(225 days)
Not Found
Not Found
No
The summary describes a knee implant system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is described as being used in total knee arthroplasty surgery for "reduction or relief of pain and/or improved knee function," which are therapeutic benefits.
No
The provided text describes the FS 1000 Knee System as a device for surgical implantation in total knee arthroplasty, which is a treatment, not a diagnostic procedure. Its intended use is to reduce pain and improve knee function for patients with various degenerative joint conditions or fractures, not to diagnose them.
No
The device description is not found, but the intended use clearly describes a "Knee System" intended for "cemented implantation" in "total knee arthroplasty surgery." This strongly indicates a physical implantable device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant (a knee system) used in vivo (inside the body) for total knee arthroplasty. IVDs are used in vitro (outside the body) to examine specimens like blood, urine, or tissue to diagnose conditions.
- Device Description (Not Found, but implied): While the description is missing, the intended use strongly suggests a physical implantable device, not a diagnostic test kit or instrument.
- No Mention of Diagnostic Testing: The text focuses on surgical treatment and correction of knee conditions, not on diagnosing them through laboratory analysis.
Therefore, based on the provided information, the FS 1000 Knee System is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The FS 1000 Knee System is intended for single-use cemented implantation for use in total knee arthroplasty surgery for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions:
- Non-inflammatory degenerative joint disease resulting from osteoarthritis, traumatic arthritis, or avascular necrosis;
- Inflammatory degenerative joint disease including rheumatoid arthritis;
- Correction of varus, valgus, or post traumatic deformity;
- Correction or revision of unsuccessful osteotomy or arthrodesis;
- Revision procedures where other treatments or devices have failed; and OR . Treatment of fractures that are unmanageable using other techniques;
Product codes
JWH
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Knee
Indicated Patient Age Range
Skeletally mature patients
Intended User / Care Setting
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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
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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.)
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.
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
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
Image /page/0/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 image of an eagle with three heads, each head facing a different direction.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nov 1 0 1999
Kent M. Samuelson, M.D. Regulatory Affairs Representative Renaissance Instruments, LLC 370 Ninth Avenue, Suite 205 Salt Lake City, Utah 84103
Re: K991052 FS 1000 Knee System Trade Name: Requlatory Class: II Product Code: JWH Dated: August 25, 1999 Received: August 26, 1999
Dear Dr. Samuelson:
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 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 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 requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. 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 requlations.
1
Page 2 - Mr. Craig Corrance
This letter will allow you to begin marketing your device as inis iceci will and the premarket notification. The FDA asboing of substantial equivalence of your device to a legally IInding of Subscanelar equits in a classification for your marketed predicate and the 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 regarddagnostic devices), please contact the Office of victo diagnobels 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 orrios or compiland, "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,
[signature]
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known): __ K 991052
Device Name: FS 1000 Knee System
Indications for Use
The FS 1000 Knee System is intended for single-use cemented implantation for use in total knee arthroplasty surgery for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions:
- Non-inflammatory degenerative joint disease resulting from osteoarthritis, traumatic ● arthritis, or avascular necrosis;
- Inflammatory degenerative joint disease including rheumatoid arthritis; ●
- Correction of varus, valgus, or post traumatic deformity; ●
- Correction or revision of unsuccessful osteotomy or arthrodesis; ●
- . Revision procedures where other treatments or devices have failed; and
OR
- . Treatment of fractures that are unmanageable using other techniques;
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Taseer To
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use (Optional Format 1-2-96)