(87 days)
Not Found
No
The summary describes a traditional knee implant system and does not mention any AI or ML components or functionalities.
Yes
The device is a knee replacement system intended to alleviate pain and correct deformities in the knee joint resulting from various conditions, which aligns with the definition of a therapeutic device.
No
Explanation: The device is described as an implant intended to replace parts of the knee joint, which falls under therapeutic intervention rather than diagnosis.
No
The device description clearly states it is a "single use implant intended for implantation with bone cement" and consists of "femoral components with augmentation pieces and three modular tibial bearings," which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states this device is a "single use implant intended for implantation with bone cement" and is designed to "replace the articular portions of the knee joint."
- Intended Use: The intended use describes conditions of the knee joint and the purpose of the implant (replacing the joint, correcting deformities, revising previous procedures).
This device is an implantable medical device, specifically a knee replacement system, not a diagnostic tool that analyzes samples outside the body.
N/A
Intended Use / Indications for Use
-
- Painful and disabled knee joint resulting from osteoarthritis, traumatic arthritis, 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 3) procedure.
The device is a single use implant intended for implantation with bone cement.
Product codes (comma separated list FDA assigned to the subject device)
87 JWH
Device Description
The Maxim Accel Knee System is intended to replace the articular portions of the knee joint. The system consists of three femoral components with augmentation pieces and three modular tibial bearings.
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: The Maxim Accel Knee System is intended to replace the articular portions of the knee joint. The system consists of three femoral components with augmentation pieces and three modular tibial bearings. All mechanical testing was done in accordance to 1994- Draft guidance for the preparation of Premarket Notifications (510(j)s) for cemented, semi-constrained total knee prostheses.
Clinical Testing: None provided as a basis for substantial equivalence.
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.
MCK (K915132), Performance (K936274)
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
0225546
BIOMET
page 1 of 1
SUMMARY OF SAFETY AND EFFECTIVENESS
| Sponsor: | Biomet Inc.
Airport Industrial Park
P.O. Box 587
Warsaw, IN 46581-0587
JAN 17 2003 |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Tracy J. Bickel
(574) 267-6639 |
| Device(s): | Maxim Accel Knee System |
| Classification Name: | Cemented semi-constrained polymer/metal/polymer (888.3560) |
| Device Classification: | Class II |
| Device Product Code: | 87 JWH |
| Substantially Equivalent Devices: | MCK (K915132); Performance (K936274) |
| Device Description: | The Maxim Accel Knee System is intended to replace the articular portions of the knee
joint. The system consists of three femoral components with augmentation pieces and
three modular tibial bearings. |
Indications for Use:
-
- Painful and disabled knee joint resulting from osteoarthritis, traumatic arthritis, 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 3) procedure.
The device is a single use implant intended for implantation with bone cement.
| Summary of Technologies: | The femoral component and tibial bearings have been redesigned.
The Maxim Accel Knee System is similar to or identical in terms of function,
labeling, and sizing to the predicate MCK device(s). |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Non-Clinical Testing: | The Maxim Accel Knee System is intended to replace the articular portions of the knee
joint. The system consists of three femoral components with augmentation pieces and
three modular tibial bearings. All mechanical testing was done in accordance to 1994-
Draft guidance for the preparation of Premarket Notifications (510(j)s) for cemented,
semi-constrained total knee prostheses. |
| Clinical Testing: | None provided as a basis for substantial equivalence. |
All trademarks are property of Biomet, Inc.
MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587
트
000015
SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582
1
OFFICE 574.267.6639
FAX 574.267.8137
E-MAIL biomet@biomet.com
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, enclosed in a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circle, with "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the left side and "USA" on the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 7 2003
Ms. Tracy Bickel Regulatory Specialist Biomet, Inc. P.O. Box 587 Warsaw, Indiana 46581-0578
Re: K023546
Trade/Device Name: Maxim Accel Knee System 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: October 18, 2002 Received: October 22, 2002
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 - Ms. Tracy 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,
Mark McMillan
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
Page _ of _
510(k) Number (if known): Device Name: Maxim Accel Knee System Indications for Use:
-
- Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, 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.
The device is a single use implant intended for implantation with bone cement.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Milham
ivision Sign-Division of General, Restorative and Neurological Devi
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