ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM

K052906 · Zimmer, Inc. · PHX · Dec 19, 2005 · Orthopedic

Device Facts

• Record ID: K052906
• Device Name: ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM
• Applicant: Zimmer, Inc.
• Product Code: PHX · Orthopedic
• Decision Date: Dec 19, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Zimmer Trabecular Metal Reverse Shoulder System is indicated for the following: Reverse application: - the treatment of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint, - ununited humeral head fractures of long duration, - irreducible 3-and 4-part proximal humeral fractures, - avascular necrosis of the humeral head, - rotator cuff arthropathy, or - other difficult clinical management problems (such as a failed total shoulder arthroplasty or grossly rotator cuff deficient joint) where arthrodesis or resectional arthroplasty is not acceptable. Hemiarthroplasty/Total application: - the treatment of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint, - ununited humeral head fractures of long duration, - irreducible 3-and 4-part proximal humeral fractures, - avascular necrosis of the humeral head. The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component or reverse components for total shoulder arthroplasty (conventional or reverse applications). The Trabecular Metal humeral and reverse base plate components are intended for either cemented or uncemented use. The reverse base plate requires two screws for initial fixation.

Device Story

Modular total shoulder prosthesis designed for patients with non-functional rotator cuffs; system allows for conversion between traditional shoulder prosthesis, reverse design, or hemi-prosthesis during surgery. Components include Trabecular Metal humeral and reverse base plate, which can be cemented or uncemented; reverse base plate requires two screws for initial fixation. Used by orthopedic surgeons in clinical settings to address severe joint pain, fractures, or necrosis. Provides structural replacement for the glenohumeral joint to restore function and reduce pain.

Clinical Evidence

No clinical data; non-clinical performance testing demonstrated safety and effectiveness equivalent to predicate devices.

Technological Characteristics

Modular shoulder prosthesis; components include Trabecular Metal humeral and reverse base plate. Fixation via cement or uncemented methods; reverse base plate requires two screws. Materials and manufacturing processes are similar to predicate devices.

Indications for Use

Indicated for patients with severe pain or disability due to degenerative, rheumatoid, or traumatic glenohumeral joint disease, ununited humeral head fractures, irreducible 3- or 4-part proximal humeral fractures, avascular necrosis, or rotator cuff arthropathy/deficiency where arthrodesis or resection is not acceptable.

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

• Aequalis Reversed Shoulder Prosthesis (K041873)
• Delta Shoulder (K021478)
• Encore Reverse Shoulder Prosthesis (K041066)
• Zimmer Trabecular Metal Humeral Stem (K041549)

Submission Summary (Full Text)

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Kos2906

# DEC 1 9 2005

### Summary of Safety and Effectiveness

| Submitter: | Zimmer, Inc.<br>P.O. Box 708<br>Warsaw, IN 46581-0708 |
|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Dalene T. Binkley<br>Senior Associate, Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone] |
| Date: | December 16, 2005 |
| Trade Name: | Zimmer Trabecular Metal™ Reverse Shoulder<br>System |
| Common Name: | Total-Shoulder System and Hemi-Shoulder System |
| Classification Name<br>and Reference: | 1. Prosthesis, Shoulder, Semi-constrained,<br>metal/polymer cemented (KWS)<br>2. Shoulder joint humeral (hemi-shoulder) metallic<br>uncemented prosthesis (HSD)<br>3. Shoulder joint metal/polymer non-constrained<br>cemented prosthesis (KWT)<br>21 CFR § 888.3660, 888.3690 and 888.3650 |
| Predicate Devices: | Aequalis Reversed Shoulder Prosthesis,<br>manufactured by Tornier, K041873, cleared August<br>25, 2004.<br><br>Delta Shoulder, manufactured by DePuy, K021478,<br>cleared November 18, 2003.<br><br>Encore Reverse Shoulder Prosthesis, manufactured<br>by Encore Medical, L.P., K041066, cleared March<br>24, 2005.<br><br>Zimmer Trabecular Metal™ Humeral Stem,<br>manufactured by Zimmer, Inc., K041549, cleared<br>September 1, 2004. |
| Device Description: | The Zimmer Trabecular Metal™ Reverse Shoulder<br>System is a modular total shoulder prosthesis that<br>was designed specifically to include patients with<br>non-functional rotator cuffs. It was developed to<br>either encompass a traditional shoulder prostheses, a<br>reverse design or be transformed into a hemi-<br>prosthesis depending on clinical cases encountered<br>during the surgical procedure. |
| Intended Use: | The Zimmer Trabecular Metal Reverse Shoulder<br>System is indicated for the following: |
| | <i>Reverse application:</i> |
| | - the treatment of severe pain or significant<br>disability in degenerative, rheumatoid, or<br>traumatic disease of the glenohumeral joint,<br>- ununited humeral head fractures of long<br>duration,<br>- irreducible 3-and 4-part proximal humeral<br>fractures,<br>- avascular necrosis of the humeral head,<br>- rotator cuff arthropathy, or<br>- other difficult clinical management problems<br>(such as a failed total shoulder arthroplasty or<br>grossly rotator cuff deficient joint) where<br>arthrodesis or resectional arthroplasty is not<br>acceptable. |
| | <i>Hemiarthroplasty/Total application:</i> |
| | - the treatment of severe pain or significant<br>disability in degenerative, rheumatoid, or<br>traumatic disease of the glenohumeral joint,<br>- ununited humeral head fractures of long<br>duration,<br>- irreducible 3-and 4-part proximal humeral<br>fractures,<br>- avascular necrosis of the humeral head |
| | The assembled humeral component may be<br>used alone for hemiarthroplasty or combined<br>with the glenoid component or reverse<br>components for total shoulder arthroplasty<br>(conventional or reverse applications). |
| | The Trabecular Metal humeral and reverse base<br>plate components are intended for either<br>cemented or uncemented use. The reverse base<br>plate requires two screws for initial fixation. |
| Comparison to Predicate Device: | The Zimmer Trabecular Metal Reverse Shoulder<br>System is packaged, manufactured, and sterilized<br>using the same or similar materials and processes as<br>the predicate devices. The subject device also has<br>similar intended use and fixation methods as the<br>predicate devices. |
| Performance Data (Nonclinical<br>and/or Clinical): | Non-Clinical Performance and Conclusions:<br>Non-clinical testing demonstrated that the Zimmer<br>Trabecular Metal Reverse Shoulder System is as<br>safe and effective as the predicate devices. |

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- rotator cuff arthropathy, or -
- other difficult clinical management problems
where arthrodesis or resectional arthroplasty is not acceptable.

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.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## DEC 1 9 2005

Dalene T. Binkley Senior Associate, Regulatory Affairs Zimmer, Inc P.O. Box 708 Warsaw, Indiana 46581

Re: K052906

Trade/Device Name: Zimmer Trabecular™ Metal Reverse Shoulder System Regulation Number: 21 CFR 888.3650 Regulation Name: Shoulder joint metal/polymer non-constrained cemented prosthesis Regulatory Class: II Product Code: KWT, KWS, HSD Dated: October 12, 2005 Received: October 14, 2005

Dear Ms. Binkley:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2-Dalene T. Binkley

This letter will allow you to begin marketing your device as described in your Section 51 (ks) I mis letter will anow you to begin mained of substantial equivalence of your device to a legally premail.com on ... The PDF mission for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific acritor 101 Job [phone]. Also, please note the regulation cutitled, Contact the Office of Conner et notification" (21CFR Part 807.97). You may obtain Misoranding of reference to premiers on your responsibilities under the Act from the Division of Small other general information of your corpumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

signature

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

#### 510(k) Number (if known):

#### Device Name:

Zimmer Trabecular Metal™ Reverse Shoulder System

#### Indications for Use:

The Zimmer Trabecular Metal Reverse Shoulder System is indicated for the following:

#### Reverse application:

な

- the treatment of severe pain or significant disability in degenerative, rheumatoid, or traumatic , disease of the glenohumeral joint;
- ununited humeral head fractures of long duration; ।
- irreducible 3-and 4-part proximal humeral fractures; i
- ifreductive 3-and ++part proximal hameral heaters,
avascular necrosis of the humeral head, or other difficult clinical management problems (such as a । avascular necrosis of the namedial nead, or grossly rotator cuff deficient joint) where arthrodesis or resectional arthroplasty is not acceptable.

#### Hemiarthroplasty/Total application:

- the treatment of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint;
- ununited humeral head fractures of long duration; -
- irreducible 3-and 4-part proximal humeral fractures; -
- irreductore >-and 4-part proximal numeral head, or other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable.

The assembled humeral component may be used alone for hemiarthroplasty or compinsel with the I he assembled intineral components for total shoulder arthroplasty (conventional or reverse applications).

The Trabecular Metal humeral and reverse base plate components are intended for either cemented or I he Travecalar Metal numeral ane note requires two screws for initial fixation.

Prescription Use X

AND/OR Over-The-Counter Use

(21 CFR 807 Subpart C)

(Part 21 CFR 801 Subpart D)

other page if needed) (Please do not write be ow this line - Continue

e Evanuation (ODE) Con Programs Por

Division of General, Restorative, and Neurological Devices

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510(k) Number K052906