(28 days)
No
The 510(k) summary describes a mechanical orthopedic implant and makes no mention of AI or ML technology.
Yes
The Genesis Unicondylar UHMWPe Articular Inserts are indicated for restoring a knee affected by various conditions, including degenerative joint disease, arthritis, and fractures, which are conditions that fall under the scope of therapeutic applications.
No
The device is an orthopedic implant (articular insert) used to restore a knee compartment affected by degenerative joint disease, fractures, or functional deformity. It is not used to diagnose a medical condition.
No
The device description clearly states it is a physical implant (UHMWPe articular inserts) intended for surgical implantation in the knee. It is a hardware device, not software.
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 device, not a diagnostic one.
- Device Description: The description details a physical implant (articular inserts) designed to be used in surgery with other implants. This is consistent with a medical device for treatment, not for analyzing samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Genesis Unicondylar UHMWPe Articular Inserts are indicated for restoring either compartment of a knee that has been affected by the following:
- Non-inflammatory 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 implants are single use only and are designed to be used in combination with Genesis Unicondylar baseplates that are intended for implantation with bone cement.
Product codes
HSX
Device Description
New unicondylar UHMWPe articular inserts have been designed and developed by Smith & Neohew Orthopaedics. The subject devices were designed to be used with existing Genesis Unicondylar baseplates (K912735) and are intended to replace either the medial or lateral tibial compartment of the knee. The overall design of the articular inserts is based on the existing Genesis Unicondylar inserts cleared via 510(k) Premarket Notification 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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Smith & Nephew Genesis Unicompartmental Articular Knee Inserts (K912735)
Reference Device(s)
Smith & Nephew Journey Unicondylar Articular Knee Inserts (K061011)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Kl:00197
510(K) Summary
Smith & Nephew Genesis Unicondylar UHMWPe Articular Inserts
| 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 FEB 1 9 2010 |
| CONTACT PERSON: | Gino J. Rouss |
| DATE SUMMARY PREPARED: | January 20, 2010 |
| TRADE OR PROPRIETARY DEVICE NAME: | Smith & Nephew Genesis Unicondylar UHMWPe Articular Inserts |
| 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 Genesis Unicondylar UHMWPe Articular Inserts are indicated for restoring either compartment of a knee that has been affected by the following:
- l Non-inflammatory 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. 포
The implants are single use only and are designed to be used in combination with existing Genesis Unicondylar baseplates that are intended for implantation with bone cement.
B. Device Description
New unicondylar UHMWPe articular inserts have been designed and developed by Smith & Neohew Orthopaedics. The subject devices were designed to be used with existing Genesis Unicondylar baseplates (K912735) and are intended to replace either the medial or lateral tibial compartment of the knee. The overall design of the articular inserts is based on the existing Genesis Unicondylar inserts cleared via 510(k) Premarket Notification K912735. *
C. Substantial Equivalence
The Smith & Nephew Genesis Unicondylar UHMWPe Articular Inserts are similar to the following commercially available devices regarding design features, overall indications, and materials:
- · Smith & Nephew Genesis Unicompartmental Articular Knee Inserts (K912735)
- · Smith & Nephew Journey Unicondylar Articular Knee Inserts (K061011)
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Smith & Nephew, Inc. % Mr. Gino J. Rouss, MS Manager, Regulatory Affairs 1450 East Brooks Road
Memphis, Tennessee 38116
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
FEB 1 9 2010
Re: K100197
Trade Name: Smith & Nephew Genesis Unicondylar UHMWPe Articular Inserts Regulation Number: 21 CFR 888.3520 Regulation Name: Knee joint femorotibial metal/polymer non-constrained cemented
prosthesis
Regulatory Class: II Product Code: HSX Dated: January 20, 2010 Received: January 22, 2010
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. 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 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 - Dr. Kelly J. Baker
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.
Barbara Buehm
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known):
Device Name: Smith & Nephew Genesis Unicondylar UHMWPe Articular Inserts
INDICATIONS FOR USE:
The Genesis Unicondylar UHMWPe Articular Inserts are indicated for restoring either compartment of a knee that has been affected by the following:
- Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
- Correction of functional deformity;
- Revision procedures where other treatments or devices have failed; and 전
- 미 Treatment of fractures that are unmanageable using other techniques.
The implants are single use only and are designed to be used in combination with Genesis Unicondylar baseplates that are intended for implantation with bone cement.
| Prescription Use | X | AND/OR | Over-The-Counter Use | |
|---|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (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)
Omitti for mxn
vision of Surgical, Ohhopedic, and Restorative Devices
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510(k) Number K100197