(30 days)
Not Found
Not Found
No
The summary describes a mechanical knee implant system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is indicated for use in painful and disabled knee joints resulting from various arthritic conditions and for corrections of deformities or failed previous procedures, which directly addresses health problems and intends to restore health.
No
The document describes "Femoral augmentation blocks" which are components of a knee replacement system used for surgical correction, not for diagnosing conditions.
No
The device description clearly states that the device is comprised of physical components made from titanium alloy (femoral augmentation blocks and locking screws), which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The provided description clearly states that the Performance Knee System is a surgical implant (femoral augmentation blocks made of titanium) intended for use in knee replacement surgery.
- Intended Use: The intended use describes the conditions for which the implant is used to treat a painful and disabled knee joint. This is a therapeutic use, not a diagnostic one.
The device is a Class II or Class III medical device (depending on the specific regulatory classification) used for surgical implantation, not for in vitro testing.
N/A
Intended Use / Indications for Use
The Performance Knee System is indicated 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 or previous joint replacement procedure.
The device is intended for use with bone cement.
Product codes (comma separated list FDA assigned to the subject device)
JWH
Device Description
The femoral augmentation blocks (FAB) may be used individually or in combinations; in a variety of positions to create an implant that fits the patient's needs. The modular femoral augmentation blocks are fastened to the femoral knee component with a locking screw. Femoral augmentation blocks are manufactured from titanium (Ti-6Al-4V) alloy with the geometry to match a corresponding size femoral component.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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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
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Not Found
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
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Summary of Safety and Effectiveness
| Sponsor: | Biomet, Inc.
Airport Industrial Park
P.O. Box 587
Warsaw, Indiana 46581-0587 |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Michelle L. McKinley |
| Device: | Performance Knee System |
| Classification: | 87JWH |
| Intended Use: | The Performance Knee System is indicated 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 or previous joint replacement procedure. The device is intended for use with bone cement. |
| Device Description: | The femoral augmentation blocks (FAB) may be used individually or in combinations; in a variety of positions to create an implant that fits the patient's needs. The modular femoral augmentation blocks are fastened to the femoral knee component with a locking screw. Femoral augmentation blocks are manufactured from titanium (Ti-6Al-4V) alloy with the geometry to match a corresponding size femoral component. |
| 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 of bone cement | Blood vessel damage | Bone fracture |
|---|---|---|
| Deformity of the joint | Soft tissue imbalance | Infection |
| Cardiovascular disease | Delayed wound healing | Hematoma |
| Fracture of the cement | Metal sensitivity | Dislocation |
| Implant loosening/migration | Fracture of the components | Excessive wear |
| Tissue growth failure | Nerve damage |
1
Substantial Equivalence:
Direct comparison was made with the following predicate:
Performance Knee System
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol of medicine, with three intertwined snakes. The logo also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 28 1999
Ms. Michelle L. McKinley Regulatory Specialist Biomet, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K992167
Trade Name: Performance Knee System- Femoral Augmentation Blocks Regulatory Class: II Product Code: JWH Dated: June 21, 1999 Received: June 28, 1999
Dear Ms. McKinley:
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, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (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 Regulation (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 regulation may result in regulatory action. In addition, FDA may publish further announcements 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. Michelle L. McKinley
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 regulation (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 Radiological Health
Enclosure
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Page 1 of 1
510(k) NUMBER (IF KNOWN):_____________________________________________________________________________________________________________________________________________________
DEVICE NAME: Performance Knee System
INDICATIONS FOR USE:
The Performance Knee is indicated 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.
This device is for use with bone cement.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
| (Per 21 CFR 801.109) | X |
|---|---|
| ------------------------------------------ | ----------------------------------------- |
OR
| Over-The-Counter-Use
| (Optional Format 1-2-96) | |
|---|---|
| -------------------------------------------------- | -- |
(Division Sign-Off)(Division Sign-Off)
Division of General Restorative Devices, (992167
510(k) Number.