(84 days)
Not Found
No
The summary describes a mechanical joint replacement device and its material properties, with no mention of AI or ML.
Yes
The device is a joint replacement patella, which is explicitly indicated for treating conditions like arthritis, avascular necrosis, and fractures, and for the salvage of previously failed surgical attempts. These are all therapeutic interventions designed to alleviate symptoms, restore function, or correct anatomical issues.
No
The description indicates the device is a patella product (implant) used for joint replacement, not a tool for diagnosing medical conditions. The "Intended Use / Indications for Use" outlines conditions for which the joint replacement is indicated, not for diagnosing those conditions.
No
The device description clearly states it is a "highly cross linked polyethylene patella infused with pharmaceutical grade alphatocopheral," indicating a physical implantable device, not software. The performance studies also describe mechanical testing of a physical object.
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 fractures. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The device is described as a polyethylene patella, which is a component of a joint replacement system. 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 screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
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 (comma separated list FDA assigned to the subject device)
OIY, JWH
Device Description
This submission is to request clearance for a line extension to the current patella product line to include a highly cross linked polyethylene patella infused with pharmaceutical grade alphatocopheral.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee joint (patellofemoral, femorotibial)
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: Previous mechanical testing 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. Material characterization testing did not need to be repeated as identical material was cleared in K091956. Testing for subluxation, and contact stresses was found not to be required due to design equivalence.
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.
K932246, K905613, K100900, K091956
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
KC 113756
MAR 1 4 2012
Date: January 25, 2012
Manufacturer: Encore Medical, L.P. 9800 Metric Blvd Austin, TX 78758
Contact Person: Teffany Hutto Manager, Regulatory Affairs Phone: (512) 834-6255 Fax: (512) 834-6313 Email: teffany.hutto@djoglobal.com
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
MALLER MELLERS WANNING MINNER MANNE MARK WANTE AND LEASE LEAST
of the | LEALERSHIP FOR I SURNAMERS FREEN FORMICAL COLLECT OF C
.
44.2
assification | A Comments of Children Comments of Children
Todatot | Product
Code | Regulation and Classification Name |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|-----------------|---------------------------------------------------------------------------------------------------------------|
| . Patella with
HIGHIV
Vitamin I
ross
inken ' | lass | 11/11/1
OIV | 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 | | | |
510(k) Summary
Description: This submission is to request clearance for a line extension to the current patella product line to include a highly cross linked polyethylene patella infused with pharmaceutical grade alphatocopheral.
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 Metal Backed Patella - K932246 DJO Surgical Tri-Peg Patella - K905613 DJO Surgical Movation Patella - K100900 DJO Surgical 3DKnee Insert - K091956
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 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. Material characterization testing did not need to be repeated as identical material was cleared in K091956. Testing for subluxation, and contact stresses was found not to be required due to design equivalence.
Clinical Testing: None provided.
1 of 1
1
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Encore Medical, L.P. % Ms. Teffany Hutto Regulatory Affairs Manager 9800 Metric Boulevard Austin, Texas 78758
MAR 1 4 2012
Re: K113756 Trade/Device Name: Highly Cross Linked Patella with Vitamin E Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: OIY, JWH Dated: January 25, 2012 Received: January 26, 2012
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 or any i 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
2
Page 2 - Ms. Susanne Smith, MS
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,
Eric Keith
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known):
KN 3756
Device Name: Highly Cross Linked Patella with Vitamin E
Indications for Use:
Highly Cross Linked Patella 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
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)
Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K113756