(20 days)
Not Found
No
The document describes a shoulder implant system and its intended use, focusing on mechanical and material properties. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is a system for shoulder arthroplasty, which is a surgical procedure to replace parts of the shoulder joint, aiming to alleviate pain and restore function in various pathological conditions like severe arthritis, fractures, and avascular necrosis. These actions directly address and attempt to improve an impaired health condition, fitting the definition of a therapeutic device.
No
The device description indicates it is a "Shoulder System" comprised of "humeral stem, humeral head, suture collar and epiphyseal (anatomical or reverse) components," which are components for shoulder arthroplasty (joint replacement surgery), not for diagnosis.
No
The device description and intended use clearly describe a system of physical implants (humeral stem, humeral head, suture collar, epiphyseal components) used in shoulder arthroplasty. There is no mention of software as the primary or sole component of the device.
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 system for shoulder arthroplasty (joint replacement). This is a medical device used in vivo (within the body) for treatment.
- Device Description: The description details components of a surgical implant (humeral stem, humeral head, etc.).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used to perform tests outside the body on biological samples. This device is a surgical implant used inside the body.
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
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 Stem is designed to conserve geometry and design features of the predicate Global Unite standard stem while eliminating the tapered distal stem body.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, 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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
September 15, 2021
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration. The Department of Health & Human Services logo is on the left and features a stylized image of a human figure. The FDA logo is on the right and features the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
DePuy Ireland UC % Yayoi Fujimaki Regulatory Project Manager DePuy Mitek, Inc. 325 Paramount Drive Raynham, Massachusetts 02767
Re: K212710
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: August 25, 2021 Received: August 26, 2021
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)
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 - K212710
As required by 21 CFR 807.92 and 21 CFR 807.93
| 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 | August 25, 2021 | |
| 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 | |
| short stem (DePuy Ireland: K202098) | ||
| Additional predicate: GLOBAL UNITE Platform Shoulder System | ||
| standard stem (DePuy Ireland: K101996, K170748) | ||
| 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 | ||
| Stem is designed to conserve geometry and design features of the | ||
| predicate Global Unite standard stem while eliminating the tapered | ||
| distal 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 metaglene |
| implants are intended for uncemented use only with additional screw |
| fixation. The HA-coated DELTA XTEND Humeral Implants are |
6
7
| intended for uncemented use only. Porous-coated epiphyses are | |||
|---|---|---|---|
| intended for cemented or uncemented use. GLOBAL UNITE Short | |||
| Humeral Stem Implants are for uncemented use only. | |||
| Summary of the Technological Characteristics of the Device Compared to the Predicate Devices | |||
| Device | Subject Device: | ||
| Global Unite Short Stem | Primary Predicate Device: | ||
| Global Unite Short Stem | Additional Predicate | ||
| Device: | |||
| Global Unite Standard | |||
| Stem | |||
| 510(k)# | This submission | K202098 (DePuy) | K101996, K170748 (DePuy) |
| 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 | Cementless | Cemented or cementless |
| Stem Material | |||
| Body | Titanium alloy | Titanium alloy | Titanium alloy |
| Coating | POROCOAT® porous | ||
| coating | POROCOAT® porous | ||
| coating | POROCOAT® porous | ||
| coating | |||
| Stem Design | |||
| Diameter Size | 8mm | 10 to 16mm | 6 to 16mm |
| Length | 44mm | 44 to 61mm | 83 to 138mm |
| 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 |