(63 days)
The Anatomical Shoulder Inverse /Reverse system is indicated for primary, fracture or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.
The Anatomical Shoulder primary humeral stem is intended for cemented or cementless use. The Anatomical Shoulder revision humeral stem is intended for cemented use only. The Anatomical Shoulder Inverse /Reverse glenoid fixation is intended for cementless, press-fit use. It requires screws for initial fixation.
The Anatomical Shoulder Inverse / Reverse system is a reverse shoulder prosthesis that allows an intra-operative change from a conventional shoulder arthroplasty to a reverse shoulder arthroplasty. The components of the system include a glenoid fixation baseplate, a glenoid head, a humeral cup and a humeral inlay. These components are intended for use with previously submitted polyaxial screws and previously cleared humeral stems.
The provided document (K053274) is a 510(k) premarket notification for a medical device called the "Anatomical Shoulder Inverse / Reverse" system. It describes the device, its intended use, and a comparison to predicate devices, but it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the context of an AI/ML algorithm.
This document pertains to a traditional orthopedic implant, not an AI-powered diagnostic or therapeutic device. As such, the standard information requested for AI/ML device evaluations (such as sample sizes for test and training sets, expert qualifications, ground truth establishment, MRMC studies, or standalone performance) is not applicable or present in this filing.
The document states:
- "Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device." This confirms that a clinical study with human subjects, which would typically involve performance metrics and acceptance criteria, was not required for its clearance.
- "Non-Clinical Performance and Conclusions: Analysis of the glenoid components, the glenoid taper connection, glenoid fixation screw stability, the humeral taper connection, the humeral cup and the connection between the humeral cup and the humeral inlay indicate that all components are adequate for their intended use." This refers to mechanical and material testing of the components, which are common for orthopedic implants, but these are not the "acceptance criteria" in the context of an AI/ML study.
Therefore, I cannot provide the requested table and information, as it is not present in the given 510(k) summary for this type of device.
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K 053274
JAN 2 5 2006
!②
Summary of Safety and Effectiveness
| Submitter: | Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708 |
|---|---|
| Contact Person: | Dalene T. Binkley, RACSenior Associate, Regulatory AffairsTelephone: (574) 372-4907Fax: (574) 372-4605 |
| Date: | January 18, 2006 |
| Trade Name: | Anatomical Shoulder™ Inverse / Reverse |
| Common Name: | Total Shoulder Prosthesis |
| Classification Namesand references: | 1. Prosthesis, shoulder, semi-constrained,metal/polymer cemented (KWS) - 888.36602. Shoulder joint metal/polymer non-constrainedcemented prosthesis (KWT) - 888.3650 |
| Predicate Devices: | • Tornier Aequalis Reversed Shoulder Prosthesis,K041873, cleared August 25, 2004• DePuy Orthopaedics Delta Shoulder,K021478, cleared November 18, 2003• Encore Medical Encore Reverse ShoulderProsthesis, K041066, cleared March 24, 2005• Centerpulse Orthopaedics Anatomical ShoulderSystem with Removable Heads, K030259,cleared April 24, 2003. |
| Device Description: | The Anatomical Shoulder Inverse / Reverse systemis a reverse shoulder prosthesis that allows an intra-operative change from a conventional shoulderarthroplasty to a reverse shoulder arthroplasty. Thecomponents of the system include a glenoid fixationbaseplate, a glenoid head, a humeral cup and ahumeral inlay. These components are intended foruse with previously submitted polyaxial screws andpreviously cleared humeral stems. |
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053274
2012
| Intended Use: | The Anatomical Shoulder Inverse /Reverse systemis indicated for primary, fracture or revision totalshoulder replacement for the relief of pain andsignificant disability due to gross rotator cuffdeficiency. |
|---|---|
| The patient's joint must be anatomically andstructurally suited to receive the selected implantsand a functional deltoid muscle is necessary to usethe device. | |
| The Anatomical Shoulder primary humeral stem isintended for cemented or cementless use. TheAnatomical Shoulder revision humeral stem isintended for cemented use only. The AnatomicalShoulder Inverse /Reverse glenoid fixation isintended for cementless, press-fit use. It requiresscrews for initial fixation. | |
| Comparison to Predicate Devices: | The Anatomical Shoulder Inverse /Reverse systemis substantially equivalent to the predicate devicesin regards to its intended use, design, size ranges,materials and manufacturing methods. |
| Performance Data (Nonclinicaland/or Clinical): | Non-Clinical Performance and Conclusions:Analysis of the glenoid components, the glenoidtaper connection, glenoid fixation screw stability,the humeral taper connection, the humeral cup andthe connection between the humeral cup and thehumeral inlay indicate that all components areadequate for their intended use. |
| Clinical Performance and Conclusions:Clinical data and conclusions were not needed forthis device. |
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with three heads, representing the department's focus on health, human services, and science. The eagle is surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 5 2006
Zimmer GMBH C/O Dalene Binkley Zimmer, Inc P.O. Box 708 Warsaw, Indiana 46581
Re: K053274
Trade/Device Name: Anatomical Shoulder™ Inverse / Reverse Regulation Number: 21 CFR 888.3660 Regulation Name: Prosthesis, Shoulder, semi-constrained, metal/polymer cemented Regulatory Class: II Product Code: KWS, KWT Dated: November 22, 2005 Received: November 23, 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 agencics. 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 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) 276-0210. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Mark N. Melkerson
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:
Anatomical Shoulder " Inverse / Reverse system
Indications for Use:
The Anatomical Shoulder Inverse /Reverse system is indicated for primary, fracture or revision total shoulder replacement for the relief of pain and significant disability due to gross rovator off deficiency.
The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.
The Anatomical Shoulder primary humeral stem is intended for cementless use. The Anatomical Shoulder revision humeral stem is intended for cemented use only. The Anatonical Shoulder Inverse /Reverse glenoid fixation is intended for cementless, press-fit use. It requires screws for initial fixation.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Signature
(Division Sign of General, Restorative, and Neurological Devic
510(k) Num
Page 1 of 1
§ 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.”