(148 days)
The Stemless Shoulder System is comprised of modular humeral heads to be used in total shoulder arthroplasty.
The Stemless Shoulder System is indicated for a severely painful and/or disabled joint resulting from osteoarthritis or traumatic arthritis.
The Stemless humeral components are intended for press-fit fixation without the use of bone cements are intended only for use with bone cement.
The GLOBAL ICON Stemless Shoulder System includes cobalt-chromium alloy humeral heads that mate with titanium alloy anchor plates. The anchor plates include four grooved peripheral legs which are seated in the proximal humerus, and hydroxyapatite coating on all bone- contacting surfaces.
The document describes the GLOBAL ICON Stemless Shoulder System, a medical device for total shoulder arthroplasty. It details the device's indications for use, technological characteristics, and a summary of non-clinical and clinical tests conducted to demonstrate substantial equivalence to predicate devices.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the GLOBAL ICON Stemless Shoulder System were based on a composite success endpoint at 24 months post-operative in a clinical study. The criteria and reported performance are summarized in the table below:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Primary Composite Success Endpoint (all criteria met at 24 months): | Overall Composite Success at 24 months: The study data were successful in meeting the protocol-specified primary endpoint. |
| a. Radiographs indicate no continuous radiolucent line around the GLOBAL ICON Stemless Shoulder System humeral component. | "There were no radiological signs of loosening or continuous radiolucent lines observed." |
| b. The adjusted Constant-Murley score is greater than 85. | "At 24-months the adjusted Constant-Murley Score was greater than 85 in 85.1% of Subjects." The mean adjusted Constant-Murley Score improved by 60.4 points at 24 months. |
| c. No GLOBAL ICON Stemless Shoulder System has been removed for any reason. | "There were no humeral components removed in 98.7% of Subjects." "Kaplan-Meier Survivorship estimate at 2.18 years is 98.72%." |
| d. No device-related serious adverse events. | "There were no device-related serious adverse events." "There were no device-related serious adverse events in 98.7% of Subjects." "There were no UADEs reported." (UADEs likely refers to Unexpected Adverse Device Effects, though not explicitly defined in the provided text). |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: The clinical study included 128 subjects for the 24-month interim data analysis.
- Data Provenance: The document does not explicitly state the country of origin for the data. However, it is a submission to the U.S. Food & Drug Administration (FDA), indicating the device is intended for the U.S. market. The study is described as having "interim 24-month data," which suggests it is a prospective study (following subjects forward in time).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
The document does not provide details on the number or qualifications of experts used to establish ground truth for the test set. It mentions "Radiographs indicate" and "adjusted Constant-Murley score," suggesting these assessments were made by healthcare professionals, but specific qualifications (e.g., radiologist with X years of experience) or the number of such experts are not specified.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the clinical outcomes or radiological assessments in the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document presents a clinical study evaluating the device's performance directly, not a comparative effectiveness study involving human readers with and without AI assistance for interpretation. The device itself is a physical medical implant, not an AI diagnostic tool.
6. Standalone Performance Study (Algorithm Only)
No. The device is a surgical implant (GLOBAL ICON Stemless Shoulder System), not an algorithm or AI software. Therefore, a standalone (algorithm only) performance study is not applicable. The clinical study evaluates the performance of the implanted device in human subjects.
7. Type of Ground Truth Used
The ground truth for the clinical study was established using a combination of:
- Radiological assessment: To determine the presence or absence of continuous radiolucent lines around the humeral component.
- Clinical outcome scores: Specifically, the adjusted Constant-Murley score, which is a functional assessment used in shoulder arthroplasty.
- Device integrity/removal data: Tracking whether the humeral component was removed for any reason.
- Adverse event reporting: Documentation of device-related serious adverse events.
8. Sample Size for the Training Set
The document describes a clinical study for device approval, not an algorithm's development. Therefore, there is no mention of a "training set" in the context of machine learning. The 128 subjects are part of the clinical evaluation for the device's performance.
9. How the Ground Truth for the Training Set Was Established
As this is not a study involving an AI algorithm that requires training data, the concept of establishing ground truth for a "training set" is not applicable to this document. The clinical study evaluated the device's performance in patients.
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January 19, 2022
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DePuy (Ireland) % Megan Bernier Regulatory Affairs Specialist DePuy Orthopaedics, Inc. 325 Paramount Dr Raynham, Massachusetts 02767
Re: K212683
Trade/Device Name: GLOBAL ICON Stemless Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PKC Dated: December 14, 2021 Received: December 16, 2021
Dear Megan Bernier:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Jiping Chen, M.D., Ph.D., M.P.H. Acting Division 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)
K212683
Device Name GLOBAL ICON Stemless Shoulder System
Indications for Use (Describe)
The Stemless Shoulder System is comprised of modular humeral heads to be used in total shoulder arthroplasty.
The Stemless Shoulder System is indicated for a severely painful and/or disabled joint resulting from osteoarthritis or traumatic arthritis.
The Stemless humeral components are intended for press-fit fixation without the use of bone cements are intended only for use with bone cement.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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As required by 21 CFR 807.92 and 21 CFR 807.93
| Submitter Information | |
|---|---|
| Sponsor Name | DePuy Ireland UC |
| Sponsor Address | LoughbegRingaskiddyCo. Cork Ireland |
| Sponsor EstablishmentRegistration Number | 9616671 |
| 510(k) Contact | Megan BernierRegulatory Affairs SpecialistTelephone: (651-325-1178Email: mbernie1@its.jnj.com |
| Date prepared | August 13th, 2021 |
| Device Information | |
| Trade or proprietary name | GLOBAL ICON Stemless Shoulder System |
| Common or usual name | Total Shoulder Arthroplasty Prosthesis |
| Classification name | Shoulder joint metal/polymer semi-constrained cemented prosthesis |
| Class | II |
| Classification panel | 87 Orthopedics |
| Regulation | 21 CFR 888.3660 |
| Product Code(s) | PKC |
| Legally marketed device(s)to which equivalence isclaimed | Primary predicate: Zimmer Sidus Stem-Free Shoulder (K171858)Additional predicates: Tornier Simpliciti™ Shoulder System(K143552), Global Advantage Shoulder System (K011047, K992065,K984541).Reference devices: GLOBAL CAP HA Humeral Heads (K033516)and Pinnacle Duofix (K192919. |
| Reason for 510(k)submission | New device |
| Device description | The GLOBAL ICON Stemless Shoulder System includes cobalt-chromium alloy humeral heads that mate with titanium alloy anchorplates. The anchor plates include four grooved peripheral legs whichare seated in the proximal humerus, and hydroxyapatite coating on allbone- contacting surfaces. |
| Intended use of the device | The GLOBAL ICON Stemless Shoulder System is comprised of modular humeral fixation components and humeral heads to be used in total shoulder arthroplasty. |
| Indications for use | The Stemless Shoulder System is comprised of modular humeral fixation components and humeral heads to be used in total shoulder arthroplasty.The Stemless Shoulder System is indicated for a severely painful and/or disabled joint resulting from osteoarthritis or traumatic arthritis.The Stemless humeral components are intended for press-fit fixation without the use of bone cement. The glenoid components are intended only for use with bone cement. |
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| SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THEDEVICE COMPARED TO THE PREDICATE DEVICES | ||||
|---|---|---|---|---|
| Characteristic | Subject Device:DePuy SynthesGLOBAL ICONStemlessShoulder System | PrimaryPredicate Device:Zimmer SidusStem-Free Shoulder(K171858) | Predicate Device:Tornier SimplicitiShoulder System(K143552) | Predicate Device:DePuy Synthes GlobalAdvantage ShoulderSystem (K011047,K992065, K984541) |
| Intended Use | Total ShoulderArthroplasty | Total ShoulderArthroplasty | Total ShoulderArthroplasty | Total or Hemi ShoulderArthroplasty |
| Material | ||||
| Humeral Head | CoCrMo | CoCr alloy | CoCr alloy | CoCrMo |
| Humeral FixationComponent | Titanium alloy | Titanium alloy | Titanium alloy | Titanium alloy |
| Fixation | ||||
| Bone Cement | Uncemented | Uncemented | Uncemented | Cemented oruncemented |
| Fixation | Non-porous gritblast withadditional plasma-sprayed HAcoating | Non-porous grit blastwith no additionalsurface coating | Porous-coating | Porous-coating |
| Sterilization | ||||
| Sterile Method | Gammairradiation | Gamma irradiation | Gamma irradiation | Gamma irradiation |
| Shelf-Life | 10 years | 5 years | 5 years | 10 years |
| PERFORMANCE DATA |
DePuy Ireland UC
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| SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATIONOF SUBSTANTIAL EQUIVALENCE |
|---|
| The following tests were performed on the GLOBAL ICON Stemless Shoulder System todemonstrate substantial equivalence of safety and efficacy with the predicate devices:Taper Analysis – Comparison to Existing Product Micromotion and Subsidence Study Surface Area Analysis Fatigue and Head Extraction Study Lever-Out Study ROM Analysis Wear Analysis Humeral Head Analysis – Comparison to Existing Product Bone-Conserving Analysis MRI Analysis Biocompatibility Study |
| SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OFSUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION |
| Included in this submission are interim 24-month data on 128 subjects. The primaryendpoint in this study is a composite success endpoint at 24 months post-operative,where an individual study Subject is deemed to be a composite success if each of thecriteria is met at the 24-month follow-up visit:Radiographs indicate there is no continuous radiolucent line around theGLOBAL ICON Stemless Shoulder System humeral component. The adjusted Constant-Murley score is greater than 85. No GLOBAL ICON Stemless Shoulder System has been removed for anyreason. There were no device-related serious adverse events. The study data were successful in meeting the protocol-specified primary endpoint. |
| Additionally:There were no radiological signs of loosening or continuous radiolucent lines observed There were no UADEs reported There were no humeral components removed in 98.7% of Subjects There were no device-related serious adverse events in 98.7% of Subjects At 24-months the mean adjusted Constant-Murley Score improved by 60.4 points At 24-months the adjusted Constant-Murley Score was greater than 85 in 85.1% of Subjects Kaplan-Meier Survivorship estimate at 2.18 years is 98.72% |
| The subject DePuy Synthes GLOBAL ICON Stemless Shoulder System is substantially equivalent to the primary predicate Zimmer Sidus Stem-Free Shoulder and additional predicates Tornier Simpliciti Shoulder System (K143552), and DePuy Synthes Global Advantage Shoulder System (K011047, K992065, K984541). |
DePuy Ireland UC
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Traditional 510(k) Notification GLOBAL ICON Stemless Shoulder System
DePuy Ireland UC
§ 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.”