(148 days)
No
The summary describes a mechanical implant (shoulder system) and its clinical performance, with no mention of AI/ML technology, image processing, or data analysis beyond standard statistical reporting of clinical trial results.
Yes.
The device is a medical implant (Stemless Shoulder System) used in total shoulder arthroplasty to treat severely painful and/or disabled joints, which aligns with the definition of a therapeutic device as it directly treats a medical condition.
No
The device description indicates it is a surgical implant (humeral heads and anchor plates) used in total shoulder arthroplasty, not a tool for diagnosis. Its intended use states "treatment" of a painful/disabled joint from arthritis, not diagnosis.
No
The device description explicitly states it includes physical components made of cobalt-chromium alloy and titanium alloy, which are hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for total shoulder arthroplasty to treat painful and/or disabled joints due to osteoarthritis or traumatic arthritis. This is a surgical procedure involving the implantation of a medical device.
- Device Description: The device is a physical implant (humeral heads and anchor plates) made of metal alloys and coated with hydroxyapatite.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is an implantable surgical device used in vivo (inside the body).
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
PKC
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder joint / proximal humerus
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 performed:
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
Clinical tests performed: Interim 24-month data on 128 subjects. The primary endpoint 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 the criteria is met at the 24-month follow-up visit:
Radiographs indicate there is no continuous radiolucent line around the GLOBAL 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 any reason.
There were no device-related serious adverse events.
The study data were successful in meeting the protocol-specified primary endpoint.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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%
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.
K171858, K143552, K011047, K992065, K984541
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.
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
January 19, 2022
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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)
3
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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 | Loughbeg |
| Ringaskiddy | |
| Co. Cork Ireland | |
| Sponsor Establishment | |
| Registration Number | 9616671 |
| 510(k) Contact | Megan Bernier |
| Regulatory Affairs Specialist | |
| Telephone: (651-325-1178 | |
| Email: 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 is | |
| claimed | 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 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. | |
| 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. |
5
6
| | SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE
DEVICE COMPARED TO THE PREDICATE DEVICES | | | |
|-------------------------------|-------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|-------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| Characteristic | Subject Device:
DePuy Synthes
GLOBAL ICON
Stemless
Shoulder System | Primary
Predicate Device:
Zimmer Sidus
Stem-Free Shoulder
(K171858) | Predicate Device:
Tornier Simpliciti
Shoulder System
(K143552) | Predicate Device:
DePuy Synthes Global
Advantage Shoulder
System (K011047,
K992065, K984541) |
| Intended Use | Total Shoulder
Arthroplasty | Total Shoulder
Arthroplasty | Total Shoulder
Arthroplasty | Total or Hemi Shoulder
Arthroplasty |
| | Material | | | |
| Humeral Head | CoCrMo | CoCr alloy | CoCr alloy | CoCrMo |
| Humeral Fixation
Component | Titanium alloy | Titanium alloy | Titanium alloy | Titanium alloy |
| | Fixation | | | |
| Bone Cement | Uncemented | Uncemented | Uncemented | Cemented or
uncemented |
| Fixation | Non-porous grit
blast with
additional plasma-
sprayed HA
coating | Non-porous grit blast
with no additional
surface coating | Porous-coating | Porous-coating |
| | Sterilization | | | |
| Sterile Method | Gamma
irradiation | Gamma irradiation | Gamma irradiation | Gamma irradiation |
| Shelf-Life | 10 years | 5 years | 5 years | 10 years |
| | PERFORMANCE DATA | | | |
DePuy Ireland UC
7
| SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION
| OF SUBSTANTIAL EQUIVALENCE |
|---|
| The following tests were performed on the GLOBAL ICON Stemless Shoulder System to |
| demonstrate 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 OF |
| SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION |
| Included in this submission are interim 24-month data on 128 subjects. The primary |
| endpoint 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 the |
| criteria is met at the 24-month follow-up visit: |
| Radiographs indicate there is no continuous radiolucent line around the |
| GLOBAL 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 any |
| reason. 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