(131 days)
No
The document describes a mechanical shoulder prosthesis and does not mention any AI or ML components or functionalities.
Yes
The device is a prosthesis indicated for replacing the glenohumeral joint due to pain or disability from various conditions, which is a therapeutic function.
No
Explanation: The device description clearly states it is a "shoulder prosthesis" used for replacement in cases of degenerative disease, trauma, or injury, which indicates it is a therapeutic device, not a diagnostic one. Its function is to replace, not to detect or diagnose.
No
The device description clearly states it consists of physical components like a stem, spherical head, and trunnion, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description and intended use clearly state that this device is a shoulder prosthesis designed for surgical implantation to replace parts of the shoulder joint. It is a physical implant used within the body, not a test performed on samples from the body.
Therefore, based on the provided information, the Arthrex Univers II Shoulder Prosthesis is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
KWS, HSD
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
glenohumeral joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
0
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. GmbH
Liebigstrasse 13
D-85757 Karlsfeld/München
Germany |
|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Distributor/Sponsor | Arthrex, Inc.
1370 Creekside Boulevard
Naples, FL 34108-1945 USA |
| 510(k) Contact | Nancy Hoft
Regulatory Affairs Associate
Arthrex, Inc.
1370 Creekside Boulevard
Naples, FL 34108-1945 USA
Telephone: 239/643.5553, ext. 1113
Fax: 239/598.5508
Email: 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,
cemented
HSD - Prosthesis, Shoulder, hemi-humeral, metal, uncemented |
| Predicate Device | Arthrex Shoulder Prosthesis (Univers Shoulder), K010124 |
| Device Description
and Intended Use | 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.
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. |
| Substantial
Equivalence Summary | The Arthrex Univers II Shoulder Prosthesis is substantially
equivalent to the predicate Arthrex Univers Shoulder Prosthesis in
which the basic features and intended uses are the same. Any
differences between the Arthrex Univers II Shoulder Prosthesis and
the predicate Arthrex Univers Shoulder Prosthesis are considered
minor and do not raise questions conceming safety and
effectiveness. Based on the information submitted, Arthrex, Inc. has
determined that the new Arthrex Univers II Shoulder Prosthesis is
substantially equivalent to the currently marketed predicate device. |
1
Arthrex D SPECIAL 510(k): Arthrex Univers II Shoulder Prosthesis
.
2
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.
3
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
4
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