(307 days)
Not Found
No
The document describes a mechanical implant system for shoulder arthroplasty and does not mention any software, algorithms, or AI/ML capabilities. The performance studies are non-clinical mechanical tests.
Yes.
This device is an implantable shoulder system used in total or hemi-shoulder arthroplasty to treat severely painful and/or disabled joints, fractures, avascular necrosis, and other clinical problems, which are therapeutic interventions.
No
The device description indicates it is a shoulder implant system intended for arthroplasty (surgical joint replacement), not for diagnosing medical conditions.
No
The device description clearly states it includes physical components made from titanium alloy (porous-coated reverse fracture epiphyseal bodies) and is 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 a surgical implant for treating various shoulder conditions through arthroplasty (joint replacement). This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is described as a shoulder implant system made of titanium alloy components designed to be surgically implanted.
- Lack of In Vitro Testing: The performance studies listed are non-clinical tests related to the mechanical properties and biocompatibility of the implant, not tests performed on biological samples outside the body to diagnose or monitor a condition.
- No Mention of Biological Samples: There is no mention of the device being used with blood, tissue, or other biological samples.
IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
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 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 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 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 validated 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 reverse 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. GLOBAL UNITE humeral implants are for cemented use. The DELTA XTEND epiphyseal components are HA-coated and are intended for uncemented use.
Product codes (comma separated list FDA assigned to the subject device)
PHX, KWS, HSD
Device Description
The subject device expands the GLOBAL UNITE Platform Shoulder System (K101996, K133834) to include new porous-coated reverse fracture epiphyseal bodies made from titanium alloy that mate with existing GLOBAL UNITE (K101996) or DELTA XTEND (K071379) stems. In fracture cases with a grossly rotator cuff deficient glenohumeral joint with severe arthropathy where a surgeon deems reverse shoulder arthroplasty appropriate, the surgeon can use a GLOBAL UNITE (K101996) or DELTA XTEND (K071379) stem with the GLOBAL UNITE reverse fracture epiphysis and the DELTA XTEND metaglene and glenosphere (K062250).
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
Surgeon
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)
The following tests were performed (per FDA's Guidance for Industry and FDA Staff – Class II Special Controls Guidance: Shoulder Joint Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis) on the GLOBAL UNITE Shoulder System to demonstrate substantial equivalence of safety and efficacy with the predicate device:
- Fatigue Test for fracture stem with fracture epiphysis (at higher assembly torque) .
- Fatigue Test for fracture stem with fracture epiphysis (at lower assembly torque)
- Fretting Corrosion Potential - Comparison to Existing Product
- Epiphysis Comparison
- 135° Neck Shaft Angle Verification
- . 128° and 142° Neck Shaft Angle Verification
- Range of Motion Analysis ●
- . Rationale for 155 Degree Neck-Shaft Angle
- Biocompatibility Study
- . Mating Parts Analysis
- Effect of Screw Retention Insert of the Implant Packaging on Humeral Cup Seating
- Print Review of Product Marking
- Print Review of Suture Features
- . Review of Label Content
- Print Review of Porocoat
- . The proposed devices also meet the requirement of bacterial endotoxin testing as specified in ANSI AAMI ST-72:2011.
No clinical testing was conducted to demonstrate substantial equivalence.
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.
Zimmer Trabecular Metal® Reverse Shoulder System, K052906, Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8mm and 10mm, K060704, DePuy GLOBAL UNITE Shoulder System, K101996, DePuy GLOBAL UNITE Shoulder System, K133834
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 and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 11, 2018
DePuy Ireland UC % Kellie Myers Regulatory Associate DePuy Orthopaedics, Inc. 700 Orthopaedic Dr. Warsaw, Indiana 46582
Re: K170748
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: January 3, 2018 Received: January 4, 2018
Dear Kellie Myers:
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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Katherine D. Kavlock -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K170748
Device Name
GLOBAL UNITE Platform Shoulder System
Indications for Use (Describe)
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 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 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 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 validated 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 reverse 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
3
only. GLOBAL UNITE humeral implants are for cemented use. The DELTA XTEND epiphyseal components are HA-coated and are intended for uncemented use.
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)
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510(K) SUMMARY
(As required by 21 CFR 807.92 and 21 CFR 807.93)
| Submitter Information | |
|---|---|
| Name | DePuy Orthopaedics |
| Address | 700 Orthopedic Drive |
| Warsaw, IN 46582 | |
| Phone number | 574-372-7276 |
| Fax number | 574- 371-4987 |
| Establishment Registration | |
| Number | 1818910 |
| Name of contact person | Kellie Myers |
| Date prepared | 11 January 2018 |
| Name of device | |
| Trade or proprietary name | GLOBAL UNITE Platform Shoulder System |
| Common or usual name | Total, Hemi-, and Reverse Shoulder Arthoplasty Prosthesis |
| Classification name | Shoulder joint metal/polymer semi-constrained cemented prosthesis; |
| Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis | |
| Class | II |
| Classification panel | 87 Orthopedics |
| Regulation | 21 CFR 888.3660; 21 CFR 888.3690 |
| Product Code(s) | PHX; KWS; HSD |
| Legally marketed device(s) to | |
| which equivalence is claimed | Zimmer Trabecular Metal® Reverse Shoulder System, K052906; |
| Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8mm and | |
| 10mm, K060704 | |
| DePuy GLOBAL UNITE Shoulder System, K101996 | |
| DePuy GLOBAL UNITE Shoulder System, K133834 | |
| Reason for 510(k) submission | This 510(k) submission is to add the GLOBAL UNITE Reverse Fracture |
| Epiphysis to the currently cleared GLOBAL UNITE Platform Shoulder | |
| System, as well as to expand the currently cleared Indications for Use for the | |
| entire GLOBAL UNITE Platform Shoulder System. | |
| Device description | The subject device expands the GLOBAL UNITE Platform Shoulder System |
| (K101996, K133834) to include new porous-coated reverse fracture | |
| epiphyseal bodies made from titanium alloy that mate with existing GLOBAL | |
| UNITE (K101996) or DELTA XTEND (K071379) stems. In fracture cases | |
| with a grossly rotator cuff deficient glenohumeral joint with severe arthropathy | |
| where a surgeon deems reverse shoulder arthroplasty appropriate, the surgeon | |
| can use a GLOBAL UNITE (K101996) or DELTA XTEND (K071379) stem | |
| with the GLOBAL UNITE reverse fracture epiphysis and the DELTA XTEND | |
| metaglene and glenosphere (K062250). | |
| Intended use of the device | Cemented or uncemented Total, Hemi-, or Reverse Shoulder Arthroplasty |
| Indications for use | 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 | |
| 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 validated 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 reverse 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. | |
| GLOBAL UNITE humeral implants are for cemented or uncemented | |
| use. The DELTA XTEND epiphyseal components are HA-coated and are | |
| intended for uncemented use. |
5
6
SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE
The subject GLOBAL UNITE Platform Shoulder System is similar to the predicate Zimmer Trabecular Metal Reverse Shoulder System (K052906, K060704) and the predicate DePuy GLOBAL UNITE Shoulder System (K101996, 133834) in intended use, design, material, and fixation. The subject and predicate systems are intended for total, hemi-, or reverse shoulder arthroplasty; have modular anatomic/reverse convertibility; are made of titanium alloy; are intended for cemented or uncemented use; and include similar tissue reattachment options such as suture holes and suture collars. Differences include the type of modularity and fixation-the subject device and the predicate GLOBAL UNITE Shoulder System (K101996, 133834) are a modular stemepiphysis design, while the predicate Zimmer Trabecular Metal Reverse Shoulder (K052906, K060704) is a monobloc stem with a dual taper adapter for the anatomic configuration. The subject device and the predicate GLOBAL UNITE Shoulder System (K101996, 133834) also use Porocoat® titanium porous coating for biological fixation, while the predicate Zimmer Trabecular Metal Reverse Shoulder (K052906, K060704) uses porous tantalum.
PERFORMANCE DATA
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE
The following tests were performed (per FDA's Guidance for Industry and FDA Staff – Class II Special Controls Guidance: Shoulder Joint Metal Nonconstrained or Semi-Constrained Porous-Coated
7
Uncemented Prosthesis) on the GLOBAL UNITE Shoulder System to demonstrate substantial equivalence of safety and efficacy with the predicate device:
- Fatigue Test for fracture stem with fracture epiphysis (at higher assembly torque) .
- Fatigue Test for fracture stem with fracture epiphysis (at lower assembly torque)
- Fretting Corrosion Potential - Comparison to Existing Product
- Epiphysis Comparison
- 135° Neck Shaft Angle Verification
- . 128° and 142° Neck Shaft Angle Verification
- Range of Motion Analysis ●
- . Rationale for 155 Degree Neck-Shaft Angle
- Biocompatibility Study
- . Mating Parts Analysis
- Effect of Screw Retention Insert of the Implant Packaging on Humeral Cup Seating
- Print Review of Product Marking
- Print Review of Suture Features
- . Review of Label Content
- Print Review of Porocoat
- . The proposed devices also meet the requirement of bacterial endotoxin testing as specified in ANSI AAMI ST-72:2011.
SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION
No clinical testing was conducted to demonstrate substantial equivalence.
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA
The subject DePuy Synthes GLOBAL UNITE Shoulder System is substantially equivalent to the predicates Zimmer Trabecular Metal Reverse Shoulder System (K052906) and Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8mm and 10mm (K060704).