(84 days)
Not Found
Not Found
No
The device description focuses solely on the physical components of a knee implant and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
Yes
The device is indicated for use in knee arthroplasty for the reduction or relief of pain and/or improved knee function, which directly addresses a medical condition (joint disease, fractures) and aims to restore or improve the patient's health and quality of life.
No
This device is a knee arthroplasty system intended for the reduction or relief of pain and/or improved knee function, which indicates it is a therapeutic or reconstructive device, not a diagnostic one.
No
The device description clearly outlines physical components made of Co-Cr and UHMWPE, which are hardware implants for knee arthroplasty.
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 knee arthroplasty to treat joint diseases and deformities. This is a therapeutic device, not a diagnostic one.
- Device Description: The device description details physical components (femoral and tibial implants) made of materials like Co-Cr and UHMWPE, which are typical for surgical implants.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
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 replace or augment a damaged joint.
N/A
Intended Use / Indications for Use
Indicated for use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following:
-
- noninflammatory degenerative joint disease including osteoarthritis, traunanc arthritis, or avascular necrosis;
-
- inflammatory degenerative joint disease including rheumatoid arthuitis;
-
- correction of functional deformity;
-
- revision procedures where other treatments or devices have failed; and
- treatment of fractures that are unmanageable using other techniques. 5)
Unicondylar knee system is indicated for patients with unicompartmental joint disease secondary to the above indications with or without valgus, varus, or flexion deformities where all ligaments are intact.
The ADVANCE® Unicondylar Knee System components are for single use only.
The ADVANCE® Unicondylar Knee System components are for cemented use only.
Product codes
HSX, HRY
Device Description
The ADVANCE® Unicondylar Knee System contains anatomically shaped, medial, nonporous Co-Cr femoral components. The tibial components will consist of all-poly ultrahigh molecular-weight polyethylene (UHMWPE) tibial implants.
The ADVANCE® Unicondylar Femoral component will be available in four anatomic sizes (to provide coverage of the condyle from posterior to anterior). The anatomic shape of the femoral component necessitates separate left and right configurations.
The ADVANCE® Unicondylar Tibial component will be available in four sizes (universal in shape- no lefts and rights).
The design features of ADVANCE® Unicondylar Knee System are substantially equivalent to the design features of competitive devices previously cleared for market.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
Indicated Patient Age Range
skeletally mature patients
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace part of 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 consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial 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.
0
K0/259/
NOV 0 2 2001
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 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of the ADVANCE® Unicondylar Knee System.
Submitted By:
Date:
Contact Person:
Proprietary Name:
Common Name:
Classification Name and Reference:
Wright Medical Technology, Inc.
August 9, 2001
Ehab M. Esmail Manager, Regulatory Affairs
ADVANCE® Unicondylar Knee System
UNICONDYLAR KNEE SYSTEM
21 CFR 888.3520 Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer -Class II
21 CFR 888.3530 Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer -Class II
Device Product Code and Panel Code:
Orthopedics/87/ HSX, HRY
DEVICE INFORMATION
A. INTENDED USE
Indicated for use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following:
-
- noninflammatory degenerative joint disease including osteoarthritis, traunanc arthritis, or avascular necrosis;
-
- inflammatory degenerative joint disease including rheumatoid arthuitis;
-
- correction of functional deformity;
-
- revision procedures where other treatments or devices have failed; and
- treatment of fractures that are unmanageable using other techniques. 5)
Image /page/0/Picture/27 description: The image shows the logo for Wright Medical Technology, Inc. The logo features a stylized "W" above the word "WRIGHT" in a bold, sans-serif font. Below "WRIGHT" is the text "MEDICAL TECHNOLOGY, INC." in a smaller font. There is also some text on the left side of the image, but it is too blurry to read.
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IOFD
51000 SUMMARY
KNIGHT
AL TECHNOLOGY, INC.
1
K012591
2 of 2
Unicondylar knee system is indicated for patients with unicompartmental joint disease secondary to the above indications with or without valgus, varus, or flexion deformities where all ligaments are intact.
The ADVANCE® Unicondylar Knee System components are for single use only.
The ADVANCE® Unicondylar Knee System components are for cemented use only.
B. DEVICE DESCRIPTION
The ADVANCE® Unicondylar Knee System contains anatomically shaped, medial, nonporous Co-Cr femoral components. The tibial components will consist of all-poly ultrahigh molecular-weight polyethylene (UHMWPE) tibial implants.
The ADVANCE® Unicondylar Femoral component will be available in four anatomic sizes (to provide coverage of the condyle from posterior to anterior). The anatomic shape of the femoral component necessitates separate left and right configurations.
The ADVANCE® Unicondylar Tibial component will be available in four sizes (universal in shape- no lefts and rights).
The design features of ADVANCE® Unicondylar Knee System are substantially equivalent to the design features of competitive devices previously cleared for market.
C. SUBSTANTIAL EQUIVALENCE INFORMATION
The intended use, material, type of interface, and design features of ADVANCE® Unicondylar Knee System are substantially equivalent to the predicate devices previously cleared for market. The safety and effectiveness of ADVANCE® Unicondylar Knee System are adequately supported by the substantial equivalence information, materials data, and testing results provided within the Premarket Notification.
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2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings. The eagle is facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 0 2 2001
Mr. Ehab M. Esmail Manager, Regulatory Affairs Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002
Re: K012591
Trade/Device Name: ADVANCE® Unicondylar Knee System Regulation Number: 21 CFR 888.3530 Regulation Name: Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: HRY Dated: August 9, 2001 Received: August 10, 2001
Dear Mr. Esmail:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becall be o(s) fee device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 use surved in the entrebate) 77 ttg enactment date of the Medical Device Amendments, or to conninered pror to 1125 2017 11:11 accordance with the provisions of the Federal Food, Drug, de rices that have been recises of require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, dierelove, mains 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 If your device is elabilitional controls. Existing major regulations affecting your device can may be back 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 r lease of acrised a determination that your device complies with other requirements of the Act that I Drives Internet and regulations administered by other Federal agencies. You must or mry receits 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 Of It Part 607); adoming (21 CFR Part 820); and if applicable, the electronic forth in also quind provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Mr. Ehab M. Esmail
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to obgen mailsoning your and equivalence of your device to a legally premits that in the Pro Promating of 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 and II you desire specific advice for your dovitro diagnostic devices), please contact the Office of additionally 21 CF R Fart 607.10 for the market on the promotion and advertising of Compliance at (301) 594-4639. Additionally, 18 41-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Tegulation clittined, "Misoranang of responsibilities under the Act may be obtained from the Outler general information on your respectional and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
L. Mark N. Milliman
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/0 description: The image shows a sequence of handwritten characters and numbers. The sequence starts with the letter 'k', followed by the number '0', then '1', '2', '5', '9', and ends with '1'. The characters are written in a simple, slightly uneven style, typical of handwriting.
NOV 0 2 2001
ADVANCE® Unicondylar Knee System
INDICATIONS STATEMENT
Indicated for use in knee arthroplasty for reduction or relief of pain and/or improved Indicated for ass as as a leater 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;
-
- convoluon of raires where other treatments or devices have failed; and
-
- freatment of fractures that are unmanageable using other techniques.
Unicondylar knee system is indicated for patients with unicompartmental joint disease secondary to the above indications with or without valgus, varus, or flexion deformities where all ligaments are intact.
The ADVANCE® Unicondylar Knee System components are for single use only.
The ADVANCE® Unicondylar Knee System components are for cemented use only.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (OD
for Mark A. Millane
Division Sior Division of General Re Devices 510(k) Number
Prescription Use
(Per21 CFR 801.109) X
OR
Over-The Counter Use (Optional Format 1-2-96)
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INDICATIONS STATEMENT
2012-214 14 11 11 1 1 1 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Image /page/4/Picture/23 description: The image shows a logo for Wright Medical Technology. The logo features a stylized "W" on the left, followed by the words "WRIGHT MEDICAL TECHNOLOGY" stacked vertically. Below the logo, it says "A Wright Medical Group Company" in smaller font. The logo appears to be for a medical technology company.