(29 days)
No
The document describes a mechanical knee implant component and its testing, with no mention of AI or ML.
Yes
The device is a knee implant designed to treat various degenerative joint diseases and deformities, which falls under the definition of a therapeutic device as it treats or alleviates a medical condition.
No
The device is an orthopedic implant for knee arthroplasty, which is a treatment, not a diagnostic procedure.
No
The device description clearly states the device is a physical implant (Tibial inserts manufactured from UHMWPE) and describes mechanical testing, indicating it is a hardware device.
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 device for surgical implantation in the knee joint to treat various conditions affecting the joint itself. This is a therapeutic and structural device, not a diagnostic one.
- Device Description: The description focuses on the physical components (tibial insert made of UHMWPE), sizes, and mechanical testing. This aligns with a medical device intended for implantation.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information about a patient's condition based on in vitro testing.
IVD devices are used to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a prosthetic implant.
N/A
Intended Use / Indications for Use
The EVOLUTION® MP Adaptive CS Insert is indicated for use in knee arthroplasty 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 4. that are unmanageable using other techniques.
The EVOLUTION® Total Knee System is for cemented use only.
Product codes
JWH, HRY
Device Description
The purpose of this submission is to introduce a new EVOLUTION® Adaptive CS Tibial Insert that allows use of a femoral component from the EVOLUTION® Total Knee System with a tibial base from the ADVANCE® Knee System. The design features of the EVOLUTION® Adaptive CS Insert are summarized below:
- . Tibial inserts manufactured from UHMWPE
- . Available in 11 sizes, left and right
- . Tibial insert thickness: 10 - 20mm
The EVOLUTION® Adaptive CS Insert was evaluated via mechanical testing and engineering analyses; including static stability, contact area, and range of motion testing. A review of these results indicates that the subject device is equivalent to predicate devices and is capable of withstanding expected in vivo loading without failure.
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)
The EVOLUTION® Adaptive CS Insert was evaluated via mechanical testing and engineering analyses; including static stability, contact area, and range of motion testing. A review of these results indicates that the subject device is equivalent to predicate devices and is capable of withstanding expected in vivo loading without failure.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K894334, K972626, K972770, K033890, K093552, K102380
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
KI13325
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 EVOLUTION® MP Adaptive CS Insert.
| Submitted By: | Wright Medical Technology, Inc.
5677 Airline Rd, Arlington TN, 38002
(800) 238-7188 |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | November 9, 2011 |
| Contact Person: | Danielle Mueller
Regulatory Affairs Specialist II |
| Proprietary Name: | EVOLUTION® MP Adaptive CS Insert |
| Common Name: | Tibial Insert |
| Classification Name and Reference: | 21 CFR 888.3560 Knee joint Patellofemorotibial
Polymer/Metal/Polymer Semi-Constrained Cemented Prosthesis Class I
21 CFR 888.3530 Knee joint Femorotibial
Metal/Polymer Semi-Constrained Cemented Prosthesis Class II |
| Subject Product Code and Panel Code: | Orthopedics/87/ JWH, HRY |
| Predicate Devices: | EVOLUTION® MP Total Knee System
ADVANCE® Total Knee System
AXIOM® Total Knee System
510(k)s: K894334, K972626, K972770, K033890
K093552, K102380 |
DEVICE INFORMATION
A. Intended Use
The EVOLUTION® MP Adaptive CS Insert is indicated for use in knee arthroplasty 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 4. that are unmanageable using other techniques.
The EVOLUTION® Total Knee System is for cemented use only.
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1
KN-3325
B. Device Description
The purpose of this submission is to introduce a new EVOLUTION® Adaptive CS Tibial Insert that allows use of a femoral component from the EVOLUTION® Total Knee System with a tibial base from the ADVANCE® Knee System. The design features of the EVOLUTION® Adaptive CS Insert are summarized below:
- . Tibial inserts manufactured from UHMWPE
- . Available in 11 sizes, left and right
- . Tibial insert thickness: 10 - 20mm
The EVOLUTION® Adaptive CS Insert was evaluated via mechanical testing and engineering analyses; including static stability, contact area, and range of motion testing. A review of these results indicates that the subject device is equivalent to predicate devices and is capable of withstanding expected in vivo loading without failure.
C. Substantial Equivalence Information
The indications for use of the EVOLUTION® Adaptive CS Insert are identical to the previously cleared predicate devices. The design features and materials of the subject devices are substantially equivalent to those of the predicate devices. The fundamental scientific technology of the modified devices has not changed relative to the predicate devices. The safety and effectiveness of the EVOLUTION® Adaptive CS Insert are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.
p. 2 of 2
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Wright Medical Technologies, Inc. % Ms. Danielle Mueller Regulatory Affairs Specialist II 5677 Airline Road Arlington Tenessee 38002
DEC - 9 2011
Re: K113325
Trade/Device Name: EVOLUTION® MP Adaptive CS Insert Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH, HRY Dated: November 9, 2011 Received: November 10, 2011
Dear Ms. Mueller:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
3
Page 2 - Ms. Danielle Mueller
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
ely yours,
for
N. Malkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
KI13325
Indications for Use
510(k) Number (if known):
Device Name: EVOLUTION® MP Adaptive CS Insert
Indications For Use:
The EVOLUTION® MP Adaptive CS Insert is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:
- Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or 1. 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 EVOLUTION® Total Knee System is for cemented use only.
Prescription Use × (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)
(Division Sign-Oft)
Division of Surgical, Orthopedic,
and Restorative Devices
510(k) Number K113325
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