(185 days)
Not Found
No
The summary describes a knee implant with a new coating (HA/TCP) and explicitly states it is identical to its predicate except for this addition. There is no mention of AI, ML, image processing, or performance studies related to algorithmic analysis.
Yes
The Indications for Use state the device is for patients with severe knee pain and disability due to various medical conditions, aiming to salvage previously failed surgical attempts or improve knee stability, fitting the description of a therapeutic device.
No
The device is described as an implant for treating severe knee pain due to various conditions, indicating a therapeutic rather than diagnostic purpose.
No
The device description and intended use clearly describe physical knee implants (femoral, tibial, and patella components) used in surgical procedures, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used to treat severe knee pain and disability by replacing damaged joint components. This is a therapeutic intervention performed in vivo (within the body), not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The device is described as components for knee replacement, which are physical implants. IVDs are typically reagents, instruments, or systems used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information.
Therefore, this device is a medical device used for surgical implantation, not an IVD.
N/A
Intended Use / Indications for Use
These devices are 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, and 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.
CR, LPS, and CR-Flex porous coated components may be used cemented or uncemented (biological fixation) while the CR and CR-Flex hydroxyapatite/tricalcium (HA/TCP) porous coated femoral or tibial baseplate components may only be used uncemented. All other femoral, tibial baseplate and all-polyethylene patella components are indicated for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
MBH
Device Description
The devices included in this 510(k), are identical to their predicates except for the addition of HA/TCP.
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: No additional testing was required.
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
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.
0
Image /page/0/Picture/0 description: The image contains a logo with a stylized letter "Z" inside a circle on the left. To the right of the logo, there is a word that appears to be "ZAMOR" in a bold, sans-serif font. The text is slightly distorted, possibly due to the image quality or perspective. The overall impression is of a corporate logo or branding element.
OCT 2 9 2004
Summary of Safety and Effectiveness
| Submitter: | Zimmer, Inc.
P.O. Box 708
Warsaw, IN 46581-0708 |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Dalene Binkley
Associate, Regulatory Affairs
Telephone: (574) 372-4907
Fax: (574) 372-4605 |
| Date: | June 16, 2004 |
| Trade Name: | NexGen® Porous, HA/TCP, Uncemented Femoral
and Tibial Baseplate Components |
| Common Name: | Total Knee Prosthesis |
| Classification Name
and Reference: | Knee joint patellofemorotibial metal/polymer
porous-coated uncemented prosthesis-
21 CFR § 888.3565 |
| Predicate Device: | NexGen® Porous, Uncemented Femoral and Tibial
Baseplate Components, manufactured by Zimmer.
Inc., K031061, cleared October 9, 2003. |
| Device Description: | The devices included in this 510(k), are identical to
their predicates except for the addition of HA/TCP. |
| Intended Use: | These devices are 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, and 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. |
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Image /page/1/Picture/0 description: The image shows the logo for Zimmer. The logo consists of a large letter Z inside of a circle, followed by the word "zimmer" in a sans-serif font. The letter Z and the word "zimmer" are both in black, while the circle is white.
CR, LPS, and CR-Flex porous coated components may be used cemented or uncemented (biological fixation) while the CR and CR-Flex hydroxyapatite/tricalcium (HA/TCP) porous coated femoral or tibial baseplate components may only be used uncemented. All other femoral, tibial baseplate and all-polyethylene patella components are indicated for cemented use only.
Comparison to Predicate Device:
Performance Data (Nonclinical and/or Clinical):
These devices are identical to their predicate devices except for the addition of HA/TCP.
Non-Clinical Performance and Conclusions:
No additional testing was required.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device.
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Image /page/2/Picture/1 description: The image contains the words "Public Health Service". The text is in a simple, sans-serif font and is left-aligned. The words are stacked on top of each other, with "Public" on the top line, "Health" on the second line, and "Service" on the third line.
Image /page/2/Picture/2 description: The image is a seal for the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
OCT 2 9 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Dalene T. Binkley Associate, Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708
Re: K041100
Trade/Device Name: NexGen® Porous, HA/TCP, Uncemented Femoral and Tibial Baseplate Components Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint, patellofemorotibial, metal/polymer, porous-coated uncemented prosthesis Regulatory Class: II Product Code: MBH Dated: October 6, 2004 Received: October 7, 2004
Dear Ms. Binkley:
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
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Page 2 - Ms. Dalene T. Binkley
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.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, 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/dsma/dsmamain.html
Sincerely yours,
Mark A. Millerson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the Zimmer logo. The logo consists of a large, stylized "Z" inside of a circle, followed by the word "zimmer" in lowercase letters. The "Z" is bold and black, contrasting with the white background of the circle. The word "zimmer" is also in black and appears to be in a sans-serif font.
Indications for Use
Kod 1100 510(k) Number (if known):
Device Name:
NexGen® Porous, HA/TCP, Uncemented Femoral and Tibial Baseplate Components
Indications for Use:
These devices are 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, and 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.
CR, LPS, and CR-Flex porous coated components may be used cemented or uncemented (biological fixation) while the CR and CR-Flex hydroxyapatite/tricalcium (HA/TCP) porous coated femoral or tibial baseplate components may only be used uncemented. All other femoral, tibial baseplate and all-polyethylene patella components are indicated 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)
Mark A. Milleson
(Division Sign Off)
Division of General, Restorative, and Neurological Devices
510(k) Number K09
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