(83 days)
No
The device description and intended use are purely mechanical, describing a physical implant for knee replacement. There is no mention of software, data processing, or any technology that would suggest AI/ML.
Yes
The device is a patellar surface replacement intended to relieve knee pain and restore knee joint function in patients, which are therapeutic goals.
No
The device is a knee implant designed to replace the patellar surface, not to diagnose medical conditions. Its purpose is to treat arthritis and restore knee function.
No
The device description clearly states it is a physical implant with a plastic articulating surface and a metal baseplate, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "cemented patellar surface replacement" used in surgical procedures (total knee arthroplasty and revision arthroplasty) to treat conditions like osteoarthritis and rheumatoid arthritis. This is a therapeutic device implanted in the body.
- Device Description: The description details a physical implantable device made of plastic and metal, designed to replace a part of the knee joint.
- Lack of IVD Characteristics: IVD devices are used in vitro (outside the body) to examine specimens (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or interaction with biological specimens for diagnostic purposes.
Therefore, the Foundation® Plasma Sprayed Metal-backed Patella is a medical device, specifically an implantable orthopedic device, not an IVD.
N/A
Intended Use / Indications for Use
The Foundation® Plasma Sprayed Metal-backed Patella is intended to be used as a cemented patellar surface replacement in treating patients who are candidates for primary total knee arthroplsty as a result of osteoarthritis, inflammatory arthritis, traumatic arthritis or rheumatoid arthritis with or without varus, valgus, or flexion deformities, or revision arthroplasty where bone loss is minimal. It is intended to aid the surgeon in relieving the patient of knee pain and restoring knee joint function.
Product codes
JWH
Device Description
The Foundation® Plasma Sprayed Metal-backed Patella has a " sombrero" shaped plastic articulating surface and a metal baseplate. The baseplate has three smooth pegs for rotational stability. The plastic component is manufactured from UHMWPe that conforms to ASTM F648. The metal baseplate is fabricated from wrought Ti-6A1-4V (ASTM F136) and is plasma sprayed with commercially pure titanium to provide a roughened surface to enhance cement fixation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee joint / patella
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)
Testing on this device included axial pushout and shear fatigue tests of the baseplate/plastic assembly. Results indicate that the attachment mechanism is sufficient to withstand the expected in-vivo loads.
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
§ 888.3560 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
DEC 1 8 1997
Summary of Safety and Effectiveness
Encore Orthopedics, Inc.
9800 Metric Blvd.
Austin, TX 78758
(512) 834-6237
| Trade Name: | Foundation® Plasma Sprayed Metal-backed Patella |
|---|---|
| Common Name: | Metal-backed Patella |
| Classification Name: | patellofemorotibial polymer/metal/polymer semiconstrained cemented prostheses as Class II. |
The Foundation® Plasma Sprayed Metal-backed Patella has a " sombrero" shaped Description: plastic articulating surface and a metal baseplate. The baseplate has three smooth pegs for rotational stability. The plastic component is manufactured from UHMWPe that conforms to ASTM F648. The metal baseplate is fabricated from wrought Ti-6A1-4V (ASTM F136) and is plasma sprayed with commercially pure titanium to provide a roughened surface to enhance cement fixation.
Intended Use: The Foundation® Plasma Sprayed Metal-backed Patella is intended to be used as a cemented patellar surface replacement in treating patients who are candidates for primary total knee arthroplsty as a result of osteoarthritis, inflammatory arthritis, traumatic arthritis or rheumatoid arthritis with or without varus, valgus, or flexion deformities, or revision arthroplasty where bone loss is minimal. It is intended to aid the surgeon in relieving the patient of knee pain and restoring knee joint function.
Comparable Features to Predicate Device(s): The Foundation® Plasma Sprayed Metal-backed Patella is the very same device in regards to articulating geometry, assembly, and indications for usage as the Porous Coated Metal-backed patella approved in K932246. The only difference is the coating applied. The Foundation® Plasma Sprayed Metal-backed Patella is equivalent in design and indications to the Miller/Galante (Zimmer) and Natural-Knee (Sulzer Orthopedics) metal-backed patella (Exhibit VII). These devices were cleared for commercial distribution on 510(k)s K863805 and K873601, respectively. Similarities include, metal-backed baseplate with Ti-6A1-4V substrate, " sombrero" shaped articulating surface and three fixation pegs.
Test Results: Testing on this device included axial pushout and shear fatigue tests of the baseplate/plastic assembly. Results indicate that the attachment mechanism is sufficient to withstand the expected in-vivo loads.
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 18 1997
Ms. Debbie De Los Santos Regulatory/Clinical Specialist Encore Orthopedics, Inc. 9800 Metric Boulevard Austin, Texas 78758
- Re : K973672 Foundation® Plasma Sprayed Metal-Backed Patella Requlatory Class: II Product Code: JWH Dated: September 24 ,1997 Received: September 26, 1997
Dear Ms. De Los Santos:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). This decision is based on this device being equivalent only to similar devices labeled and intended to be fixed within bone with acrylic "bone cement." You may, therefore, market your device subject to the general controls provisions of the Act and the following limitations :
-
- This device may not be labeled or promoted for noncemented use.
-
- All labeling for this device, including package label and labeling included within the package, must prominently state that the device is intended for cemented use only.
2
Page 2 - Ms. Debbie De Los Santos
- Any non-cemented fixation of this device is considered 3. investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulation under 21 CFR, Part 812. All users of the device for noncemented fixation must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) to conduct the investigation.
The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. ਕਿ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be
3
Page 3 - Ms. Debbie De Los Santos
obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
C. Edwin McWhirter, Ph.D.
ia M. Witten, Ph.D., M.D. Ce Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K973672
Device Name:
Indications For Use:
Foundation® Plasma Sprayed Metal-backed Patella Indications For Use
The Foundation® Plasma Sprayed Metal-backed Patella is intended to be used as a cemented patellar surface replacement in treating patients who are candidates for primary total knee arthroplsty as a result of osteoarthritis, inflammatory arthritis, traumatic arthritis or rheumatoid arthritis with or without varus, valgus, or flexion deformities, or revision arthroplasty where bone loss is minimal. It is intended to aid the surgeon in relieving the patient of knee pain and restoring knee joint function.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
oneurrence of CDRH Office of Device Evaluation (ODE)
coeeef
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K973672
Prescription Use (per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)_