(28 days)
No
The summary describes a knee replacement device and its materials, with no mention of AI or ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes.
The device is a joint replacement, which is a medical device used to treat disability due to various conditions, fitting the definition of a therapeutic device.
No
Explanation: The provided text describes a joint replacement device intended for treatment of various knee joint conditions. It is a therapeutic device, not a diagnostic one, as it addresses existing conditions rather than identifying or characterizing them.
No
The device description explicitly states it is a "new domed design patella," which is a physical implant, not software. The performance studies also describe mechanical testing of a physical device.
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 surgical implant for joint replacement, addressing conditions like arthritis, avascular necrosis, and deformities. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The device is a patella component for knee replacement systems, made of UHMWPE. This is a physical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. This device is a surgical implant used in vivo 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.
This system is to be used for cemented applications
Product codes
JWH, OIY
Device Description
The purpose of this application is to include a new domed design patella for the Foundation and 3DKnee systems manufactured with both the standard UHMWPE and highly crossed linked UHMWPE infused with Vitamin E.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee joint
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
Non-Clinical Testing: Previous mechanical testing outlined in K 1 13756 demonstrated the device's ability to perform under expected conditions. Testing included mechanical characterization testing, push out, lever out, torsion, Izod impact, small punch, tensile, FTIR, wear, animal implant for toxilogical response, and cytotoxicity.
Clinical Testing: None provided.
Key Metrics
Not Found
Predicate Device(s)
K905613, K100900, K020114, K113756
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
JUL 20 2012
Date: July 12, 2012
Manufacturer:
Encore Medical, L.P. 9800 Metric Blvd Austin, TX 78758
Contact Person: Michaela Norris Regulatory Affairs Associate Phone: (512) 834-6291 Fax: (512) 834-6313 Email: michaela.norris@djoglobal.com
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| Product
| Code | Regulation and Classification Name |
|---|---|
| JWH | Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis per 21 CFR 888.3560 |
| OIY | Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis per 21 CFR 888.3560 |
· Regulation Number/Name
21 CFR 888.3560 - Knee joint patellofemoratibial polymer semi-constrained cemented prosthesis.
Description: The purpose of this application is to include a new domed design patella for the Foundation and 3DKnee systems manufactured with both the standard UHMWPE and highly crossed linked UHMWPE infused with Vitamin E.
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.
This system is to be used for cemented applications
Predicate Devices:
DJO Surgical Domed Tri-Peg Patella - K905613
DJO Surgical Movation Domed Patella - K100900
DJO Surgical 3DKnee Standard Poly Material - K020114
DJO Surgical e+ Patella HXL VE Poly - K113756
DJO Surgical 3DKnee Sterilization and Packaging of Standard Poly - K020114
DJO Surgical e+ Patella Sterilization and Packaging of HXL VE Poly - K113756
1
Comparable Features to Predicate Device(s): Features comparable to predicate devices include the same design features, materials, indications sterilization, packaging and intended use.
Non-Clinical Testing: Previous mechanical testing outlined in K 1 13756 demonstrated the device's ability to perform under expected conditions. Testing included mechanical characterization testing, push out, lever out, torsion, Izod impact, small punch, tensile, FTIR, wear, animal implant for toxilogical response, and cytotoxicity.
Clinical Testing: None provided.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure embracing a bird, which is a symbol of care and protection. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Encore Medical, L.P. % Ms. Michaela Norris Regulatory Affairs Associate 9200 Metric Boulevard Austin, Texas 78758
JUL 20 2012
Re: K121835
Trade/Device Name: Domed Tri-Peg Patella Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis. Regulatory Class: Class II Product Code: JWH, OIY
Dated: June 22, 2012 Received: June 22, 2012
Dear Ms. Norris:
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
3
Page 2 - Ms. Michaela Norris
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 Ant. Macedo
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): ____________________________________________________________________________________________________________________________________________________
Device Name: Domed Tri-Peg Patella
Indications for Use:
Domed Tri-Peg Patella 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.
This system is to be used 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)
A
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K121835