(130 days)
No
The document describes a physical knee implant component and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a knee femoral component intended for implantation to address conditions like arthritis and failed osteotomies, which are therapeutic interventions.
No
The device is a knee femoral component intended for implantation to replace parts of the knee joint, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a physical implant (femoral components for knee replacement) made of CoCr and Oxinium materials, intended for surgical implantation.
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 text describes a surgical implant used to replace parts of the knee joint. It is a physical device implanted into the body, not a test performed on a sample outside the body.
- Intended Use: The intended use is to treat conditions affecting the knee joint through surgical implantation, not to diagnose or monitor a condition through laboratory testing.
Therefore, based on the provided information, the Competitor Duo Knee Femoral Components are a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Competitor Duo Knee Femoral Components are intended to be used for those patients whereby conditions exist that can not be solely addressed by a device that treats a single compartment (i.e. unicondylar or patellofemoral prosthesis) of the knee.
Indications include:
- post-traumatic arthritis;
- degenerative arthritis; and
- failed osteotomies, hemiarthroplasties; and unicompartmental replacement .
These indications will be used for the Competitor Duo Knee Femoral Components, whereby the medial condyle and patellofemoral regions have been affected by one or more of these conditions.
The Competitor Duo Knee Femoral Components are single use only and are intended for implantation only with bone cement
Product codes
NPJ
Device Description
The components are used to replace the medial condyle and patellofemoral regions of a femoral knee joint. The Competitor Duo will include both CoCr and Oxinium femorals. The overall Knee joint. The Competitor Duo femoral component are based upon the existing Hybrid Knee Femoral Component subject of K042896.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
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)
Reference Device(s)
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
DEC 2 7 2005
510(K) SUMMARY SMITH & NEPHEW COMPETITOR DUO KNEE FEMORAL COMPONENT
| SUBMITTER'S NAME: | Smith & Nephew, Inc., Orthopaedic Division |
|---|---|
| SUBMITTER'S ADDRESS: | 1450 East Brooks Road, Memphis, TN 38116 |
| SUBMITTER'S TELEPHONE NUMBER: | 901-399-6707 |
| CONTACT PERSON: | Gino J. Rouss |
| DATE SUMMARY PREPARED: | August 17, 2005 |
| TRADE OR PROPRIETARY DEVICE | |
| NAME: | Smith & Nephew Competitor Duo Knee Femoral |
| COMMON OR USUAL NAME: | Knee Femoral Replacement |
| CLASSIFICATION NAME: | Knee joint femorotibial metal/polymer semi-constrained |
| cemented prosthesis, 21 CFR 888.3530 | |
| DEVICE CLASS: | Class II |
| PANEL CODE: | NPJ Orthopedics Panel/87 |
A. INTENDED USE:
The Competitor Duo Knee Femoral Components are intended to be used for those patients The Competitions exist that can not be solely addressed by a device that treats a single whereby ochaitions exist in the matellofemoral prosthesis) of the knee.
Indications include:
- · post-traumatic arthritis;
- · degenerative arthritis; and
- = failed osteotomies, and unicompartmental replacemental replacement
These indications will be used for the Competitor Duo Knee Femoral Components, whereby the medial condyle and patellofemoral regions have been affected by one or more of these conditions.
The Competitor Duo Knee Femoral Components are single use only and are intended for implantation only with bone cement
B. DEVICE DESCRIPTION:
D. BEVIOL DEOOKIPHON:
The components are used to replace the medial condyle and patellofemoral regions of a femoral knee joint. The Competitor Duo will include both CoCr and Oxinium femorals. The overall Knee joint. The Competitor Duo femoral component are based upon the existing Hybrid Knee Femoral Component subject of K042896.
C. SUBSTANTIAL EQUIVALENCE INFORMATION:
The Smith & Nephew Competitor Duo Knee Femoral Components are similar to the following The Ommercially available devices regarding design features, overall indications, and materials:
- · Smith & Nephew Hybrid Knee Femoral (K042896)
- "Smith & Nephew Hyphd Rhoo Pomoral (Roll260)
= "Genesis II and Legion (Revision) Knee Femorals (Oxinium Material) (K962557 and K043440)
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol often associated with healthcare. The caduceus in the logo is depicted with three lines forming the snake and staff.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 7 2005
Mr. Gino J. Rouss Regulatory Affairs Specialist Smith & Nephew, Inc. Orthopaedic Division 1450 E. Brooks Road Memphis, Tennessee 38116
K052265 Re:
Trade/Device Name: Competitor Duo Knee Femoral Components Regulation Number: 21 CFR 888.3530 Regulation Name: Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis Regulatory Class: Il Product Code: NPJ Dated: December 13, 2005 Received: December 14, 2005
Dear Mr. Rouss:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed 5 our betermined 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 10 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). and Costietier rever roo, has the device, subject to the general controls provisions of the Act. The r ou may, mererors, mains 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 rr your device to such additional controls. Existing major regulations affecting your device can may or dato established 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 than i Dir has and regulations administered by other Federal agencies. You must
2
Page 2 – Mr. Gino J. Rouss
comply with all the Act's requirements, including, but not limited to: registration and listing (21 l comply with all the Act S requirements, mortalism and in a practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing pactice the electronic CFR Part 807); labeling (21 CFR Part 801); good and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000 (21 CFR 1000 1050 forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Action Section S product radiation control provisions (Sections over device as described in your Section 510(k)
This letter will allow you to begin marketing your device of your daying to 1 l This letter will allow you to begin marketing your artial equivalence of your device to a legally premarket notification. The PDA miding of backanda experience 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
r the recultive and consembers and and any and the reculetion entitled If you desire specific advice for your device of the comments on the regulation entitled, Contact the Office of Compulation at (210) 210 cart 807.97). You may obtain "Misbranding by relefence to premation in the Act from the Division of Small other general international on your responsion.com its toll-free number (800) 638-2041 or Manufacturers, International and Consailer Prosessor Prosisions of the new only industry/support/index.html.
Sincerely yours,
Mark N. McPherson
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
KO52265 510(k) Number (if known):
Device Name: Competitor Duo Knee Femoral Components
Indications for Use:
The Competitor Duo Knee Femoral Components are intended to be used for those patients whereby conditions exist that can not be solely addressed by a device that treats a single compartment (i.e. unicondylar or patellofemoral prosthesis) of the knee.
Indications include:
- post-traumatic arthritis; .
- degenerative arthritis; and .
- failed osteotomies, hemiarthroplasties; and unicompartmental replacement .
These indications will be used for the Competitor Duo Knee Femoral Components, whereby the medial condyle and patellofemoral regions have been affected by one or more of these conditions.
The Competitor Duo Knee Femoral Components are single use only and are intended for implantation only with bone cement
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 of G. neral, Restorative, and Neurological Devices
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
510(k) Number K052265