(151 days)
Not Found
No
The summary describes a system of shoulder implants and their indications for use and fixation methods. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML. The performance studies focus on material compatibility and physical properties.
Yes
The device is indicated for shoulder replacement for conditions like severe pain, disability from arthritis, and fractures, all of which are medical conditions that this device is intended to treat.
No
This device is a total or hemi-shoulder replacement system, which is a prosthetic device used for surgical treatment, not for diagnosing conditions.
No
The device description explicitly states it is comprised of physical components (humeral stems, humeral heads, and glenoids) intended for surgical implantation. This is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a shoulder replacement system used in surgical procedures to treat various conditions affecting the shoulder joint (osteoarthritis, rheumatoid arthritis, fractures, etc.). This is a therapeutic device implanted in the body.
- Device Description: The description confirms the device is comprised of components for hemi- and/or total-shoulder arthroplasty and reverse shoulder arthroplasty. These are all surgical implants.
- Lack of IVD Characteristics: An In Vitro Diagnostic device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The provided text does not mention any such use or interaction with bodily specimens outside the body.
- Anatomical Site: The device is used on the Shoulder, which is an anatomical site for surgical intervention, not for in vitro testing.
Therefore, the DePuy GLOBAL ADVANTAGE Shoulder Systems and related components are medical devices for surgical implantation, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The DePuy GLOBAL ADVANTAGE Shoulder Systems is indicated for use in total or hemi-shoulder replacement for the treatment of:
-
- A severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis;
-
- Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory;
-
- Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component).
The DePuy GLOBAL ADVANTAGE Shoulder System is also indicated for hemi-shoulder replacement for the treatment of:
-
- Ununited humeral head fractures;
-
- Avascular necrosis of the humeral head.
The DePuy GLOBAL ADVANTAGE CTA Humeral Heads are indicated only for hemi-shoulder replacement in patients with rotator cuff tears.
The DePuy GLOBAL ADVANTAGE CTA Humeral Heads can be used with the GLOBAL FX and GLOBAL ADVANTAGE Humeral Stems in hemi-shoulder replacement in patients with rotator cuff tears.
The DePuy GLOBAL ADVANTAGE Systems are indicated for the following fixation methods:
- POROCOAT™ Porous-Coated Components - Porocoat porous-coated humeral stem prostheses are indicated for cemented or uncemented use with fixation provided by biological tissue ingrowth into the porous coating.
- Cemented Components - Humeral Stem and Glenoid components labeled "For cemented use only" are indicated only for use with bone cement.
- Press-fit or Cemented Components - Humeral stem prostheses without porous coating and labeled "For press-fit or cemented use only" are indicated for press-fit uncemented use or for use with bone cement.
The DePuy GLOBAL FX Shoulder System is indicated only for hemi-shoulder replacement for the treatment of:
-
- A severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis;
-
- Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory;
-
- Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component);
-
- Ununited humeral head fractures;
-
- Avascular necrosis of the humeral head.
The DePuy GLOBAL FX Shoulder System is indicated for the following fixation methods:
- POROCOAT™ Porous-Coated Components Porocat porous-coated humeral stem prostheses are indicated for cemented or uncemented use with fixation provided by biological tissue ingrowth into the porous coating.
- Cemented Components Humeral Stem and Glenoid components labeled "For cemented use only" are indicated only for use with bone cement.
- Press-fit or Cemented Components Humeral stem prostheses without porous coating and labeled "For press-fit or cemented use only" are indicated for press-fit uncemented use or for use with bone cement.
The DePuy GLOBAL™ CAP Resurfacing Shoulder Humeral Heads are intended as a total or hemi-shoulder replacement in patients where the humeral head and neck are of sufficient bone stock cuff is intact or reconstructable. This device is designed to increase shoulder mobility by: reducing alignment; restoring flexion and extension movement: and resisting dislocation.
The DePuy GLOBAL™ CAP Resurfacing Shoulder Humeral Heads are indicated for use as a replacement of shoulder joints disabled by rheumatoid arthritis with pain, non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis), deformity and/or limited motion, fractures of the humeral head and traumatic arthritis.
The DePuy GLOBAL™ CAP Resurfacing Shoulder Humeral Heads are intended for uncemented use only.
The DePuy GLOBAL ™ CAP CTA Resurfacing Shoulder is indicated only for hemi-shoulder replacement in patients with rotator cuff tears and arthritis. Specific indications include:
- Rotator cuff tear arthropathy.
- Difficult clinical management problems where other methods of treatment may not be inadequate.
The DePuy GLOBAL ™CAP CTA Resurfacing Shoulder Humeral Heads are intended for uncemented use only.
The Glenoid is intended for use in total shoulder replacement surgery for patients suffering from:
-
- A severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis
-
- Fracture-dislocations of the proximal humerus where the articular surface is severely communited, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory.
-
- Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g revision of a failed primary component).
Glenoid components are intended for cemented use only.
The DePuy GLOBAL AP Shoulder System is indicated for use in total or hemi-shoulder replacement for the treatment of:
-
- A severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis;
-
- Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory;
-
- Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component).
The DePuy GLOBAL AP Shoulder Systems is also indicated for hemi-shoulder replacement for the treatment of:
-
- Ununited humeral head fractures;
-
- Avascular necrosis of the humeral head.
The DePuy GLOBAL AP CTA Humeral Heads are indicated only for hemi-shoulder replacement in patients with rotator cuff tears.
The GLOBAL AP CTA Humeral Head can be used with the GLOBAL AP Humeral Stem in hemi-shoulder replacement in patients with rotator cuff tears.
The DePuy GLOBAL AP Shoulder Systems are indicated for the following fixation methods:
- POROCOAT™ Porous-Coated Components - Porocoat porous-coated humeral stem prostheses are indicated for cemented or uncemented use with fixation provided by biological tissue ingrowth into the porous coating.
- Cemented Components - Humeral Stem and Glenoid components labeled "For cemented use only" are indicated only for use with bone cement.
- Press-fit or Cemented Components - Humeral stem prostheses without porous coating and labeled "For press-fit or cemented use only" are indicated for press-fit uncemented use or for use with bone cement.
The StepTech Anchor Peg Glenoid is intended for use in total shoulder replacement surgery for patients suffering from:
-
- A severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis
-
- Fracture-dislocations of the proximal humerus where the articular surface is severely communited, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory.
-
- Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component).
Glenoid components are intended for cemented use only.
The Glenoid is intended for use in total shoulder replacement surgery for patients suffering from:
- A severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis
- Fracture-dislocations of the proximal humerus where the articular surfaces are severely communited, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory.
- Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component).
Glenoid components are intended for cemented use only.
The DELTA CTA™ Reverse Shoulder Prosthesis is indicated for use in:
-
- Grossly rotator cuff deficient joint with severe arthropathy or a previous failed joint replacement with a grossly rotator cuff deficient joint.
-
- The DELTA CTA™ hemi-shoulder replacement is also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively or for revision surgery in cases with insufficient glenoid bone stock.
-
- The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional Deltoid muscle is necessary to use the device.
For US use only: All components are intended for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
KWS, KWT, HSD, MBF, PHX
Device Description
The Global Shoulder System is comprised of multiple brands (Global Advantage, Global FX, Global AP, Global CAP, Global APG and Global Steptech), each comprised of different components (humeral stems, humeral heads and glenoids) intended for hemi-and/or total-shoulder arthroplasty.
The DELTA CTA System is comprised of components intended for reverse shoulder arthroplasty.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder
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 testing was conducted with the following standards:
• ASTM F2213 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
• ASTM F2052 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
• ASTM F2119 Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
• ASTM F2182 Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging
Results demonstrated compatibility conditions of the subject devices in the MR environment.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K984541, K992065, K000575, K011047, K011099, K033516, K080990, K981487, K052472, K060874, K063652, K082715, K092122, K914000, K905786, K021478, K050315, K062116, K122442
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
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
April 2, 2021
DePuy Inc. Megan Bernier Regulatory Affairs Specialist 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
Re: K203230
Trade/Device Name: Global Shoulder and Delta CTA systems Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS, KWT, HSD, MBF, PHX Dated: February 19, 2021 Received: February 22, 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 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 requirements,
1
including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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-devices/medical-device-safety/medical-device-reporting-mdr-howreport-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) CDRH and 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 DICE (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatorythe website assistance/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 Michael Owens Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known) K203230
Device Name
Trade Name: GLOBAL ADVANTAGE
Indications for Use (Describe) The DePuy GLOBAL ADVANTAGE Shoulder Systems
The DePuy GLOBAL ADVANTAGE Shoulder Systems is indicated for use in total or hemi-shoulder replacement for the treatment of:
-
- A severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis;
-
- Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory;
-
- Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component).
The DePuy GLOBAL ADVANTAGE Shoulder System is also indicated for hemi-shoulder replacement for the treatment of:
- Ununited humeral head fractures;
-
- Avascular necrosis of the humeral head.
GLOBAL ADVANTAGE CTA Humeral Heads
- Avascular necrosis of the humeral head.
The DePuy GLOBAL ADVANTAGE CTA Humeral Heads are indicated only for hemi-shoulder replacement in patients with rotator cuff tears.
The DePuy GLOBAL ADVANTAGE CTA Humeral Heads can be used with the GLOBAL FX and GLOBAL ADVANTAGE Humeral Stems in hemi-shoulder replacement in patients with rotator cuff tears.
GLOBAL ADVANTAGE Shoulder Systems Fixation Methods
The DePuy GLOBAL ADVANTAGE Systems are indicated for the following fixation methods:
POROCOAT™ Porous-Coated Components - Porocoat porous-coated humeral stem prostheses are indicated for
cemented or uncemented use with fixation provided by biological tissue ingrowth into the porous coating.
Cemented Components - Humeral Stem and Glenoid components labeled "For cemented use only" are indicated only for use with bone cement.
Press-fit or Cemented Components - Humeral stem prostheses without porous coating and labeled "For press-fit or cemented use only" are indicated for press-fit uncemented use or 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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
4
510(k) Number (if known)
K203230
Device Name Trade Name: GLOBAL FX
Indications for Use (Describe)
The DePuy GLOBAL FX Shoulder System is indicated only for hemi-shoulder replacement for the treatment of:
-
- A severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis;
-
- Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory;
-
- Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component);
-
- Ununited humeral head fractures;
-
- Avascular necrosis of the humeral head.
GLOBAL FX Shoulder Systems Fixation Methods
- The DePuy GLOBAL FX Shoulder System is indicated for the following fixation methods:
- · POROCOAT™ Porous-Coated Components Porocat porous-coated humeral stem prostheses are indicated for cemented or uncemented use with fixation provided by biological tissue ingrowth into the porous coating.
- · Cemented Components Humeral Stem and Glenoid components labeled "For cemented use only" are indicated only for use with bone cement.
- · Press-fit or Cemented Components Humeral stem prostheses without porous coating and labeled "For press-fit or cemented use only" are indicated for press-fit uncemented use or for use with bone cement.
Type of Use (Select one or both, as applicable)
| ☑ Remediation Use (Part 61 CFR 331 Subpart D) | ☐ On-Site Corrective Use (61 CFR 331 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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
5
510(k) Number (if known) K203230
Device Name Trade Name: GLOBAL™ CAP
Indications for Use (Describe) GLOBAL™ CAP
The DePuy GLOBAL™ CAP Resurfacing Shoulder Humeral Heads are intended as a total or hemi-shoulder replacement in patients where the humeral head and neck are of sufficient bone stock cuff is intact or reconstructable. This device is designed to increase shoulder mobility by: reducing alignment; restoring flexion and extension movement: and resisting dislocation.
The DePuy GLOBAL™ CAP Resurfacing Shoulder Humeral Heads are indicated for use as a replacement of shoulder joints disabled by rheumatoid arthritis with pain, non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis), deformity and/or limited motion, fractures of the humeral head and traumatic arthritis.
The DePuy GLOBAL™ CAP Resurfacing Shoulder Humeral Heads are intended for uncemented use only.
GLOBAL™ CAP CTA™
The DePuy GLOBAL ™ CAP CTA Resurfacing Shoulder is indicated only for hemi-shoulder replacement in patients with rotator cuff tears and arthritis. Specific indications include:
-
Rotator cuff tear arthropathy.
-
Difficult clinical management problems where other methods of treatment may not be inadequate.
The DePuy GLOBAL ™CAP CTA Resurfacing Shoulder Humeral Heads are intended for uncemented use only.
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.
6
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
7
510(k) Number (if known)
Device Name Trade Name: Global APG
Indications for Use (Describe)
The Glenoid is intended for use in total shoulder replacement surgery for patients suffering from:
-
- A severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis
-
- Fracture-dislocations of the proximal humerus where the articular surface is severely communited, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory.
-
- Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g revision of a failed primary component).
Glenoid components are intended for cemented use only.
Type of Use (Select one or both, as applicable)
| 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
8
510(k) Number (if known) K203230
Device Name
Trade Name: GLOBAL AP Shoulder System
Indications for Use (Describe) The DePuy GLOBAL AP Shoulder System
The DePuy GLOBAL AP Shoulder System is indicated for use in total or hemi-shoulder replacement for the treatment of:
-
- A severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis;
-
- Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its
- blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory;
-
- Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component).
The DePuy GLOBAL AP Shoulder Systems is also indicated for hemi-shoulder replacement for the treatment of:
-
- Ununited humeral head fractures;
-
- Avascular necrosis of the humeral head.
GLOBAL AP™ CTA Humeral Heads
| The DePuy GLOBAL AP CTA Humeral Heads are indicated only for hemi-shoulder replacement in patients with rotator |
|---|
| cuff tears. |
The GLOBAL AP CTA Humeral Head can be used with the GLOBAL AP Humeral Stem in hemi-shoulder replacement in patients with rotator cuff tears.
GLOBAL APTM Shoulder Systems Fixation Methods.
The DePuy GLOBAL AP Shoulder Systems are indicated for the following fixation methods:
POROCOAT™ Porous-Coated Components - Porocoat porous-coated humeral stem prostheses are indicated for cemented or uncemented use with fixation provided by biological tissue ingrowth into the porous coating. Cemented Components - Humeral Stem and Glenoid components labeled "For cemented use only" are indicated only for use with bone cement.
Press-fit or Cemented Components - Humeral stem prostheses without porous coating and labeled "For press-fit or cemented use only" are indicated for press-fit uncemented use or 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
9
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
10
510(k) Number (if known) K203230
Device Name
Trade Name: Global StepTech
Indications for Use (Describe)
The StepTech Anchor Peg Glenoid is intended for use in total shoulder replacement surgery for patients suffering from:
-
- A severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis
-
- Fracture-dislocations of the proximal humerus where the articular surface is severely communited, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory.
-
- Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component).
Glenoid components are intended for cemented use only.
| 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
11
510(k) Number (if known) K203230
Device Name Trade Name: Global Shoulder
Indications for Use (Describe)
The Glenoid is intended for use in total shoulder replacement surgery for patients suffering from:
-
A severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis
-
Fracture-dislocations of the proximal humerus where the articular surfaces are severely communited, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory.
-
Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component).
Glenoid components are intended for cemented use only.
| 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
12
510(k) Number (if known) K203230
Device Name Trade Name: DELTA CTA™
Indications for Use (Describe)
The DELTA CTA™ Reverse Shoulder Prosthesis is indicated for use in:
-
- Grossly rotator cuff deficient joint with severe arthropathy or a previous failed joint replacement with a grossly rotator cuff deficient joint.
-
- The DELTA CTA™ hemi-shoulder replacement is also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively or for revision surgery in cases with insufficient glenoid bone stock.
-
- The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional Deltoid muscle is necessary to use the device.
For US use only: All components are intended for cemented use only
| 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
13
Traditional 510(k) Notification Global Shoulder and Delta CTA MRI
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92.
I. SUBMITTER
DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
| Contact Person: | Megan Bernier |
|---|---|
| Email: | mberniel@its.jnj.com |
| Phone/Fax: | (651) 325-1178 ; FAX (612) 435-2377 |
| Mobile: | (651) 325-1178 |
| Date Prepared: | |
| Prepared By: | March 30, 2021 |
| Megan Bernier | |
| Trade/Device Name: | Global Shoulder and |
| Delta CTA systems | |
| Regulation Name: | Shoulder Joint |
| Metal/Polymer | |
| Semi-Constrained | |
| Cemented Prosthesis | |
| Product Codes: | KWS:888.3660 |
| KWT:888.3650 | |
| HSD:888.3690 | |
| MBF:888.3670 | |
| PHX:888.3660 |
14
Traditional 510(k) Notification Global Shoulder and Delta CTA MRI
II. DEVICE
Table 5- 1 Global Shoulder - GLOBAL ADVANTAGE
| Trade Name: GLOBAL ADVANTAGE | ||||
|---|---|---|---|---|
| Device Name: | GlobalTM | |||
| Shoulder | ||||
| -GlobalTM Fx | ||||
| Humeral Stem | ||||
| -+GlobalTM | ||||
| Advantage® | ||||
| Humeral Head | Global | |||
| Advantage | ||||
| Shoulder, | ||||
| Global | ||||
| Advantage | ||||
| Humeral Stem, | ||||
| Global | ||||
| Advantage | ||||
| Eccentric Head | Global Advantage | |||
| Extended Humeral | ||||
| Head | Global Advantage Humeral | |||
| Stem with Porocoat | ||||
| Common Name: | Shoulder | |||
| prosthesis, | ||||
| humeral head | Shoulder | |||
| prosthesis, | ||||
| humeral head | Prosthesis, Shoulder, | |||
| Humeral Head | Prosthesis, Shoulder, | |||
| Humeral Head | ||||
| Classification | ||||
| Name: | Prosthesis, | |||
| Shoulder, Semi- | ||||
| Constrained, | ||||
| Metal/Polymer | ||||
| Cemented | Prosthesis, | |||
| Shoulder, | ||||
| Semi- | ||||
| Constrained, | ||||
| Metal/Polymer | ||||
| Cemented | Prosthesis, Shoulder, | |||
| Hemi-, Humeral, | ||||
| Metallic Uncemented | Prosthesis, Shoulder, Semi- | |||
| Constrained, | ||||
| Metal/Polymer, | ||||
| Uncemented | ||||
| Product Code: | KWT | KWS | HSD | MBF |
| Regulatory Class: | Class II | Class II | Class II | Class II |
| Regulation Number: | 888.3670 | 888.3660 | 888.3690 | 888.3670 |
| 510 (k) Review | ||||
| Panel: | Orthopedic | Orthopedic | Orthopedic | Orthopedic |
Table 5- 2 Global Shoulder - GLOBAL FX
| Trade Name: Global FX | |||
|---|---|---|---|
| Device Name: | Global FX Porous-coated | ||
| humeral STEM | Global FX Porous-coated | ||
| humeral STEM | |||
| Common Name: | Shoulder prosthesis, humeral | ||
| head | Shoulder prosthesis, humeral | ||
| head | |||
| Classification Name: | Prosthesis, Shoulder, Semi- | ||
| Constrained, Metal/Polymer | |||
| Cemented | Prosthesis, Shoulder, Hemi-, | ||
| Humeral, Metallic | |||
| Uncemented | |||
| Product Code: | KWT | MBF | |
| Regulatory Class: | Class II | Class II | |
| Regulation Number: | 888.3670 | 888.3670 | |
| 510 (k) Review | |||
| Panel: | Orthopedic | Orthopedic |
15
| Trade Name: Global CAP | ||
|---|---|---|
| Device Name: | DePuy Global CAP™ HA | |
| Resurfacing Shoulder | ||
| Humeral | DePuy Global CAP CTA | |
| Resurfacing Shoulder | ||
| Common Name: | Prosthesis, Shoulder, | |
| Humeral Head | Prosthesis, Shoulder, | |
| Humeral Head | ||
| Classification | ||
| Name: | Prosthesis, Shoulder, Hemi-, | |
| Humeral, Metallic | ||
| Uncemented | Prosthesis, Shoulder, | |
| Hemi-, Humeral, Metallic | ||
| Uncemented | ||
| Product Code: | HSD | HSD |
| Regulatory Class: | Class II | Class II |
| Regulation Number: | 888.3690 | 888.3690 |
| 510 (k) Review | ||
| Panel: | Orthopedic | Orthopedic |
Table 5- 3 Global Shoulder - GLOBAL™ CAP
Table 5- 4 Global Shoulder - Global APG
| Trade Name: Global APG | ||
|---|---|---|
| Device Name: | DePuy Global Shoulder Glenoid | DePuy Global Shoulder Crosslink |
| Glenoid DePuy Orthopaedica. Inc. | ||
| Common Name: | Shoulder Prosthesis | Shoulder Prosthesis |
| Classification Name: | Prosthesis, Shoulder, Semi- | |
| Constrained, Metal/Polymer | ||
| Cemented | Prosthesis, Shoulder, Semi- | |
| Constrained, Metal/Polymer | ||
| Cemented | ||
| Product Code: | KWS | KWS |
| Regulatory Class: | Class II | Class II |
| Regulation Number: | 888.3660 | 888.3660 |
| 510 (k) Review | ||
| Panel: | Orthopedic | Orthopedic |
Table 5- 5 Global Shoulder - GLOBAL AP
| Trade Name: Global AP | |||
|---|---|---|---|
| Device Name: | DePuy Global APTM | ||
| Shoulder System | Global AP Porous Coated Humeral | ||
| Steme | DePuy Global AP CTA | ||
| Humeral Head | |||
| Common Name: | Shoulder Prosthesis | Shoulder Prosthesis | Prosthesis, Shoulder, |
| Humeral Head | |||
| Classification Name: | Prosthesis, Shoulder, | ||
| Semi-Constrained, | |||
| Metal/Polymer | |||
| Cemented | Prosthesis, Shoulder, Semi- | ||
| Constrained, Metal/Polymer | |||
| Cemented | Prosthesis, Shoulder, | ||
| Hemi-, Humeral, | |||
| Metallic Uncemented | |||
| Product Code: | KWS | KWS | HSD |
| Regulatory Class: | Class II | Class II | Class II |
| Regulation Number: | 888.3660 | 888.3660 | 888.3690 |
| 510 (k) Review | |||
| Panel: | Orthopedic | Orthopedic | Orthopedic |
16
Traditional 510(k) Notification Global Shoulder and Delta CTA MRI
| Trade Name: GLOBAL® STEPTECH® | |
|---|---|
| Device Name: | Global Shoulder StepTech Anchor Peg Glenoid |
| Common Name: | Shoulder Prosthesis |
| Classification Name: | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented |
| Product Code: | KWS |
| Regulatory Class: | Class II |
| Regulation Number: | 888.3660 |
| 510(k) Review Panel: | Orthopedic |
Table 5- 6 Global Shoulder – Global StepTech
Table 5- 7 Global Shoulder - Global Shoulder
| Trade Name: GLOBAL® SHOULDER | ||
|---|---|---|
| Device Name: | Device Name Global™ Total | |
| Shoulder W/DuPont Enhanced | ||
| UHMWPE | DePuy Global Shoulder | |
| Crosslink Glenoid | ||
| Common Name: | Shoulder Prosthesis | Shoulder Prosthesis |
| Classification Name: | Prosthesis, Shoulder, Non- | |
| Constrained, Metal/polymer | ||
| Cemented | Prosthesis, Shoulder, | |
| Semi-Constrained, | ||
| Metal/Polymer | ||
| Cemented | ||
| Product Code: | KWT | KWS |
| Regulatory Class: | Class II | Class II |
| Regulation Number: | 888.3650 | 888.3660 |
| 510 (k) Review | ||
| Panel: | Orthopedic | Orthopedic |
17
Traditional 510(k) Notification Global Shoulder and Delta CTA MRI
DePuy Synthes
Table 5- 8 DELTA CTA™
| Trade Name: DELTA CTA | ||||
|---|---|---|---|---|
| Device Name: | Delta Shoulder | Delta Humeral Cups | Delta Reverse Shoulder System | |
| Humeral Head | DePuy CTA Reverse Shoulder System | |||
| Common Name: | Shoulder Prosthesis | Shoulder Prosthesis | Shoulder Prosthesis | Shoulder Prosthesis |
| Classification | ||||
| Name: | Shoulder Prosthesis, Reverse | |||
| Configuration | Shoulder Prosthesis, | |||
| Reverse | ||||
| Configuration | Shoulder Prosthesis, | |||
| Reverse | ||||
| Configuration | Shoulder Prosthesis, | |||
| Reverse | ||||
| Configuration | ||||
| Product Code: | PHX | PHX | PHX | PHX |
| Regulatory Class: | Class II | Class II | Class II | Class II |
| Regulation | ||||
| Number: | 888.3660 | 888.3660 | 888.3660 | 888.3660 |
| 510 (k) Review | ||||
| Panel: | Orthopedic | Orthopedic | Orthopedic | Orthopedic |
III. PREDICATE DEVICE(S)
Table 5- 9 Predicate Devices: Global Shoulder - GLOBAL ADVANTAGE
| Trade Name: GLOBAL ADVANTAGE® | ||||
|---|---|---|---|---|
| K984541 | K992065 | K000575 | K011047 | |
| Device | ||||
| Name: | Global™ Shoulder | |||
| -Global™ Fx | ||||
| Humeral Stem | ||||
| -+Global™ | ||||
| Advantage® | ||||
| Humeral Head | Global | |||
| Advantage | ||||
| Shoulder, Global | ||||
| Advantage | ||||
| Humeral Stem, | ||||
| Global | ||||
| Advantage | ||||
| Eccentric Head | Global Advantage | |||
| Extended Humeral | ||||
| Head | Global | |||
| Advantage | ||||
| Humeral Stem | ||||
| with Porocoat | ||||
| Common | ||||
| Name: | Shoulder | |||
| prosthesis, | ||||
| humeral head | Shoulder | |||
| prosthesis, | ||||
| humeral head | Prosthesis, | |||
| Shoulder, Humeral | ||||
| Head | Prosthesis, | |||
| Shoulder, | ||||
| Humeral Head | ||||
| Classification | ||||
| Name: | Prosthesis, | |||
| Shoulder, Semi- | ||||
| Constrained, | ||||
| Metal/Polymer | ||||
| Cemented | Prosthesis, | |||
| Shoulder, Semi- | ||||
| Constrained, | ||||
| Metal/Polymer | ||||
| Cemented | Prosthesis, | |||
| Shoulder, Hemi, | ||||
| Humeral, Metallic | ||||
| Uncemented | Prosthesis, | |||
| Shoulder, Semi- | ||||
| Constrained, | ||||
| Metal/Polymer, | ||||
| Uncemented | ||||
| Product | ||||
| Code: | KWT | KWS | HSD | MBF |
| Regulatory | ||||
| Class: | Class II | Class II | Class II | Class II |
| Regulation | ||||
| Number: | 888.3670 | 888.3660 | 888.3690 | 888.3670 |
18
| Trade Name: Global FX | |||
|---|---|---|---|
| K984541 | K011099 | ||
| Device Name: | Global FX Porous-coated | ||
| humeral STEM | Global FX Porous-coated | ||
| humeral STEM | |||
| Common Name: | Shoulder prosthesis, humeral | ||
| head | Shoulder prosthesis, humeral | ||
| head | |||
| Classification Name: | Prosthesis, Shoulder, Semi- | ||
| Constrained, Metal/Polymer | |||
| Cemented | Prosthesis, Shoulder, Hemi-, | ||
| Humeral, Metallic | |||
| Uncemented | |||
| Product Code: | KWT | MBF | |
| Regulatory Class: | Class II | Class II | |
| Regulation Number: | 888.3670 | 888.3670 |
Table 5- 10 Predicate Devices: Global Shoulder - GLOBAL FX
Table 5- 11 Predicate Devices: Global Shoulder - GLOBAL™ CAP
| Trade Name: Global CAP | ||
|---|---|---|
| K033516 | K080990 | |
| Device Name: | DePuy Global CAP™ HA | |
| Resurfacing Shoulder | ||
| Humeral | DePuy Global CAP CTA | |
| Resurfacing Shoulder | ||
| Common Name: | Prosthesis, Shoulder, | |
| Humeral Head | Prosthesis, Shoulder, | |
| Humeral Head | ||
| Classification | ||
| Name: | Prosthesis, Shoulder, Hemi-, | |
| Humeral, Metallic | ||
| Uncemented | Prosthesis, Shoulder, | |
| Hemi-, Humeral, Metallic | ||
| Uncemented | ||
| Product Code: | HSD | HSD |
| Regulatory Class: | Class II | Class II |
| Regulation Number: | 888.3690 | 888.3690 |
Table 5- 12 Predicate Devices: Global Shoulder - Global APG
| Trade Name: Global APG | ||
|---|---|---|
| K981487 | K052472 | |
| Device Name: | DePuy Global Shoulder Glenoid | DePuy Global Shoulder |
| Crosslink Glenoid DePuy | ||
| Orthopaedica. Inc. | ||
| Common Name: | Shoulder Prosthesis | Shoulder Prosthesis |
| Classification Name: | Prosthesis, Shoulder, Semi- | |
| Constrained, Metal/Polymer | ||
| Cemented | Prosthesis, Shoulder, Semi- | |
| Constrained, Metal/Polymer | ||
| Cemented | ||
| Product Code: | KWS | KWS |
| Regulatory Class: | Class II | Class II |
| Regulation Number: | 888.3660 | 888.3660 |
19
| Table 5- 13 Predicate Devices: Global Shoulder - GLOBAL AP | |||
|---|---|---|---|
| Trade Name: Global AP | |||
| K060874 | K063652 | K082715 | |
| Device Name: | DePuy Global APTM | ||
| Shoulder System | Global AP Porous Coated Humeral | ||
| Stem | DePuy Global AP CTA | ||
| Humeral Head | |||
| Common Name: | Shoulder Prosthesis | Shoulder Prosthesis | Prosthesis, Shoulder, |
| Humeral Head | |||
| Classification Name: | Prosthesis, Shoulder, | ||
| Semi-Constrained, | |||
| Metal/Polymer | |||
| Cemented | Prosthesis, Shoulder, Semi- | ||
| Constrained, Metal/Polymer | |||
| Cemented | Prosthesis, Shoulder, | ||
| Hemi-, Humeral, | |||
| Metallic Uncemented | |||
| Product Code: | KWS | KWS | HSD |
| Regulatory Class: | Class II | Class II | Class II |
| Regulation Number: | 888.3660 | 888.3660 | 888.3690 |
ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤ CLODAL AD Clobol Ch E
Table 5- 14 Predicate Devices: Global Shoulder – Global StepTech
| Trade Name: GLOBAL® STEPTECH® | |
|---|---|
| K092122 | |
| Device Name: | Global Shoulder StepTech Anchor |
| Peg Glenoid | |
| Common Name: | Shoulder Prosthesis |
| Classification Name: | Prosthesis, Shoulder, Semi- |
| Constrained, Metal/Polymer | |
| Cemented | |
| Product Code: | KWS |
| Regulatory Class: | Class II |
| Regulation Number: | 888.3660 |
| Table 5- 15 Predicate Devices: Global Shoulder - Global Shoulder | |
|---|---|
| ------------------------------------------------------------------ | -- |
| Trade Name: GLOBAL® SHOULDER | ||
|---|---|---|
| K914000; K905786 | K052472 | |
| Device Name: | Device Name Global™ Total | |
| Shoulder W/DuPont Enhanced | ||
| UHMWPE | DePuy Global Shoulder | |
| Crosslink Glenoid | ||
| Common Name: | Shoulder Prosthesis | Shoulder Prosthesis |
| Classification Name: | Prosthesis, Shoulder, Non- | |
| Constrained, Metal/polymer | ||
| Cemented | Prosthesis, Shoulder, | |
| Semi-Constrained, | ||
| Metal/Polymer | ||
| Cemented | ||
| Product Code: | KWT | KWS |
| Regulatory Class: | Class II | Class II |
| Regulation Number: | 888.3650 | 888.3660 |
20
| Trade Name: DELTA CTA; IFU: W90926 and W90916 | ||||
|---|---|---|---|---|
| K021478 | K050315 | K062116 | K122442 | |
| Device Name: | Delta Shoulder | Delta Humeral Cups | Delta Reverse | |
| Shoulder System | ||||
| Humeral Head | DePuy CTA Reverse | |||
| Shoulder System | ||||
| Common Name: | Shoulder Prosthesis | Shoulder Prosthesis | Shoulder Prosthesis | Shoulder Prosthesis |
| Classification | ||||
| Name: | Shoulder Prosthesis, Reverse | |||
| Configuration | Shoulder Prosthesis, | |||
| Reverse | ||||
| Configuration | Shoulder Prosthesis, | |||
| Reverse | ||||
| Configuration | Shoulder Prosthesis, | |||
| Reverse | ||||
| Configuration | ||||
| Product Code: | PHX | PHX | PHX | PHX |
| Regulatory Class: | Class II | Class II | Class II | Class II |
| Regulation | ||||
| Number: | 888.3660 | 888.3660 | 888.3660 | 888.3660 |
Table 5- 16 Predicate Devices: DELTA CTATM
IV. DEVICE DESCRIPTION
The Global Shoulder System is comprised of multiple brands (Global Advantage, Global FX, Global AP, Global CAP, Global APG and Global Steptech), each comprised of different components (humeral stems, humeral heads and glenoids) intended for hemiand/or total-shoulder arthroplasty.
The DELTA CTA System is comprised of components intended for reverse shoulder arthroplasty.
21
Traditional 510(k) Notification
Global Shoulder and Delta CTA MRI
INDICATIONS FOR USE V.
Global Shoulder - GLOBAL ADVANTAGE
The DePuy GLOBAL ADVANTAGE Shoulder Systems
The DePuy GLOBAL ADVANTAGE Shoulder Systems is indicated for use in total or hemi-shoulder replacement for the treatment of:
-
A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis:
-
Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its
blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory;
- Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of
a failed primary component).
The DePuy GLOBAL ADVANTAGE Shoulder System is also indicated for hemishoulder replacement for the treatment of:
-
Ununited humeral head fractures:
-
Avascular necrosis of the humeral head.
GLOBAL ADVANTAGE CTA Humeral Heads
The DePuy GLOBAL ADVANTAGE CTA Humeral Heads are indicated only for hemishoulder replacement in patients with rotator cuff tears.
The DePuy GLOBAL ADVANTAGE CTA Humeral Heads can be used with the GLOBAL FX and GLOBAL ADVANTAGE Humeral Stems in hemi-shoulder replacement in patients with rotator cuff tears.
GLOBAL ADVANTAGE Shoulder Systems Fixation Methods
The DePuy GLOBAL ADVANTAGE Systems are indicated for the following fixation methods:
- POROCOAT™ Porous-Coated Components Porocoat porous-coated humeral . stem prostheses are indicated for cemented or uncemented use with fixation provided by biological tissue ingrowth into the porous coating.
22
- . Cemented Components - Humeral Stem and Glenoid components labeled "For cemented use only" are indicated only for use with bone cement.
- Press-fit or Cemented Components Humeral stem prostheses without porous . coating and labeled "For press-fit or cemented use only" are indicated for press-fit uncemented use or for use with bone cement.
Global Shoulder – GLOBAL FX
The DePuy GLOBAL FX Shoulder System is indicated only for hemi-shoulder replacement for the treatment of:
-
A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis;
-
Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its
blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory;
- Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of
a failed primary component);
-
- Ununited humeral head fractures:
-
- Avascular necrosis of the humeral head.
GLOBAL FX Shoulder Systems Fixation Methods
The DePuy GLOBAL FX Shoulder Systems are indicated for the following fixation methods:
- . POROCOAT™ Porous-Coated Components - Porocoat porous-coated humeral stem prostheses are indicated for cemented or uncemented use with fixation provided by biological tissue ingrowth into the porous coating.
- . Cemented Components - Humeral Stem and Glenoid components labeled "For cemented use only" are indicated only for use with bone cement.
- Press-fit or Cemented Components Humeral stem prostheses without porous . coating and labeled "For press-fit or cemented use only" are indicated for press-fit uncemented use or for use with bone cement.
23
Traditional 510(k) Notification Global Shoulder and Delta CTA MRI
Global Shoulder – GLOBAL™ CAP
GLOBAL™ CAP
The DePuy GLOBAL™ CAP Resurfacing Shoulder Humeral Heads are intended as a total or hemi-shoulder replacement in patients where the humeral head and neck are of sufficient bone stock and the rotator cuff is intact or reconstructable. This device is designed to increase shoulder mobility by: reducing pain; restoring alignment; restoring flexion and extension movement; and resisting dislocation.
The DePuy GLOBAL™ CAP Resurfacing Shoulder Humeral Heads are indicated for use as a replacement of shoulder joints disabled by rheumatoid arthritis with pain, noninflammatory degenerative ioint disease (i.e. osteoarthritis and avascular necrosis). deformity and/or limited motion. fractures of the humeral head and traumatic arthritis.
The DePuy GLOBAL™ CAP Resurfacing Shoulder Humeral Heads are intended for uncemented use only.
GLOBAL™ CAP CTA™
The DePuy GLOBAL™ CAP CTA Resurfacing Shoulder is indicated only for hemishoulder replacement in patients with rotator cuff tears and arthritis. Specific indications include:
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Rotator cuff tear arthropathy.
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Difficult clinical management problems where other methods of treatment may not be suitable or mav be inadequate.
The DePuy GLOBAL™ CAP CTA Resurfacing Shoulder Humeral Heads are intended for uncemented use only.
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Traditional 510(k) Notification Global Shoulder and Delta CTA MRI
Global Shoulder - Global APG
The Glenoid is intended for use in total shoulder replacement surgery for patients suffering from:
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A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis
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Fracture-dislocations of the proximal humerus where the articular surface is severely communited, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory.
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Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g revision of a failed primary component).
Glenoid components are intended for cemented use only.
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Traditional 510(k) Notification
Global Shoulder and Delta CTA MRI
Global Shoulder - GLOBAL AP Shoulder System
The DePuy GLOBAL AP Shoulder System
The DePuy GLOBAL AP Shoulder System is indicated for use in total or hemi-shoulder replacement for the treatment of:
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A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis;
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Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its
blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory:
- Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of
a failed primary component).
The DePuy GLOBAL AP Shoulder Systems is also indicated for hemi-shoulder replacement for the treatment of:
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Ununited humeral head fractures;
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Avascular necrosis of the humeral head.
GLOBAL AP™ CTA Humeral Heads
The DePuy GLOBAL AP CTA Humeral Heads are indicated only for hemi-shoulder replacement in patients with rotator cuff tears.
The GLOBAL AP CTA Humeral Head can be used with the GLOBAL AP Humeral Stem in hemi-shoulder replacement in patients with rotator cuff tears.
GLOBAL APTM Shoulder Systems Fixation Methods.
The DePuy GLOBAL AP Shoulder Systems are indicated for the following fixation methods:
- POROCOAT™ Porous-Coated Components Porocoat porous-coated humeral . stem prostheses are indicated for cemented or uncemented use with fixation provided by biological tissue ingrowth into the porous coating.
- . Cemented Components - Humeral Stem and Glenoid components labeled "For cemented use only" are indicated only for use with bone cement.
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- . Press-fit or Cemented Components - Humeral stem prostheses without porous coating and labeled "For press-fit or cemented use only" are indicated for press-fit uncemented use or for use with bone cement.
Global Shoulder - Global StepTech
The StepTech Anchor Peg Glenoid is intended for use in total shoulder replacement surgery for patients suffering from:
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A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis
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Fracture-dislocations of the proximal humerus where the articular surface is severely communited, separated from its
blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory.
- Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g revision of a failed primary component).
Glenoid components are intended for cemented use only.
Global Shoulder – Global Shoulder
The Glenoid is intended for use in total shoulder replacement surgery for patients suffering from:
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A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis
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Fracture-dislocations of the proximal humerus where the articular surfaces are severely communited, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory.
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Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component).
Glenoid components are intended for cemented use only.
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Global Shoulder - DELTA CTATM
The DELTA CTA™ Reverse Shoulder Prosthesis is indicated for use in:
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Grossly rotator cuff deficient joint with severe arthropathy or a previous failed joint replacement with a grossly rotator cuff deficient joint.
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The DELTA CTA™ hemi-shoulder replacement is also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively or for revision surgery in cases with insufficient glenoid bone stock.
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The Patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional Deltoid muscle is necessarv to use the device.
For US use only: All components are intended for cemented use only.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The subject devices maintain the design characteristics of the predicate devices. Intended use of the subject devices remains the same as the predicate devices. The subject devices are provided with additional labeling language regarding magnetic resonance (MR) compatibility when compared to the predicate devices.
VII. MATERIALS
The subject device materials remain identical to the predicate device materials.
VIII. PERFORMANCE DATA
Non-clinical testing was conducted with the following standards:
• ASTM F2213 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment • ASTM F2052 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment • ASTM F2119 Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants • ASTM F2182 Standard Test Method for Measurement of Radio Frequency
Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging
Results demonstrated compatibility conditions of the subject devices in the MR environment.
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IX. CONCLUSION
Evaluation of subject device intended use and technological characteristics demonstrates substantial equivalence with the predicate devices. Performance data supports the addition of magnetic resonance compatibility information to subject device labeling.