(119 days)
Not Found
No
The device description and intended use focus on a physical spacer made of PMMA cement, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are explicitly marked as "Not Found".
No
The device, a PMMA cement spacer, is used to assist in the surgical implantation of a total knee prosthesis by helping to adjust extension gaps and maintain a uniform cement mantle. It does not directly treat a disease or condition itself, but rather facilitates a surgical procedure that is therapeutic.
No
Explanation: The device is a Distal Femoral Spacer, used during knee replacement surgery to create a uniform cement mantle. Its intended use and description do not involve diagnosing any medical conditions; rather, it is a tool for surgical implantation.
No
The device description clearly states it is a physical spacer made of poly(methyl methacrylate) [PMMA] cement, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The provided description clearly states that this device is a Distal Femoral Spacer, a physical component used during knee replacement surgery. It's a mechanical aid for positioning and creating space for bone cement.
- Intended Use: The intended use is for patients with severe knee pain and disability due to various conditions, and it's used during surgery to help with the placement of a total knee prosthesis. This is a surgical implant/accessory, not a diagnostic test performed on a specimen.
The description focuses on the physical characteristics and surgical application of the device, not on analyzing biological samples.
N/A
Intended Use / Indications for Use
This device is indicated for patients with severe knee pain and disability due to:
Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
Collagen disorders and/or avascular necrosis of the femoral condyle.
Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy
Moderate valgus, varus or flexion deformities.
The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
This device is intended for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
JDI
Device Description
The Distal Femoral Spacer is a poly(methyl methacrylate) [PMMA] cement spacer designed to help adjust extension gaps and maintain a uniform cement mantle when used with the femoral component of a cemented total knee prosthesis. It is used in pairs; each Distal Femoral Spacer fits over one of the femoral posts. This creates a defined space between the femoral component and the prepared bone, helping maintain a uniform cement mantle. The Distal Femoral Spacers themselves are then incorporated into the cement mantle by the polymerizing bone cement. The Distal Femoral Spacer is available in 2mm and 4mm thicknesses.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
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 Performance and Conclusions: Non-clinical performance testing was not required for this device.
Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device.
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.
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
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip 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 an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
MAY 1 7 2005
Summary of Safety and Effectiveness
:
| Submitter: | Zimmer, Inc.
P.O. Box 708
Warsaw, IN 46581-0708 |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Brandon Hipsher
Specialist, Corporate Regulatory Affairs
Telephone: (574) 371-8083
Fax: (574) 372-4605 |
| Date: | January 17, 2005 |
| Trade Name: | NexGen® Complete Knee Solution Distal Femoral
Spacers |
| Common Name: | Total knee prosthesis |
| Classification Name
and Reference: | Knee joint patellofemorotibial
polymer/metal/polymer semi-constrained cemented
prosthesis
21 CFR § 888.3560 |
| Predicate Device: | ZCA® All-Poly Acetabular Cup, Snap-In (PMMA
spacer) manufactured by Zimmer, Inc., K030153,
cleared April 1, 2003. |
| Device Description: | The Distal Femoral Spacer is a poly(methyl
methacrylate) [PMMA] cement spacer designed to
help adjust extension gaps and maintain a uniform
cement mantle when used with the femoral
component of a cemented total knee prosthesis. It is
used in pairs; each Distal Femoral Spacer fits over
one of the femoral posts. This creates a defined
space between the femoral component and the
prepared bone, helping maintain a uniform cement
mantle. The Distal Femoral Spacers themselves are
then incorporated into the cement mantle by the
polymerizing bone cement. The Distal Femoral
Spacer is available in 2mm and 4mm thicknesses. |
| Intended Use: | This device is indicated for patients with severe
knee pain and disability due to: |
:
1
50105
.
Rheumatoid arthritis, osteoarthritis, traumatic
2/2
arthritis, polyarthritis. Collagen disorders and/or avascular necrosis of . the femoral condyle. Post-traumatic loss of joint configuration, . particularly when there is patellofemoral erosion, dysfunction or prior patellectomy Moderate valgus, varus or flexion deformities. . The salvage of previously failed surgical . attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. This device is intended for cemented use only. The Distal Femoral Spacers are substantially Comparison to Predicate Device: equivalent to the predicate PMMA spacer in that both are manufactured from the same material and are intended to help maintain a uniform cement mantle. Non-Clinical Performance and Conclusions: Performance Data (Nonclinical and/or Clinical): Non-clinical performance testing was not required for this device. Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling three stylized human figures or birds in flight, stacked on top of each other.
MAY 1 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Brandon Hipsher Zimmer Incorporated 345 East Main Street Warsaw, Indiana 46580
Re: K050105
Trade/Device Name: Nex Gen® Complete Knee Solution Distal Femoral Spacers Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial metal/ polymer porous-coated uncemented prosthesis Regulatory Class: II Product Code: JDI Dated: April 13, 2005 Received: April 14, 2005
Dear Mr. Hipsher:
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.
3
Page 2- Mr. Brandon Hipsher
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis icher will anow your to organization of substantial equivalence of your device to a legally premarket notification: "The 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 If you desire specific arrivate - J at (240) 276-0120 . Also, please note the regulation entitled, coniact the Office of Companise notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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/industry/support/index.html.
Sincerely yours,
Stypt Rurle
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name:
NexGen® Complete Knee Solution Distal Femoral Spacers
Indications for Use:
This device is indicated for patients with severe knee pain and disability due to:
- Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. ।
- Collagen disorders and/or avascular necrosis of the femoral condyle. ﺍ
- Conagen disorders and or trussenaration, particularly when there is patellofemoral l erosion, dysfunction or prior patellectomy
- Moderate valgus, varus or flexion deformities. ।
- The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
This device is intended for cemented use only.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Stupt Purde
(Division Sign-Off)
Division of General, Restorative. and Neurological Devices
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