NEXGEN COMPLETE KNEE SOLUTION LPS-FLEX AND KNEE GENDER SOLUTIONS FEMALE (GSF) POROUS FEMORAL COMPONENTS

• K Number: K072619
• Device Name: NEXGEN COMPLETE KNEE SOLUTION LPS-FLEX AND KNEE GENDER SOLUTIONS FEMALE (GSF) POROUS FEMORAL COMPONENTS
• Manufacturer: ZIMMER, INC.
• Date Cleared: 2007-11-21 ( 65 days)
• Product Code: MBH , JWH
• Regulation Number: 888.3565
• Type: Traditional
• Panel: OR
• Reference & Predicate Devices: K031061 , K060370

Intended 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:

• 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.

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.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (NexGen® Complete Knee Solution LPS-Flex Porous Femoral Component, NexGen Knee Gender Solutions™ Female (GSF) Porous Femoral Components). It describes the device, its indications for use, and a comparison to predicate devices, but it does not contain information related to software or AI-driven diagnostic devices, nor does it present specific acceptance criteria or a study proving that such criteria are met.

Therefore, I cannot extract the requested information regarding acceptance criteria, reported device performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, or MRMC studies for an AI device from this document. The document explicitly states:

"Clinical data and conclusions were not needed for these devices."

And the performance data section states:

"Mechanical testing of the proposed devices indicate that they are substantially equivalent to the predicate devices."

This indicates that the clearance for these orthopedic implants was based on substantial equivalence to existing predicate devices, primarily through non-clinical mechanical testing, rather than through clinical studies with acceptance criteria as would be typical for a diagnostic or AI-driven device.

Regulation Number and Section

§ 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.