The Stabil Orthopaedic Solutions Total Knee System is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities.

The Stabil Orthopaedic Solutions Total Knee System may also be indicated in the salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery. The Stabil Orthopaedic Solutions Total Knee System is designed for cemented use only.

Device Description

The Stabil Orthopaedic Solutions Total Knee System is a fixed bearing implant available in posterior-stabilized (PS) and cruciate-retaining (CR) configurations. It is a patellofemorotibial, polymer/metal/polymer, semiconstrained, cemented knee prosthesis that consists of a femoral component, tibial insert, tibial tray and patellar component. The PS version has tibial inserts with posts and femoral components with cams that interact with the posts to help stabilize the knee after the posterior cruciate ligament is removed. The CR version of the Stabil Orthopaedic Solutions Total Knee System has tibial inserts and femoral components without posts or cams, allowing the posterior cruciate ligament to be "retained" and provide stability to the knee joint. The femoral component articulates with the tibial insert component. The underside of the tibial insert component is flat and "snaps" into the tibial baseplate component. The design and sizing of the femoral components correspond to the natural femoral anatomy, enhancing stress distribution and restoring original femoral dimensions and normal rotation and flexion. Each femoral component has the same intercondylar distance and radius of curvature. Each tibial insert component is complimentarily shaped to conform to the femoral components. This allows any size femoral component to be matched with any size tibial component. The dome shape of each UHMWPE patellar component provides excellent contact with the femoral component and evenly distributes stresses. The dome shape of each patellar component also simplifies implantation by eliminating the need for rotational orientation.

AI/ML Overview

This document describes a 510(k) premarket notification for the Stabil Orthopaedic Solutions Total Knee System. The core of this submission is a claim of substantial equivalence to a predicate device, the Progressive Orthopaedic Total Knee System (K142649/K150783), rather than a study proving the device meets de novo acceptance criteria.

Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable in the sense of a new clinical or diagnostic validation study for the Stabil Orthopaedic Solutions Total Knee System itself. Instead, the "acceptance criteria" here are met by demonstrating identicality to an already cleared device, and the "study" is the preclinical performance testing previously conducted for the predicate device.

Here's the information based on the provided document:

1. A table of acceptance criteria and the reported device performance

Since this is a substantial equivalence claim based on identicality to a predicate device, the "acceptance criteria" are implied by the predicate device's prior clearance and its successful preclinical testing. The reported performance of the subject device (Stabil Orthopaedic Solutions Total Knee System) is that it is identical to the predicate device and thus its performance aligns with the predicate's established performance.

Acceptance Criteria (Implied by Predicate Clearance)	Reported Device Performance (Stabil Orthopaedic Solutions Total Knee System)
Fatigue performance of the tibial tray is acceptable	Identical to predicate device which demonstrated acceptable fatigue performance.
Interlock mechanism strength of the tibial tray and insert is acceptable	Identical to predicate device which demonstrated acceptable interlock mechanism strength.
Shear fatigue strength of the tibial insert post is acceptable	Identical to predicate device which demonstrated acceptable shear fatigue strength.
Tibiofemoral contact area and stress are acceptable	Identical to predicate device which demonstrated acceptable tibiofemoral contact area and stress.
Tibiofemoral constraint is acceptable	Identical to predicate device which demonstrated acceptable tibiofemoral constraint.
Patellofemoral constraint is acceptable	Identical to predicate device which demonstrated acceptable patellofemoral constraint.
Range of motion is acceptable	Identical to predicate device which demonstrated acceptable range of motion.
Materials are safe and effective for intended use	Identical to predicate device which uses identical materials deemed safe and effective.
Design features are safe and effective for intended use	Identical to predicate device which has identical design features deemed safe and effective.
Indications for use are appropriate and align with predicate	Identical to predicate device's indications for use.
Manufacturing methods are acceptable	Utilizes manufacturing methods identical to the predicate device.
Packaging and sterilization processes are acceptable	Utilizes packaging and sterilization processes identical to the predicate device.

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

This information is not directly available for the Stabil Orthopaedic Solutions Total Knee System as no new testing was performed for this specific submission. The submission relies on "Extensive preclinical testing performed on the predicate devices per K142649 and K150783." The sample sizes and detailed provenance of those predicate device tests are not provided in this document. The tests mentioned (fatigue, strength, contact, constraint, range of motion) are typically bench tests (laboratory testing) rather than clinical studies with human subjects.

3. 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)

Not applicable. The "ground truth" here is established through engineering and biomechanical performance standards, not through expert consensus on diagnostic images or clinical outcomes. These are typically assessed by engineers and testing laboratories.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This concept typically refers to the resolution of discrepancies among expert opinions in clinical or diagnostic studies. For mechanical and material testing, results are typically quantitative and compared against predefined engineering specifications.

5. 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

Not applicable. This device is a total knee replacement system, not an AI or diagnostic imaging device. Therefore, MRMC studies and AI assistance are not relevant to its assessment.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a mechanical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the predicate device's performance testing (which this submission relies upon) would be defined by biomechanical and material science standards and specifications. For example:

Material properties: Measured against ISO or ASTM standards for UHMWPE, cobalt-chromium, titanium alloys.
Mechanical strength, fatigue, and wear: Measured against established biomechanical testing standards for knee implants (e.g., ISO 14243 for wear, ISO 21536 for knee joint prostheses).
Geometric and dimensional accuracy: Measured against design specifications.

8. The sample size for the training set

Not applicable. This is a medical device (implant), not a machine learning model requiring training data.

9. How the ground truth for the training set was established

Not applicable. As above, this is not a machine learning model.

Summary

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Stabil Orthopaedic Solutions, LLC Jim Moore CEO 20031 Henrici Road Oregon City, Oregon 97045

February 15, 2019

Re: K183225

Trade/Device Name: Stabil Orthopaedic Solutions Total Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH Dated: November 19, 2018 Received: November 20, 2018

Dear Jim Moore:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Daniel S. Ramsey -S 2019.02.15 16:34:58 -05'00'

FOR Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K183225

Device Name Stabil Orthopaedic Solutions Total Knee System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Stabil Orthopaedic Solutions Total Knee System

510(k) Summary

The following 510(k) Summary is provided in accordance with 21 CFR 807.92.

510(k) Owner and Registration 6.1

Owner's Name:	Stabil Orthopaedic Solutions, LLC
Address:	20031 Henrici Road., Oregon City, OR 97045
Phone Number:	(503) 421-1251
Fax Number:	N/A
Date Summary Prepared:	November 15, 2018
Establishment Registration Number:	N/A

6.2 510(k) Contact

Contact:	Jim Moore
Address:	20031 Henrici RoadOregon City, OR 97045
Phone Number:	(503) 421-1251
Fax Number:	N/A
Contact Person:	Jim Moore

6.3 Device Name and Classification

Device Trade Name:	Stabil Orthopaedic Solutions Total Knee System
Device Common Name:	Total Knee Replacement
Regulation Number and Description:	21 CFR 888.3560
Device Class:	Class II
Product Codes:	JWH
Advisory Panel:	87 (Orthopedic)

Legally Marketed Predicate 6.4

Stabil Orthopaedic Solutions is utilizing the Progressive Orthopaedic Total Knee System as the predicate device (K142649/K150783). The Stabil Orthopaedic Solutions Total Knee System features component designs, materials, indications, and manufacturing methods that are identical to the Progressive Orthopaedic Total Knee System.

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6.5 Device Description

6.6 Intended Use

The Stabil Orthopaedic Solutions Total Knee System is identical to the predicate Progressive Orthopaedic Total Knee System. The indications for use are also identical.

6.7 Summary of Technological Characteristics

The Stabil Orthopaedic Solutions Total Knee system is identical to the predicate Progressive Orthopaedic Total Knee System. Both devices are manufactured from identical materials, possess the same sizes, and feature the same packaging and sterilization processes. Extensive preclinical testing was performed on the predicate devices per K142649 and K150783 and found substantially equivalent. The performance tests are listed below and used herein to establish substantial equivalence (Section 19 Performance Testing – Bench)

Given that the subject device is identical to the predicate, the substantially equivalent to the predicate systems (K142649/K150783).

6.8 Performance Testing

Extensive preclinical performance testing was conducted and substantial equivalence determined per K142649 and K150783. The components of the subject device are identical to the predicate device, and therefore the predicate device testing demonstrates substantial equivalence for the results confirm that

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all components of the Stabil Orthopaedic Solutions Total Knee System exhibit the appropriate mechanical characteristics for total knee joint replacement, and are substantially equivalent to the predicate devices.

Fatigue performance of the tibial tray 0
. Interlock mechanism strength of the tibial tray and insert
o Shear fatigue strength of the tibial insert post
Tibiofemoral contact area and stress
Tibiofemoral constraint
. Patellofemoral constraint
Range of motion

Conclusions 6.9

The Stabil Orthopaedic Solutions Total Knee System is identical to the predicate Progressive Orthopaedic Total Knee System. The subject device has the same design features, materials, and indications for use as the predicate devices. The testing performed for the predicate that the Stabil Orthopaedic Solutions Total Knee System is safe for clinical use.

The Stabil Orthopaedic Solutions Total Knee System is substantially equivalent to the predicate device.

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.