(79 days)
No
The description focuses solely on the materials, sizes, and design iterations of the physical knee replacement components. There is no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is a total knee replacement system intended to treat various degenerative joint diseases and correct functional deformities.
No
Explanation: The device is a total knee replacement system, which is a prosthetic implant used to replace a damaged knee joint. Its intended use is to treat various degenerative joint diseases and deformities, not to diagnose them.
No
The device description clearly outlines multiple hardware components made of various materials (Co-Cr-Mo alloy, UHMWPe) that are implanted into the patient. This is not a software-only device.
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 replacing a knee joint in patients with various conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the materials and components of a physical implant designed to be surgically placed within the body. IVDs are typically reagents, instruments, or systems used to examine specimens from the human body.
- Anatomical Site: The device is used on the knee joint, which is a part of the human body, not a specimen taken from the body.
IVD devices are used to perform tests on samples (like blood, urine, tissue) taken from the body to diagnose diseases or conditions. This device is a prosthetic implant placed within the body to treat a condition.
N/A
Intended Use / Indications for Use
The Active Knee Total Knee Replacement System is indicated to be used only with bone cement in patients suffering from 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 such as varus, valgus, or flexion . deformities.
- Revision procedures where other treatments or devices have failed. .
- Treatment of fractures that are unmanageable using other techniques.
The device is intended for single use only.
Product codes (comma separated list FDA assigned to the subject device)
JWH
Device Description
The Active Knee System is a modular knee system consisting of a femoral component, a meniscal (tibial) insert, a tibial base plate implant and a patella. The tibial base plates and patella components included in this submission have been previously cleared in K021740. The femoral components are a design iteration of the femoral components cleared in K021740. The Ultracongruent Plus tibial inserts included in this submission are similar to the Ultracongruent tibial inserts previously cleared in K021740 but are designed with a higher anterior lip for use in patients with an absent or severely deficient posterior cruciate ligament.
The Active Knee System femoral components are manufactured from Co-Cr-Mo alloy conforming to ASTM F75 and are available in sizes 1 - 5. Sizes 2, 3, 4, and 5 are also available in a narrow version. The femoral components are asymmetric and are available in right and left versions.
The Active Knee System tibial base plates are manufactured from Co-Cr-Mo alloy conforming to ASTM F75 and are available in sizes 1-5. All sizes are available in narrow and wide versions.
The Active Knee System Ultracongruent Plus tibial inserts are manufactured from Ultra High Molecular Weight Polyethylene (UHMWPe) conforming to ASTM F648 and are available in sizes 1 - 5. Sizes 2, 3 4, and 5 are also available in narrow versions. The tibial inserts are available in thicknesses ranging from of 6.0 to 17.5mm.
The Active Knee System patella implants are manufactured from UHMWPe conforming to ASTM F648 and are available in sizes 1 - 5.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee joint
Indicated Patient Age Range
Not Found
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
§ 888.3560 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
| 3.
| 510(K) SUMMARY | |
|---|---|
| Applicant / Sponsor: | ANOVA Implant Solutions, LLC |
| Two Maryland Farms, Suite 120 | |
| Brentwood, TN 37027 | |
| FEB - 5 2010 | |
| Contact Person: | Walter Spires |
| Tel: (615) 457-3311 | |
| Fax: (615) 457-3312 | |
| Proprietary Name: | Active Knee Total Knee Replacement System |
| Common Name: | Total Knee Replacement System |
| Classification Name: | 21 CFR 888.3560 Knee joint patellofemorotibial |
| polymer/metal/polymer semi-constrained cemented | |
| prosthesis, Class II | |
| Product Codes: | JWH |
| Substantially | |
| Equivalent Devices: | Active Knee Total Knee Replacement System (K021740) |
Device Description:
The Active Knee System is a modular knee system consisting of a femoral component, a meniscal (tibial) insert, a tibial base plate implant and a patella. The tibial base plates and patella components included in this submission have been previously cleared in K021740. The femoral components are a design iteration of the femoral components cleared in K021740. The Ultracongruent Plus tibial inserts included in this submission are similar to the Ultracongruent tibial inserts previously cleared in K021740 but are designed with a higher anterior lip for use in patients with an absent or severely deficient posterior cruciate ligament.
The Active Knee System femoral components are manufactured from Co-Cr-Mo alloy conforming to ASTM F75 and are available in sizes 1 - 5. Sizes 2, 3, 4, and 5 are also available in a narrow version. The femoral components are asymmetric and are available in right and left versions.
8
1
The Active Knee System tibial base plates are manufactured from Co-Cr-Mo alloy conforming to ASTM F75 and are available in sizes 1-5. All sizes are available in narrow and wide versions.
The Active Knee System Ultracongruent Plus tibial inserts are manufactured from Ultra High Molecular Weight Polyethylene (UHMWPe) conforming to ASTM F648 and are available in sizes 1 - 5. Sizes 2, 3 4, and 5 are also available in narrow versions. The tibial inserts are available in thicknesses ranging from of 6.0 to 17.5mm.
The Active Knee System patella implants are manufactured from UHMWPe conforming to ASTM F648 and are available in sizes 1 - 5.
Intended Use / Indications:
The Active Knee Total Knee Replacement System is indicated to be used only with bone cement in patients suffering from 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 such as varus, valgus, or flexion . deformities.
- Revision procedures where other treatments or devices have failed. .
- Treatment of fractures that are unmanageable using other techniques.
The device is intended for single use only.
Summary of Technologies/Substantial Equivalence:
The Active Knee Total Knee Replacement System with Ultracongruent Plus tibial inserts has the same indications, is offered in the same range of sizes and is manufactured from the same materials as the previously cleared Active Knee Total Knee Replacement System. The femoral components, tibial baseplates and patella implants are similar or identical to the The Ultracongruent Plus tibial inserts are a design previously cleared components. modification of the previously cleared Ultracongruent tibial inserts.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is an emblem featuring a stylized depiction of a bird or eagle with outstretched wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
ANOVA Implant Solutions, LLC % Mr. Walter Spires Two Maryland Farms, Suite 120 Brentwood. Tennessee 37027
FEB - 5 2010
Re: K093567
Trade/Device Name: Active Knee Total Knee Replacement System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prothesis Regulatory Class: II Product Code: JWH Dated: January 21, 2010 Received: January 27, 2010
Dear Mr. Spires:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Mr. Walter Spires
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/Reportal]yoblem/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark A. Milliman
Mark N. Melkerso Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
2. INDICATIONS FOR USE
510(k) Number (if known): _K093567
Device Name: Active Knee Total Knee Replacement System
Indications for Use:
The Active Knee Total Knee Replacement System is indicated to be used only with bone cement in patients suffering from the following conditions:
- Noninflammatory degenerative joint disease including osteoarthritis, . traumatic arthritis, or avascular necrosis.
- Inflammatory degenerative joint disease including theumatoid arthritis. .
- Correction of functional deformity such as varus, valgus, or flexion deformities.
- Revision procedures where other treatments or devices have failed. .
- Treatment of fractures that are unmanageable using other techniques.
The device is intended for single use only.
Prescription Use _ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Doutie for mxn
(Division Sign-Off) (Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of 1
510(k) Number K093567