(85 days)
Not Found
No
The document describes a knee implant system and its components, with no mention of AI or ML technology in the intended use, device description, or performance studies sections.
Yes
The device is indicated for the reduction or relief of pain and/or improved knee function, which are therapeutic effects.
No
The device description indicates it is a component of a knee replacement system (ADVANCE® Unicondylar Knee System) and is used for treatment, not for diagnosing conditions.
No
The device description clearly details physical components made of metal and UHMWPE, which are implanted in the knee. This is a hardware medical device, not software-only.
Based on the provided text, 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 various knee conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The device description details the physical components of a knee implant (femoral component, tibial components made of metal and plastic). This is consistent with a surgical implant.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device is a physical implant used in the body to treat a condition.
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, 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)
HSX, HRY
Device Description
The ADVANCE® Unicondylar modular metal-backed tibia is part of the ADVANCE® Unicondylar Knee System that was previously submitted and cleared under 510(k): K012591- ADVANCE® Unicondylar Knee System. Wright Medical Technology is now enhancing the ADVANCE® Unicondylar Knee System by adding a modular titanium metal-backed UHMWPE tibial component. The ADVANCE® Unicondylar Knee System now contains the following components; Co-Cr femoral component, all-poly ultra-high molecular-weight polyethylene (UHMWPE) tibial component and modular titanium metal-backed UHMWPE tibial component.
The ADVANCE® Unicondylar femoral component is identical to the femoral component previously submitted and cleared under ADVANCE® Unicondylar Knee System -510(k): K012591.
The ADVANCE® Unicondylar all-poly tibial component is identical to the all-poly tibial component previously submitted and cleared under ADVANCE® Unicondylar Knee System - 510(k): K012591.
The ADVANCE® Unicondylar modular metal-backed tibial base is manufactured from The ADVANCE® Unicondylar modular tibial insert is titanium (ASTM F136). manufactured from the identical UHMWPE as the ADVANCE® Unicondylar all-poly tibial components (510(k): K012591). The profile and sizing (Sizes 1, 2, 3 & 4) of the ADVANCE® Unicondylar modular metal-backed tibial components are identical to the ADVANCE® Unicondylar all-poly tibial components (510(k): K012591). The cement interface for the ADVANCE® Unicondylar modular metal-backed tibial components consist of a peripheral dovetail and two pegs and is substantially equivalent to the cement interface of the ADVANCE® Unicondylar all-poly tibial components (510(k): K012591). The articulating surface is identical for both the ADVANCE® Unicondylar modular metal-backed tibial insert and the all-poly tibial component (510(k): K012591). The locking mechanism for the ADVANCE® Unicondylar modular metal-backed tibial components is substantially equivalent to the ADVANTIM® Unicondylar modular metalbacked tibial components (510(k): K881779). Table 1 is a comparison chart summarizing the above design features for the ADVANCE® Unicondylar modular metalbacked tibial components.
The design features of ADVANCE® Unicondylar modular metal-backed tibial components are substantially equivalent to the design features of the ADVANCE® Unicondylar All-Poly Tibial Component - 510(k): K012591 and the ADVANTIM® Unicondylar modular metal-backed tibial base (Submitted and cleared under 510(k) -K881779 Whiteside Ortholoc II Unicondylar Knee System).
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): 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.
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.
Not Found
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).
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
Image /page/0/Picture/0 description: The image shows the logo for Wright Medical Technology, Inc. The logo includes a stylized "W" and the company name in bold, sans-serif font. Below the company name is the address: 5677 Airline Road, Arlington, TN 38002. At the top of the image is the number K014171.
MAR 1 5 2002
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.
December 19, 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, 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/27 description: The image shows the logo for Wright Medical Technology, Inc. The logo consists of the word "WRIGHT" in a bold, sans-serif font, with the words "MEDICAL TECHNOLOGY, INC." in a smaller, sans-serif font below it. Above the word "WRIGHT" is a stylized "W" shape, which is formed by two overlapping triangles. The logo is black and white.
Image /page/0/Picture/28 description: The image shows a globe with a focus on the continents of Asia and Australia. The globe is depicted in black and white and appears to be a simple illustration. The continents are outlined, and the oceans are left blank, creating a clear contrast. The globe is set on a stand, suggesting it is a physical object.
1
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 modular metal-backed tibia is part of the ADVANCE® Unicondylar Knee System that was previously submitted and cleared under 510(k): K012591- ADVANCE® Unicondylar Knee System. Wright Medical Technology is now enhancing the ADVANCE® Unicondylar Knee System by adding a modular titanium metal-backed UHMWPE tibial component. The ADVANCE® Unicondylar Knee System now contains the following components; Co-Cr femoral component, all-poly ultra-high molecular-weight polyethylene (UHMWPE) tibial component and modular titanium metal-backed UHMWPE tibial component.
The ADVANCE® Unicondylar femoral component is identical to the femoral component previously submitted and cleared under ADVANCE® Unicondylar Knee System -510(k): K012591.
The ADVANCE® Unicondylar all-poly tibial component is identical to the all-poly tibial component previously submitted and cleared under ADVANCE® Unicondylar Knee System - 510(k): K012591.
The ADVANCE® Unicondylar modular metal-backed tibial base is manufactured from The ADVANCE® Unicondylar modular tibial insert is titanium (ASTM F136). manufactured from the identical UHMWPE as the ADVANCE® Unicondylar all-poly tibial components (510(k): K012591). The profile and sizing (Sizes 1, 2, 3 & 4) of the ADVANCE® Unicondylar modular metal-backed tibial components are identical to the ADVANCE® Unicondylar all-poly tibial components (510(k): K012591). The cement interface for the ADVANCE® Unicondylar modular metal-backed tibial components consist of a peripheral dovetail and two pegs and is substantially equivalent to the cement interface of the ADVANCE® Unicondylar all-poly tibial components (510(k): K012591). The articulating surface is identical for both the ADVANCE® Unicondylar modular metal-backed tibial insert and the all-poly tibial component (510(k): K012591). The locking mechanism for the ADVANCE® Unicondylar modular metal-backed tibial components is substantially equivalent to the ADVANTIM® Unicondylar modular metalbacked tibial components (510(k): K881779). Table 1 is a comparison chart summarizing the above design features for the ADVANCE® Unicondylar modular metalbacked tibial components.
Image /page/1/Figure/10 description: The image shows the logo for Wright Medical Technology, Inc. The logo features a stylized "W" symbol above the word "WRIGHT" in a serif font. Below "WRIGHT" is the text "MEDICAL TECHNOLOGY, INC." in a smaller, sans-serif font.
Image /page/1/Picture/11 description: The image shows a black and white drawing of a globe. The globe is sitting on a stand. The continents of Asia and Australia are visible on the globe.
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Abbreviated 510(k) ADV ANCE® Unicondylar Knee System 510(K) SUMMARY Page 3 of 3
| Design Feature | ADVANCE® Unicondylar All-Poly
Tibial Component
(510(k): K012591) | ADVANCE® Unicondylar Modular
Metal-Backed Tibial Components |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Material | All-poly Tibial Component - UHMWPE
(previously submitted and cleared under
ADVANCE® Unicondylar Knee System –
510(k): K012591) | Tibial Insert - UHMWPE – Insert (Identical to the
material used for the ADVANCE® Unicondylar All-
Poly Tibial Component - 510(k): K012591 and the
ADVANTIM® Unicondylar modular metal-backed
tibial base- 510(k): K881779)
Tibial Base - Titanium (Identical to material used
for the ADVANTIM® Unicondylar modular metal-
backed tibial base- 510(k): K881779) |
| Cement Interface | 2 pegs with peripheral dovetail (previously
submitted and cleared under ADVANCE®
Unicondylar Knee System – 510(k): K012591) | 2 pegs with peripheral dovetail (substantially
equivalent to the ADVANCE® Unicondylar All-
Poly Tibial Component - 510(k): K01259) |
| Articulating
Surface | Previously submitted and cleared under
ADVANCE® Unicondylar Knee System –
510(k): 012591 -Exhibit 1 | Identical to the articulating surface used on the
ADVANCE® Unicondylar All-Poly Tibial
Component - 510(k): K012591 |
| Profile/Sizing | Previously submitted and cleared under
ADVANCE® Unicondylar Knee System –
510(k): 012591 -Exhibit 1 | Identical profile and sizing scheme as the
ADVANCE® Unicondylar All-Poly Tibial
Component - 510(k): K012591 |
| Locking
Mechanism | Not Applicable (one piece all-poly tibial
component) | Peripheral lock is substantially equivalent to the
ADVANTIM® Unicondylar modular metal-backed
tibial components (510(k): K881779) |
| Table 1 - Comparison Between the ADVANCE® Unicondylar Modular Metal-Backed Tibia | ||||
|---|---|---|---|---|
| Components and the ADVANCE® Unicondylar All-Poly Tibial Component |
The design features of ADVANCE® Unicondylar modular metal-backed tibial components are substantially equivalent to the design features of the ADVANCE® Unicondylar All-Poly Tibial Component - 510(k): K012591 and the ADVANTIM® Unicondylar modular metal-backed tibial base (Submitted and cleared under 510(k) -K881779 Whiteside Ortholoc II Unicondylar Knee System).
C. SUBSTANTIAL EQUIVALENCE INFORMATION
The intended use, material, type of interface, and design features of the ADVANCE® Unicondylar Knee System are substantially equivalent to the ADVANTIM® Unicondylar Femoral component (Submitted and cleared under 510(k) - K881779 Whiteside Ortholoc II Unicondylar Knee System) and also to predicate devices previously cleared for market. The safety and effectiveness of the ADVANCE® Unicondylar Knee System are adequately supported by the substantial equivalence information, materials data, and testing results provided within this Premarket Notification.
Image /page/2/Picture/6 description: The image shows a black and white drawing of a globe. The globe is tilted on its axis and is sitting on a stand. The continents of Asia and Australia are visible on the globe. The drawing is simple and does not have a lot of detail.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 5 2002
Mr. Ehab M. Esmail Manager, Regulatory Affairs Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002
Re: K014171
Trade/Device Name: ADVANCE® Unicondylar Knee System Regulation Number: 21 CFR 888.3530 and 888.3520 Regulation Name: Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis and knee joint femorotibial metal/polymer non-constrained cemented prosthesis Regulatory Class: Class II Product Code: HRY and HSX
Dated: December 19, 2001 Received: December 20, 2001
Dear Mr. Esmail:
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.
4
Page 2 - Mr. Ehab M. Esmail
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 you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 vours.
Mark McMullen
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
5
Image /page/5/Picture/1 description: The image shows a logo with a stylized letter "W" on the left side. To the right of the "W" is the letter "M" above a horizontal line, followed by the number "5" and the letter "A" below the line. The logo appears to be a company or brand identifier.
ADVANCE® Unicondylar Knee System
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;
-
- 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)
Mark H. Malkerson
General, Restorative ological Devices
510(k) Number K014171
Prescription Use (Per21 CFR 801.109) OR
(Division Sign-Off) Division of General Restorative Devices 510(k) Number
Over-The Counter Use (Optional Format 1-2-96)
Image /page/5/Picture/21 description: The image shows a black and white drawing of a globe. The globe is tilted and shows the continents of Asia and Australia. The globe is sitting on a stand.
Image /page/5/Picture/22 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 TECHNOLOGY" stacked on top of each other. Below the text is the phrase "A Wright Medical Group Company".
INDICATIONS STATEMENT