Sidus Stem-Free Shoulder

K171858 · Zimmer GmbH · PKC · Dec 18, 2017 · Orthopedic

Device Facts

• Record ID: K171858
• Device Name: Sidus Stem-Free Shoulder
• Applicant: Zimmer GmbH
• Product Code: PKC · Orthopedic
• Decision Date: Dec 18, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Intended for Total Arthroplasty of the Shoulder

Device Story

Modular humeral shoulder prosthesis; replaces proximal humeral bone and articulating surface. Components: humeral anchor (titanium alloy) and humeral head (cobalt chromium alloy). Anchor features four fins and baseplate; head features articulation surface. Components mate via Morse taper. Used in total shoulder arthroplasty; implanted via anatomical reconstruction surgical technique. Anchor fixed in proximal humerus via uncemented interference press-fit. Surgeon-operated in clinical setting. Output is a reconstructed joint surface; restores shoulder function and reduces pain. Benefits include anatomical reconstruction without humeral stem.

Clinical Evidence

Clinical evidence includes a multicenter US/Canada IDE trial (n=71) and a European PMCF study (n=43). IDE trial success rate was 93.0% at 2 years (composite criteria: ASES score improvement ≥30, radiographic success, no SAEs, no revision) vs 85.4% for Bigliani/Flatow historical control. 98.5% of IDE patients showed >30 point ASES improvement; 95.8% survivorship. PMCF study showed 88.4% success rate. Non-clinical testing included FEA, fatigue, primary stability, and cadaveric testing.

Technological Characteristics

Humeral anchor: titanium alloy, rough blasted finish, 4 fenestrated fins. Humeral head: cobalt chromium alloy, highly polished. Fixation: cementless press-fit. Modular connection: Morse taper. Sterilization: Gamma irradiation. Sizes: 3 anchor sizes (16-22mm), head diameters 38-52mm.

Indications for Use

Indicated for patients with osteoarthritis, posttraumatic arthrosis, focal avascular necrosis of the humeral head, or previous shoulder surgeries not compromising fixation. Components are intended for cementless use.

Regulatory Classification

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).

Special Controls

*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.”

Predicate Devices

• Simpliciti Shoulder System (K143552)
• Bigliani/Flatow Shoulder Size 6mm x 60mm and Standard (concentric) Humeral Heads (K982981)

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] 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

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# 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)

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# 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<br>Sulzer Allee 8<br>CH-8404 Winterthur, Switzerland | | | | | | |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|-----------------------------------------------------|-----------------------------------------|---------------------------------|-------------------------------------------------------------------------------------------|--------------|
| Contact Person: | Dalene T. Binkley<br>Project Manager, Extremities Regulatory Affairs<br>Telephone: [phone] | | | | | | |
| Date: | December 15, 2017 | | | | | | |
| Subject Device: | Trade Name: Sidus Stem-Free Shoulder<br>Common Name: Shoulder Prosthesis | | | | | | |
| | Classification Name:<br>PKC - Shoulder joint metal/polymer semi-constrained<br>cemented prosthesis (21 CFR § 888.3660) | | | | | | |
| Predicate Device(s): | <table><tr><td>K143552<br/>(cleared 3/4/2015)</td><td>Primary Predicate:<br/>Simpliciti Shoulder<br/>System</td><td>Wright Medical<br/>(formerly<br/>Tornier)</td></tr><tr><td>K982981<br/>(cleared 12/17/1998)</td><td>Bigliani/Flatow Shoulder<br/>Size 6mm x 60mm and<br/>Standard (concentric)<br/>Humeral Heads</td><td>Zimmer, Inc.</td></tr></table> | K143552<br>(cleared 3/4/2015) | Primary Predicate:<br>Simpliciti Shoulder<br>System | Wright Medical<br>(formerly<br>Tornier) | K982981<br>(cleared 12/17/1998) | Bigliani/Flatow Shoulder<br>Size 6mm x 60mm and<br>Standard (concentric)<br>Humeral Heads | Zimmer, Inc. |
| K143552<br>(cleared 3/4/2015) | Primary Predicate:<br>Simpliciti Shoulder<br>System | Wright Medical<br>(formerly<br>Tornier) | | | | | |
| K982981<br>(cleared 12/17/1998) | Bigliani/Flatow Shoulder<br>Size 6mm x 60mm and<br>Standard (concentric)<br>Humeral Heads | Zimmer, Inc. | | | | | |
| Purpose and Device Description: | The Sidus Stem-Free Shoulder is a modular humeral<br>component (consisting of a humeral anchor and a head)<br>designed to be used as a total- shoulder arthroplasty long-<br>term implant. Both humeral anchor and humeral head | | | | | | |

components are available in multiple sizes.

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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:

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| Property or<br>Characteristic | Proposed Device | Primary Predicate<br>Device | Predicate Device |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FDA Product<br>Code(s) | Sidus Stem-Free<br>Shoulder | Simpliciti Shoulder<br>System (K143552) | Bigliani/Flatow<br>Shoulder (K982981) |
| Intended Use | Intended for Total<br>Arthroplasty of the<br>Shoulder | PKC | HSD, KWS and KWT |
| Indications for<br>Use | Intended for Total<br>Arthroplasty of the<br>Shoulder<br><br>The Indications for Use<br>of the Sidus Stem-Free<br>Shoulder are:<br>- Osteoarthritis;<br>- Posttraumatic arthrosis;<br>- Focal avascular<br>necrosis of the humeral<br>head;<br>- Previous surgeries of<br>the shoulder that do not<br>compromise the fixation.<br><br>The Sidus Stem-Free<br>Shoulder components<br>(Anchors and Humeral<br>Heads) are intended for<br>cementless use. | Intended for Total<br>Arthroplasty of the<br>Shoulder<br><br>The Simpliciti<br>Shoulder System is<br>indicated for severely<br>painful and/or disabled<br>joint resulting from<br>osteoarthritis and<br>traumatic arthritis.<br><br>The metaphyseal<br>humeral stems are<br>indicated for press-fit,<br>un-cemented use.<br><br>The glenoid<br>components are<br>indicated for cemented<br>use only and are<br>indicated only for use<br>with bone cement.<br><br>This device is for<br>single use. | Intended for Total or<br>Hemi Arthroplasty of<br>the Shoulder<br><br>Prosthetic replacement<br>with this device may be<br>indicated for the<br>treatment of severe pain<br>or significant disability<br>in degenerative,<br>rheumatoid, or<br>traumatic disease of the<br>glenohumeral joint;<br>ununited humeral head<br>fractures of long<br>duration; irreducible 3-<br>and 4- part proximal<br>humeral fractures;<br>avascular necrosis of the<br>humeral head; or other<br>difficult clinical<br>management problems<br>where arthrodesis or<br>resectional arthroplasty<br>is not acceptable. The<br>assembled humeral<br>component may be used<br>alone for<br>hemiarthroplasty or<br>combined with the<br>glenoid component for<br>total shoulder<br>arthroplasty. Humeral<br>heads with heights of 27<br>mm or greater may be<br>used for difficult<br>clinical management<br>problems involving |
| FDA Product<br>Code(s) | PKC | PKC | HSD, KWS and KWT |
| Intended Use | Intended for Total<br>Arthroplasty of the<br>Shoulder | Intended for Total<br>Arthroplasty of the<br>Shoulder | Intended for Total or<br>Hemi Arthroplasty of<br>the Shoulder |
| Indications for<br>Use | The Indications for Use<br>of the Sidus Stem-Free<br>Shoulder are:<br>- Osteoarthritis;<br>- Posttraumatic arthrosis;<br>- Focal avascular<br>necrosis of the humeral<br>head;<br>- Previous surgeries of<br>the shoulder that do not<br>compromise the fixation.<br><br>The Sidus Stem-Free<br>Shoulder components<br>(Anchors and Humeral<br>Heads) are intended for<br>cementless use. | The Simpliciti<br>Shoulder System is<br>indicated for severely<br>painful and/or disabled<br>joint resulting from<br>osteoarthritis and<br>traumatic arthritis.<br><br>The metaphyseal<br>humeral stems are<br>indicated for press-fit,<br>un-cemented use.<br><br>The glenoid<br>components are<br>indicated for cemented<br>use only and are<br>indicated only for use<br>with bone cement.<br><br>This device is for<br>single use. | Prosthetic replacement<br>with this device may be<br>indicated for the<br>treatment of severe pain<br>or significant disability<br>in degenerative,<br>rheumatoid, or<br>traumatic disease of the<br>glenohumeral joint;<br>ununited humeral head<br>fractures of long<br>duration; irreducible 3-<br>and 4- part proximal<br>humeral fractures;<br>avascular necrosis of the<br>humeral head; or other<br>difficult clinical<br>management problems<br>where arthrodesis or<br>resectional arthroplasty<br>is not acceptable. The<br>assembled humeral<br>component may be used<br>alone for<br>hemiarthroplasty or<br>combined with the<br>glenoid component for<br>total shoulder<br>arthroplasty. Humeral<br>heads with heights of 27<br>mm or greater may be<br>used for difficult<br>clinical management<br>problems involving |
| | | | rotator cuff deficiency<br>where arthrodesis or<br>conventional<br>nonconstrained<br>arthroplasty is not<br>acceptable. |
| Fixation<br>Method | Uncemented (press fit) | Uncemented (press fit)<br>- Porous | Cemented or<br>Uncemented (press fit) |
| Sterilization<br>for<br>Anchor/Stem<br>and Head | Gamma Irradiation | Gamma Irradiation | Gamma Irradiation |
| Anchor/Stem<br>Sizes | 3 Sizes: Small (16mm),<br>Medium (19mm) and<br>Large (22mm) | 3 Sizes: 18mm to<br>24mm | Diameter: 6mm to<br>16mm<br>Length: 60mm to<br>200mm |
| Number of<br>Fins | 4 (fenestrated) | 3 (full) | 4 (full) |
| Anchor/Stem<br>Coating | Rough blasted titanium | Sintered titanium bead<br>coating | Rough blasted titanium |
| Head Diameter | 38mm to 52mm | 39mm to 56mm | 40mm to 56mm |
| Head<br>Thickness | 13mm to 23mm | 14mm to 23mm | 15mm to 42mm |
| Material<br>Substrate | Humeral Anchor:<br>Titanium alloy | Humeral Anchor:<br>Titanium alloy | Humeral Stem:<br>Cobalt Chromium alloy |
| | Humeral Head:<br>Cobalt Chromium alloy | Humeral Head:<br>Cobalt Chromium alloy | Humeral Head:<br>Cobalt Chromium alloy |

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## 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<br>Verification/Validation | Acceptance Criteria | Results |
|-----------------------------------------|---------------------|---------|
|-----------------------------------------|---------------------|---------|

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| Literature review to ensure<br>appropriate materials are<br>used | Identify the most appropriate<br>synthetic materials used to<br>simulate the proximal humerus | Acceptable |
|---------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|------------|
| Literature review of joint<br>loading conditions | Identify the most appropriate<br>loading conditions against<br>which to evaluate the long-<br>term performance of humeral<br>implants | Acceptable |
| Analysis of acceptable<br>implant geometry | Assess the geometry of the<br>proximal humerus, fit of the<br>implant and the cancellous<br>bone material of the humerus. | Acceptable |
| Finite Element Analysis<br>(FEA) – Stress Analysis | Use FEA to identify worst case<br>conditions in-vivo. | Acceptable |
| Mechanical Testing -<br>Fatigue | Verify sufficient fatigue<br>strength | Acceptable |
| Finite Element Analysis<br>(FEA) - Initial stability | Evaluate with FEA the initial<br>fixation | Acceptable |
| Mechanical Testing -<br>Primary Stability Testing | Determine the influence of<br>bone quality and implant size<br>on implant displacement | Acceptable |
| Mechanical Testing -<br>Primary Stability with<br>Cadaveric Testing | Verify primary stability in<br>worst case physical testing in<br>cadaveric bone | Acceptable |
| Magnetic Resonance<br>Imaging (MRI) Analysis | Verify component can be used<br>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).

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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.

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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<br>e | N of<br>e | Percent | ે તેરી જેવી જેવી સવલતો પ્રાપ્ |
|--------|------------|-----------|---------|--------------------------------|
|--------|------------|-----------|---------|--------------------------------|

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| Size | Success | Failure | of<br>Success<br>(PS) | Exact<br>CI of<br>PS |
|------|---------|---------|-----------------------|----------------------|
| 43 | 38 | 5 | 88.4% | (74.9%.<br>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.