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• 1. Loss of joint configuration and joint function.
• 2. Osteoarthritis of the knee joint.
• 3. Rheumatoid arthritis of the knee joint.
• 4. Post-traumatic arthritis of the knee joint.
• 5. Valgus, varus, or flexion deformities of the knee joint.
• 6. 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 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.

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.

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.

• 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.

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