THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4316-XX-XX

K043061 · Zimmer Trabecular · KWS · Nov 23, 2004 · Orthopedic

Device Facts

• Record ID: K043061
• Device Name: THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4316-XX-XX
• Applicant: Zimmer Trabecular
• Product Code: KWS · Orthopedic
• Decision Date: Nov 23, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Prosthetic replacement with this device may be indicated for the treatment of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; un-united humeral head fractures of long duration; irreducible 3- and 4-part proximal humeral fractures; avascular necrosis of the humeral 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 combined with the glenoid component for total shoulder arthroplasty. Humeral heads with heights greater than 27 mm may be used for difficult clinical management problems involving rotator cuff deficiency where arthrodesis or conventional non-constrained arthroplasty is not acceptable. The Trabecular Metal Glenoid must be fully or partially cemented in place in the USA.

Device Story

Monoblock glenoid component; Trabecular Metal base; direct compression molded polyethylene articular surface. Interfaces with Zimmer B/F humeral components. Used in total shoulder arthroplasty; implanted by orthopedic surgeons in clinical settings. Provides articular surface for humeral head; restores joint function; reduces pain. Manufacturing change increases interfacial area between polyethylene and metal base to improve attachment strength.

Clinical Evidence

Bench testing only. Engineering analysis performed to evaluate the effect of increased polyethylene infiltration area on device strength and attachment area.

Technological Characteristics

Monoblock design; Trabecular Metal base; direct compression molded UHMWPE articular surface. 5 mm thickness. Cemented fixation. No software or electronic components.

Indications for Use

Indicated for patients with severe pain or disability due to degenerative, rheumatoid, or traumatic glenohumeral joint disease; un-united humeral head fractures; irreducible 3- and 4-part proximal humeral fractures; avascular necrosis; or conditions requiring arthroplasty over arthrodesis/resection. Used for total shoulder arthroplasty or hemiarthroplasty. Must be cemented.

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

• B/F glenoids (K022377)
• B/F glenoids (K031449)

Submission Summary (Full Text)

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### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

# The Trabecular Metal Glenoid
Bigliani/Flatow® (B/F) The Complete Shoulder Solution

| Submitter Name<br>And Address: | Zimmer Trabecular Metal Technology, Inc.<br>80 Commerce Drive<br>Allendale, New Jersey 07401-1600 |
|------------------------------------|-------------------------------------------------------------------------------------------------------|
| Contact Person: | Marci Halevi |
| Phone Number: | [phone] X 507 |
| Fax Number: | [phone] |
| Date Prepared: | November 2, 2004 |
| Device Trade Name: | The Trabecular Metal Glenoid, the B/F Complete Shoulder Solutio |
| Device Common Name: | Glenoid Component |
| Classification Number<br>and Name: | 21 CFR 888.3660 & 888.3650; Prosthesis, shoulder, semi & non-<br>constrained, metal/polymer cemented. |

Substantial The term "substantial equivalence" as used in this 510(k) notification is Equivalence: limited to the definition of substantial equivalence found in the Federal Food, Drug and Cosmetic Act, as amended and as applied under 21 CFR 807, Subpart E under which a device can be marketed without premarket approval or reclassification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or their application by the courts.

Device The device is a monoblock glenoid component comprised of a Description: Trabecular Metal base with an articular surface comprised of direct compression molded polyethylene. The TM Glenoid is designed to interface & articulate with Zimmer B/F humeral components and is available in one thickness option of 5 mm, and the same outer geometry and dimensions as the B/F glenoids cleared in K022377 and K031449.

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Kod3061

TM Glenoid Bl Special 510(k) Premarket Notific

## 510(k) Summary (Continued)

- Indications for use: Prosthetic replacement with this device may be indicated for the treatment of severe pain or significant disability in degenerative. rheumatoid, or traumatic disease of the glenohumeral joint; un-united humeral head fractures of long duration; irreducible 3- and 4-part proximal humeral fractures; avascular necrosis of the humeral 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 combined with the glenoid component for total shoulder arthroplasty. Humeral heads with heights greater than 27 mm may be used for difficult clinical management problems involving rotator cuff deficiency where arthrodesis or conventional non-constrained arthroplasty is not acceptable. The Trabecular Metal Glenoid must be fully or partially cemented in place in the USA.
Device The subject device possesses the same external geometry and Technological dimensions, the same articulation geometry, the same minimum polyethylene thickness, and same size options as the predicate devices. Characteristics & The Trabecular Metal, direct compression molded polyethylene and Comparison to monoblock design is similar to numerous cleared Zimmer Trabecular Predicate Device: Metal devices. This 510(k) clearance provides a change in manufacturing technique to increase the interfacial area between the UHMWPE and the Trabecular Metal glenoid base.

- An engineering analysis showed that the increased area of polyethylene Performance infiltration does not adversely affect device strength and increases the Data: area of attachment between the UHMWPE and the Trabecular Metal glenoid base.
Conclusion: The Trabecular Metal Glenoid is substantially equivalent to the identified predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 23 2004

Ms. Marci Halevi Manager of Regulatory Affairs Zimmer Trabecular Metal Technology 80 Commerce Drive Allendale, New Jersey 07401-1600

K043061 Re:

R042001
Trade/Device Name: Trabecular Metal Glenoid – B/F Complete Shoulder Solution Regulation Numbers: 21 CFR 888.3660, 21 CFR 888.3650 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis, shoulder joint metal/polymer non-constrained cemented prosthesis Regulatory Class: II Product Codes: KWS, KWT Dated: November 3, 2004 Received: November 4, 2004

Dear Ms. Halevi:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations of the enactment date of the Medical Device Amendments, or 10 conniner of price to may 20, 20, 20, 20, 2017 11:45 provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmetier For (10) inter the device, subject to the general controls provisions of the Act. The r ou may, mereleve, mains 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 -- Ms. Marci Halevi

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Special 510(k) Premarket N

510(k) Number (if known) :

K043061

Device Name:

The Trabecular Metal Glenoid - The B/F Complete Shoulder Solution

Indications For Use:

Prosthetic replacement with this device may be indicated for the treatment of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; un-united humeral head fractures of long duration; irreducible 3- and 4-part proximal humeral fractures; avascular necrosis of the humeral 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 combined with the glenoid component for total shoulder arthroplasty. Humeral heads with heights greater than 27 mm may be used for difficult clinical management problems involving rotator cuff deficiency where arthrodesis or conventional non-constrained arthroplasty is not acceptable. The Trabecular Metal Glenoid must be fully or partially cemented in place in the USA.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

| Concurrence of CDRH; Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|------------------------------------------------------------|
| | (Division Sign-Off) |
| | Division of General, Restorative, and Neurological Devices |

| Prescription Use (Per 21 CFR 801.109) | <div style="text-align:center;">X</div> |
|-------------------------------------------------------------|-----------------------------------------|
| OR... | |
| Over-The-Counter Use 510(k) Number (Optional Format 1-2-96) | K043061 |