(218 days)
No
The summary describes a mechanical shoulder prosthesis and does not mention any AI or ML components or functionalities.
Yes
The device is a prosthesis indicated for replacement due to severe pain or significant disability from various joint conditions, aiming to alleviate symptoms and restore function.
No
This device is a shoulder prosthesis, indicated for replacement of the glenohumeral joint due to various conditions. It is an implant used for treatment/repair, not for diagnosing conditions.
No
The device description clearly states it is a physical implant (shoulder prosthesis) made from UHMWPE with pegs for fixation, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing a joint (glenohumeral joint) due to various conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a physical prosthesis made of UHMWPE designed for surgical implantation and articulation within the body. This is consistent with a medical device used for treatment, not for analyzing samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a physical implant used to restore function and alleviate pain within the body.
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, theumatoid, 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.
Product codes
KWS, HSD
Device Description
The Arthrex Univers II Shoulder Pegged Glenoid is manufactured in three sizes from UHMWPE. The glenoid articular (lateral) surface is concave and articulates with the humeral head of the Univers or Univers II humeral stems. The fixation (medial) surface is convex and is designed with three pegs for cement interdigitation fixation. The glenoid components are designed for cemented fixation in the joint and must only be used with an appropriate.bone cement.
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
Prescription Use
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
K083435 (pg. 1 of 2)
JUN 26 2009
. .
Arthrex: SPECIAL: 510(li); Arthrex Univers II Shoulder Peagged Glenoid
:
:
510(Jk) Summary of Safety and Eilectiv
| Manufacturer/Distributor/Sponsor | Arthrex, Inc.
1370 Creekside Boulevard
Naples, FL 34108-1945 USA |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact | Sally Foust
Regulatory Affairs Project Manager
Arthrex, Inc.
1370 Creekside Boulevard
Naples, FL 34108-1945 USA
Telephone: 239/643.5553, ext. 1251
Fax: 239/598.5508
Email: sally.foust@arthrex.com |
| Trade Name | Arthrex Univers II Shoulder Pegged Glenoid |
| Common Name | Shoulder Prosthesis |
| Product Code -Classification Name | KWS - Prosthesis, Shoulder, semi constrained
metal/polymer, cemented
HSD - Prosthesis, Shoulder, hemi-humeral, metal,
uncemented |
| Predicate Devices | Arthrex Univers II Shoulder Prosthesis, K071032
Arthrex Univers Shoulder Prosthesis, K010124 |
| Device Description and Intended
Use | The Arthrex Univers II Shoulder Pegged Glenoid is
manufactured in three sizes from UHMWPE. The
glenoid articular (lateral) surface is concave and
articulates with the humeral head of the Univers or
Univers II humeral stems. The fixation (medial) surface is
convex and is designed with three pegs for cement
interdigitation fixation.
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 Pegged Glenoid 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 Pegged Glenoid and the
predicate Arthrex Univers Shoulder Prosthesis or
Univers II 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 Pegged Glenoid is substantially
equivalent to the currently marketed predicate device. |
1
K083435 (pg. 2 of 2)
ArthreX SPECIAL 510gly): Arthrex Univers II Shoulder Peagged Glerioid
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA".
Public Health Service
JUN 26 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Arthrex, Incorporated % Ms. Sally Foust, RAC Regulatory Affairs Project Manager 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K083435
Trade/Device Name: Arthrex Univers II Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal-polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: KWS, HSD Dated: May 29, 2009 Received: June 3, 2009
Dear Ms. Foust:
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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. Sally Foust, RAC
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/cdrh/comp/ for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Harbay Mueller
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
K083435-Arthrex, Incorporated
4
Arthrex SPECIAL 510(k): Airthrex Univers 11 Shoulder Regged Glenolds
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, theumatoid, 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 Byaluation (ODE)
PAGE 1 of 1
Charlae Burns
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K083435