(65 days)
Not Found
No
The document 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 a femoral component of a knee replacement system intended to alleviate severe knee pain and disability.
No
Explanation: The device described is a knee prosthesis, which is an implant used for treatment (joint replacement) rather than for diagnosing a medical condition.
No
The device description clearly describes physical components (femoral components, fiber metal pads) which are hardware, not software.
Based on the provided text, 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, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states that this device is a "semi-constrained, condylar system" and "femoral components" which are parts of a knee prosthesis. These are implanted devices used to replace damaged knee joints.
- Intended Use/Indications for Use: The intended use and indications describe conditions like arthritis, avascular necrosis, and deformities, and the device's purpose is to alleviate pain and disability by replacing the joint. This is a therapeutic intervention, not a diagnostic test performed on a sample.
The device is a surgical implant used in knee replacement surgery.
N/A
Intended Use / Indications for Use
General Indications for the NexGen Complete Knee Solution Femoral Components:
- 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.
Porous coated femoral components may be used cemented or uncemented (biological fixation).
Specific Indications for the LPS-Flex Porous Femoral Components:
- LPS- Flex porous coated femoral and tibial baseplate components may be used cemented or uncemented (biological fixation).
- Specific uses with the 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 range of motion (ROM) is expected to be less than or equal to 155 degrees.
Specific Indications for the NexGen Knee GSF Knee Porous Femoral Components:
- CR-Flex GSF and LPS-Flex GSF porous coated femoral components may be used cemented or uncemented (biological fixation).
- Specific uses with CR-Flex GSF or LPS-Flex GSF femorals:
- Provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range.
- The CR-Flex GSF femoral, when used with 90-prefix NexGen CR articular surfaces, 00-prefix 10, 12 or 14mm or 90-prefix 17 or 20mm Prolong " Highly Crosslinked Polyethylene CR articular surfaces, or with Gender Solutions Natural-Knee® Flex Congruent articular surfaces, is designed for use with a functional posterior cruciate ligament and when load bearing range of motion (ROM) is expected to be less than or equal to 155 degrees.
- The LPS-Flex GSF femoral, when used with 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)
MBH, JWH
Device Description
The LPS-Flex Fixed-bearing Knee is a semi-constrained, 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. The LPS-Flex Porous femoral component is designed to have a maximum active, load bearing range of motion of 155 degrees. It contains a fiber metal pad to allow for cementless use.
The GSF Porous femoral components include both LPS-Flex GSF and CR-Flex GSF versions and are part of the Zimmer Flex-series of semi-constrained, non-linked, condylar knee prostheses that are designed to have a maximum active, load bearing range of motion of 155 degrees. The GSF designation indicates that the femoral component is designed to better match distal femoral anatomic features more typical of female patients. They contain fiber metal pads to allow for cementless use.
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:
Mechanical testing of the proposed devices indicate that they are substantially equivalent to the predicate devices.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for these devices.
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
Summary of Safety and Effectiveness
| Submitter: | Zimmer, Inc.
P.O. Box 708
Warsaw, IN 46581-0708
NOV 21 2007 |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Daniel J. Williman
Specialist, Corporate Regulatory Affairs
Telephone: 574-371-8065
Fax: (574) 372-4605 |
| Date: | September 14, 2007 |
| Trade Name: | NexGen ® Complete Knee Solution LPS-Flex Porous
Femoral Component, NexGen Knee Gender
Solutions ™ Female (GSF) Porous Femoral
Components |
| Common Name: | Total Knee Prosthesis |
| Classification Name
and Reference: | Knee joint, patellofemorotibial, metal/polymer,
porous-coated, uncemented prosthesis -- 21 CFR §
888.3565
Knee joint, patellofemorotibial,
polymer/metal/polymer, semi-constrained,
cemented prosthesis -- 21 CFR § 888.3560 |
| Predicate Devices: | NexGen Complete Knee Solution Porous,
Uncemented Femoral and Tibial Baseplate
Components, manufactured by Zimmer, Inc.
(K031061, cleared October 9, 2003)
NexGen Knee Gender Solutions Female (GSF)
Femoral Components, manufactured by Zimmer,
Inc (K060370, cleared April 28, 2006) |
| Device Description: | The LPS-Flex Fixed-bearing Knee is a semi-
constrained, 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. The LPS-Flex |
、
:
.
:
1
1-072619
Porous femoral component is designed to have a maximum active, load bearing range of motion of 155 degrees. It contains a fiber metal pad to allow for cementless use.
The GSF Porous femoral components include both LPS-Flex GSF and CR-Flex GSF versions and are part of the Zimmer Flex-series of semi-constrained, non-linked, condylar knee prostheses that are designed to have a maximum active, load bearing range of motion of 155 degrees. The GSF designation indicates that the femoral component is designed to better match distal femoral anatomic features more typical of female patients. They contain fiber metal pads to allow for cementless use.
General Indications for the NexGen Complete Knee Solution Femoral Components:
- 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.
Porous coated femoral components may be used cemented or uncemented (biological fixation).
Specific Indications for the LPS-Flex Porous Femoral Components:
- · LPS- Flex porous coated femoral and tibial baseplate components may be used cemented or uncemented (biological fixation).
- · Specific uses with the LPS-Flex femorals:
Intended Use:
2
- 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 range of motion (ROM) is expected to be less than or equal to 155 degrees.
Specific Indications for the NexGen Knee GSF Knee Porous Femoral Components:
- · CR-Flex GSF and LPS-Flex GSF porous coated femoral components may be used cemented or uncemented (biological fixation).
- · Specific uses with CR-Flex GSF or LPS-Flex GSF femorals:
- Provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range.
- The CR-Flex GSF femoral, when used with 90prefix NexGen CR articular surfaces, 00-prefix 10, 12 or 14mm or 90-prefix 17 or 20mm Prolong" Highly Crosslinked Polyethylene CR articular surfaces, or with Gender Solutions Natural-Knee® Flex Congruent articular surfaces, is designed for use with a functional posterior cruciate ligament and when load bearing range of motion (ROM) is expected to be less than or equal to 155 degrees.
- The LPS-Flex GSF femoral, when used with 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.
The LPS-Flex Porous femoral component geometry differs slightly from that of the predicate LPS Porous femoral component. However, the articulating geometry is identical to that of the LPS-Flex femoral component substrate.
The LPS-Flex Porous GSF and CR-Flex Porous GSF femoral component geometries are identical to those of their predicate devices, the LPS-Flex GSF and CR-Flex GSF.
Comparison to Predicate Device:
3
072619 #414
Except for slight differences in shape, the fiber metal pads on all of the proposed femoral components are identical to the fiber metal pads of the porous-coated predicate devices.
Performance Data (Nonclinical and/or Clinical):
Non-Clinical Performance and Conclusions:
Mechanical testing of the proposed devices indicate that they are substantially equivalent to the predicate devices.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for these devices.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/4/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black against a white background. The overall design is simple and conveys a sense of official authority.
NOV 2 1 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Zimmer, Inc. % Mr. Daniel J. Williman Specialist, Corporate Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708
K072619 Re: Trade/Device Name: NexGen® Complete Knee Solution LPS-Flex Porous Femoral Component, NexGen Knee Gender Solutions™ Female (GSF) Porous Femoral Components Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint, patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: MBH, JWH Dated: September 17, 2007 Received: September 19, 2007
Dear Mr. Williman:
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.
5
Page 2 - Daniel J. Williman
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket, Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N Mulhearn
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): KO72619
Device Name:
NexGen® Complete Knee Solution LPS-Flex Porous Femoral Component, NexGen Knee Gender Solutions " Female (GSF) Porous Femoral Components
Indications for Use:
General Indications for the NexGen Complete Knee Solution Femoral Components:
- · 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.
Porous coated femoral components may be used cemented or uncemented (biological fixation).
Specific Indications for the LPS-Flex Porous Femoral Components:
- · LPS- Flex porous coated femoral and tibial baseplate components may be used cemented or uncemented (biological fixation).
- · Specific uses with the 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 range of motion (ROM) is expected to be less than or equal to 155 degrees.
Deubau Buchun
Division of General, Restorative, and Neurological Devices
510(k) Number K022614 Page 1 of 2
7
Specific Indications for the NexGen Knee GSF Knee Porous Femoral Components:
- · CR-Flex GSF and LPS-Flex GSF porous coated femoral components may be used cemented or uncemented (biological fixation).
- · Specific uses with CR-Flex GSF or LPS-Flex GSF femorals:
- Provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range.
- The CR-Flex GSF femoral, when used with 90-prefix NexGen CR articular surfaces, 00-prefix 10, 12 or 14mm or 90-prefix 17 or 20mm Prolong "" Highly Crosslinked Polyethylene CR articular surfaces, or with Gender Solutions Natural-Knee® Flex Congruent articular surfaces, is designed for use with a functional posterior cruciate ligament and when load bearing range of motion (ROM) is expected to be less than or equal to 155 degrees.
- The LPS-Flex GSF femoral, when used with 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)
Barbara Trump
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K152619 Page 2 of 2