(18 days)
No
The 510(k) summary describes a mechanical knee joint replacement prosthesis and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is a knee joint replacement prosthesis, which is a medical implant used to replace a damaged knee joint, primarily for structural and functional restoration rather than applying therapeutic energy or substances.
No
This device is a Biomet knee joint replacement prosthesis, indicated for treating painful and disabled knee joints, correcting deformities, and revising previous unsuccessful procedures. It is an implantable medical device used for treatment, not for diagnosis.
No
The device description clearly describes a physical knee joint replacement prosthesis, which is a hardware device, 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 surgical implant for replacing a damaged knee joint. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a physical prosthesis designed to be implanted into the body. IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a person's health.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information based on in vitro testing.
Therefore, this device falls under the category of a surgical implant/prosthesis, not an IVD.
N/A
Intended Use / Indications for Use
The indications for use for Biomet knee joint replacement prostheses include: 1) painful and disabled knee joint resulting from osteoarthritis, theumatoid arthritis, traumatic arthritis where one or more compartments are involved; 2) Correction of varus, valgus, or posttraumatic deformity; and 3) Corrections or revision of unsuccessful osteotomy, arhtrodesis, or failure of previous joint replacement procedure.
This device is for use with bone cement
Product codes
JWH
Device Description
The Ascent Closed Box Posterior Stabilized Femoral Component is a stemmable knee component designed for use in cases where extensive ligament damage has occurred. This design is based upon the features of the currently marketed Performance Closed Box Knee Components with certain modifications.
There are five sizes available in both right and left configurations. The femoral articulation is the same as the Performance Posterior Stabilized Knee (K936274). 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 Ascent Closed Box PS Femoral Component can be used with either a constrained or PS tibial bearing. The femoral component also has independent posterior and distal augments to correct bone loss deficiencies and can still be used with previously cleared Performance stems and locking screw.
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)
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
SUMMARY OF SAFETY AND EFFECTIVENESS
Sponsor: Biomet, Inc. Airport Industrial Park P.O. Box 587 Warsaw, IN 46581-0587
Contact Person: Dalene Hufziger Binkley (219) 372-1612
Trade Name: Ascent Knee System
Classification Name: Knee joint patello-femorotibial polymer/metal/polymer semiconstrained cemented prosthesis (CFR 888.3560).
Device Description: The Ascent Closed Box Posterior Stabilized Femoral Component is a stemmable knee component designed for use in cases where extensive ligament damage has occurred. This design is based upon the features of the currently marketed Performance Closed Box Knee Components with certain modifications.
There are five sizes available in both right and left configurations. The femoral articulation is the same as the Performance Posterior Stabilized Knee (K936274). 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 Ascent Closed Box PS Femoral Component can be used with either a constrained or PS tibial bearing. The femoral component also has independent posterior and distal augments to correct bone loss deficiencies and can still be used with previously cleared Performance stems and locking screw.
Potential Risks: The potential risks associated with this device are the same as with any joint replacement disease. These include, but not limited to:
Reaction to bone cement Deformity of the joint Cardiovascular diseases 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
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 5 1999
Ms. Mary L. Verstynen Manager of Clinical Affairs Biomet, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K993111
Trade Name: Ascent Knee System Regulatory Class: II Product Code: JWH Dated: September 16, 1999 Received: September 17, 1999
Dear Ms. Verstynen:
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 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 (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 (OS) 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.
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Page 2 -- Ms. Mary L. Verstynen
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 vour 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 at (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 _ of _
510 (k) NUMBER (if KNOWN): __ K 9 3 | | (
DEVICE NAME: Ascent Closed Box Posterior Stabilized Femoral
INDICATIONS FOR USE:
The indications for use for Biomet knee joint replacement prostheses include: 1) painful and disabled knee joint resulting from osteoarthritis, theumatoid arthritis, traumatic arthritis where one or more compartments are involved; 2) Correction of varus, valgus, or posttraumatic deformity; and 3) Corrections or revision of unsuccessful osteotomy, arhtrodesis, 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 NEEDED.)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |||
|---|---|---|---|
| Prescription Use | |||
| (Per 21 CFR 801.109) | OR | Over-The-Counter-Use | |
| (Optional Format 1-2-96) | |||
| 000007 | (Division Sign-Off) | ||
| Division of General Restorative Devices / 9931 | |||
| 510(k) Number |