(131 days)
The Arthrex Univers II Shoulder Prosthesis is indicated in replacements(s) when conditions include severe pain or significant disability resulting from degenerative, rheumatoid, traumatic disease, or injury of the glenohumeral joint; non-union humeral head fractures of long duration; irreducible 2- 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 glenoid components are designed for cemented fixation in the joint and must only be used with an appropriate bone cement.
The Arthrex Univers II Shoulder Prosthesis consists of a stem for attachment to the humerus, a spherical head for replacing the humeral head, and a trunnion construct to connect the stem to the spherical head. The modified device is identical to the cleared predicate (K010124) except for how it addresses two of the three key angles that can be adapted to match the geometry of the humeral head.
This is a 510(k) summary for a medical device, the Arthrex Univers II Shoulder Prosthesis, not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, ground truth, and training sets is not applicable in the context of AI/ML performance evaluation.
This document describes a medical device submission based on "substantial equivalence" to a predicate device (Arthrex Shoulder Prosthesis (Univers Shoulder), K010124). For devices cleared via 510(k), particularly those seeking substantial equivalence to a predicate, the "study" demonstrating that the device meets "acceptance criteria" often refers to non-clinical testing (e.g., mechanical, materials, biocompatibility) and a comparison of the new device's characteristics and intended use to those of the predicate device. The FDA's letter explicitly states: "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..."
Therefore, I cannot provide the requested information as it is not present in the provided text, nor would it typically be part of a 510(k) for a non-AI medical implant.
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K07/032
AUG 2 0 2007
Arthrex 8 SPECIAL 510(k): Arthrex Univers II Shoulder Prosthesis
4 510(k) Summary of Safety and Effectiveness
| Manufacturer | Arthrex Med. Inst. GmbHLiebigstrasse 13D-85757 Karlsfeld/MünchenGermany |
|---|---|
| Distributor/Sponsor | Arthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USA |
| 510(k) Contact | Nancy HoftRegulatory Affairs AssociateArthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USATelephone: 239/643.5553, ext. 1113Fax: 239/598.5508Email: nancy.hoft@arthrex.com |
| Trade Name | Arthrex Univers II Shoulder Prosthesis |
| Common Name | Shoulder Prosthesis |
| Product Code -Classification Name | KWS - Prosthesis, Shoulder, semi constrained metal/polymer,cementedHSD - Prosthesis, Shoulder, hemi-humeral, metal, uncemented |
| Predicate Device | Arthrex Shoulder Prosthesis (Univers Shoulder), K010124 |
| Device Descriptionand Intended Use | The Arthrex Univers II Shoulder Prosthesis consists of a stem forattachment to the humerus, a spherical head for replacing thehumeral head, and a trunnion construct to connect the stem to thespherical head. The modified device is identical to the clearedpredicate (K010124) except for how it addresses two of the threekey angles that can be adapted to match the geometry of thehumeral head.The Arthrex Univers II Shoulder Prosthesis is indicated inreplacements(s) when conditions include severe pain or significantdisability resulting from degenerative, rheumatoid, traumatic disease,or injury of the glenohumeral joint; non-union humeral head fracturesof long duration; irreducible 2- and 4- part proximal humeralfractures; avascular necrosis of the humeral head; or other difficultclinical management problems where arthrodesis or resectional |
| arthroplasty is not acceptable. | |
| The glenoid components are designed for cemented fixation in thejoint and must only be used with an appropriate bone cement. | |
| SubstantialEquivalence Summary | The Arthrex Univers II Shoulder Prosthesis is substantiallyequivalent to the predicate Arthrex Univers Shoulder Prosthesis inwhich the basic features and intended uses are the same. Anydifferences between the Arthrex Univers II Shoulder Prosthesis andthe predicate Arthrex Univers Shoulder Prosthesis are consideredminor and do not raise questions conceming safety andeffectiveness. Based on the information submitted, Arthrex, Inc. hasdetermined that the new Arthrex Univers II Shoulder Prosthesis issubstantially equivalent to the currently marketed predicate device. |
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Arthrex D SPECIAL 510(k): Arthrex Univers II Shoulder Prosthesis
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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 stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 0 2007
Arthrex, Inc. % Ms. Nancy Holt Regulatory Affairs Associate 1370 Creekside Boulevard Naples, FL 34108-1945
Re: K071032
Trade/Device Name: Arthrex Univers II Shoulder Prosthesis Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal-polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: KWS, HSD Dated: July 20, 2007 Received: July 23, 2007
Dear Ms. Holt:
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. Nancy Holt
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/cdrh/dsma/dsmamain.html
Sincerely vours.
Barbara Buchup
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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SPECIAL 510(k): Arthrex Univers II Shoulder Prosthesis
Indications for Use
510(k) Number:
Device Name:
Arthrex Univers II Shoulder Prosthesis
The Arthrex Univers II Shoulder Prosthesis is indicated in replacements(s) when conditions include severe pain or significant disability resulting from degenerative, rheumatoid, traumatic disease, or injury of the glenohumeral joint; non-union humeral head fractures of long duration; irreducible 2- and 4part proximal humeral fractures; avascular necrosis of the humeral head; or, other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable.
The glenoid components are designed for cemented fixation in the joint and must only be used with an appropriate bone cement.
Prescription Use X AND/OR Over-The-Counter Use (Per 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
PAGE 1 of 1
Darlene Buenn
Division of General, Restorative, and Neurological Devices
510(k) Number K07/032
Page 7 of 39
§ 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.”