DEPUY GLOBAL UNITE SHOULDER SYSTEM

K133834 · Depuy(Ireland) · KWS · Apr 3, 2014 · Orthopedic

Device Facts

• Record ID: K133834
• Device Name: DEPUY GLOBAL UNITE SHOULDER SYSTEM
• Applicant: Depuy(Ireland)
• Product Code: KWS · Orthopedic
• Decision Date: Apr 3, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

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 arthritis 2. 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 3. 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 fractures 2. Avascular necrosis of the humeral head 3. 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.

Device Story

Modular shoulder arthroplasty system; includes cobalt-chrome humeral heads and titanium alloy epiphyseal bodies/stems. Designed for cemented or uncemented total or hemi-shoulder replacement. Features modular neck shaft angles (128°, 135°, 142°) and porous coating for fixation. Allows conversion to reverse shoulder prosthesis (using Delta Xtend components) without removing well-fixed distal stem. Used by orthopedic surgeons in clinical settings to restore joint function in patients with severe arthritis, fractures, or failed prior replacements. Provides mechanical support and articulation for the glenohumeral joint.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via bench testing per FDA Class II Special Controls Guidance for shoulder joint prostheses, including epiphysis/head/screw comparisons, fretting/corrosion analysis, torque-to-failure, fatigue testing, and cadaveric insertion testing.

Technological Characteristics

Materials: Titanium alloy (Ti-6Al-4V) stems/epiphyses, cobalt-chrome-molybdenum alloy humeral heads. Proximally porous-coated with commercially pure titanium. Modular design with pin/hole mating and captured screw fixation. Multiple neck shaft angles (128°, 135°, 142°).

Indications for Use

Indicated for patients requiring total or hemi-shoulder replacement due to osteoarthritis, traumatic/rheumatoid arthritis, proximal humerus fracture-dislocations, ununited humeral head fractures, avascular necrosis, or joint deformity/limited motion. Also indicated for conversion to reverse shoulder arthroplasty in patients with grossly deficient rotator cuff joints and functional deltoid muscles.

Regulatory Classification

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).

Special Controls

*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.”

Predicate Devices

• DePuy Global Advantage Humeral Stem with Porocoat (K011047)
• DePuy Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric Head (K992065)

Reference Devices

• Delta Xtend Reverse (K120174)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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:

- 1. A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis
- 2. 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
- 3. 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 fractures
- 2. Avascular necrosis of the humeral head
- 3. 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. [phone] F. [phone]

#### Section 5: 510(k) Summary

(As required by 21 CFR 807.92 and 21 CFR 807.93)

| NAME OF SPONSOR: | DePuy (Ireland)<br>Loughbeg<br>Ringaskiddy<br>Co. Cork Ireland<br>Establishment Registration Number: 9616671 |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) CONTACT: | Kellie Myers<br>Regulatory Affairs Associate<br>Telephone: [phone]<br>Facsimile: [phone]<br>Electronic Mail: [e-mail] |
| DATE PREPARED: | January 06, 2014 |
| PROPRIETARY NAME: | DePuy Global UNITE Shoulder System |
| COMMON NAME: | Total and Hemi Shoulder Arthroplasty Prosthesis |
| CLASSIFICATION AND<br>REGULATION: | Shoulder joint metal/polymer semi-constrained cemented<br>prosthesis (21 CFR 888.3660, Product Code KWS)<br><br>Shoulder joint humeral (hemi-shoulder) metallic uncemented<br>prosthesis (21 CFR 888.3690, Product Code HSD) |
| PREDICATE DEVICE: | DePuy Global Advantage Humeral Stem with Porocoat,<br>K011047<br>DePuy Global Advantage Shoulder, Global Advantage<br>Humeral 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:<br>1. A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis<br>2. 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<br>3. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component)<br>Hemi-shoulder replacement is also indicated for:<br>1. Ununited humeral head fractures<br>2. Avascular necrosis of the humeral head<br>3. Deformity and/or limited motion<br>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.<br>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 TO<br>PREDICATE DEVICE | Like the predicate device, the subject Global UNITE Shoulder<br>System employs a fluted distal stem, with an epiphysis that features<br>a medial face with a hole for cerclage, as well as anterior/posterior<br>lateral fins with suture holes to provide a fixation point for tissue<br>reattachment. The subject device features a modular design where<br>the distal stem mates with an epiphyseal body via a pin/hole<br>relationship, along with an anti-rotation tab/slot, and locked<br>together using a captured screw. The stems and epiphyses of both<br>devices are manufactured from medical-grade titanium alloy (Ti-<br>6Al-4V) and both are proximally porous-coated with commercially<br>pure titanium. |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The Global UNITE humeral heads are also similar to the predicate<br>Global Advantage humeral heads in that both are fitted with a fixed<br>taper (the predicate has the female taper end on the stem side,<br>whereas the subject has the opposite), are semi-spherical in design<br>and are manufactured from cobalt-chrome-molybdenum alloy. |
| | Indications and intended use for both subject and predicate devices<br>are the same. |
| | The subject anatomic epiphyseal devices differ from the predicate<br>in that they are modular in design and offer multiple neck shaft<br>angles (128°, 135°, and 142°), whereas the predicate device has an<br>integrated stem-epiphysis design with a fixed 135° neck shaft angle. |
| | Based on similarities in intended use, indications for use, materials<br>and design, DePuy believes the subject Global UNITE Shoulder<br>System is substantially equivalent to the previously cleared DePuy<br>Global Advantage Shoulder System, cleared in K992065 and<br>K011047. |

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| PERFORMANCE DATA | The following tests were performed (per FDA's Guidance for<br>Industry and FDA Staff - Class II Special Controls Guidance:<br>Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-<br>Constrained Porous-Coated Uncemented Prosthesis) on the Global<br>UNITE Shoulder System to demonstrate substantial equivalence of<br>safety 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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