The BKS Revision is indicated in the salvage of previously failed surgical attempts where bone loss may require the use of augments, sleeves or stem extensions.

The BKS Revision is indicated for cemented application only. The porous-coated metaphyseal sleeves are intended for cemented and uncemented biological fixation application.

Device Description

The BKS® Revision Sleeves System expands the capabilities of the Balanced Knee® System (BKS®) Revision through the introduction of femoral and tibial sleeves, a tapered junction box, locking bolt, and a sleeve specific tibial tray. All new implants are a single-use modular system used in revision knee surgery to accommodate metaphyseal bone defects and provide rotational stability. The system is designed for cemented or uncemented fixation with the bone. The porous-coated femoral sleeve is affixed to the modular femoral component via a tapered junction box. The porous-coated tibial sleeve is affixed to a sleeve tibial tray.

AI/ML Overview

This document describes a 510(k) premarket notification for the "BKS Revision Sleeves System." This is a medical device submission, and the focus is on demonstrating substantial equivalence to previously cleared predicate devices, rather than proving a specific clinical performance metric against acceptance criteria in the way a diagnostic AI device would.

Therefore, the requested information about acceptance criteria, study design, ground truth, and human reader performance is not applicable in the context of this device submission. The primary "study" conducted here is non-clinical mechanical testing to ensure the device meets engineering standards and performs similarly to existing devices.

Here's a breakdown of what the document provides, and why the requested information is not present:

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

Acceptance Criteria (Non-Clinical): The document states that the following non-clinical tests were conducted and "successfully met the predetermined acceptance criteria":
- Static Disassembly per ASTM F-1814 and ASTM F-2083
- Cyclic fatigue per ASTM F1800, ASTM F1814, and ASTM F2083
- Bacterial endotoxin testing using LAL pyrogen testing methodology per ANSI/AAMI ST72:2011
Reported Device Performance (Non-Clinical): The document simply states that the tests were "successfully met," indicating compliance with the standards. It does not provide specific numerical results or performance metrics like sensitivity, specificity, or accuracy, which would be relevant for a diagnostic device.

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

Not applicable. This device is an orthopedic implant, not a diagnostic or AI-driven system that uses data in this manner. The "test set" consists of physical devices subjected to mechanical and biological safety tests. The document doesn't specify the number of individual sleeve components tested for each mechanical test, but it would be a small number of physical samples, not a dataset of patient information.

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. Ground truth in this context refers to the engineering standards themselves (e.g., ASTM standards) and the established methods for bacterial endotoxin testing. These are defined by scientific and engineering bodies, not established by individual experts reviewing a test set for clinical accuracy.

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

Not applicable. No adjudication method is described or required for this type of non-clinical testing. The tests are designed to objectively measure physical properties or biological safety against defined standards.

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:

No, not applicable. This device is an implant, not an AI-assisted diagnostic tool. No MRMC studies were performed.

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

No, not applicable. This device is an implant, not an algorithm.

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

Ground Truth (Non-Clinical): The "ground truth" for this submission is adherence to established engineering standards (ASTM) for mechanical properties and biological testing standards (ANSI/AAMI ST72:2011) for pyrogenicity. The device's performance is compared against these predetermined, objective standards rather than expert consensus on clinical cases or pathology.

8. The sample size for the training set:

Not applicable. There is no "training set" as this is not a machine learning or AI device.

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

Not applicable. See point 8.

In summary: The BKS Revision Sleeves System is an orthopedic implant. Its "acceptance criteria" and "study" are focused on demonstrating mechanical integrity, biocompatibility, and substantial equivalence to existing devices through non-clinical testing against established engineering and biological safety standards. Clinical studies or AI-specific performance metrics (like those for diagnostic devices) were not part of this 510(k) submission, and the document explicitly states: "No clinical studies were performed."

Summary

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Ortho Development Corporation Dan Petersen Regulatory Affairs Specialist 12187 So. Business Park Drive Draper, Utah 84020

Re: K181569 Trade/Device Name: BKS Revision Sleeves System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH, MBH Dated: June 13, 2018 Received: September 13, 2018

10/12/2018

Dear Dan Petersen:

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

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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); 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 (QS) 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 2018.10.12 11:12:21 -04'00'

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

Enclosure

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Indications for Use

510(k) Number (if known) K181569

Device Name BKS Revision Sleeves System

Indications for Use (Describe)

These devices are intended for use in total knee arthroplasty procedures for the following conditions:

1. Loss of joint configuration and joint function.
1. Osteoarthritis of the knee joint.
1. Rheumatoid arthritis of the knee joint.
1. Post-traumatic arthritis of the knee joint.
1. Valgus, varus, or flexion deformities of the knee joint.
1. Revision procedures where other treatments or devices have failed.

The BKS Revision is indicated in the salvage of previously failed surgical attempts where bone loss may require the use of augments, sleeves or stem extensions.

The BKS Revision is indicated for cemented application only. The porous-coated metaphyseal sleeves are intended for cemented and uncemented biological fixation application.

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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12187 So. Business Park Drive Draper, Utah 84020 801-553-9991/ fax 553-9993 Orthodevelopment.com

Image /page/3/Picture/2 description: The image shows the logo for "Ortho Development". The logo consists of a stylized purple circle with three gray arcs emanating from the left side, followed by the word "ORTHO" in purple, block letters. Below the word "ORTHO" is the word "DEVELOPMENT" in a smaller, less bold font.

Section 5 510(k) Summary

Name of Sponsor:	Ortho Development Corporation12187 South Business Park DriveDraper, Utah 84020
510(k) Contact:	Dan PetersenRegulatory Affairs SpecialistTelephone: (801) 619-3416Email: RA@OrthoDevelopment.com
Date Prepared:	August 8, 2018
Submission Type:	Traditional 510(k)
Proprietary Name:	BKS® Revision Sleeves System
Common Name:	Knee Joint Replacement Prosthesis
Classification:	21 CFR 888.3560: Knee joint patellofemorotibialpolymer/metal/polymer semi-constrained cemented prosthesis
	21 CFR 888.3565: Knee joint patellofemorotibial metal/polymerporous-coated uncemented prosthesis
Device Class:	Class II device
Device Product Code:	JWH, MBH
Primary Predicate Device:	BKS® Revision Knee System; Ortho Development (K031201, K060569,K103837)
Additional Predicate Device:	ATTUNE® Revision Knee System; DePuy (K160700)Vanguard® 360 OsseoTi™ Tibial Sleeve Augments, Biomet (K140883)

5.1 Device Description

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5.2 Indications for Use

These devices are intended for use in total knee arthroplasty procedures for the following conditions:

1. Loss of joint configuration and joint function.
1. Osteoarthritis of the knee joint.
1. Rheumatoid arthritis of the knee joint.
1. Post-traumatic arthritis of the knee joint.
1. Valgus, varus, or flexion deformities of the knee joint.
1. Revision procedures where other treatments or devices have failed.

The BKS Revision is indicated in the salvage of previously failed surgical attempts where bone loss may require the use of augments, sleeves or stem extensions.

The BKS Revision is indicated for cemented application only. The porous-coated metaphyseal sleeves are intended for cemented and uncemented biological fixation application.

5.3 Basis for Substantial Equivalence:

The BKS Revision Sleeves System has the same technological characteristics as the predicates. These include:

Indications for use
Intended use
Basic design
Function
Manufacturer
Manufacturing Process
Packaging
. Sterilization

The following non-clinical tests were conducted on the worst-case configurations of the BKS Revision Sleeves System and successfully met the predetermined acceptance criteria:

Static Disassembly per ASTM F-1814 and ASTM F-2083
Cyclic fatigue per ASTM F1800, ASTM F1814, and ASTM F2083 0
Bacterial endotoxin testing using LAL pyrogen testing methodology per ANSI/AAMI ST72:2011

The fundamental scientific technology of the BKS Revision Sleeves System is the previously cleared predicates. The test results demonstrate that the BKS Revision Sleeves System is as safe, as effective, and performs as well as or better than the legally marketed predicates. No clinical studies were performed.

Based on similarities in intended use, design, manufacturing methods, sterilization, packaging, and the mechanical test results, the BKS Revision Sleeves System is substantially equivalent to the previously cleared predicates.

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.