(269 days)
Not Found
Not Found
No
The document describes a mechanical implant (tibial insert) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is indicated for the reduction or relief of pain and/or improved knee function, which are therapeutic goals.
No
Explanation: The device is a tibial insert for knee arthroplasty, which is a prosthetic implant used for treatment and replacement, not for diagnosing conditions.
No
The device description clearly outlines a physical implantable component made of UHMWPE, not software.
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 conditions affecting the knee joint. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the physical characteristics and materials of a tibial insert, which is a component of a knee replacement system. This aligns with a surgical implant.
- 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 does not fit that description.
N/A
Intended Use / Indications for Use
The ADVANCE A-CLASS Tibial Insert is indicated for use with the Advance Total Knee system 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.
The ADVANCE A-CLASS Insert is for single use. The Advance Total Knee System porous components are for use without bone cement. The Advance Total Knee System non-porous components are for use with bone cement.
Product codes
JWH, MBH
Device Description
The design features of the ADVANCE® A-CLASS® Tibial Insert are summarized below:
- Articulating Surface: Medial Pivot rotation
- Lock Detail: Perimeter capture with central dove tail .
- Size Range: Sizes 1-6, thicknesses of 10mm-25mm .
- Material: Cross-Linked GRU1020 UHMWPE
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.
Not Found
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
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.
0
FEB 2 0 2009
1081479
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® A-CLASS® Tibial Base '
Submitted By:
Date:
Contact Person:
Proprietary Name:
Common Name:
Classification Name and Reference:
Wright Medical Technology, Inc.
May 9, 2008
Fred W. Bowman, P.E.
Senior Regulatory Affairs Specialist
ADVANCE® A-CLASS® Insert
Tibial Insert
21 CFR 888.3560 Knee, Patellofemorotibial, Semiconstrained, cemented, Polymer/ metal/polymer
21 CFR 888.3565 Knee, patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
Device Product Code and Panel Code:
Orthopedics/87/ JWH Orthopedics/87/ MBH
DEVICE INFORMATION
A. INTENDED USE
The ADVANCE A-CLASS Tibial Insert is indicated for use with the Advance Total Knee system 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.
The ADVANCE A-CLASS Insert is for single use: The Advance Total Knee System porous components are for use without bone cement. The Advance Total Knee System non-porous components are for use with bone cement.
1
B. DEVICE DESCRIPTION
The design features of the ADVANCE® A-CLASS® Tibial Insert are summarized below:
- Articulating Surface: Medial Pivot rotation
- Lock Detail: Perimeter capture with central dove tail .
- Size Range: Sizes 1-6, thicknesses of 10mm-25mm .
- Material: Cross-Linked GRU1020 UHMWPE ●
C. SUBSTANTIAL EQUIVALENCE INFORMATION
The design features of the ADVANCE® A-CLASS® Tibial Insert are substantially equivalent to the design features, excluding material, of the ADVANCE® Medial Pivot Tibial Insert. The material of the ADVANCE® A-CLASS® Tibial Insert is substantially equivalent to the material of the LINEAGE® A-CLASS® Acetabular Liner.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains an image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Wright Medical Technology, Inc. % Mr. Fred W. Bowman. P.E. Senior Regulatory Affairs Specialist 5677 Airline Road Arlington, Tennessee 38002
Re: K081479
Trade/Device Name: ADVANCE® A-CLASS Tibial Insert
Regulation Number: 21 CFR 888,3565
Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis
FEB 2 0 2009
Regulatory Class: II Product Code: MBH, JWH Dated: January 30, 2009 Received: February 2, 2009
Dear Mr. Bowman:
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
3
Page 2 - Mr. Fred W. Bowman, P.E.
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.
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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.
For
mo
N.V.
2/26/05
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radioingical Health -
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: ADVANCE® A-CLASS Tibial Insert
Indications For Use:
The ADVANCE A-CLASS Tibial Insert is indicated for use with the Advance Total Knee system 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.
The ADVANCE A-CLASS Insert is for single use. The Advance Total Knee System porous components are for use without bone cement. The Advance Total Knee System non-porous 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
(Division Sign-Off) Division of General. Restorative. and Neurological Devices
510(k) Number K081479