(90 days)
Not Found
No
The document describes a mechanical implant (tibial baseplate) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is a knee implant component used to restore a compartment of a knee affected by various conditions like osteoarthritis or fractures, which is a structural or reconstructive function, not a therapeutic one that treats or cures a disease.
No
This device is a tibial baseplate component intended for implantation to restore a knee compartment. It is a treatment device, not a diagnostic one.
No
The device description explicitly states the device is "metal-backed tibial baseplates," which are physical hardware components intended for surgical implantation.
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 device for surgical implantation to restore a knee joint affected by various conditions. This is a therapeutic intervention, not a diagnostic test performed in vitro (outside the body).
- Device Description: The device is described as a "metal-backed tibial baseplate" intended for implantation with bone cement. This is a physical implant, not a reagent, instrument, or system used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), detecting diseases or conditions through in vitro analysis, or providing information for diagnosis, monitoring, or screening.
Therefore, this device falls under the category of a surgical implant and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Competitor Unicondylar Tibial Baseplate Components are indicated for restoring either compartment of a knee that has been affected by the following:
- Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or . avascular necrosis;
- . correction of functional deformity;
- 트 revision procedures where other treatments or devices have failed; and
- treatment of fractures that are unmanageable using other techniques
The baseplate components are single use only and are intended for implantation only with bone cement.
Product codes (comma separated list FDA assigned to the subject device)
HSX
Device Description
New unicondylar knee tibial baseplate components have been designed and developed by Smith & Nephew Orthopaedics. The subject devices are metal-backed tibial baseplates that are designed to be used with specific articular inserts. The overall designs of the components are based upon the existing Genesis Unicompartmental tibial implants subject of K912735.
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): 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
§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
K061011 (pg 1 of 1)
510(K) Summary
JUL 1 1 2006
Smith & Nephew Competitor Unicondylar Tibial Baseplate Components
| 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: | April 10, 2006 |
| TRADE OR PROPRIETARY DEVICE NAME: | Smith & Nephew Competitor Unicondylar Tibial Baseplate Components |
| COMMON OR USUAL NAME: | Knee Prosthesis |
| CLASSIFICATION NAME: | Knee joint femorotibial metal/polymer non-constrained cemented prosthesis, 21 CFR 888.3520 |
| DEVICE CLASS: | Class II |
| PANEL CODE: | HSX Orthopedics Panel/87 |
A. INTENDED USE:
The Competitor Unicondylar Tibial Baseplate Components are indicated for restoring either compartment of a knee that has been affected by the following:
- Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or . avascular necrosis;
- . correction of functional deformity;
- 트 revision procedures where other treatments or devices have failed; and
- treatment of fractures that are unmanageable using other techniques
The baseplate components are single use only and are intended for implantation only with bone cement.
B. DEVICE DESCRIPTION:
New unicondylar knee tibial baseplate components have been designed and developed by Smith & Nephew Orthopaedics. The subject devices are metal-backed tibial baseplates that are designed to be used with specific articular inserts. The overall designs of the components are based upon the existing Genesis Unicompartmental tibial implants subject of K912735.
C. SUBSTANTIAL EQUIVALENCE INFORMATION:
The Smith & Nephew Competitor Unicondylar Tibial Baseplate Components are similar to the following commercially available devices regarding design features, overall indications, and materials:
- · Smith & Nephew Genesis Unicompartmental Knee System (K912735)
- · Smith & Nephew Unicondylar Femoral Component (K030301)
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three distinct head profiles, suggesting a sense of community or collaboration. The bird is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA". The text is arranged around the circumference of the circle, framing the bird symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 1 2006
Smith & Nephew, Inc. Orthopaedic Division % Mr. Gino J. Rouss Regulatory Affairs Specialist 1450 Brooks Road Memphis, Tennessee 38116
Re: K061011
Trade/Device Name: Competitor Unicondylar Tibial Baseplate Components Regulation Number: 21 CFR 888.3520 Regulation Name: Knee joint femorotibial metal/polymer non-constrained cemented prosthesis Regulatory Class: Class II Product Code: HSX Dated: April 10, 2006 Received: April 12, 2006
Dear Mr. Rouss:
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, Dr u 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, incl. Ast. A 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
2
Page 2 -- Mr. Gino J. Rouss
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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 vours.
Barbara Buchun
to
Mark N. Melin
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known):
KO61011
Device Name: Competitor Unicondylar Tibial Baseplate Components
Indications for Use:
The Competitor Unicondylar Tibial Baseplate Components are indicated for restoring either compartment of a knee that has been affected by the following:
- Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or . avascular necrosis;
- correction of functional deformity; ●
- revision procedures where other treatments or devices have failed; and .
- treatment of fractures that are unmanageable using other techniques ●
The baseplate components are for single use only and are intended for implantation only with bone cement.
Prescription Use x (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 Division of General. Restorative. and Neurological Devices
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
510(k) Number K061011