(66 days)
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, 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, 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 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.
The Zimmer Trabecular Metal™ Reverse Shoulder System is a modular total shoulder prosthesis that was designed specifically to include patients with non-functional rotator cuffs. It was developed to either encompass a traditional shoulder prostheses, a reverse design or be transformed into a hemi-prosthesis depending on clinical cases encountered during the surgical procedure.
The provided text is a 510(k) summary for a medical device called the "Zimmer Trabecular Metal™ Reverse Shoulder System," submitted to the FDA. It does not contain information about acceptance criteria or a study that proves the device meets those criteria.
Instead, this document is a premarket notification for a new device, demonstrating its substantial equivalence to previously cleared predicate devices. The information provided focuses on the device's description, intended use, comparison to predicates, and regulatory classification.
Therefore, I cannot fulfill your request to create a table of acceptance criteria and reported device performance or answer the specific questions about the study design, sample sizes, expert qualifications, or ground truth establishment, as this information is not present in the provided text.
The "Performance Data (Nonclinical and/or Clinical):" section explicitly states: "Non-clinical testing demonstrated that the Zimmer Trabecular Metal Reverse Shoulder System is as safe and effective as the predicate devices." This general statement does not provide specific acceptance criteria or detailed study results. The FDA's clearance (K052906) indicates that they found it "substantially equivalent" based on this information and comparison to predicates, not necessarily on a detailed study against pre-defined performance acceptance criteria unique to this device that would be included in this summary.
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Kos2906
DEC 1 9 2005
Summary of Safety and Effectiveness
| Submitter: | Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708 |
|---|---|
| Contact Person: | Dalene T. BinkleySenior Associate, Regulatory AffairsTelephone: (574) 372-4907Fax: (574) 372-4605 |
| Date: | December 16, 2005 |
| Trade Name: | Zimmer Trabecular Metal™ Reverse ShoulderSystem |
| Common Name: | Total-Shoulder System and Hemi-Shoulder System |
| Classification Nameand Reference: | 1. Prosthesis, Shoulder, Semi-constrained,metal/polymer cemented (KWS)2. Shoulder joint humeral (hemi-shoulder) metallicuncemented prosthesis (HSD)3. Shoulder joint metal/polymer non-constrainedcemented prosthesis (KWT)21 CFR § 888.3660, 888.3690 and 888.3650 |
| Predicate Devices: | Aequalis Reversed Shoulder Prosthesis,manufactured by Tornier, K041873, cleared August25, 2004.Delta Shoulder, manufactured by DePuy, K021478,cleared November 18, 2003.Encore Reverse Shoulder Prosthesis, manufacturedby Encore Medical, L.P., K041066, cleared March24, 2005.Zimmer Trabecular Metal™ Humeral Stem,manufactured by Zimmer, Inc., K041549, clearedSeptember 1, 2004. |
| Device Description: | The Zimmer Trabecular Metal™ Reverse ShoulderSystem is a modular total shoulder prosthesis thatwas designed specifically to include patients withnon-functional rotator cuffs. It was developed toeither encompass a traditional shoulder prostheses, areverse design or be transformed into a hemi-prosthesis depending on clinical cases encounteredduring the surgical procedure. |
| Intended Use: | The Zimmer Trabecular Metal Reverse ShoulderSystem is indicated for the following: |
| Reverse application: | |
| - the treatment of severe pain or significantdisability in degenerative, rheumatoid, ortraumatic disease of the glenohumeral joint,- ununited humeral head fractures of longduration,- irreducible 3-and 4-part proximal humeralfractures,- avascular necrosis of the humeral head,- rotator cuff arthropathy, or- other difficult clinical management problems(such as a failed total shoulder arthroplasty orgrossly rotator cuff deficient joint) wherearthrodesis or resectional arthroplasty is notacceptable. | |
| Hemiarthroplasty/Total application: | |
| - the treatment of severe pain or significantdisability in degenerative, rheumatoid, ortraumatic disease of the glenohumeral joint,- ununited humeral head fractures of longduration,- irreducible 3-and 4-part proximal humeralfractures,- avascular necrosis of the humeral head | |
| The assembled humeral component may beused alone for hemiarthroplasty or combinedwith the glenoid component or reversecomponents for total shoulder arthroplasty(conventional or reverse applications). | |
| The Trabecular Metal humeral and reverse baseplate components are intended for eithercemented or uncemented use. The reverse baseplate requires two screws for initial fixation. | |
| Comparison to Predicate Device: | The Zimmer Trabecular Metal Reverse ShoulderSystem is packaged, manufactured, and sterilizedusing the same or similar materials and processes asthe predicate devices. The subject device also hassimilar intended use and fixation methods as thepredicate devices. |
| Performance Data (Nonclinicaland/or Clinical): | Non-Clinical Performance and Conclusions:Non-clinical testing demonstrated that the ZimmerTrabecular Metal Reverse Shoulder System is assafe 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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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is simple and recognizable, representing the department's role in protecting the health of all Americans.
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 (240) 276-0120. 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 (800) 638-2041 or (301) 443-6597 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
Page 1 of 1
510(k) Number K052906
§ 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.”