(29 days)
No
The summary focuses on material changes and predicate device equivalence, with no mention of AI/ML in the intended use, device description, or performance studies.
Yes
The device is a knee joint replacement (femoral components) intended to address painful and disabled knee joints resulting from various conditions like osteoarthritis and rheumatoid arthritis, which are therapeutic interventions.
No
The document describes a medical device (femoral components) used for joint replacement and correction of deformities, which is a therapeutic intervention, not a diagnostic one. Its "Intended Use / Indications for Use" outlines conditions it treats, not conditions it diagnoses.
No
The device description explicitly states it is a femoral component, which is a physical implant, 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 describes a device used for surgical implantation to treat painful and disabled knee joints. This is a therapeutic intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a femoral component for knee replacement, a surgical implant.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
IVD devices are used to examine specimens 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
Intended Use:
-
- Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved,
- Failure of previous joint replacement procedure, 2)
-
- Correction of varus, valgus, or posttraumatic deformity.
-
- Correction or revision of unsuccessful osteotomy or arthrodesis
- Device designed for use in patients with metal sensitivity. .
- Standard surgical and rehabilitative procedures are indicated with this device. .
- The device is a single use device intended for use with bone cement. .
Product codes
JWH
Device Description
The femoral components found in this submission (AGC® and Maxim®) are identical to their predecessors (K981996) with the exception of the vendor who will complete the nitrogen ion implantation on the Ti-6Al-4V femoral surfaces.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device(s) are functional within their intended use.
Clinical Testing: None provided as a basis for substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
K041466 1fl
BIOMET
JUI 01 2004
510(k) Summary
| Sponsor: | Biomet Manufacturing, Corp.
P.O. Box 587
Warsaw, IN 46581-0587 |
|-------------------|---------------------------------------------------------------------------------------------------|
| Contact Person: | Tracy Bickel Johnson, RAC
Regulatory Associate
Biomet Manufacturing Corp.
(574) 267-6639 |
| Proprietary Name: | Titanium Femoral Knee Components (Maxim® and AGC®) |
| Common Name: | Knee Femoral Components (K981996) |
Classification Name: Cemented semi-constrained polymer/metal/polymer knee prosthesis (888.3560)
Substantially Equivalent Devices: Titanium Femoral Components (K981996)
Device Description: The femoral components found in this submission (AGC® and Maxim®) are identical to their predecessors (K981996) with the exception of the vendor who will complete the nitrogen ion implantation on the Ti-6Al-4V femoral surfaces.
Intended Use:
-
- Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved,
- Failure of previous joint replacement procedure, 2)
-
- Correction of varus, valgus, or posttraumatic deformity.
-
- Correction or revision of unsuccessful osteotomy or arthrodesis
- Device designed for use in patients with metal sensitivity. .
- Standard surgical and rehabilitative procedures are indicated with this device. .
- The device is a single use device intended for use with bone cement. .
Summary of Technologies: The femoral components in this submission have not been modified from their original state in terms of materials, design, sizing, and indications. The only modification is a vendor change for nitrogen ion implantation.
Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device(s) are functional within their intended use.
Clinical Testing: None provided as a basis for substantial equivalence.
All trademarks are property of Biomet, Inc.
| MAILING ADDRESS | P.O. Box 587 |
|---|---|
| SHIPPING ADDRESS | 56 E. Bell Drive |
| OFFICE | 574.267.6639 |
| FAX | 574.267.8137 |
| E MAIL | biomet@biomet.com |
90
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.
JUL 01 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Tracy J. Bickel Biomet Manufacturing Corporation 56 East Bell Drive Warsaw, Indiana 46582
Re: K041466 Trade/Device Name: Titanium Femoral Knee Components Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint, patellofemorotibial, polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: June 1, 2004 Received: June 2, 2004
Dear Ms.Bickel:
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 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.
2
Page 2 - Tracy J. Bickel
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" (21CFR 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,
Miriam C. Provost
(d 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
Indications for Use
510(k) Number (if known):
Device Name: Titanium Femoral Knee Components
Indications For Use:
-
- Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved,
-
- Failure of previous joint replacement procedure,
-
- Correction of varus, valgus, or posttraumatic deformity.
-
- Correction or revision of unsuccessful osteotomy or Arthrodesis
- Device designed for use in patients with metal sensitivity. .
- Standard surgical and rehabilitative procedures are indicated with . this device.
- The device is a single use device intended for use with bone . cement.
Prescription Use X __ X __ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
uriam C. Provost
(Division Sign-Off) Division of General, Restorative. and Neurological Devices
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K041466 510(k) Number_