(258 days)
Not Found
No
The summary describes changes to the coating and porous surface of a knee implant, with no mention of AI/ML technology or related concepts like image processing, training/test sets, or performance metrics typically associated with AI/ML.
Yes
The device is a joint replacement, which is a common therapeutic intervention for conditions like arthritis, avascular necrosis, and fractures, aiming to restore joint function and alleviate pain.
No
Explanation: The provided text describes a joint replacement device (knee implant) and changes to its coating. It is a therapeutic device used for treatment, not for diagnosing conditions.
No
The device description clearly indicates changes to the physical components of a knee replacement system (adding a coating, removing porous coating). There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for joint replacement surgery to treat conditions affecting the knee joint. This is a surgical implant, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a femoral component of a knee replacement system, including materials and coatings. This is a physical implant.
- Anatomical Site: The anatomical site is the Knee joint, which is where the implant is placed within the body.
- Performance Studies: The performance studies listed are related to the biocompatibility and mechanical properties of the implant (toxicity, implantation, wear resistance, etc.), not the accuracy or performance of a diagnostic test.
IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical implant used to replace a damaged joint.
N/A
Intended Use / Indications for Use
Joint replacement is indicated for patients suffering from disability due to:
- degenerative, post-traumatic or rheumatoid arthritis; .
- avascular necrosis of the femoral condyle; .
- post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, . dysfunction or prior patellectomy;
- moderate valgus, varus or flexion deformities; .
- treatment of fractures that are unmanageable using other techniques. .
This device may also be indicated in the salvage of previously failed surgical attempts. The device is intended for cemented applications.
Product codes (comma separated list FDA assigned to the subject device)
JWH
Device Description
The change that is the subject of this 510(k) is to add a coating of Titanium Nitride (TiNbN) to the entire surface of the above listed femoral components. Additionally, the porous coating has been removed from the Foundation Knee Femoral Component. There is no change to the fundamental scientific technology of the referenced knee systems with the modifications in this 510(k) submission. This includes no changes to materials, design, sterilization, packaging, or method of manufacture.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee joint (implied by "Knee System" and "patellofemoral")
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)
Non-Clinical Testing: Accute System Toxicity Study, Bone Implantation Study, Cytotoxicity Study, GC/MS Fingerprint Study, Irritation Study, 28 Day Muscle Implantation Study, 90 Day Muscle Implantation Study, Sensitisation Study, Coating Chemical Composition, Coating Thickness, Coating Hardness, Adhesion Strength, Roughness, Wear Resistance
Clinical Testing: None provided.
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.
K923277, K933593, K020114, K100900, K964008
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
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
510(k) Summary
Date: April 9, 2013
Manufacturer:
DJO Surgical (Legal Name: Encore Medical, L.P.) 9800 Metric Blvd Austin, TX 78758
Contact Person: Teffany Hutto Manager, Regulatory Affairs Phone: (512) 834-6255 Fax: (760) 597-3466 Email: teffany.hutto@djoglobal.com
| Product | Original 510(k) Number, Clearance Date/ Classification | Product Code | Product Code | Regulation and Classification Name |
|---|---|---|---|---|
| Foundation® Knee System | K923277, February 9, 1993 / Class II | JWH | JWH | Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis per 21 |
| CFR 888.3560 | ||||
| Foundation® PS Knee System | K933539, November 8, 1994 / Class II | JWH | ||
| 3DKnee™ System | K020114, July 12, 2002 / Class II | JWH |
Description: The change that is the subject of this 510(k) is to add a coating of Titanium Nitride (TiNbN) to the entire surface of the above listed femoral components. Additionally, the porous coating has been removed from the Foundation Knee Femoral Component. There is no change to the fundamental scientific technology of the referenced knee systems with the modifications in this 510(k) submission. This includes no changes to materials, design, sterilization, packaging, or method of manufacture.
Indications for Use:
Joint replacement is indicated for patients suffering from disability due to:
- degenerative, post-traumatic or rheumatoid arthritis; .
- avascular necrosis of the femoral condyle; .
- post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, . dysfunction or prior patellectomy;
- moderate valgus, varus or flexion deformities; .
- treatment of fractures that are unmanageable using other techniques. .
This device may also be indicated in the salvage of previously failed surgical attempts. The device is intended for cemented applications.
Predicate Devices:
- DJO Surgical, Foundation® Knee System, K923277 .
- DJO Surgical, Foundation® PS Knee System, K933593 .
- DJO Surgical, 3DKnee™ System, K020114 .
- . DJO Surgical, Movation Knee System, K100900
- DJO Surgical, Foundation® Plasma Coated Femur, K964008 .
Comparable Features to Predicate Device(s): Features comparable to predicate devices include the same indications, dimensions, materials, packaging, sterilization, surgical implantation technique, and intended use.
Non-Clinical Testing: Accute System Toxicity Study, Bone Implantation Study, Cytotoxicity Study, GC/MS Fingerprint Study, Irritation Study, 28 Day Muscle Implantation Study, 90 Day Muscle Implantation Study, Sensitisation Study, Coating Chemical Composition, Coating Thickness, Coating Hardness, Adhesion Strength, Roughness, Wear Resistance
Clinical Testing: None provided.
APR 1 1 2013
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Letter dated: April 11, 2013
Encore Medical, L.P. % Ms. Teffany Hutto Manager, Regulatory Affairs 9800 Metric Boulevard Austin, Texas 78758
Re: K122239
Trade/Device Name: Foundation®, Foundation® PS, and 3DKnee™ Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Codes: JWH Dated: March 7, 2013 Received: March 8, 2013
Dear Ms. Hutto:
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
2
Page 2 -- Ms. Teffany Hutto
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.
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark Nighterson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
K122239 510(k) Number (if known):
Device Name: Foundation®, Foundation® PS, and 3DKnee™
Indications for Use:
Foundation®, Foundation® PS, and 3DKnee™ Indications for Use
Joint replacement is indicated for patients suffering from disability due to:
- degenerative, post-traumatic or rheumatoid arthritis; .
- avascular necrosis of the femoral condyle; .
- post-traumatic loss of joint configuration, particularly when there is patellofemoral . erosion, dysfunction or prior patellectomy;
- . moderate valgus, varus or flexion deformities;
- treatment of fractures that are unmanageable using other techniques. .
This device may also be indicated in the salvage of previously failed surgical attempts.
The device is intended for cemented applications.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Casey L. Hanley Ph.D.
Division of Orthopaedic Devices