(71 days)
No
The document describes a mechanical knee implant system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is a knee system indicated for restoring compartments of a knee affected by various conditions like degenerative joint disease, traumatic arthritis, avascular necrosis, and for revision procedures or treatment of fractures, which falls under the definition of a therapeutic device.
No
The device is a knee implant system used for restoring a compartment of a knee. Its indications for use are related to treatment (e.g., noninflammatory degenerative joint disease, correction of functional deformity, revision procedures, treatment of fractures), not diagnosis.
No
The device description clearly states that the device is a physical implant component made of Cobalt Chrome and Oxidized Zirconium alloy, intended for surgical implantation. It is a hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for restoring a knee joint affected by various conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details femoral implant components made of metal alloys, designed for surgical implantation. This aligns with a medical device for treatment, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device is a physical implant used to treat a condition directly.
N/A
Intended Use / Indications for Use
The Journey Unicondylar Knee System is 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; 2.
- ల్లా Revision procedures where other treatments or devices have failed; and
-
- Treatment of fractures that are unmanageable using other techniques.
The Journey Unicondylar Knee System components are single use only and are intended for implantation only with bone cement.
Product codes
HSX
Device Description
The devices, subject of this Premarket Notification, are the Smith & Nephew, Inc. Journey Unicondylar Femoral Implant components. The Journey unicondylar femoral implants are intended for cemented medial and lateral tibiofemoral replacement. The femoral implants will be offered in both Cobalt Chrome and Oxidized Zirconium alloy (OXINIUM) materials in sizes 1 through 7. The Smith & Nephew Journey Unicondylar femoral components feature the same articular surface geometry as existing femoral implants cleared in K073175.
The Journey Unicondylar femoral components are intended to be used in combination with the Competitor Unicondvlar All-Poly Tibial Baseplates IK061779), or the Competitor Unicondylar Knee Tibial Baseplates and Polyethylene Inserts {K061011}.
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)
Design Control Activities have been completed and the results indicated that the subject device is safe and effective.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K073175, K912735, K030301, K033363
Reference Device(s)
Not Found
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
JUL 2 4 2008
Kori351
510(K) Summary Smith & Nephew Smith & Nephew Journey Unicondylar Femoral Implant
| SUBMITTER'S NAME: | Smith & Nephew, Inc., Orthopaedic Division |
|---|---|
| SUBMITTER'S ADDRESS: | 1450 East Brooks Road, Memphis, TN 38116 |
| SUBMITTER'S TELEPHONE NUMBER: | 901-399-6017 |
| CONTACT PERSON: | Nicholas B. Tabrizi |
| DATE SUMMARY PREPARED: | May 2, 2008 |
| TRADE OR PROPRIETARY DEVICE NAME: | Smith & Nephew Journey Unicondylar Femoral Implant |
| COMMON OR USUAL NAME: | Unicompartmental Knee Prosthesis |
| CLASSIFICATION NAME: | Knee joint femorotibial metal/polymer semi constrained cemented |
| prosthesis, 21 CFR 8888.3520 | |
| DEVICE CLASS: | Class II |
| PANEL CODE: | Orthopaedics/87/HSX |
A. INTENDED USE:
The Journey Unicondylar Knee System is 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; 2.
- ల్లా Revision procedures where other treatments or devices have failed; and
-
- Treatment of fractures that are unmanageable using other techniques.
The Journey Unicondylar Knee System components are single use only and are intended for implantation only with bone cement.
B. DEVICE DESCRIPTION:
The devices, subject of this Premarket Notification, are the Smith & Nephew, Inc. Journey Unicondylar Femoral Implant components. The Journey unicondylar femoral implants are intended for cemented medial and lateral tibiofemoral replacement. The femoral implants will be offered in both Cobalt Chrome and Oxidized Zirconium alloy (OXINIUM) materials in sizes 1 through 7. The Smith & Nephew Journey Unicondylar femoral components feature the same articular surface geometry as existing femoral implants cleared in K073175.
The Journey Unicondylar femoral components are intended to be used in combination with the Competitor Unicondvlar All-Poly Tibial Baseplates IK061779), or the Competitor Unicondylar Knee Tibial Baseplates and Polyethylene Inserts {K061011}.
1
ﻥ SUBSTANTIAL EQUIVALENCE INFORMATION:
The Smith & Nephew Journey Unicondylar Femoral Implant is similar to the following commercially available devices regarding design features, overall indications, and materials:
| Manufacturer | Description | Submission
Number | Clearance
Date |
|----------------------|--------------------------------------|----------------------|-------------------|
| Smith & Nephew, Inc. | Journey Unicondylar Femoral Implants | K073175 | 12/28/2007 |
| Smith & Nephew, Inc. | GENESIS Unicompartmental Knee System | K912735 | 12/27/1991 |
| Smith & Nephew, Inc. | Unicondylar Femoral Component | K030301 | 02/25/2003 |
| Zimmer, Inc. | Unicompartmental Knee System | K033363 | 01/10/2004 |
D. SUMMARY OF TECHNOLOGICAL COMPARISON:
The intended use, design, and materials of the Journey Unicondylar Femoral Implants are substantially equivalent to the previously cleared Journey Unicondylar Femoral Implants (K073175). Design Control Activities have been completed and the results indicated that the subject device is safe and effective.
2
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 stylized caduceus, which is a symbol of medicine, with a double helix representing DNA. The caduceus is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" written around it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Smith & Nephew, Inc. Orthopaedic Division % Mr. Nicholas B. Tabrizi 1450 East Brooks Road Memphis, TN 38116
JUL 2 4 2008
K081351 Trade/Device Name: Smith & Nephew Journey Unicondylar Femoral Implant Regulation Number: 21 CFR 888.3520 Regulation Name: Knee joint femorotibial metal/polymer non-constrained cemented prothesis Regulatory Class: Class II Product Code: HSX Dated: June 24, 2008 Received: July 1, 2008
Dear Mr. Tabrizi:
Re:
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.
3
Page 2 -- Mr. Nicholas B. Tabrizi
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N. Miller
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: Smith & Nephew Journey Unicondylar Femoral Implant
Indications for Use:
The Journey Unicondylar Knee System is indicated for restoring either compartment of a knee that has been affected by the following:
- Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or 1. 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 Journey Unicondylar Knee System components are single use only and are intended for implantation only with bone cement.
x 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)
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
(Division Sigr Division of General, Restorative, and Neurological Devices
510(k) Number K081351