(119 days)
DELIVERY, KWS, HSD
No
The document describes a shoulder implant system and its intended use, focusing on mechanical and material properties. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities.
Yes
The device is a shoulder implant system intended to treat conditions like osteoarthritis, rheumatoid arthritis, and fractures, which are therapeutic interventions to alleviate pain and restore function.
No
This device is a shoulder arthroplasty system, intended for surgical implantation to treat severe shoulder joint issues, not to diagnose a condition.
No
The device description clearly states it is comprised of physical components (humeral stem, humeral head, suture collar, epiphyseal components) and the intended use describes surgical procedures involving these implants. There is no mention of software as the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for treating various conditions of the shoulder joint (osteoarthritis, rheumatoid arthritis, fractures, avascular necrosis, failed joint replacements). This is a therapeutic device, not a diagnostic one.
- Device Description: The device is described as a system of components (humeral stem, humeral head, suture collar, epiphyseal components) designed to replace or augment parts of the shoulder joint. This aligns with a surgical implant.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples (blood, tissue, etc.) or to provide information for diagnosing a disease or condition.
- Performance Studies: The performance studies focus on biocompatibility, mechanical properties (fatigue strength, torque testing), and MRI compatibility, which are relevant for surgical implants. There are no studies related to diagnostic accuracy (sensitivity, specificity, etc.).
Therefore, the GLOBAL UNITE Platform Shoulder System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Section 1: Applicable for the GLOBAL UNITE™ Platform Shoulder System with GLOBAL UNITE™ Standard or Revision/Long Humeral Stem Implants
The GLOBAL UNITE Platform Shoulder System is intended for cemented total or hemi-shoulder arthroplasty in treatment of the following:
- · A severely painful and/or disabled ioint resulting from osteoarthritis or rheumatoid arthritis
- · Fracture 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
- · Irreducible 3- and 4-part fractures of the proximal humerus
- · Ununited humeral head fractures
- Avascular necrosis of the humeral head
- · Other difficult clinical problems where shoulder arthrodesis or not acceptable (e.g., revision of a failed primary component)
- Hemi-shoulder arthroplasty is also indicated for:
- Deformity and/or limited motion
The GLOBAL UNITE™ Reverse Fracture Epiphyseal Component, in conjunction with components from the existing DELTA XTEND™ Reverse Shoulder System and GLOBAL UNITE Platform Shoulder System, is indicated for use in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy failed joint replacement with a gross rotator cuff deficiency. The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. It is intended for cemented reverse shoulder arthroplasty in treatment of the following:
· Fracture 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
- · Irreducible 3- and 4-part fractures of the proximal humerus
· Ununited humeral head fractures
The GLOBAL UNITE Reverse Fracture Epiphyseal Component is only intended for use in the treatment of proximal humeral fractures. Bone preparation instrumentation has not been developed to accommodate its use in a non-fracture press-fit application.
GLOBAL UNITE Humeral Stems, in conjunction with existing DELTA XTEND Epiphyseal Components, are indicated for use in reverse shoulder arthroplasty in treatment of a grossly deficient rotator cuff joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. When used in a total shoulder arthroplasty, the GLOBAL UNITE™ Implants are to be used with DePuy glenoid components. The glenoid components are for cemented use only. GLOBAL UNITE Humeral Implants are for cemented or uncemented use.
When used in a reverse shoulder arthroplasty, the GLOBAL UNITE and DELTA XTEND™ Humeral Implants are to be used with the HA-coated DELTA XTEND Metaglene Devices. The metaglene implants are intended for uncemented use only with additional screw fixation. The HA-coated DELTA XTEND Humeral Implants are intended for uncemented use only. Porous-coated epiphyses are intended for cemented or uncemented use. GLOBAL UNITE Humeral Implants are for cemented or uncemented use.
Section 2: Applicable for the GLOBAL UNITE™ Platform Shoulder System with GLOBAL UNITE™ Short Humeral Stem Implants
GLOBAL UNITE Short Humeral Stem Implants are for uncemented use only. The GLOBAL UNITE Platform Shoulder System with Short Humeral Stem is intended for uncemented total or hemi-shoulder arthroplasty in treatment of the following:
- · A severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis
- · Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component)
- Hemi-shoulder arthroplasty is also indicated for:
- Deformity and/or limited motion
GLOBAL UNITE Short Humeral Stems, in conjunction with existing DELTA XTEND Epiphyseal Components, are indicated for use in reverse shoulder arthroplasty in treatment of a grossly deficient rotator cuff joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff joint. 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.
When used in a total shoulder arthroplasty, the GLOBAL UNITE Implants are to be used with DePuy glenoid components. The glenoid components are for cemented use only.
When used in a reverse shoulder arthroplasty, the GLOBAL UNITE and DELTA XTEND Humeral Implants are to be used with the HA-coated DELTA XTEND Metaglene Devices. The metaglene implants are intended for uncemented use only with additional screw fixation. The HA-coated DELTA XTEND Humeral Implants are intended for uncemented use only. Porous-coated epiphyses are intended for cemented use. GLOBAL UNITE Short Humeral Stem Implants are for uncemented use only.
Product codes (comma separated list FDA assigned to the subject device)
PHX, KWS, HSD
Device Description
The Global Unite Platform Shoulder System is comprised of humeral stem, humeral head, suture collar and epiphyseal (anatomical or reverse) components. The subject Global Unite Short Stems are designed to conserve geometry and features of the predicate Global Unite standard stems while removing the distal segment of the stem body.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder joint, proximal humerus, glenohumeral joint
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)
Summary of non-clinical study: Biocompatibility evaluation per ISO10993-1. Dimensional and geometrical equivalency analysis, fatigue strength evaluation, tolerance analysis and torque testing are conducted. MRI compatibility evaluation is conducted for MRI labeling.
Summary of animal study: Animal study was not necessary.
Summary of clinical study: Clinical study was not necessary.
Conclusion: The results of the non-clinical testing and evaluations have demonstrated that the subject device is as safe and effective as the predicate device and therefore, substantially equivalent to the predicate device.
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.
K101996, K133834, K170748, K162024, K172351, K190290
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
November 25, 2020
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 consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
DePuy Ireland UC % Yayoi Fujimaki Regulatory Project Manager DePuy Mitek 325 Paramount Drive Raynham, Massachusetts 02767 USA
Re: K202098
Trade/Device Name: GLOBAL UNITE™ Platform Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, KWS, HSD Dated: July 28, 2020 Received: July 29, 2020
Dear Yayoi Fujimaki:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (QS) 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 medical devices and radiation-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 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
Indications for Use
510(k) Number (if known) K202098
Device Name
GLOBAL UNITE™ Platform Shoulder System
Indications for Use (Describe)
Section 1: Applicable for the GLOBAL UNITE™ Platform Shoulder System with GLOBAL UNITE™ Standard or Revision/Long Humeral Stem Implants
The GLOBAL UNITE Platform Shoulder System is intended for cemented total or hemi-shoulder arthroplasty in treatment of the following:
- · A severely painful and/or disabled ioint resulting from osteoarthritis or rheumatoid arthritis
- · Fracture 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
- · Irreducible 3- and 4-part fractures of the proximal humerus
- · Ununited humeral head fractures
- Avascular necrosis of the humeral head
- · Other difficult clinical problems where shoulder arthrodesis or not acceptable (e.g., revision of a failed primary component)
- Hemi-shoulder arthroplasty is also indicated for:
- Deformity and/or limited motion
The GLOBAL UNITE™ Reverse Fracture Epiphyseal Component, in conjunction with components from the existing DELTA XTEND™ Reverse Shoulder System and GLOBAL UNITE Platform Shoulder System, is indicated for use in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy failed joint replacement with a gross rotator cuff deficiency. The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. It is intended for cemented reverse shoulder arthroplasty in treatment of the following:
· Fracture 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
- · Irreducible 3- and 4-part fractures of the proximal humerus
· Ununited humeral head fractures
The GLOBAL UNITE Reverse Fracture Epiphyseal Component is only intended for use in the treatment of proximal humeral fractures. Bone preparation instrumentation has not been developed to accommodate its use in a non-fracture press-fit application.
GLOBAL UNITE Humeral Stems, in conjunction with existing DELTA XTEND Epiphyseal Components, are indicated for use in reverse shoulder arthroplasty in treatment of a grossly deficient rotator cuff joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. When used in a total shoulder arthroplasty, the GLOBAL UNITE™ Implants are to be used with DePuy glenoid components. The glenoid components are for cemented use only. GLOBAL UNITE Humeral Implants are for cemented or uncemented use.
When used in a reverse shoulder arthroplasty, the GLOBAL UNITE and DELTA XTEND™ Humeral Implants are to be used with the HA-coated DELTA XTEND Metaglene Devices. The metaglene implants are intended for uncemented use only with additional screw fixation. The HA-coated DELTA XTEND Humeral Implants are intended for uncemented use only. Porous-coated epiphyses are intended for cemented or uncemented use. GLOBAL UNITE Humeral Implants are for cemented or uncemented use.
3
Section 2: Applicable for the GLOBAL UNITE™ Platform Shoulder System with GLOBAL UNITE™ Short Humeral Stem Implants
GLOBAL UNITE Short Humeral Stem Implants are for uncemented use only. The GLOBAL UNITE Platform Shoulder System with Short Humeral Stem is intended for uncemented total or hemi-shoulder arthroplasty in treatment of the following:
- · A severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis
- · Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component)
- Hemi-shoulder arthroplasty is also indicated for:
- Deformity and/or limited motion
GLOBAL UNITE Short Humeral Stems, in conjunction with existing DELTA XTEND Epiphyseal Components, are indicated for use in reverse shoulder arthroplasty in treatment of a grossly deficient rotator cuff joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff joint. 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.
When used in a total shoulder arthroplasty, the GLOBAL UNITE Implants are to be used with DePuy glenoid components. The glenoid components are for cemented use only.
When used in a reverse shoulder arthroplasty, the GLOBAL UNITE and DELTA XTEND Humeral Implants are to be used with the HA-coated DELTA XTEND Metaglene Devices. The metaglene implants are intended for uncemented use only with additional screw fixation. The HA-coated DELTA XTEND Humeral Implants are intended for uncemented use only. Porous-coated epiphyses are intended for cemented use. GLOBAL UNITE Short Humeral Stem Implants are 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)
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4
510(k) Summary
| Submission Information | ||
|---|---|---|
| Sponsor Name | DePuy Ireland UC | |
| Sponsor Address | Loughbeg, Ringaskiddy Co. Cork Ireland | |
| Sponsor Establishment | ||
| Registration Number | 3015516266 | |
| 510(k) Contact | Yayoi Fujimaki | |
| DePuy Mitek | ||
| Regulatory Project Manager | Phone: 508.828.3541 | |
| Email: yfujima1@its.jnj.com | ||
| Date prepared | July 28, 2020 | |
| Device Information | ||
| Trade or proprietary name | GLOBAL UNITET™ Platform Shoulder System | |
| Common or usual name | Shoulder Prosthesis | |
| Classification name | Shoulder joint metal/polymer semi-constrained cemented | |
| prosthesis; Shoulder joint humeral (hemi-shoulder) metallic | ||
| uncemented prosthesis | ||
| Class, regulation | Class II, 21CFR 888.3660, 21CFR 888.3690 | |
| Product Code | PHX, KWS, HSD | |
| Classification panel | Orthopedics panel | |
| Legally marketed | ||
| device(s) to which | ||
| equivalence is claimed | Primary Predicate: GLOBAL UNITE Platform Shoulder System | |
| standard stem (DePuy Ireland: K101996, K133834, K170748) | ||
| Secondary Predicate: AltiVate Shoulder System short stem (Encore | ||
| Medical, LP: K162024, K172351, K190290) | ||
| Device description | The Global Unite Platform Shoulder System is comprised of | |
| humeral stem, humeral head, suture collar and epiphyseal | ||
| (anatomical or reverse) components. | ||
| The subject Global Unite Short Stems are designed to conserve | ||
| geometry and features of the predicate Global Unite standard stems | ||
| while removing the distal segment of the stem body. | ||
| Indications for use | Section 1: Applicable for the GLOBAL UNITE Platform Shoulder | |
| System with GLOBAL UNITE Standard or Revision/Long | ||
| Humeral Stem Implants | ||
| The GLOBAL UNITE Platform Shoulder System is intended for | ||
| cemented or uncemented total or hemi-shoulder arthroplasty in | ||
| treatment of the following: | ||
| • A severely painful and/or disabled joint resulting from | ||
| osteoarthritis, traumatic arthritis or rheumatoid arthritis | ||
| • Fracture of the proximal humerus where the articular surface is | ||
| severely comminuted, separated from its blood supply or where the |
5
| surgeon's experience indicates that alternative methods of treatment
| are unsatisfactory |
|---|
| • Irreducible 3- and 4-part fractures of the proximal humerus |
| • Ununited humeral head fractures |
| • Avascular necrosis of the humeral head |
| • Other difficult clinical problems where shoulder arthrodesis or |
| resection arthroplasty are not acceptable (e.g., revision of a failed |
| primary component) |
| Hemi-shoulder arthroplasty is also indicated for: |
| • Deformity and/or limited motion |
| The GLOBAL UNITE Reverse Fracture Epiphyseal Component, in |
| conjunction with components from the existing DELTA XTEND |
| Reverse Shoulder System and GLOBAL UNITE Platform Shoulder |
| System, is indicated for use in a grossly rotator cuff deficient |
| glenohumeral joint with severe arthropathy or a previously failed |
| joint replacement with a gross rotator cuff deficiency. 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. It is intended for cemented or uncemented reverse |
| shoulder arthroplasty in treatment of the following: |
| • Fracture 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 |
| • Irreducible 3- and 4-part fractures of the proximal humerus |
| • Ununited humeral head fractures |
| The GLOBAL UNITE Reverse Fracture Epiphyseal Component is |
| only intended for use in the treatment of proximal humeral |
| fractures. Bone preparation instrumentation has not been developed |
| to accommodate its use in a non-fracture press-fit application. |
| GLOBAL UNITE Humeral Stems, in conjunction with existing |
| DELTA XTEND Epiphyseal Components, are indicated for use in |
| reverse shoulder arthroplasty in treatment of a grossly deficient |
| rotator cuff joint with severe arthropathy or a previously failed joint |
| replacement with a grossly deficient rotator cuff joint. 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. |
| When used in a total shoulder arthroplasty, the GLOBAL UNITE |
| Implants are to be used with DePuy glenoid components The |
| glenoid components are for cemented use only. GLOBAL UNITE |
| Humeral Implants are for cemented or uncemented use. |
| When used in a reverse shoulder arthroplasty, the GLOBAL |
| UNITE and DELTA XTEND Humeral Implants are to be used with |
| the HA-coated DELTA XTEND Metaglene Devices. The |
| metaglene implants are intended for uncemented use only with |
| additional screw fixation. The HA-coated DELTA XTEND |
| Humeral Implants are intended for uncemented use only. Porous- |
| coated epiphyses are intended for cemented or uncemented use. |
| GLOBAL UNITE Humeral Implants are for cemented or |
| uncemented use. |
| Section 2: Applicable for the GLOBAL UNITE Platform Shoulder |
| System with GLOBAL UNITE Short Humeral Implants |
| GLOBAL UNITE Short Humeral Stem Implants are for |
| uncemented use only. |
| The GLOBAL UNITE Platform Shoulder System with Short |
| Humeral Stem is intended for uncemented total or hemi-shoulder |
| arthroplasty in treatment of the following: |
| • A severely painful and/or disabled joint resulting from |
| osteoarthritis, traumatic arthritis or rheumatoid arthritis |
| • Other difficult clinical problems where shoulder arthrodesis or |
| resection arthroplasty are not acceptable (e.g. revision of a failed |
| primary component) |
| Hemi-shoulder arthroplasty is also indicated for: |
| • Deformity and/or limited motion |
| GLOBAL UNITE Short Humeral Stems, in conjunction with |
| existing DELTA XTEND Epiphyseal Components, are indicated |
| for use in reverse shoulder arthroplasty in treatment of a grossly |
| deficient rotator cuff joint with severe arthropathy or a previously |
| failed joint replacement with a grossly deficient rotator cuff joint. |
| 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. |
| When used in a total shoulder arthroplasty, the GLOBAL UNITE |
| Implants are to be used with DePuy glenoid components. The |
| glenoid components are for cemented use only. |
| When used in a reverse shoulder arthroplasty, the GLOBAL |
| UNITE and DELTA XTEND Humeral Implants are to be used with |
| the HA-coated DELTA XTEND Metaglene Devices. The |
6
7
| Summary of the Technological Characteristics of the Device Compared to the Predicate Devices | ||||
|---|---|---|---|---|
| Device | Subject Device: | Predicate Device: | Predicate Device: | |
| Global Unite Short Stem | Global Unite Standard Stem | Altivate Shoulder System | ||
| Short Stem | ||||
| 510(k)# | This submission | |||
| (DePuy) | K101996, K133834, | |||
| K170748 (DePuy) | K162024, K172351, | |||
| K190290 | ||||
| (Encore Medical, LP) | ||||
| Intended Use | Total anatomical, hemi | |||
| and total reverse | ||||
| arthroplasty | Total anatomical, hemi and | |||
| total reverse arthroplasty | Total anatomical, hemi and | |||
| total reverse arthroplasty | ||||
| Cement | Cementless | Cemented or cementless | Cemented or cementless | |
| Stem Material | ||||
| Body | Titanium alloy | Titanium alloy | Titanium alloy | |
| Coating | POROCOAT® porous | |||
| coating | POROCOAT® porous | |||
| coating | Titanium porous coating | |||
| Stem Design | ||||
| Diameter Size | 10 to 16mm | 6 to 16mm | 6 to 18mm, 8 to 18mm | |
| Length | 44 to 61mm | 83 to 138mm | 48mm | |
| Others | ||||
| Sterilization | Gamma sterile, single use | Gamma sterile, single use | Sterile, single use | |
| Testing Data | ||||
| Summary of non-clinical | ||||
| study | Biocompatibility evaluation per ISO10993-1. Dimensional and | |||
| geometrical equivalency analysis, fatigue strength evaluation, | ||||
| tolerance analysis and torque testing are conducted. MRI | ||||
| compatibility evaluation is conducted for MRI labeling. | ||||
| Summary of animal study | Animal study was not necessary. | |||
| Summary of clinical study | Clinical study was not necessary. | |||
| Conclusion | The results of the non-clinical testing and evaluations have | |||
| demonstrated that the subject device is as safe and effective as the | ||||
| predicate device and therefore, substantially equivalent to the | ||||
| predicate device. |