(30 days)
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No
The document describes a knee implant system made of UHMWPE and focuses on its intended use and material composition, with no mention of AI or ML.
Yes
The device is indicated for the reduction or relief of pain and improved knee function in patients with various degenerative joint diseases and fractures, which aligns with the definition of a therapeutic device.
No
The device is a knee system intended for surgical intervention to reduce pain and improve knee function, not to diagnose a condition.
No
The device description explicitly states the device is a "tibial component" made of "ultra high molecular weight polyethylene (UHMWPE)", which is a physical hardware component.
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 treating knee conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is described as a knee system component made of UHMWPE, designed for surgical implantation. This aligns with a medical device used in surgery, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing information for diagnosis.
- Anatomical Site: The device is used directly on the knee joint during surgery. IVDs typically interact with biological samples.
Therefore, this device falls under the category of a medical device used for surgical treatment, not an in vitro diagnostic device.
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 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.
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 (comma separated list FDA assigned to the subject device)
HRY
Device Description
The ADVANCE® Unicondylar Knee System Less Conforming Tibial Component will be offered based on surgeon preference and patients requiring less conforming tibial components. The tibial components will consist of all poly ultra high molecular weight polyethylene (UHMWPE).
The design features of ADVANCE® Less Conforming Tibial Component are substantially equivalent to the design features of previously cleared predicate devices cited in this Premarket Notification.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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FEB 2 0 2003
Image /page/0/Picture/1 description: The image shows the logo for Wright Medical Technology. The logo consists of a stylized "W" formed by three thick, angled lines on the left. To the right of the "W" is the text "WRIGHT MEDICAL TECHNOLOGY" stacked vertically in three lines. The font is a serif typeface, and the entire logo is in black.
A Wright Medical Group Company
K030193
Page 1 of 2
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 ADVANCE® Less Conforming Tibial Component.
| Submitted By: | Wright Medical Technology, Inc. |
|---|---|
| Date: | January 15, 2003 |
| Contact Person: | Tim Crabtree |
| Senior Regulatory Affairs Specialist | |
| Phone: 901-867-4754 Fax: 901-867 4630 | |
| Proprietary Name: | ADVANCE® Less Conforming Tibial Component |
| Common Name: | Unicondylar Knee System |
| Classification Name and Reference: | 21 CFR 888.3530 Prosthesis |
| Device Product Code and Panel Code: | Orthopedics/87/HRY |
DEVICE INFORMATION
A. INTENDED USES/ INDICATIONS
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.
Image /page/0/Picture/15 description: The image shows the logo for Wright Medical Technology. The logo consists of a stylized "W" on the left, followed by the words "WRIGHT MEDICAL" stacked on top of "TECHNOLOGY". Below the logo is the text "A Wright Medical Group Company".
Image /page/0/Picture/16 description: The image shows a black and white drawing of a person's face in profile. The person has a prominent nose and chin, and their hair is pulled back. The drawing is somewhat stylized, with bold lines and shading. The person's expression is neutral.
1
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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 Less Conforming Tibial Component will be offered based on surgeon preference and patients requiring less conforming tibial components. The tibial components will consist of all poly ultra high molecular weight polyethylene (UHMWPE).
The design features of ADVANCE® Less Conforming Tibial Component are substantially equivalent to the design features of previously cleared predicate devices cited in this Premarket Notification.
C. SUBSTANTIAL EQUIVALENCE INFORMATION
The intended use, material, and design features of the ADVANCE® Less Conforming Tibial Component are substantially equivalent to the previously cleared predicate devices cited in this submission. The safety and effectiveness of the ADVANCE® Less Conforming Tibial Component is adequately supported by the substantial equivalence information, materials, and testing results provided within this Premarket Notification.
Image /page/1/Picture/9 description: The image shows a black and white illustration of a human torso. The torso is in a side view, and the internal organs are visible. The organs include the lungs, heart, liver, and intestines. The illustration is detailed and appears to be from an anatomy textbook.
Image /page/1/Picture/10 description: The image shows the logo for Wright Medical Technology. The logo features a stylized "W" on the left, followed by the words "WRIGHT MEDICAL TECHNOLOGY" stacked on top of each other. Below the logo is the text "A Wright Medical Group Company".
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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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 0 2003
Mr. Tim Crabtree Senior Regulatory Affairs Specialist Wright Medical Technology, Inc. 5677 Airline Road Arlington, TN 38002
Re: K030193 Trade/Device Name: ADVANCE® Less Conforming Tibial Component Regulation Number: 21 CFR 888.3530 Regulation Name: Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: HRY Dated: January 17, 2003 Received: January 21, 2003
Dear Mr. Crabtree:
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,
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Page 2 - Mr. Tim Crabtree
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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 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,
Miriam C. Provost
for 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
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Image /page/4/Picture/0 description: The image shows the logo for Wright Medical Technology. The logo consists of a stylized "W" formed by three thick, angled bars on the left. To the right of the "W" are the words "WRIGHT MEDICAL TECHNOLOGY" stacked vertically in a serif font. The word "WRIGHT" is on top, followed by "MEDICAL" and then "TECHNOLOGY".
A Wright Medical Group Company
ADVANCE® Less Conforming Tibial Component
K030193
Page 1 of 1
INDICATIONS STATEMENT
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; 3)
-
- revision procedures where other treatments or devices have failed; and
-
- treatment 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 (ODE)
Miriam C. Provost
eral. Restorative and Neurologic
(Division Sign-Off) Division of General Restorative Devices 510(k) Number
Prescription Use
(Per21 CFR 801.10510(k) Number K0309R93
Over-The Counter Use (Optional Format 1-2-96)
Image /page/4/Picture/21 description: The image shows the logo for Wright Medical Technology. The logo consists of a large, stylized "W" on the left, followed by the words "WRIGHT MEDICAL TECHNOLOGY" stacked on top of each other. Below the logo, there is the text "A Wright Medical Group Company".
Image /page/4/Picture/22 description: The image shows the text "INDICATIONS STATEMENT.doc" in a serif font. The text is black and is set against a white background. The text appears to be a file name, likely a document related to indications statements.
Image /page/4/Picture/23 description: The image is a black and white illustration of a human torso. The torso is in a side view, and the internal organs are visible. The lungs, heart, and other organs are clearly visible. The image is likely from a medical textbook or other educational material.