral head
fractures of long
duration; irreducible 3-
and 4- part proximal
humeral fractures;
avascular necrosis of the
humeral head; or other
difficult clinical
management problems
where arthrodesis or
resectional arthroplasty
is not acceptable. The
assembled humeral
component may be used
alone for
hemiarthroplasty or
combined with the
glenoid component for
total shoulder
arthroplasty. Humeral
heads with heights of 27
mm or greater may be
used for difficult
clinical management
problems involving |
| | | | rotator cuff deficiency
where arthrodesis or
conventional
nonconstrained
arthroplasty is not
acceptable. |
| Fixation
Method | Uncemented (press fit) | Uncemented (press fit)
- Porous | Cemented or
Uncemented (press fit) |
| Sterilization
for
Anchor/Stem
and Head | Gamma Irradiation | Gamma Irradiation | Gamma Irradiation |
| Anchor/Stem
Sizes | 3 Sizes: Small (16mm),
Medium (19mm) and
Large (22mm) | 3 Sizes: 18mm to
24mm | Diameter: 6mm to
16mm
Length: 60mm to
200mm |
| Number of
Fins | 4 (fenestrated) | 3 (full) | 4 (full) |
| Anchor/Stem
Coating | Rough blasted titanium | Sintered titanium bead
coating | Rough blasted titanium |
| Head Diameter | 38mm to 52mm | 39mm to 56mm | 40mm to 56mm |
| Head
Thickness | 13mm to 23mm | 14mm to 23mm | 15mm to 42mm |
| Material
Substrate | Humeral Anchor:
Titanium alloy | Humeral Anchor:
Titanium alloy | Humeral Stem:
Cobalt Chromium alloy |
| | Humeral Head:
Cobalt Chromium alloy | Humeral Head:
Cobalt Chromium alloy | Humeral Head:
Cobalt Chromium alloy |
6
Summary of Performance Data (Nonclinical and/or Clinical)
. Non-Clinical Tests:
Non-clinical testing demonstrated that the Sidus Stem-Free Shoulder meets performance requirements as defined by Design Control activities and is substantially equivalent to the predicate devices in terms of safety and efficacy.
| Non-Clinical
| Verification/Validation | Acceptance Criteria | Results |
|---|---|---|
| ----------------------------------------- | --------------------- | --------- |
7
| Literature review to ensure
appropriate materials are
used | Identify the most appropriate
synthetic materials used to
simulate the proximal humerus | Acceptable |
|---------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|------------|
| Literature review of joint
loading conditions | Identify the most appropriate
loading conditions against
which to evaluate the long-
term performance of humeral
implants | Acceptable |
| Analysis of acceptable
implant geometry | Assess the geometry of the
proximal humerus, fit of the
implant and the cancellous
bone material of the humerus. | Acceptable |
| Finite Element Analysis
(FEA) – Stress Analysis | Use FEA to identify worst case
conditions in-vivo. | Acceptable |
| Mechanical Testing -
Fatigue | Verify sufficient fatigue
strength | Acceptable |
| Finite Element Analysis
(FEA) - Initial stability | Evaluate with FEA the initial
fixation | Acceptable |
| Mechanical Testing -
Primary Stability Testing | Determine the influence of
bone quality and implant size
on implant displacement | Acceptable |
| Mechanical Testing -
Primary Stability with
Cadaveric Testing | Verify primary stability in
worst case physical testing in
cadaveric bone | Acceptable |
| Magnetic Resonance
Imaging (MRI) Analysis | Verify component can be used
safely in a MRI environment | Acceptable |
Clinical Tests: ●
A Multicenter Investigational Device Exemption (IDE) Trial of the Sidus Stem-Free Shoulder Investigational was conducted in the United States and Canada to demonstrate the safety and effectiveness of the Sidus Stem-Free Shoulder. The results of this clinical study were compared to a Clinical Performance Goal using the stemmed Bigliani/Flatow prosthesis (Sidus IDE historical control). The Clinical Performance Goal for was established at 85.42% based on the historical performance of the Bigliani/Flatow Shoulder. The exact binomial confidence interval of the estimate is 72.24%. 93.93% (lower bound, upper bound).
8
To be considered a success, a Sidus subject must meet the following composite clinical success criteria at 2 years:
- ASES overall score improvement of at least 30 트 points from baseline.
- . Radiographic success defined as:
- . No progressive radiolucencies of the humeral component > 2 mm, and
- No progressive migration or subsidence of . the humeral component ≥ 5 mm.
- l No device-related serious adverse events (SAE).
- I No reoperation or revision of the study implants.
93.0% of subjects included in the Sidus IDE analysis were considered a success based on the above criteria. In comparison, 85.4% of the Bigliani/Flatow historical control were considered a success based on the same criteria.
| Study | Sample Size | N of Success | No of Failure | Percent of Success (PS) | 95% Exact CI of PS |
|---|---|---|---|---|---|
| Sidus IDE | 71 | 66 | 5 | 93.0% | (84.3%, 97.7%) |
| Historica l Control | 48 | 41 | 7 | 85.4% | (72.24%, 93.93) |
In addition, 98.5% of Sidus IDE patients have over a 30 point improvement on the ASES score from preoperative. The study yielded excellent survivorship with 95.8% surviving. 98.5% of patients completing two year visits successfully passed the radiographic success criteria with no progressive radiolucencies of the humeral component >2 mm and no migration or subsidence of the humeral component. Three adverse events resulted in revision of the components and subsequent failure of the device.
In comparison, 91.7% of historical control patients have over a 30 point improvement on the ASES score from preoperative. The control yielded excellent survivorship with 97.9% surviving. 100% of patients exhibited radiographic success. 10.4% of patients experienced serious device related adverse events.
9
A total of 163 adverse events were reported in the Sidus IDE. 27 of those adverse events were determined to be definitely, possibly, or uncertain in their relation to the investigational device. Of these events, three revisions were reported. The first patient was revised by a non-study surgeon due to probable rotator cuff tear and possible loosening of the implants 7 months post-operatively. The non-study surgeon reported the subscapularis was possibly impinged between the head and anchor during the original implantation and was potentially the cause of the head not properly seating. The second revision occurred in a patient due to an acute subscapularis rupture 6 months postoperatively. The head and anchor were removed. The third revision included a patient who slipped on his garage floor 5 days post-operatively and fell with an outstretched arm resulting in a tear of the supraspinatous which was subsequently surgically repaired. The patient improved, but elected to proceed with shoulder revision surgery with a non-study surgeon. The operative report of the revising surgeon did not note any rotator cuff injury, infection or loose implants.
In comparison, the historical control study reported 5 serious adverse events probably related to the device. These events included glenoid loosening, rotator cuff tear, deep vein thrombosis leading to pulmonary embolism, superior migration of the humeral head leading to articulation with the acromion after lifting an 8 lb. weight and pain located at the anterior aspect of the shoulder requiring a second surgery.
A second Sidus study was conducted in Europe, Sidus Stem-Free Shoulder: A Multicenter, Prospective, Non-Controlled Post-Market Clinical Follow-up Study (PMCF), to further confirm performance of the device. When measuring PMCF subjects against the same Clinical Performance Goal, 88.4% of subjects were considered a success.
| Sample | IN of
e | N of
e | Percent | ે તેરી જેવી જેવી સવલતો પ્રાપ્ |
| -------- | ------------ | ----------- | --------- | -------------------------------- |
|---|
10
| Size | Success | Failure | of
Success
(PS) | Exact
CI of
PS |
|------|---------|---------|-----------------------|----------------------|
| 43 | 38 | 5 | 88.4% | (74.9%.
96.1%) |
Thirteen adverse events were reported in the PMCF study. Adverse events were classified as not related, definitely related, possibly related, or unknown in their relation to the device. One event was categorized as an adverse device effect and included subluxation in the cranial direction due to insufficiency/rupture of the pectoralis major tendon. A second event occurred which included revision. This subject suffered a serious adverse event approximately 3.5 months after implantation which included a tear of the superior cuff and subsequent upward migration of the humeral head with pseudoparalysis. This resulted in device removal and subsequent revision of the study components.
Considering the performance data gathered during the Sidus IDE for the Sidus Stem-Free Shoulder, evidence suggests that it will perform equal or better than the currently marked Bigliani/Flatow stemmed shoulder for the intended use. This data was further supplemented by the evidence collected during the Sidus PMCF study.
Substantial Equivalence Conclusion
The Sidus Stem-Free Shoulder has the same intended use and the same fundamental scientific technology as the cleared Simpliciti Shoulder System and Bigliani/Flatow Shoulder System. Based on the clinical and non-clinical data presented for the subject and predicate devices, Zimmer GmbH concludes that subject device is substantially equivalent to the predicate device.