(107 days)
The Global UNITE Shoulder System humeral stems, suture collars, epiphyseal components and humeral heads are intended for cemented or uncemented total shoulder or hemi-shoulder replacement in treatment of the following:
- 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)
Hemi-shoulder replacement is also indicated for: - Ununited humeral head fractures
- Avascular necrosis of the humeral head
- Deformity and/or limited motion
When used in a total shoulder replacement, the Global Unite implants are to be used with DePuy glenoids. The glenoids are for cemented use only.
When well-fixed, the Global Unite humeral stems, in conjunction with existing Delta Xtend epiphyseal components, are also indicated for conversion to a reverse, 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. The Delta Xtend metaglene is HA-coated and is intended for uncemented use with the addition of screws for fixation. The Delta Xtend epiphyseal components are HA-coated and are intended for uncemented use.
The subject devices expand the Global UNITE Shoulder System to include two additional cobalt-chrome alloy humeral heads that mate with existing Global UNITE epiphyseal bodies, as well as new porous-coated anatomic epiphyseal bodies made from titanium alloy that mate with existing Global UNITE humeral heads and stems. In the case of further deterioration of the joint or rotator cuff, the surgeon has the option to remove the Global UNITE anatomic epiphyseal component and replace it with a Delta Xtend Reverse (K120174) epiphyseal component for conversion to a reverse shoulder prosthesis without removing the well-fixed distal stem.
This document describes DePuy Global UNITE Shoulder System. As this is not an AI/ML device, the following information is not applicable:
- Acceptance criteria and device performance table
- Sample sizes for test set and training set
- Data provenance or ground truth establishment
- Number and qualification of experts
- Adjudication method
- Multi-reader multi-case (MRMC) comparative effectiveness study
- Standalone algorithm performance
The device underwent various non-clinical performance tests to demonstrate substantial equivalence to its predicate devices. These tests, listed below, were performed according to FDA's Guidance for Industry and FDA Staff - Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis. Clinical data was not required for this device.
The performance tests included:
- Epiphysis Comparison
- Head Comparison
- Screw Comparison
- Test Rationale
- Fretting and Corrosion
- Torque Test to Failure for Screw Fastener
- Human Torque Test for Screw Fastener
- Fatigue Test for Complete Implant with Lower Torque
- Cadaver Test Report
- Implant Insertion Test
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol to the right of the text. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 2, 2016
DePuy (Ireland) Ms. Kellie Myers Regulatory Affairs Associate Loughbeg Ringaskiddy County Cork, Ireland
Re: K133834
Trade/Device Name: DePuy Global UNITE 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: March 18, 2014 Received: March 19, 2014
Dear Ms. Myers:
This letter corrects our substantially equivalent letter of April 3, 2014.
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
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Page 2 - Ms. Kellie Myers
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Lori A. Wiggins -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 4: Indications for Use Statement
510(k) Number (if known): _ K133834
Device Name: DePuy Global UNITE Shoulder System
Indications for Use:
The Global UNITE Shoulder System humeral stems, suture collars, epiphyseal components and humeral heads are intended for cemented or uncemented total shoulder or hemi-shoulder replacement in treatment of the following:
-
- 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)
Hemi-shoulder replacement is also indicated for:
-
- Ununited humeral head fractures
-
- Avascular necrosis of the humeral head
-
- Deformity and/or limited motion
When used in a total shoulder replacement, the Global Unite implants are to be used with DePuy glenoids. The glenoids are for cemented use only.
When well-fixed, the Global Unite humeral stems, in conjunction with existing Delta Xtend epiphyseal components, are also indicated for conversion to a reverse, 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. The Delta Xtend metaglene is HA-coated and is intended for uncemented use with the addition of screws for fixation. The Delta Xtend epiphyseal components are HA-coated and are intended for uncemented use.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Subpart D)
Over-the-Counter Use (21 CFR 807 Subpart C)
(Please do not write below this line. Continue on another page if needed.)
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K133834 Page 1 of 5
never stop moving
Image /page/3/Picture/2 description: The image shows the DePuy company logo, which is a black circle with the company name in bold black letters next to it. Below the company name is the text "companies of Johnson&Johnson" in a smaller font. Above the logo, the date "APR 0: 3 2014" is printed in black ink.
DePuy Orthopaedics Worldwide
DePuy (Ireland) Loughbeg
Ringaskiddy Co. Cork lreland
T. +353 (21) 4914 000 F. +353 (21) 4914 199
Section 5: 510(k) Summary
(As required by 21 CFR 807.92 and 21 CFR 807.93)
| NAME OF SPONSOR: | DePuy (Ireland)LoughbegRingaskiddyCo. Cork IrelandEstablishment Registration Number: 9616671 |
|---|---|
| 510(K) CONTACT: | Kellie MyersRegulatory Affairs AssociateTelephone: (574) 372-7276Facsimile: (574)371-4987Electronic Mail: kmyers8@its.jnj.com |
| DATE PREPARED: | January 06, 2014 |
| PROPRIETARY NAME: | DePuy Global UNITE Shoulder System |
| COMMON NAME: | Total and Hemi Shoulder Arthroplasty Prosthesis |
| CLASSIFICATION ANDREGULATION: | Shoulder joint metal/polymer semi-constrained cementedprosthesis (21 CFR 888.3660, Product Code KWS)Shoulder joint humeral (hemi-shoulder) metallic uncementedprosthesis (21 CFR 888.3690, Product Code HSD) |
| PREDICATE DEVICE: | DePuy Global Advantage Humeral Stem with Porocoat,K011047DePuy Global Advantage Shoulder, Global AdvantageHumeral Stem, Global Advantage Eccentric Head, K992065 |
Image /page/3/Picture/8 description: The image contains two distinct circular designs. The design on the left features a profile of a person's head, possibly a historical figure, surrounded by a decorative border that resembles a wreath or a series of small, repeating elements. The design on the right consists of concentric circles intersected by lines, creating a pattern reminiscent of a stylized target or a technical diagram. The overall image has a stark, black-and-white contrast, which emphasizes the shapes and patterns of the designs.
Defey Orthopaedics Worldeide is a rading diristian of DePoy (littland)
Registered Office: Defur Greand), Loughbeg, Ringaskludy Co. Contineland
Registered in Feland No. 263572
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DEVICE DESCRIPTION
The subject devices expand the Global UNITE Shoulder System to include two additional cobalt-chrome alloy humeral heads that mate with existing Global UNITE epiphyseal bodies, as well as new porous-coated anatomic epiphyseal bodies made from titanium alloy that mate with existing Global UNITE humeral heads and stems. In the case of further deterioration of the joint or rotator cuff, the surgeon has the option to remove the Global UNITE anatomic epiphyseal component and replace it with a Delta Xtend Reverse (K120174) epiphyseal component for conversion to a reverse shoulder prosthesis without removing the well-fixed distal stem.
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| INTENDED USE | The Global UNITE Shoulder System humeral stems, suture collars, epiphyseal components and humeral heads are intended for cemented or uncemented total shoulder or hemi-shoulder replacement in treatment of the following:1. A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis2. 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 unsatisfactory3. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component)Hemi-shoulder replacement is also indicated for:1. Ununited humeral head fractures2. Avascular necrosis of the humeral head3. Deformity and/or limited motionWhen used in a total shoulder replacement, the Global Unite implants are to be used with DePuy glenoids. The glenoids are for cemented use only.When well-fixed, the Global Unite humeral stems, in conjunction with existing Delta Xtend epiphyseal components, are also indicated for conversion to a reverse, 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. The Delta Xtend metaglene is HA-coated and is intended for uncemented use with the addition of screws for fixation. The Delta Xtend epiphyseal components are HA-coated and are intended for uncemented use. |
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K133834 Page 4 of 5
| COMPARISON TOPREDICATE DEVICE | Like the predicate device, the subject Global UNITE ShoulderSystem employs a fluted distal stem, with an epiphysis that featuresa medial face with a hole for cerclage, as well as anterior/posteriorlateral fins with suture holes to provide a fixation point for tissuereattachment. The subject device features a modular design wherethe distal stem mates with an epiphyseal body via a pin/holerelationship, along with an anti-rotation tab/slot, and lockedtogether using a captured screw. The stems and epiphyses of bothdevices are manufactured from medical-grade titanium alloy (Ti-6Al-4V) and both are proximally porous-coated with commerciallypure titanium. |
|---|---|
| The Global UNITE humeral heads are also similar to the predicateGlobal Advantage humeral heads in that both are fitted with a fixedtaper (the predicate has the female taper end on the stem side,whereas the subject has the opposite), are semi-spherical in designand are manufactured from cobalt-chrome-molybdenum alloy. | |
| Indications and intended use for both subject and predicate devicesare the same. | |
| The subject anatomic epiphyseal devices differ from the predicatein that they are modular in design and offer multiple neck shaftangles (128°, 135°, and 142°), whereas the predicate device has anintegrated stem-epiphysis design with a fixed 135° neck shaft angle. | |
| Based on similarities in intended use, indications for use, materialsand design, DePuy believes the subject Global UNITE ShoulderSystem is substantially equivalent to the previously cleared DePuyGlobal Advantage Shoulder System, cleared in K992065 andK011047. |
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| PERFORMANCE DATA | The following tests were performed (per FDA's Guidance forIndustry and FDA Staff - Class II Special Controls Guidance:Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis) on the GlobalUNITE Shoulder System to demonstrate substantial equivalence ofsafety and efficacy with the predicate device: |
|---|---|
| • Epiphysis Comparison | |
| • Head Comparison | |
| • Screw Comparison | |
| • Test Rationale | |
| • Fretting and Corrosion | |
| • Torque Test to Failure for Screw Fastener | |
| • Human Torque Test for Screw Fastener | |
| • Fatigue Test for Complete Implant with Lower Torque | |
| • Cadaver Test Report | |
| • Implant Insertion Test | |
| Clinical data was not required for this device. |
·
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§ 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.”