(293 days)
Not Found
No
The summary describes a traditional knee replacement implant and does not mention any AI or ML components or functionalities.
Yes
The device is a knee replacement system intended to relieve knee pain and restore knee joint function, which are therapeutic actions.
No
This device is a component of a total knee replacement system, intended to aid in surgical treatment and restore joint function, not to diagnose a condition.
No
The device description explicitly states it is a "porous coated femoral component manufactured from CoCr alloy," which is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided information clearly describes a surgical implant used in total knee replacement surgery. Its purpose is to replace damaged parts of the knee joint to relieve pain and restore function. It is implanted directly into the patient's body.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens.
Therefore, based on the provided information, this device falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
This device is part of a total knee replacement system utilized in treating patients who are candidates for primary total knee arthroplasty or revision arthroplasty where bone loss is minimal and the collateral ligaments are intact. It is intended to aid the surgeon in relieving the patient of knee pain and restoring knee joint function.
- Noninflammatory degenerative joint disease including osteoarthritis or traumatic 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
- Rheumatoid arthritis
- Treatment of fractures that are unmanageable using other techniques.
Product codes (comma separated list FDA assigned to the subject device)
MBH
Device Description
The 3DKnee™ porous coated femoral component is manufactured from CoCr alloy conforming to ASTM F75. The inner surface is porous coated with CoCrMo beads (ASTM F75) to provide a porous surface for enhanced fixation. It is available in 7 sizes (2-12) and is provided in left and right configurations. The femoral component is designed to match the condyles of the tibial insert for greater congruency and is the same design as the 3DKnee™ cleared in K020114.
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
surgeon
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): 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.
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
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.
0
Summary of Safety and Effectiveness
K032905
Page 1 of 1
Encore Medical, L.P. 9800 Metric Blvd Austin, TX 78758 512-834-6237
Trade Name: 3DKnee™ Porous Coated Femoral Component
Common Name: Porous Coated Femoral Component
Classification Name: Knee joint patellofemoraotibial metal/polymer porous coated uncemented prosthesis per 21 CFR888.3565.
Indications:
This device is part of a total knee replacement system utilized in treating patients who are candidates for primary total knee arthroplasty or revision arthroplasty where bone loss is minimal and the collateral ligaments are intact. It is intended to aid the surgeon in relieving the patient of knee pain and restoring knee joint function. This device is for uncemented use only.
Description:
The 3DKnee™ porous coated femoral component is manufactured from CoCr alloy conforming to ASTM F75. The inner surface is porous coated with CoCrMo beads (ASTM F75) to provide a porous surface for enhanced fixation. It is available in 7 sizes (2-12) and is provided in left and right configurations. The femoral component is designed to match the condyles of the tibial insert for greater congruency and is the same design as the 3DKnee™ cleared in K020114.
Substantial Equivalence
The 3DKnee™ porous femoral component is similar in design, materials and indications to the 3DKnee™ (K020114).
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white circular seal. The seal features a stylized eagle with three stripes forming its wings and body. Encircling the eagle is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged along the perimeter of the circle, with the eagle positioned in the center.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 6 2004
Ms. Debbie De Los Santos Supervisor, Regulatory/Clinical Services Encore Medical, L.P. 9800 Metric Boulevard Austin, Texas 78758
Re: K032905
Trade/Device Name: 3DKnee Porous Coated Femoral Component Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous coated uncemented prosthesis Regulatory Class: II Product Code: MBH Dated: September 12, 2003 Received: September 22, 2003
Dear Ms. De Los Santos:
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
2
Page 2 – Ms. Debbie De Los Santos
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. 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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html .
Sincerely yours,
for Miriam C. Provost
Celia M. Witten, Ph.D., M.D. 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: 3DKnee™ Porous Coated Femoral Component
Indications For Use:
3DKnee™ Porous Coated Femoral Component Indications For Use
This device is part of a total knee replacement system utilized in treating patients who are candidates for primary total knee arthroplasty or revision arthroplasty where bone loss is minimal and the collateral ligaments are intact. It is intended to aid the surgeon in relieving the patient of knee pain and restoring knee joint function.
- Noninflammatory degenerative joint disease including osteoarthritis or traumatic arthritis ●
- Avascular necrosis of the femoral condyle 체
- Post-traumatic loss of joint configuration, particularly when there is patellofemoral 피 erosion, dysfunction or prior patellectomy
- 1 Moderate valgus, varus or flexion deformities
- 제 Rheumatoid arthritis
- Treatment of fractures that are unmanageable using other techniques. 트
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K032905
Concurrence of CDRH, Office of Device Evaluation (ODE)
Image /page/3/Picture/16 description: The image shows the text "Prescription Use" followed by the text "(per 21 CFR 801.109)". There is a line going through the text "Prescription Use". The text is in black font and the background is white.
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)