(87 days)
JWH
Not Found
No
The summary describes a mechanical implant (tibial baseplate) and does not mention any software, algorithms, or data processing that would indicate AI/ML.
No.
The device is a component of a knee replacement system, intended for surgical implantation to replace a diseased or damaged joint. It directly treats the condition rather than assisting in diagnosis or guiding therapy.
No
Explanation: The device is a component for total knee arthroplasty, specifically a tibial baseplate, used in treatment rather than diagnosis.
No
The device description clearly states it is a physical implantable component made of CoCr alloy, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The provided description clearly states that this device is a tibial baseplate, which is a component used in total knee arthroplasty (joint replacement surgery). It is a physical implant.
- Intended Use: The intended use is for the surgical treatment of knee conditions by replacing the joint, not for testing bodily samples.
The device is a surgical implant, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The Natural-Knee II CoCr Tibial Baseplate is a primary component intended for cemented use only in total knee arthroplasty in skeletally mature individuals for treatment of the following:
- Patient conditions of Noninflammatory Degenerative Joint Disease (NIDJD); . e.g., avascular necrosis, osteoarthritis and Inflammatory Joint Disease (IJD); e.g, rheumatoid arthritis.
- Correctable valgus-varus deformity and moderate flexion contracture. .
Product codes
JWH
Device Description
The CoCr tibial baseplate, manufactured from cast CoCr alloy (ASTM-F-75), is a nonporous, stemmed configuration and intended for cemented use only. The CoCr tibial baseplate is anatomic and asymmetric in design, available in sizes 00-5 and left and right configurations.
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 individuals
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)
Natural Knee II System Non-porous Stemmed Tibial Baseplate
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
Q21578
page 1 of 1
AUG 0 9 2002
510(k) SUMMARY OF SAFETY AND EFFECTIVENES
In accordance with the Food and Drug Administration Interim Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21CFR 807, this is to serve as a Summary of Safety and Effectiveness for the Sulzer Orthopedics Inc. Natural Knee II System CoCr Tibial Baseplate.
| Submitter: | Sulzer Orthopedics Inc.
9900 Spectrum Drive
Austin, Texas 78717
(512) 432-9900 |
|----------------------|-------------------------------------------------------------------------------------------------|
| Date: | May 13, 2002 |
| Contact Person: | Frances E. Harrison
Manager, Regulatory Projects |
| Classification Name: | Knee joint femorotibial metal/polymer semi-
constrained cemented prosthesis, 21 CFR 888.3560 |
| Common/Usual Name: | Knee Prosthesis, Partially Constrained |
| Trade/Proprietary: | Natural-Knee® II System CoCr Tibial Baseplate |
PRODUCT DESCRIPTION
The CoCr tibial baseplate, manufactured from cast CoCr alloy (ASTM-F-75), is a nonporous, stemmed configuration and intended for cemented use only. The CoCr tibial baseplate is anatomic and asymmetric in design, available in sizes 00-5 and left and right configurations.
SPECIFIC DIAGNOSTIC INDICATIONS
The Natural-Knee II CoCr Tibial Baseplate is a primary component intended for cemented use only in total knee arthroplasty in skeletally mature individuals for treatment of the following:
- മ Patient conditions of Noninflammatory Degenerative Joint Disease (NIDJD): e.g., avascular necrosis, osteoarthritis and Inflammatory Joint Disease (IJD); e.g, rheumatoid arthritis.
- D Correctable valgus-varus deformity and moderate flexion contracture.
SUBSTANTIAL EQUIVALENCE
The Natural Knee II CoCr Tibial Baseplate is to the following commercially available in devices in terms of general design, intended use and indications for use:
- O Natural Knee II System Non-porous Stemmed Tibial Baseplate
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines above them. The overall design is simple and recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 0 9 2002
Ms. Frances E. Harrison, RAC Manager, Regulatory Projects Sulzer Orthopedics, Inc. 9900 Spectrum Drive Austin, Texas 78717
Re: K021578
Trade/Device Name: Natural-Knee II CoCr Tibial Baseplate Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: May 13, 2002 Received: May 14, 2002
Dear Ms. Harrison:
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.
2
Page 2 - Ms. Frances E. Harrison, RAC
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 yours,
Sincerely yours,
Mark A. Milburn
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/3/Picture/1 description: The image shows the text '510(k) Number (if known):' followed by the number 'KO21578'. This indicates that the image is likely part of a document or form related to medical device regulation, specifically the 510(k) premarket notification process. The number 'KO21578' is the 510(k) number assigned to a specific medical device.
Device Name: Natural-Knee IL System
Indications for Use:
The Natural-Knee II CoCr Tibial Baseplate is a primary component intended for cemented use only in total knee arthroplasty in skeletally mature individuals for treatment of the following:
- Patient conditions of Noninflammatory Degenerative Joint Disease (NIDJD); . e.g., avascular necrosis, osteoarthritis and Inflammatory Joint Disease (IJD); e.g, rheumatoid arthritis.
- Correctable valgus-varus deformity and moderate flexion contracture. .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use
Mark A. Milliman (Optional Format 1-2-96)
(Division Sign-Off)
Division of General, Restorative
and Neurologic Devices
510(k) Number K021578