(37 days)
No
The document describes a physical implant and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is an implantable femoral component used to restore function to a knee affected by degenerative joint disease, trauma, or fractures, which aligns with the definition of a therapeutic device.
No
The document describes a surgical implant intended for knee replacement, not a device used to diagnose medical conditions.
No
The device description clearly states it consists of "femoral implants," which are physical components intended for surgical implantation, 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 and Intended Use: The description clearly states that the Journey Unicondylar Femoral Implant components are implants intended for surgical implantation into the knee joint to restore a damaged compartment. They are physical devices placed within the body, not used to test samples outside the body.
The information provided describes a surgical implant, which falls under the category of medical devices, but specifically not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Journey Unicondylar Femoral Implant 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 Journey Unicondylar Femoral Implant components are single use only and are intended for implantation only with bone cement.
Product codes
HSX
Device Description
The Journey Unicondylar Femoral Implant components will consist of various size and hand femoral implants for medial and lateral tibiofemoral compartment replacement. The femoral implants are anatomically shaped and are available in right and left, medial-lateral hand configurations (LL/RM and RL/LM). The femoral implants are offered in sizes 1-7.
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
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
510(K) Summary of Safety and EFFECTIVENESS SMITH & NEPHEW JOURNEY UNICONDYLAR FEMORAL IMPLANTS
SUBMITTER'S NAME: SUBMITTER'S ADDRESS: SUBMITTER'S TELEPHONE NUMBER: CONTACT PERSON: DATE SUMMARY PREPARED: TRADE OR PROPRIETARY DEVICE NAME: Implant COMMON OR USUAL NAME: CLASSIFICATION NAME:
DEVICE CLASS: PANEL CODE:
Smith & Nephew, Inc., Orthopaedic Division 1450 Brooks Road, Memphis, TN 38116 901-399-6055 Marlon D. Ridley December 12, 2007 Smith & Nephew Journey Unicondylar Femoral Implants Knee Prosthesis 21 CFR 8888.3520 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis. Class II Orthopedics/87 HSX
DEVICE INFORMATION:
DEC 2 0 2007
A. INTENDED USE:
The Journey Unicondylar Femoral Implant 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 1. necrosis:
-
- Correction of functional deformity;
- Revision procedures where other treatments or devices have failed; and 3.
-
- Treatment of fractures that are unmanageable using other techniques.
The Journey Unicondylar Femoral Implant components are single use only and are intended for implantation only with bone cement.
B. DEVICE DESCRIPTION:
The Journey Unicondylar Femoral Implant components will consist of various size and hand femoral implants for medial and lateral tibiofemoral compartment replacement. The femoral implants are anatomically shaped and are available in right and left, medial-lateral hand configurations (LL/RM and RL/LM). The femoral implants are offered in sizes 1-7.
C. SUBSTANTIAL EQUIVALENCE INFORMATION:
The Smith & Nephew Journey Unicondylar Femoral Implant components are substantially equivalent to the following commercially available devices with respect to design, overall indications, and materials:
- . Smith & Nephew's GENESIS Unicompartmental Knee System (K912735)
- Smith & Nephew's Unicondylar Femoral Component (K030301) .
- . Zimmer, Inc. Unicompartmental Knee System (K033363)
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
DEC 2 0 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Zimmer, Inc. % Mr. Marlon D. Ridley Regulatory Affairs Specialist 1450 Brooks Rd. Memphis, TN 38116
Re: K073175 Trade/Device Name: Journey Unicondylar Femoral Implant 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: November 8, 2007 Received: November 13, 2007
Dear Mr. Ridley:
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.
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Page 2 -- Mr. Marlon Ridley
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 the reporting 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 H. Milliman
Mark N. Melkerson Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known):
Device Name: Smith & Nephew Journey Unicondylar Femoral Implant
Indications for Use:
The Journey Unicondylar Femoral Implant 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;
- కి. Revision procedures where other treatments or devices have failed; and
- এ. Treatment of fractures that are unmanageable using other techniques.
The Journey Unicondylar Femoral Implant components are 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)
Harbere Inellin AM
(Division Sign-Off)
Page 1 of
Division of General. Restorative. and Neurological Devices
510(k) Nun