Prosthetic replacement with this device may be indicated for the treatment of severe pain or significant disability in degenerative, theumatic 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 nonconstrained arthroplasty is not acceptable. In the USA, the device must be cemented under the base (see surgical technique for details) or fully cemented in place.

Device Description

The device is a monoblock glenoid component comprised of a Trabecular Metal base with an articular surface composed of direct compression molded polyethylene (UHMWPE). 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 articular geometry and dimensions as the B/F Glenoid implants cleared in K022377 and K031449.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device, the Zimmer Trabecular Metal Glenoid. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, this document does not contain acceptance criteria for device performance or a study that proves the device meets such criteria.

Instead, this is a regulatory submission focused on demonstrating that the new device's technological characteristics, materials, and intended use are similar enough to previously cleared devices that it can be marketed without undergoing a new premarket approval process. The information provided is primarily for regulatory clearance rather than a performance study report.

Therefore, I cannot provide the requested information, such as:

A table of acceptance criteria and the reported device performance: This document does not establish performance acceptance criteria or report device performance against them.
Sample size used for the test set and the data provenance: There is no mention of a clinical or ex-vivo test set used to demonstrate performance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no such test set is described.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical implant, not an AI algorithm.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

The document discusses "documentation" that was provided to demonstrate substantial equivalence, focusing on:

Intended use/indications for use
Materials (Trabecular Metal and UHMWPE, similar to numerous other cleared Zimmer devices)
Technological characteristics (same external articulating geometry, dimensions, minimum polyethylene thickness, sizing options as predicate).
Basic principles of operation.

It also highlights that modifications were made to:

Increase interfacial area for attachment between Trabecular Metal and UHMWPE.
Increase interfacial area between UHMWPE and bone cement mantle.
Decrease likelihood of center pilot post damage during impaction/insertion.
Increase overall fatigue and static strength of the Trabecular Metal base.

These points describe design improvements and comparisons to predicate devices, but they do not constitute a performance study with acceptance criteria and measured outcomes. For a 510(k) submission like this, the "study" is often a comparison of technical specifications, materials, and intended use to a legally marketed predicate device, rather than a clinical trial demonstrating specific performance metrics against an acceptance threshold.

Summary

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Zimmer TMT, Inc.

10 Pomeroy Road Parsippany, NJ 07054 973.576.0032 www.zimmer.com

JUN 2 9 2007

510(k) Summary

Submitter:	Zimmer Trabecular Metal Technology, Inc.10 Pomeroy RoadParsippany, New Jersey 07054
Contact Person:	Kathleen RutherfordAssociate Director, Regulatory AffairsTelephone: (973) 576-0139Fax: (973) 884-8795
Date:	April 16, 2007
Trade Name:	The Trabecular Metal Glenoid- the Bigliani/Flatow Complete ShoulderSolution
Common Name:	Glenoid Component
Classification Name andReference:Product Code:	Prosthesis, shoulder, semi & non-constrained, metal/polymercemented, 21 CFR 888.3660KWS and KWT

DEVICE DESCRIPTION

INDICATIONS FOR USE

Prosthetic replacement with this device may be indicated for the treatment of severe pain or significant disability in degenerative, theumatoid, 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-

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K071090 (pg. 2 of 2)

constrained arthroplasty is not acceptable. In the USA, the device must be cemented under the base (see surgical technique for details) or fully cemented in place.

SUBSTANTIAL EQUIVALENCE

Documentation was provided which demonstrated that the Gen III Trabecular Metal Glenoid B/F Complete Shoulder Solution is substantially equivalent to its predicate devices with respect to intended use/indications for use, materials, technological characteristics and basic principles of operation.

Device Technological Characteristics & Comparison to Predicate Device

The subject device possesses the same external articulating geometry and dimensions, the same minimum polyethylene thickness, and same sizing options as the predicate devices. The Trabecular Metal and direct compression molded UHMWPE materials, incorporated in the monoblock device are similar to numerous cleared Zimmer Trabecular Metal devices. This 510(k) covers changes in the geometry of the Trabecular Metal base, or keel, as well as a modification to the underside of the UHMWPE articular construct.

The modifications are designed to:

increase the interfacial area for attachment between the Trabecular Metal and UHMWPE .
increase the interfacial area between the UHMWPE and the bone cement mantle .
decrease the likelihood of center pilot post damage during impaction/insertion .
increase the overall fatigue and static strength of the Trabecular Metal base, making it less . susceptible to damage in instances where it is not completely supported

Conclusion

The Trabecular Metal Glenoid is substantially equivalent to the identified predicate TM Glenoid devices.

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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a bold, sans-serif font. The text is centered and appears to be the heading of a document or page. The words are all capitalized and evenly spaced.

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 9 2007 Zimmer Trabecular Metal Technology, Inc.

% Ms. Kathleen Rutherford Associate Director, Regulatory Affairs 10 Pomeroy Road Parsippany, New Jersey 07054

Re: K071090

Trade/Device Name: The Trabecular Metal Glenoid - the Bigliani/Flatow (B/F) Complete Shoulder Solution Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS. KWS. KWT Dated: April 16, 2007 Received: April 18, 2007

Dear Ms. Rutherford:

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 - Ms. Kathleen Rutherford

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 (240) 276-0120. 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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrb/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson
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): K07 1090

Device Name: The Trabecular Metal Glenoid- Bigliani/Flatow® The Complete Shoulder Solution Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

ign-Off Division of General, Restorative and Neurological Devices

510(k) Number k0 8517

Regulation Number and Section

§ 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.”