(74 days)
No
The 510(k) summary describes a mechanical implant (tibial baseplates) and its performance testing. There is no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The focus is on the physical design and mechanical properties of the device.
Yes
The device is indicated for restoring a compartment of a knee affected by specific conditions like degenerative joint disease, allowing for correction of functional deformity, and revision procedures, which are typical uses for therapeutic devices.
No
This device is a medical implant (tibial baseplate) used for knee replacement, not for diagnosing conditions.
No
The device description clearly states it is a metal tibial baseplate, which is a physical implant, 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The provided text describes a surgical implant (tibial baseplates) designed to be surgically implanted into the knee joint to replace a damaged compartment.
- Intended Use: The intended use clearly states the device is for restoring a knee compartment affected by various conditions and for revision procedures. This is a therapeutic use, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of testing samples, analyzing biological markers, or providing diagnostic information.
The device described is a Class II medical device (specifically, a knee prosthesis) used in surgical procedures.
N/A
Intended Use / Indications for Use
The Journey Unicondylar Tibial Baseplates 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 labeled for single use only. The tibial baseplates are designed to be implanted using bone cement.
Product codes
HSX
Device Description
New unicondylar metal tibial baseplates have been designed and developed by Smith & Nephew Orthopaedics. In keeping with the design philosophy of the predicate Genesis Unicondylar Tibial Baseplates (K912735), the subject devices share the same design features such as:
- Shape (footprint)
- Size Offering (6 sizes with each size being offered in a RM/LL or LM/RL configuration)
- Cement Grooves
- Keel on Distal Surface
Given that the newly designed Journey tibial baseplates contain the same shape (footprint) and locking mechanism as the existing Journey Unicondylar Tibial Baseplates, the subject devices are intended to inter-lock with the currently marketed Journey Unicondylar UHMWPe Articular Inserts (K061011) in order to form a unicondylar tibial construct to replace either the medial or lateral tibial compartment of the knee.
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 verification testing has been performed based on requirements outlined in FDA's Droft Guidance for the Preparation of Prematket Notifications (510(k)s) for Cemented, Semi-Constrained Total Knee Prostheses, dated April 1993. Mechanical testing provided in the submission demonstrated that the Journey Unicondylar Tibial Baseplates met performance requirements and are as safe and effective as the predicate.
Mechanical testing included:
- Unsupported Baseplate Fatigue Testing; and
- Fully Supported Fatigue/Cement Adhesion Testing.
Clinical data was not needed to support the safety and effectiveness of the subject device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
K102069 (1/2)
Summary of Safety and Effectiveness JOURNEY Unicondylar Tibial Baseplates Smith & Nephew, Inc.
Date of Summary: October 4, 2010
| Contact Person: | Company and Address: | |
|---|---|---|
| Gino J. Rouss, MS | Smith & Nephew, Inc. | |
| Manager, Regulatory Affairs | Orthopaedic Division | |
| T (901) 399-6707 | 1450 East Brooks Road | OCT · 5 2010 |
| Memphis, Tennessee 38116 |
Name of Device: Smith & Nephew Journey Unicondylar Tibial Baseplate Common Name: Knee Prosthesis Device Classification Name and Reference: Knee joint femorotibial metal/polymer non-constrained cemented prosthesis, 21 CFR 888.3520 Device Class: Class II
Panel Code: Orthopaedics/87 HSX
Device Description
New unicondylar metal tibial baseplates have been designed and developed by Smith & Nephew Orthopaedics. In keeping with the design philosophy of the predicate Genesis Unicondylar Tibial Baseplates (K912735), the subject devices share the same design features such as:
- · Shape (footprint)
- · Size Offering (6 sizes with each size being offered in a RM/LL or LM/RL configuration)
- · Cement Grooves
- · Keel on Distal Surface
Given that the newly designed Journey tibial baseplates contain the same shape (footprint) and locking mechanism as the existing Journey Unicondylar Tibial Baseplates, the subject devices are intended to inter-lock with the currently marketed Journey Unicondylar UHMWPe Articular Inserts (K061011) in order to form a unicondylar tibial construct to replace either the medial or lateral tibial compartment of the knee.
Intended Use
The Journey Unicondylar Tibial Baseplates 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 labeled for single use only. The tibiat baseplates are designed to be implanted using bone cement.
1
Summary of Safety and Effectiveness JOURNEY Unicondylar Tibial Baseplates Smith & Nephew, Inc.
Performance Data
Design verification testing has been performed based on requirements outlined in FDA's Droft Guidance for the Preparation of Prematket Notifications (510)k)s) for Cemented, Semi-Constrained Total Knee Prostheses, dated April 1993. Mechanical testing provided in the submission demonstrated that the Journey Unicondylar Tibial Baseplates met performance requirements and are as safe and effective as the predicate.
Mechanical testing included:
- 트 Unsupported Baseplate Fatigue Testing; and
- I Fully Supported Fatigue/Cement Adhesion Testing.
Clinical data was not needed to support the safety and effectiveness of the subject device.
Substantial Equivalence Information
The modified Journey Unicondylar Tibial Baseplates are similar to the Smith & Nephew Genesis Unicompartmental Tibial Baseplates (K912735) regarding design features, overall indications, and materials.
Conclusion
As previously noted, this Traditional 510|k| Premarket Notification is being submitted for new unicondylar metal tibial baseplates that have been designed and developed by Smith & Nephew Orthopaedics. Given that the new devices have met all performance requirements and share the same design features, overall indications, and materials as the predicates, the devices can be considered substantially equivalent to the unicondylar baseplates currently marketed under K912735.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Smith and Nephew Endoscopy, Inc. % Mr. Gino Rouss Regulatory Affairs Specialist 1450 East Brooks Road Memphis, Tennessee 38116
OCT 5 2010
Re: K102069
Trade/Device Name: Smith & Nephew Journey Unicondylar Tibial Baseplates 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: July 21, 2010 Received: July 23, 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.
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
3
Page 2 - Mr. Gino 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.
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,
for Notturno Perillo
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): 《102.0 69
Device Name: Smith & Nephew Journey Unicondylar Tibial Baseplate
INDICATIONS FOR USE:
The Journey Unicondylar Tibial Baseplates 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 l 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 labeled for single use only. The tibial baseplates are designed to be implanted using 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)
Ooutti for mxm
(Division Sign)
rthopedic. storative Devices
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510(k) Number K102069