(28 days)
Not Found
No
The summary describes a mechanical knee implant and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is indicated for patients with severe knee pain and disability due to various arthritic conditions and post-traumatic loss of joint configuration, aiming to restore joint function and alleviate pain.
No
Explanation: This device is a prosthetic knee implant used for treatment of severe knee pain and disability, not for diagnosis.
No
The device description clearly states it is a "semiconstrained, condylar system," which describes a physical implant, not software. The intended use also describes conditions requiring surgical intervention and implantation of a physical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly indicates that this device is a knee implant used for surgical replacement of the knee joint in patients with severe knee pain and disability. It is a physical implant, not a test performed on a biological sample.
- Lack of IVD Characteristics: The information does not mention any analysis of biological samples, detection of biomarkers, or diagnostic testing.
Therefore, this device falls under the category of a surgical implant or prosthetic device, not an in vitro diagnostic.
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.
Specific uses with LPS-Flex femorals:
· Provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range.
· The LPS-Flex femoral, when used with the LPS-Flex articular surfaces, is designed for use with both cruciate ligaments excised and when load bearing ROM is expected to be less than or equal to 155 degrees.
Product codes (comma separated list FDA assigned to the subject device)
JWH
Device Description
The LPS-Flex Fixed Bearing Knee is a semiconstrained, condylar system for use without the cruciate ligaments when additional stability is required to prevent anterior subluxation of the femur relative to the tibia in flexion.
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)
Results of non-clinical (laboratory) performance testing demonstrate that the device is safe and effective and substantially equivalent to the predicate 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
§ 888.3560 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/0 description: The image shows the word "zimmer" with a stylized "Z" in a circle to the left of the word. The "Z" is black and bolded, and the circle is white with a black outline. The word "zimmer" is in a bold, sans-serif font. The image is in black and white.
Summary of Safety and Effectiveness
OCT 1 3 2006
| Submitter: | Zimmer, Inc.
P.O. Box 708
Warsaw, IN 46581-0708 | |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact Person: | Anthony Francalancia
Senior Associate, Regulatory Affairs
Telephone: (574) 372-4570
Fax: (574) 372-4605 | |
| Date: | September 14, 2006 | |
| Trade Name: | NexGen® Complete Knee Solution Legacy®
Posterior Stabilized (LPS)-Flex Fixed Bearing
Tivanium® Ti-6Al-4V Alloy Femoral Components | |
| Common Name: | LPS-Flex Fixed Bearing Tivanium Femoral
Components | |
| Classification Name: | Knee joint patellofemorotibial
polyethylene/metal/polyethylene semiconstrained
cemented total knee prosthesis | |
| Classification Reference: | 21 CFR § 888.3560 | |
| Predicate Device: | NexGen® Complete Knee Solution Legacy®
Posterior Stabilized (LPS)-Flex Fixed Bearing
Femoral and Articular Surface Components,
manufactured by Zimmer, Inc., K991581, cleared
July 30, 1999 | |
| Device Description: | The LPS-Flex Fixed Bearing Knee is a
semiconstrained, condylar system for use without
the cruciate ligaments when additional stability is
required to prevent anterior subluxation of the
femur relative to the tibia in flexion. | |
| Intended 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. | |
1
Image /page/1/Picture/0 description: The image shows the text "Special 510(k): Device Modification". The text is written in a bold, sans-serif font. The words "Special" and "Device Modification" are larger than the number "510(k)". The text is centered on the image.
· Post-traumatic loss of joint configuration,
dysfunction or prior patellectomy.
particularly when there is patellofemoral erosion,
· Moderate valgus, varus, or flexion deformities. · The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in
Image /page/1/Picture/1 description: The image shows the logo for Zimmer Biomet. The logo consists of a large, stylized "Z" enclosed in a circle, followed by the word "zimmer" in lowercase letters. The "Z" is bold and black, and the word "zimmer" is also black and in a sans-serif font.
flexion cannot be obtained at the time of surgery. Specific uses with LPS-Flex femorals: · Provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range. · The LPS-Flex femoral, when used with the LPS-Flex articular surfaces, is designed for use with both cruciate ligaments excised and when load bearing ROM is expected to be less than or equal to 155 degrees. Comparison to Predicate Device: Except for a change in material and surface hardening processing, the LPS-Flex Fixed Bearing Tivanium Femoral Components are identical to the predicate device's femoral components. The modifications do not change the intended use or the fundamental scientific technology. The device is packaged using the same materials and processes. Performance Data (Non-clinical Non-Clinical Performance and Conclusions: and/or Clinical): The results of non-clinical (laboratory) performance testing demonstrate that the device is safe and effective and substantially equivalent to the predicate 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 & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Zimmer, Inc. % Mr. Anthony Francalancia Senior Associate, Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708
OCT 1 3 2006
Re: K062768
Trade/Device Name: NexGen® Complete Knee Solution Legacy® Posterior Stabilized (LPS)-Flex Fixed Bearing Tivanium® Ti-6AI-4V Alloy Femoral
Components Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: September 14, 2006 Received: September 15, 2006
Dear Mr. Francalancia:
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. Anthony Francalancia
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and w Jourse organ finding of substantial equivalence of your device to a legally premaince hourieation. The 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 If you active 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 Other golfinational and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
fa Vah
Mark N. Melkerson 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 Legacy® Posterior Stabilized (LPS)-Flex Fixed Bearing Tivanium® Ti-6AI-4V Alloy Femoral Components
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 connivale.
- 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.
- Specific uses with LPS-Flex femorals:
- Provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range.
- The LPS-Flex femoral, when used with the LPS-Flex articular surfaces, is designed for use with both cruciate ligaments excised and when load bearing ROM is expected to be less than or equal to 155 degrees.
| 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)
(Division Sign-Off)
Division of General, Restoration and Neurological Devices
Page 1 of 1
510(k) Number: k06 2768