The BKS is indicated in the salvage of previously failed surgical attempts where bone loss does not require the use of augments or stem extensions and where collateral ligaments may be relied upon for medial/lateral (M/L) stability.

BKS TriMax is intended in the salvage of previously failed surgical attempts where bone loss does not require the use of augments or stem extensions, where collateral ligaments may be relied upon for medial/lateral stability, where postoperative flexion up to 150° may be desirable, and the patient meets all indications requirements.

The BKS Revision system 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 system is indicated for cemented use only. The porous-coated metaphyseal sleeves are intended for cemented and uncemented applications.

The BKS Revision CK Tibial Insert is indicated for use with the BKS Revision Modular femoral and Modular, Offiset, or Sleeve tibial components where collateral ligaments may not be relied upon for medial/lateral (M/L) stability.

Device Description

The purpose of this special 510(k) submission is to request clearance for BKS Revision Sleeve Junction Box of the BKS Revision System which is an extension of Ortho Development's previously cleared predicate BKS Revision Sleeves System (K181569).

The subject device incorporates the same locking taper interface for mating with the BKS Revision Sleeves and the same principle of operation for locking the A/P position relative to the BKS Revision Modular Femoral Component. The subject device is manufactured in the same manner from the same material. The subject device also employs the same packaging components and sterilization method.

Differences between the subject and predicate device include small adjustments to the envelope geometry, internal configuration, and driving feature for assembly during use. These changes have been made to optimize the Sleeve Junction Box for use specifically with femoral sleeves. The mechanics of the connection and locking mechanism are the same as the predicate device.

AI/ML Overview

This document describes Ortho Development's 510(k) submission for the BKS Revision System, specifically focusing on the BKS Revision Sleeve Junction Box. The submission is a "special 510(k)" which implies that the changes to the device are minor and do not alter its fundamental scientific technology or indications for use. Therefore, the acceptance criteria and the study proving the device meets them are based on demonstrating that the modified device performs equivalently to the predicate device.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a special 510(k) for a modification to an existing device (BKS Revision Sleeves System, K181569), the acceptance criteria are implicitly that the modified device (BKS Revision Sleeve Junction Box) performs comparably to the predicate device and meets established consensus standards for orthopedic implants.

Acceptance Criterion (Implicit)	Reported Device Performance
Mechanical Performance: Equivalent or superior mechanical strength, particularly in fatigue and disassembly, compared to the predicate device.	Evaluation includes:- Geometric analysis: Confirms adjustments to envelope geometry, internal configuration, and driving feature are optimized for femoral sleeves.- Axial fatigue strength per ASTM F1814: Demonstrated to meet requirements.- Disassembly strength: Demonstrated to meet requirements.- Assembly evaluation: Confirmed proper assembly and function.
Material: Use of same materials as the predicate device.	The subject device is manufactured from the same material as the predicate.
Principle of Operation: Maintain the same mechanism for connection and locking as the predicate.	The mechanics of the connection and locking mechanism are the same as the predicate device.
Packaging and Sterilization: No change in packaging components or sterilization method.	The subject device employs the same packaging components and sterilization method as the predicate. Labeling, packaging, and sterilization do not change.
Indications for Use: Maintain the same indications for use as the predicate device.	The Sleeve Junction Box is technologically the same as the already cleared Tapered Junction Box, including in terms of indications for use/intended use.
Overall Design Inputs: Meet the original design inputs of the predicate device.	Performance data demonstrate that the original design inputs of the predicate are met. Verification and validation conducted according to design control procedures within a risk analysis framework to determine that the design outputs meet the design inputs using the same test criteria and methodology as the predicate K181569.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size for mechanical testing (e.g., number of devices tested for fatigue or disassembly). The evaluation performed involved testing of the device itself rather than a clinical study with patient data. Therefore, there is no "test set" in the context of patient data, nor is there data provenance in terms of country of origin or retrospective/prospective collection as this is a physical device testing study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This is not a study involving expert review of medical images or clinical data to establish ground truth. The "ground truth" here is the established performance characteristics and safety profile of the predicate device, against which the modified device's mechanical properties are compared using established engineering test methods.

4. Adjudication Method for the Test Set

Not applicable. There is no expert adjudication process for this type of mechanical engineering study. The evaluation relies on standardized test methods (like ASTM F1814) and engineering analysis.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This submission is for a medical implant (knee joint prosthesis components), not an AI-assisted diagnostic or prognostic device that would typically involve MRMC studiescomparing human readers with and without AI assistance. Therefore, there is no effect size of human readers improving with AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable, as this is a physical medical device, not an algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" for this special 510(k) is the established performance and safety profile of the predicate device (BKS® Revision Sleeves System, K181569) as demonstrated through its initial clearance and compliance with recognized consensus standards. The modified device is tested against these established benchmarks using engineering principles and standardized tests to confirm equivalence.

8. The Sample Size for the Training Set

Not applicable. There is no training set in the context of machine learning or AI models, as this is a physical medical device.

9. How the Ground Truth for the Training Set Was Established

Not applicable, for the same reason as point 8.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 25, 2024

Ortho Development Corp. Drew Weaver Director of Regulatory Affairs 12187 S. Business Park Drive Draper, Utah 84020

Re: K242984

Trade/Device Name: BKS Revision 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: October 25, 2024 Received: September 26, 2024

Dear Drew Weaver:

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.

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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 and Part 809); 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Peter G. Allen -S Allen-S
Digitally signed by Peter G.
Date: 2024.10.25 15:56:31
-04'00'

For: Lixin Liu, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K242984

Device Name BKS Revision System

Indications for Use (Describe)

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, BKS TriMax, and BKS Revision are intended for total knee arthroplasty procedures.

The BKS Revision system 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 system is indicated for cemented use only. The porous-coated metaphyseal sleeves are intended for cemented and uncemented applications.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/4/Picture/2 description: The image shows the logo for "Ortho Development". The logo consists of a purple circle with gray lines emanating from the top left, followed by the word "ORTHO" in purple block letters. Below "ORTHO" is the word "DEVELOPMENT" in a smaller, lighter font, with a registered trademark symbol.

510(k) Summary of Safety & Effectiveness

In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR §807.92, the following summary of information is provided:

Name of the Sponsor:	Ortho Development® Corporation12187 South Business Park DriveDraper, Utah 84020
510(k) Contact:	Name:	Drew Weaver
	Position:	Director of Regulatory Affairs
	Address:	12187 S. Business Park DriveDraper, UT 84020 USA
	Telephone:	(801) 553-9991
	Email:	dweaver@orthodevelopment.com
Date Prepared:	October 25, 2024
Submission Type:	Special
Proprietary Name:	BKS Revision System
Common Name:	BKS Revision Sleeve Junction Box
Product Code /Classification:	JWH	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer21 CFR 888.3560: Knee joint patellofemorotibialpolymer/metal/polymer semi-constrained cementedprosthesis.
Associated ProductCode(s) / Classification:	MBH	Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated,polymer/metal/polymer21 CFR 888.3565: Knee joint patellofemorotibialmetal/polymer porous-coated uncemented prosthesis.
Device Class:	Class 2
Primary PredicateDevice:	BKS® Revision Sleeves System (K181569)

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Image /page/5/Picture/2 description: The image shows the logo for "Ortho Development". The logo consists of a purple circle with three curved lines emanating from the top left, followed by the word "ORTHO" in purple, block letters. Below the word "ORTHO" is the word "DEVELOPMENT" in gray, smaller letters.

1.0 Device Description:

2.0 Indication for Use:

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, BKS TriMax, and BKS Revision are intended for total knee arthroplasty procedures.

The BKS Revision system 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 system is indicated for cemented use only. The porous-coated metaphyseal sleeves are intended for cemented and uncemented applications.

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Image /page/6/Picture/2 description: The image shows the logo for "Ortho Development". The logo consists of a 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, gray font with a trademark symbol.

The BKS Revision CK Tibial Insert is indicated for use with the BKS Revision Modular femoral and Modular, Offset, or Sleeve tibial components where collateral ligaments may not be relied upon for medial/lateral (M/L) stability.

3.0 Comparison of Technological Characteristic:

The Sleeve Junction Box is technologically the same as the already cleared Tapered Junction Box that was a component of BKS Revision Sleeves (K181569). It is the same in terms of indications for use/intended use, basic design, device materials, and principles of operation.

Labeling, packaging and sterilization do not change.

The modified device was evaluated using well established methods and recognized consensus standards to confirm that it meets the original design inputs of the predicate.

4.0 Performance Data:

The modified device was evaluated using well established methods and recognized consensus standards to confirm that it meets the original design inputs of the predicate.

The evaluation includes: geometric analysis, axial fatigue strength per ASTM F1814, disassembly strength, assembly evaluation, and packaging evaluation.

These performance data demonstrate that the original design inputs of the predicate are met.

5.0 Substantial Equivalence Conclusion:

Verification and validation has been conducted according to design control procedures within a risk analysis framework to determine that the design outputs meet the design inputs using the same test criteria and methodology as the predicate K181569.

Based on similarities in indication for use/intended use, technological characteristic, basic design, device material, and principle of operation, the BKS Revision Sleeve Junction Box of the BKS Revision System is considered substantially equivalent to the previously cleared 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.