(23 days)
Not Found
No
The description focuses on the material composition, mechanical design, and surgical indications of a knee implant, with no mention of AI or ML capabilities.
Yes
The device is a knee system indicated for treating painful and disabled knee joints resulting from various arthritic conditions and deformities, which are therapeutic uses.
No
The device description indicates it is a knee replacement system used to correct and replace damaged knee joints. This is a therapeutic device, not a diagnostic one.
No
The device description clearly details physical components made of Co-Cr-Mo, including femoral components with specific design features and finishes, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The provided description clearly states that the Maxim Knee System is a knee implant designed to replace or correct a damaged knee joint. It is a physical device implanted into the body.
- Intended Use: The intended use describes treating painful and disabled knee joints, correcting deformities, and revising previous joint replacement procedures. These are all surgical procedures involving the physical manipulation and replacement of a body part.
The description of the device, its intended use, and the fact that it is a physical implant for surgical use all point away from it being an IVD.
N/A
Intended Use / Indications for Use
The Maxim Knee System is indicated for:
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- Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, and/or traumatic arthritis where one or more compartments are involved.
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- Correction of varus, valgus, or posttraumatic deformity.
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- Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
This device is for use with bone cement
- Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
Product codes
JWH
Device Description
The Maxim Knee femorals are composed of Co-Cr-Mo conforming to ASTM F-75 standards. The posterior stabilized femoral components provide stabilization in knees with soft tissue deficiencies. The devices achieve stability against posterior tibial subluxation through the posterior flange of the femoral component meeting a central polyethylene post on the tibial component. This configuration allows for minimal femoral femoral roll back and rotational instability. The modifications made to the anterior flange were the increase in height and the decrease in angle. The femoral augment holes are now threaded instead of unthreaded and material was removed from the anterior flange in the form of retinaculum relief.
There are six sizes available in both right and left configurations for the Maxim PS V-II femoral components as well as the Maxim PS w/ Retinacular Relief femoral components. The femoral articulation is the same as the Maximum Congruent Knee (K915132). The anatomic component design allows the surgeon to reconstruct the anatomic dimensions and kinematics of the natural femur. The femoral component has an Interlok finish for use in cemented applications.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
K 9 9 3 1 5 9
OCT 1 4 1999
10/00/ 28 100 / 22
SUMMARY OF SAFETY AND EFFECTIVENESS
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Sponsor: Biomet Inc. Airport Industrial Park P.O. Box 587 Warsaw, IN 46581-0587
4225 UI 4 1100 -
Contact Person: Tracy J. Bickel (219) 372-1761
Device(s): Maxim Knee System (Maxim PS w/ Retinacular Relief and Maxim PS V-II).
Knee joint patellofemorotibial polymer/metal/polymer semi-Classification: constrained cemented prosthesis (CFR 888.3560)
Device Description: The Maxim Knee femorals are composed of Co-Cr-Mo conforming to ASTM F-75 standards. The posterior stabilized femoral components provide stabilization in knees with soft tissue deficiencies. The devices achieve stability against posterior tibial subluxation through the posterior flange of the femoral component meeting a central polyethylene post on the tibial component. This configuration allows for minimal femoral femoral roll back and rotational instability. The modifications made to the anterior flange were the increase in height and the decrease in angle. The femoral augment holes are now threaded instead of unthreaded and material was removed from the anterior flange in the form of retinaculum relief.
There are six sizes available in both right and left configurations for the Maxim PS V-II femoral components as well as the Maxim PS w/ Retinacular Relief femoral components. The femoral articulation is the same as the Maximum Congruent Knee (K915132). The anatomic component design allows the surgeon to reconstruct the anatomic dimensions and kinematics of the natural femur. The femoral component has an Interlok finish for use in cemented applications.
The Maxim Knee System is indicated for:
-
- Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, and/or traumatic arthritis where one or more compartments are involved.
-
- Correction of varus, valgus, or posttraumatic deformity.
-
- Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
1
Potential Risks: The potential risks associated with this device are the same as with any joint replacement device. These include, but are not limited to:
Reaction to bone cement Deformity of the joint Cardiovascular disease Fracture of the cement Implant loosening/migration Tissue growth failure
Blood vessel damage Soft tissue imbalance Delayed wound healing Metal sensitivity Fracture of the components Nerve damage
Bone fracture Infection Hematoma Dislocation Excessive wear
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, with flowing lines beneath them.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 4 1999
Ms. Tracy J. Bickel Regulatory Specialist Biomet, Inc. P.O. Box 587 46581-0587 Warsaw, Indiana
K993159 Re: Maxim Knee System Requlatory Class: II Product Code: JWH September 20, 1999 Dated: Received: September 21, 1999
Dear Ms. Bickel:
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 You may, therefore, Food, Drug, and Cosmetic Act (Act). market the device, subject to the general controls provisions The general controls provisions of the Act 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 (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. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: 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 regulations.
3
Page 2 - Ms. Tracy J. Bickel
This letter will allow you to begin marketing your device as described in your 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 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 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,
Celia M. Witten, Ph.D., M.D.
Director
Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
4
K913159 510(k) Number (if known): Device Name: Maxim Knee System Indications for Use:
The Maxim Knee System is indicated for:
- Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, 1) and/or traumatic arthritis where one or more compartments are involved.
- Correction of varus, valgus, or posttraumatic deformity. 2)
- Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of 3) . previous joint replacement procedure.
This device is for use with bone cement
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X | OR | Over-The |
|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional) | ||
| (Division Sign-Off) | 000007 | ||
| Division of General Restorative Devices | |||
| 510(k) Number | K992159 |
he-Counter Use al Format 1-2-96)