(29 days)
No
The 510(k) summary describes a mechanical knee revision femoral stem and its modifications. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities. The focus is on material, size, and design changes to a previously cleared device.
Yes
The device is described as an implantable component for total knee replacement, indicated for treating painful and disabled knee joints resulting from various arthritic conditions and deformities. These are all conditions that affect the structure or function of the body, and the device is intended to assist in these conditions, which aligns with the definition of a therapeutic device.
No
This device is an implantable knee stem designed for joint replacement procedures. Its intended use is to correct painful and disabled knee joints, deformities, or failures of previous procedures, not to diagnose a condition.
No
The device description clearly states it is a femoral stem, which is a physical implant made of titanium alloy, not software.
Based on the provided information, 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 and Intended Use: The description clearly states that the Ascent Knee Revision Femoral Stem is an implantable device used in surgical procedures to replace or revise a knee joint. It is a physical component implanted into the body.
- Lack of Mention of Samples or Testing: There is no mention of the device being used to analyze samples or perform any kind of diagnostic test outside of the body.
Therefore, the Ascent Knee Revision Femoral Stem is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Ascent Knee Revision Femoral Stem is indicated for use in:
-
- 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
-
- Corrections or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
This device is for Cemented Use Only
Product codes
JWH
Device Description
The Ascent Knee Revision Stems are similar to the previously cleared Performance Posterior Stabilized (PS) Total Knee System (K936274) used to ensure component placement and stability. The modifications made add a larger and smaller diameter size, decrease the slot width, and change the stem material. The distal diameter on stems sized 10 - 16 were also increased. Minor modifications were also made to the femoral locking screw.
There are sixteen new wrought titanium alloy (Ti-6Al-4v) Ascent Revision Stems available. Twelve of these sixteen have the same diameter and length as the previously cleared Performance PS Total Knee System (K936274). The larger diameter revision stem has been added to fit within larger canals. The smaller diameter revision stem has been added to fit within smaller canals.
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 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
SUMMMARY OF SAFETY AND EFFECTIVENESS
SPONSOR: Biomet, Inc. Airport Industrial Park P. O. Box 587 Warsaw IN 46580 -0587
CONTACT PERSON: Tina Lakin (219) 267-6639 ext. 1816
DEVICE NAME: Ascent Knee Revision Femoral Stem
CLASSIFACTION NAME: Knee joint patello-femorotibial polymer/metal/polymer semi-constrained cemented prosthesis (CFR 888.3560).
INDICATIONS FOR USE: Ascent Knee Revision Femoral Stem is indicated for use in:
-
- 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
-
- Corrections or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
This device is for Cemented Use Only
DEVICE DESCRIPTION: The Ascent Knee Revision Stems are similar to the previously cleared Performance Posterior Stabilized (PS) Total Knee System (K936274) used to ensure component placement and stability. The modifications made add a larger and smaller diameter size, decrease the slot width, and change the stem material. The distal diameter on stems sized 10 - 16 were also increased. Minor modifications were also made to the femoral locking screw.
There are sixteen new wrought titanium alloy (Ti-6Al-4v) Ascent Revision Stems available. Twelve of these sixteen have the same diameter and length as the previously cleared Performance PS Total Knee System (K936274). The larger diameter revision stem has been added to fit within larger canals. The smaller diameter revision stem has been added to fit within smaller canals.
POTENTIAL RISKS: The potential risks with this device are the same with any other joint replacement device. These include, but are not limited to:
-
Reaction to bone cement Fracture of component Cardiovascular disorders Blood vessel damaqe Deformity of the joint Delayed wound healing
Fracture of bone cement Metal sensitivity Implant loosening/migration Soft tissue loosening Tissue growth failure Dislocation -
Hematoma Nerve damage Infection Bone fracture
00038
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SUBSTANTIAL EQUIVALENCE: The Ascent Knee Revision femoral stem is modified from the Performance P/S Knee femoral stem (Biomet - K936274).
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, arranged in a way that suggests a bird in flight. The profiles are connected and form a single, flowing shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 7 2000
Ms. Tina Lakin Regulatory Specialist Biomet, Inc. P.O. Box 587 Airport Industrial Park Warsaw, Indiana 46581-0587
Re: K001010
Trade Name: Ascent Knee Revision Femoral Stems Regulatory Class: II Product Code: JWH Dated: March 28, 2000 Received: March 29, 2000
Dear Ms. Lakin:
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.
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.
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Page 2 - Ms. Tina Lakin
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,
Donna R Lochner
Image /page/3/Picture/4 description: The image shows the name and title of Celia M. Witten, Ph.D., M.D., who is the Director of the Division of General, Restorative and Neurological Devices. The image also indicates that this division is part of the Office of Device Evaluation, which is under the Center for Devices and Radiological Health. The text is arranged in a hierarchical manner, with the name and title at the top, followed by the division, office, and center.
Enclosure
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510(k) NUMBER (if KNOWN):_____________________________________________________________________________________________________________________________________________________
DEVICE NAME: Ascent Knee Revision Femoral Stems
INDICATIONS FOR USE:
The Ascent Knee Revision Femoral Stem is indicated for:
-
- 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
-
- Corrections or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
This device is a single use implant
This device is for cemented use only
(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)
Dunn R. Lochner.
(Division Sign-Off) (Division Sign-Off)
Division of General Restorative Devices
Division of General Restorative Collect C) Division of General Roolo TO