(29 days)
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No
The document describes a knee implant (tibial insert and base) made of standard materials (UHMWPE and Cobalt Chrome) with no mention of software, algorithms, or any technology related to AI or ML. The description focuses solely on the physical components and their intended use in knee arthroplasty.
Yes
The device is indicated for use in knee arthroplasty to reduce or relieve pain and/or improve knee function in patients with various conditions, which aligns with the purpose of a therapeutic device.
No
Explanation: The device, the ADVANCE® 913 Medial Pivot Tibial Insert and Base, is indicated for use in knee arthroplasty to reduce pain and improve knee function in patients with various knee conditions. It is a prosthetic implant used for treatment, not for diagnosing conditions.
No
The device description clearly outlines physical components (Tibial Insert and Tibial Base) made from specific materials (UHMWPE and Cobalt Chrome alloy) with defined sizes and characteristics. This indicates a hardware medical device, not a software-only one.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The ADVANCE® 913 Medial Pivot Tibial Insert and Tibial Base are implants designed to be surgically placed within the human body to replace damaged knee joints. They are made of materials like UHMWPE and Cobalt Chrome.
- Intended Use: The intended use is for knee arthroplasty to reduce pain and improve knee function in patients with various knee conditions. This is a surgical intervention, not a diagnostic test performed on a specimen.
Therefore, based on the provided information, this device is a surgical implant, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The ADVANCE® 913 Medial Pivot Tibial Insert and ADVANCE® 913 Medial Pivot Tibial Base are indicated for use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions:
- noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
- inflammatory degenerative joint disease including rheumatoid arthritis;
- correction of functional deformity;
- revision procedures where other treatments or devices have failed; and
- treatment of fractures that are unmanageable using other techniques.
ADVANCE® 913 Medial Pivot Tibial Base and Insert Components are for usc with bone cement.
Product codes
JWH
Device Description
Tibial Insert
The design features of the ADVANCE® 913 Medial Pivot Tibial Insert are summarized below:
- Manufactured from UHMWPE conforming to ASTM F648 .
- Sizes: 1-5 Left & Right .
- Thickness: 10, 12, 14, 17 mm .
Tibial Base
The design features of the ADVANCE® 913 Medial Pivot Tibial Base are summarized below:
- Manufactured from Cobalt Chrome alloy conforming to ASTM F75 .
- Sizes: 1-5 plus .
- Symmetrical .
- No screw holes .
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
knee
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee 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 femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the alphanumeric string "K092201" written in a cursive style. To the right of this string, there is a symbol that resembles a number sign followed by "1/2". The text and symbol are written in black ink on a white background.
AUG 200 2009
ADVANCE® 913 Medial Pivot SPECIAL 510(k) Summary of Safety and Effectiveness
In accordance with the food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807, this information serves as a Summary of Safety and Effectiveness for the use of the ADVANCE® 913 Medial Pivot Tibial Insert and Base.
Submitted By:
Primary Contact:
Proprietary Name:
Common Name:
Classification Name and Reference:
Wright Medical Technology, Inc.
Sarah Fairfield
ADVANCE® 913 Medial Pivot Tibial Base ADVANCE® 913 Medial Pivot Tibial Insert
Tibial Base Tibial Insert
21 CFR 888.3560 Knee, Patellofemorotibial, Semi-constrained, cemented, Polymer/ metal/polymer Orthopedics/87/ JWH
Device Product Code and Panel Code:
A. INTENDED USES/ INDICATIONS
The ADVANCE® 913 Medial Pivot Tibial Insert and ADVANCE® 913 Medial Pivot Tibial Base are indicated for use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions:
-
- noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
-
- inflammatory degenerative joint disease including rheumatoid arthritis;
-
- correction of functional deformity;
-
- revision procedures where other treatments or devices have failed; and
-
- treatment of fractures that are unmanageable using other techniques.
ADVANCE® 913 Medial Pivot Tibial Base and Insert Components are for usc with bone cement.
1
K092201 #2/2
B. DEVICE DESCRIPTION
Tibial Insert
The design features of the ADVANCE® 913 Medial Pivot Tibial Insert are summarized below:
- Manufactured from UHMWPE conforming to ASTM F648 .
- Sizes: 1-5 Left & Right .
- Thickness: 10, 12, 14, 17 mm .
Tibial Base
The design features of the ADVANCE® 913 Medial Pivot Tibial Base are summarized below:
- Manufactured from Cobalt Chrome alloy conforming to ASTM F75 .
- Sizes: 1-5 plus .
- Symmetrical .
- No screw holes .
C. SUBSTANTIAL EQUIVALENCE INFORMATION
The indications for use for the ADVANCE® 913 Medial Pivot Tibial Insert and the ADVANCE® 913 Medial Pivot Tibial Base are identical to the indications for use for the previously cleared predicate devices. The design features of the subject devices are substantially equivalent to those of the predicate devices. The fundamental scientific technology of the modified device has not changed relative to the predicate devices. The safety and effectiveness of the ADVANCE® 913 Medial Pivot Tibial Insert and the ADVANCE® 913 Medial Pivot Tibial Base is adequately supported by the substantial equivalence information, materials information and the analysis data provided within this Premarket Notification.
2
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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Wright Medical Technology, Inc. % Ms. Sarah Fairfield Regulatory Affairs Specialist 5677 Airline Road Arlington, Tennessee 38002
AUG 200 2009
Re: K092201
Trade/Device Name: ADVANCE 913 Medial Pivot Tibial Insert, ADVANCE 913 Medial Pivot Tibial Base
Regulation Number: 21 CFR 888.3560
Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis
Regulatory Class: II Product Code: JWH Dated: July 14, 2009 Received: July 22, 2009
Dear Ms. Fairfield:
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.
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Page 2 - Ms. Sarah Fairfield
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 Buchner
Mark N. Mel Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): KO92201
Device Name: ADVANCE® 913 Medial Pivot Tibial Insert ADVANCE® 913 Medial Pivot Tibial Base
Indications For Use:
The ADVANCE® 913 Medial Pivot Tibial Insert and the ADVANCE® 913 Medial Pivot Tibial Base are indicated for use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions:
- noninflammatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or avascular necrosis
-
- inflammatory degenerative joint disease including rheumatoid arthritis:
-
correction of functional deformity;
-
revision procedures where other treatments or devices have failed: and
-
treatment of fractures that are unmanageable using other techniques.
ADVANCE® 913 Medial Pivot Tibial Base and Insert Components are for use with bone cement.
Prescription Use XXX (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)
1 of 1
Anitta for mxn
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K092201