(13 days)
No
The document describes a physical implant (glenoid component) and does not mention any software, algorithms, or AI/ML capabilities.
Yes
This device is a therapeutic device because its intended use is to treat severely painful and/or disabled joints, fracture-dislocations, and other difficult clinical problems by replacing the shoulder joint a total shoulder replacement surgery through arthroplast.
No
Explanation: The device is a glenoid component for total shoulder replacement surgery, which is a therapeutic intervention, not a diagnostic tool.
No
The device description explicitly states the glenoid component is manufactured from crosslinked polyethylene, indicating it is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description and Intended Use: The provided information clearly describes a surgical implant (a glenoid component for shoulder replacement) that is intended to be surgically implanted inside the human body to replace a damaged joint. It is a physical device used in a surgical procedure, not a test performed on a sample.
Therefore, based on the provided information, the StepTech™ Anchor Peg Glenoid is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The StepTech Anchor Peg Glenoid is intended for use in total shoulder replacement surgery for patients suffering from:
-
- A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis.
-
- Fracture-dislocations of the proximal humerus where the articular surface is severely communited, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory.
-
- Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component).
Glenoid components are intended for cemented use only.
Product codes
KWS
Device Description
The DePuy Global Shoulder StepTech Anchor Peg Glenoid is designed for use as the glenoid component in a total shoulder arthroplasty. The glenoid is manufactured from crosslinked polyethylene conforming to ASTM F648, and is offered in sizes 40, 44, 48, 52 and 56 (bearing diameter and outside profile size) with step heights of +3, +5 and +7 (size of posterior buildup).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
JUL 2 7 2009
92122
Section 6: 510 (k) Summary
(As required by 21 CFR 807.92 and 21 CFR 807.93)
510(K) OWNER:
DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46582 Establishment Registration Number: 1818910
510(K) CONTACT:
Rhonda Myer Senior Regulatory Affairs Associate Telephone: (574) 371-4927 Facsimile: (574) 371-4987 Electronic Mail: Rmyer7@its.jnj.com
DATE PREPARED:
PROPRIETARY NAME:
COMMON NAME:
CLASSIFICATION:
July 8, 2009
DePuy Global Shoulder StepTech" Anchor Peg Glenoid
Shoulder Prosthesis
21 CFR 888.3660 - Shoulder joint metal/polymer semi-constrained cemented prosthesis
DEVICE PRODUCT CODE:
KWS
SUBSTANTIALLY EQUIVALENT DEVICE:
DePuy Global Shoulder Crosslinked Glenoid. K052472 (October 11, 2005)
DEVICE DESCRIPTION:
The DePuy Global Shoulder StepTech Anchor Peg Glenoid is designed for use as the glenoid component in a total shoulder arthroplasty. The glenoid is manufactured from crosslinked polyethylene conforming to ASTM F648, and is offered in sizes 40, 44, 48, 52 and 56 (bearing diameter and outside profile size) with step heights of +3, +5 and +7 (size of posterior buildup).
DePuy Orthopaedics, Inc.
1
INDICATIONS FOR USE:
The StepTech Anchor Peg Glenoid is intended for use in total shoulder replacement surgery for patients suffering from:
-
- A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis.
-
- Fracture-dislocations of the proximal humerus where the articular surface is severely communited, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory.
-
- Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component).
Glenoid components are intended for cemented use only.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The subject Global Shoulder StepTech Anchor Peg Glenoid has the same indications for and intended use, material, sterilization, packaging, and bearing sizes as the previouslycleared DePuy Global Shoulder Crosslinked Glenoids, K052472. The difference between the subject and predicate device is that the subject glenoid has a step in the backside geometry. Because of these similarities, DePuy proposes that the subject of this submission, the Global Shoulder StepTech Anchor Peg Glenoid, is substantially equivalent to the predicate Global Shoulder Crosslinked Glenoid, cleared in K052472 on October 11, 2005.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
DePuy Orthopaedics, Inc. % Ms. Rhonda A. Myer Senior Regulatory Associate, Regulatory Affairs P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
JUL 2 7 2009
Re: K092122
Trade/Device Name: Global Shoulder StepTech Anchor Peg Glenoid Regulation Number: 21 CFR. 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: KWS Dated: July 9, 2009 Received: July 14, 2009
Dear Ms. Myer:
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 (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.
Image /page/2/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized depiction of an eagle, with its wings spread and head turned to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
3
Page 2 - Ms. Rhonda A. Myer
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,
Barbara Buell
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Section 5: Indications for Use Statement
510 (k) Number (if known): _ 6,092122
Device Name: DePuy Global Shoulder StepTech™ Anchor Peg Glenoid
Indications for Use:
The StepTech™ Anchor Peg Glenoid is intended for use in total shoulder replacement surgery for patients suffering from:
-
- A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis.
-
- Fracture-dislocations of the proximal humerus where the articular surface is severely communited, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory.
-
- Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component).
Glenoid components are intended for cemented use only.
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.)
Oputa
(Division Sign-Off)
for nym
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K092122
DePuy Orthopaedics, Inc.
Global Shoulder StepTech Anchor Peg Glenoid Special 510(k)
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