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.

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.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device modification, specifically for the NexGen® Complete Knee Solution Legacy® Posterior Stabilized (LPS)-Flex Fixed Bearing Tivanium® Ti-6Al-4V Alloy Femoral Components. It seeks to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

A table of acceptance criteria and the reported device performance

This document does not explicitly list quantitative acceptance criteria in a table format in the way one might expect for a software or diagnostic device. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence through non-clinical (laboratory) performance testing. The main criterion is that the modified device performs comparably to the predicate device and meets safety and effectiveness standards for its intended use.

Acceptance Criteria (Implicit)	Reported Device Performance
Device is safe and effective.	The results of non-clinical (laboratory) performance testing demonstrate that the device is safe and effective.
Device is substantially equivalent to the predicate device (NexGen® Complete Knee Solution Legacy® Posterior Stabilized (LPS)-Flex Fixed Bearing Femoral and Articular Surface Components, K991581).	The results of non-clinical (laboratory) performance testing demonstrate that the device is substantially equivalent to the predicate device. The modifications (change in material and surface hardening processing) do not change the intended use or the fundamental scientific technology. Device is packaged using the same materials and processes.

Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document states: "The results of non-clinical (laboratory) performance testing demonstrate that the device is safe and effective and substantially equivalent to the predicate device."
- Sample Size for Test Set: The document does not specify the sample size for the non-clinical (laboratory) performance testing.
- Data Provenance: The data provenance is "non-clinical (laboratory) performance testing." There's no information about the country of origin or whether it was retrospective or prospective, as these terms typically apply to clinical data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable. The study conducted was non-clinical (laboratory) performance testing of a mechanical device (femoral components for a knee replacement). There was no "ground truth" to be established by human experts in the context of interpreting medical images or data. Performance was likely evaluated against engineering specifications and comparison to the predicate device's characteristics.
Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in studies involving human interpretation or clinical outcomes, typically for diagnostic devices or AI algorithms. This submission pertains to a mechanical orthopedic implant, where "adjudication" in this sense is not relevant.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. An MRMC study is relevant for evaluating the impact of an AI algorithm on human reader performance, particularly in diagnostic imaging. The device in question is a knee implant component, not a diagnostic AI tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This refers to a mechanical device, not an algorithm. Therefore, "standalone algorithm only" testing is not applicable. The "standalone performance" was the non-clinical laboratory testing of the physical components.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This is not explicitly stated in terms of a "ground truth" as it would be for a diagnostic device. For a mechanical implant, "ground truth" generally relates to adherence to design specifications, material properties, mechanical strength, wear characteristics, and biocompatibility, as confirmed through laboratory testing. The implicit ground truth would be that the modified device's performance characteristics (e.g., strength, durability, wear resistance) are equivalent or superior to the predicate device, and meet a predefined set of engineering and biocompatibility standards.
The sample size for the training set

This is not applicable. This device is a mechanical implant, not an AI/ML algorithm that requires a "training set."
How the ground truth for the training set was established

This is not applicable, as there is no training set for a mechanical implant.

Summary

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Summary of Safety and Effectiveness

OCT 1 3 2006

Submitter:	Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708
Contact Person:	Anthony FrancalanciaSenior Associate, Regulatory AffairsTelephone: (574) 372-4570Fax: (574) 372-4605
Date:	September 14, 2006
Trade Name:	NexGen® Complete Knee Solution Legacy®Posterior Stabilized (LPS)-Flex Fixed BearingTivanium® Ti-6Al-4V Alloy Femoral Components
Common Name:	LPS-Flex Fixed Bearing Tivanium FemoralComponents
Classification Name:	Knee joint patellofemorotibialpolyethylene/metal/polyethylene semiconstrainedcemented total knee prosthesis
Classification Reference:	21 CFR § 888.3560
Predicate Device:	NexGen® Complete Knee Solution Legacy®Posterior Stabilized (LPS)-Flex Fixed BearingFemoral and Articular Surface Components,manufactured by Zimmer, Inc., K991581, clearedJuly 30, 1999
Device Description:	The LPS-Flex Fixed Bearing Knee is asemiconstrained, condylar system for use withoutthe cruciate ligaments when additional stability isrequired to prevent anterior subluxation of thefemur relative to the tibia in flexion.
Intended Use:	This device is indicated for patients with severeknee pain and disability due to:• Rheumatoid arthritis, osteoarthritis, traumaticarthritis, polyarthritis.• Collagen disorders, and/or avascular necrosis ofthe femoral condyle.

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· 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.

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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.

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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

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Indications for Use

510(k) Number (if known):

K062768

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

Regulation Number and Section

§ 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.