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· Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis
· Revision of previous unsuccessful surgical procedures, either involving, or not involving, previous use of a unicompartmental knee prosthesis
· As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis
· Where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by deficiencies of the femoral condyle/tibial plateau.

These components are intended for implantation with bone cement.

The subject Triathlon® PKR System X3® Tibial Inserts (5630-G-XXX-E) are unchanged since the last premarket notification for the devices in K180612. The subject Triathlon® PKR System X3® Tibial Inserts (5630-G-XXX), Triathlon® PKR Unicompartmental Femoral Component, and Triathlon® PKR Unicompartmental Tibial Baseplate are unchanged since the last premarket notification for the devices in K172326.

The subject Triathlon® PKR System X3® Tibial Inserts (5630-G-XXX-E), Triathlon® PKR System X3® Tibial Inserts (5630-G-XXX), Triathlon® PKR Unicompartmental Femoral Component, and Triathlon® PKR Unicompartmental Tibial Baseplate are collectively referred to throughout this submission as the subject devices.

The purpose of this "Change Being Effected" premarket notification is to add a contraindication for the Triathlon® PKR X3® Tibial Inserts, Triathlon® PKR Unicompartmental Femoral Component, and Triathlon® PKR Unicompartmental Tibial Baseplate. Additionally, minor clarifications are being made to the labeling.

The provided text is a 510(k) summary for the Triathlon PKR System, which describes a partial knee joint replacement device. This document is a regulatory submission to the FDA and primarily focuses on establishing substantial equivalence to previously cleared predicate devices.

Crucially, the document explicitly states: "No additional testing was conducted for this submission, as the only changes being made are the addition of a contraindication and minor labeling clarifications. Testing performed in the previously cleared premarket notifications is applicable to this submission."

Therefore, this specific 510(k) submission (K203099) does not contain independent studies or data proving the device meets new acceptance criteria. Instead, it relies on the acceptance criteria and studies from its predicate devices (referenced as K180612, K172326, K082567, and K071881). Without access to those specific predicate 510(k) summaries, a detailed answer to your request cannot be fully provided based solely on the text you've supplied.

However, I can extract information regarding the device's indications for use and the general statement about relying on prior testing:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this submission did not involve new testing, there are no new acceptance criteria or reported performance data specific to this submission. The device is considered to meet the same performance criteria as its predicates due to "identical in intended use, indications, design, technological characteristics and operational principles."

Missing Information (Cannot be answered from the provided text as this submission relies on predicate data):

• Sample sizes used for the test set
• Data provenance for the test set
• Number of experts used to establish ground truth for the test set
• Qualifications of those experts
• Adjudication method
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done
• Effect size of human reader improvement with AI vs. without AI assistance
• Whether a standalone (algorithm only) performance study was done
• Type of ground truth used (e.g., pathology, outcomes data)
• Sample size for the training set
• How ground truth for the training set was established

Key Takeaway from this Document:

This 510(k) submission (K203099) for the Triathlon PKR System is primarily an administrative update to add a contraindication and clarify labeling. It does not present new performance data or studies. Instead, it asserts substantial equivalence by retaining the intended use, indications, design, technological characteristics, and operational principles of its previously cleared predicate devices, thereby leveraging the testing and acceptance criteria established in those earlier submissions (K180612, K172326, K082567, and K071881). To answer the more detailed questions about acceptance criteria and study designs, one would need to review the 510(k) summaries for the predicate devices.

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General Total Knee Arthroplasty (TKR) Indications:

• Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative . joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis.
• Post-traumatic loss of knee joint configuration and function.
• . Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
• Revision of previous unsuccessful knee replacement or other procedure. ●
• Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture -management techniques.

The Triathlon® Tritanium® Total Knee System components are indicated for both uncemented and cemented use.

The Triathlon® Total Knee System beaded and beaded with Peri-Apatite components are intended for uncemented use only.

The Triathlon® All Polyethylene tibial components are indicated for cemented use only.

Additional Indications for Posterior Stabilized (PS) and Total Stabilizer (TS) Components:

• . Ligamentous instability requiring implant bearing surface geometries with increased constraint.
• Absent or non-functioning posterior cruciate ligament.
• Severe anteroposterior instability of the knee joint. ●

Additional Indications for Total Stabilizer (TS) Components:

• Severe instability of the knee secondary to compromised collateral ligament integrity or ● function.
  Indications for Bone Augments:
• Painful, disabling joint disease of the knee secondary to: degenerative arthritis, . rheumatoid arthritis, or post-traumatic arthritis, complicated by the presence of bone loss.
• Salvage of previous unsuccessful total knee replacement or other surgical procedure, . accompanied by bone loss.

Additional Indications for Cone Augments:

• Severe degeneration or trauma requiring extensive resection and replacement .
• Femoral and Tibial bone voids ●
• Metaphyseal reconstruction o

The Triathlon TS Cone Augment components are intended for cemented or cementless use.

Indications for Use for the Triathlon Tritanium Tibial Baseplate are:
General Total Knee Arthroplasty (TKR) Indications:

• . Painful, disabling joint disease of the knee resulting from: non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or rheumatoid arthritis
• Post-traumatic loss of knee joint configuration and function ●
• Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be ● returned to adequate function and stability
• Revision of previous unsuccessful knee replacement or other procedure
• Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture management techniques

Additional General Total Knee Arthroplasty (TKR) Indications specific to the PS implant:

• Ligamentous instability requiring implant bearing surface geometries with increased o constraint
• . Absent or non-functioning posterior cruciate ligament
• Severe anteroposterior instability of the knee joint .

The Triathlon Tritanium Tibial Baseplates are indicated for both cemented and uncemented use.

Indications for Use for the Triathlon Low Profile Tibial Tray are:
The Triathlon Low Profile Tibial Tray is intended to be used with commercially available Triathlon® femoral components and associated patellar components, and tibial bearing inserts in primary cemented total knee arthroplasty. The indications for the Triathlon® Low Profile Tibial Tray are outlined below:

Indications for Use:

• · Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis.
• · Post-traumatic loss of knee joint configuration and function.
• · Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.

Indications for Use for the Triathlon Metal Backed Patella are:

• . Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis or avascular necrosis;
• Rheumatoid arthritis; .
• Correction of functional deformity; ●
• Revision procedures where other treatments or devices have failed; ●
• Post traumatic loss of joint anatomy, particularly when there is patello-femoral erosion, ● dysfunction or prior patellectomy; and,
• Irreparable fracture of the knee. .

These products are intended to achieve fixation without the use of bone cement.

Indications for Use for the Triathlon PKR System are:

• . Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis
• . Revision of previous unsuccessful surgical procedures, either involving, or not involving, previous use of a unicompartmental knee prosthesis
• As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis ●
• Where bone stock is of poor quality or inadequate for other reconstructive techniques as ● indicated by deficiencies of the femoral condyle/tibial plateau.

These components are intended for implantation with bone cement.

Indications for Use for the Restoris MCK System:
Restoris MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIQ, the Robotic Arm Interactive Orthopedic System, in individuals with osteoarthritis, or post-traumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces.

The specific knee replacement configurations include:

• Medial unicondylar ●
• Lateral unicondylar
• Patellofemoral ●
• Medial bi-compartmental (medial unicondylar and patellofemoral)

Restoris Multi Compartmental Knee is for single use only and is intended for implantation with bone cement.

The devices covered by this submission include femoral components, tibial baseplates, tibial inserts, all-polyethylene tibial components, patellar components, metal backed patellar components, tibial and femoral augments, stems, stem extenders and offset adaptors used in total knee arthroplasty procedures, as well as femoral components, tibial inserts, tibial baseplates, patellofemoral components and patellar components used in partial knee replacements. All devices have been previously determined substantially equivalent in prior 510(k) submissions and are commercially available. The Triathlon/Restoris Knee system components are manufactured from the following materials Cobalt Chromium Alloy, Titanium Alloy, Commercially Pure Titanium, Ultra-High Molecular Weight Polyethylene and Calcium Phosphate.

The purpose of this submission is to modify the labeling of the Triathlon Total Knee System, Triathlon PKR System, and Restoris MCK System to add MR Conditional labeling. Additionally, a revision to the contraindications for the Triathlon PKR System is being made.

This document describes the premarket notification (510(k)) for the Stryker Orthopaedics Triathlon Total Knee System, Triathlon PKR System, and Restoris MCK System. The submission primarily focuses on modifying the labeling to add MR Conditional labeling and revising contraindications for the Triathlon PKR System. Therefore, the "device" in question is the existing knee replacement systems with updated MRI compatibility information.

As such, the provided text DOES NOT describe a study that proves a device meets acceptance criteria related to its functional performance (e.g., accuracy, sensitivity, specificity, or improvement in human reader performance for an AI/CAD device). Instead, it details the non-clinical testing performed to establish the MR compatibility of the knee systems.

Given this, I will tailor the answer to reflect the information available regarding the MR compatibility studies, rather than a clinical performance study often associated with AI/CAD devices.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

The acceptance criteria are implicitly defined by the standards and guidance used for MR compatibility testing. The reported performance is that the devices passed these tests and are therefore deemed "MR Conditional" under specific parameters.

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

The text does not specify the sample size in terms of the number of devices tested for MR compatibility. Typically, for such non-clinical bench testing, a representative sample of device types and sizes would be tested according to the standards. The data provenance is "non-clinical laboratory testing." This is implicitly a prospective study conducted in a controlled lab setting, not involving human or animal data, and thus no country of origin for patients or retrospective/prospective human data is applicable.

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)

This question is not applicable to the type of testing performed. For MR compatibility, the "ground truth" is established by the physical measurements taken according to standardized test methods (e.g., measuring temperature rise, displacement, torque, or evaluating artifact characteristics against defined limits). This does not involve human expert consensus on diagnostic images.

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

This question is not applicable to the type of testing performed. Adjudication methods are typically used when human interpretation of data (e.g., radiologist reads) is required to establish ground truth or evaluate performance, for example in clinical trials of AI algorithms. For MR compatibility testing, the results are objectively measured per established 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 such study was performed or described. This type of study is relevant for AI/CAD devices where human reader performance is a key metric. This submission is for knee implants and their MR compatibility, not an AI device.

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

This question is not applicable. The device is a physical knee implant, not an algorithm.

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

The ground truth for MR compatibility testing is based on:

• Physical measurements: Quantifiable measurements of magnetic force, torque, temperature rise, and the extent of image artifacts, as defined by the respective ASTM standards.
• Standardized protocols: Adherence to established test methods that determine safety in the MR environment.

This is a form of objective, physical measurement ground truth, not based on expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This question is not applicable. The device is a physical product (knee implant) and there is no mention of an AI/machine learning component that would require a training set.

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

This question is not applicable as there is no training set mentioned for this product.

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• Moderately disabling joint disease of the knee resulting from painful osteo- or post . traumatic arthritis
• Revision of previous unsuccessful surgical procedures, either involving, or not . involving, previous use of a unicompartmental knee prosthesis
• As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis .
• Where bone stock is of poor quality or inadequate for other reconstructive techniques as . indicated by deficiencies of the femoral condyle/tibial plateau.

These components are intended for implantation with bone cement.

The Triathlon® PKR System is a modular unicondylar knee prostheses consisting of sterile, single-use components intended for replacement of the medial or lateral femoral condyle regions for either the right or left knee.

This document, K071881, pertains to the 510(k) summary for the Triathlon® PKR System, a knee prosthesis. It focuses on demonstrating substantial equivalence to predicate devices rather than providing performance data against specific acceptance criteria for a novel device. Therefore, much of the requested information regarding acceptance criteria, study details, and ground truth establishment is not present in this type of submission.

Here's a breakdown of the available information based on your request:

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

• Acceptance Criteria: Not explicitly stated as quantifiable metrics. The submission's primary "acceptance criteria" for the 510(k) clearance process is demonstrating substantial equivalence to legally marketed predicate devices in terms of intended use, design, materials, and operational principles.
• Reported Device Performance: The document states that "Based upon the mechanical testing, the Triathlon® PKR System is substantially equivalent for its intended use to other femorotibial replacement knees currently on the market." However, no specific performance metrics (e.g., wear rate, fatigue strength values, range of motion, clinical outcomes) or a comparison table against acceptance criteria are provided in this summary. Instead, it refers to "mechanical testing" generally.

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 provided in the 510(k) summary. The submission focuses on demonstrating substantial equivalence through design and material comparisons and the mention of general mechanical testing, not a clinical study with a test set of patients.

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)

• This information is not applicable/not provided. Ground truth establishment by experts for a test set is typically relevant for studies evaluating diagnostic or AI-driven devices. This submission concerns a physical implant (knee prosthesis).

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

• This information is not applicable/not provided for the same reasons as point 3.

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

• This information is not applicable/not provided. MRMC studies are relevant for diagnostic devices, particularly those involving human interpretation of images with or without AI assistance. This submission does not describe such a study.

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

• This information is not applicable/not provided. This device is a physical knee implant, not an algorithm.

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

• For the purpose of substantial equivalence for a physical implant, the "ground truth" is typically established through:
  • Material properties and design specifications: Demonstrating that the materials and design conform to established standards and are equivalent to predicate devices.
  • Mechanical testing: In vitro laboratory tests (e.g., fatigue, wear, strength) serve as the "ground truth" for demonstrating the physical robustness and performance characteristics under simulated conditions. The summary mentions "mechanical testing" but does not detail the specific tests or their results.
  • Clinical history of predicate devices: The long-standing safe and effective use of the predicate devices implicitly forms a "ground truth" for the intended use and performance expectations.

8. The sample size for the training set

• This information is not applicable/not provided. A "training set" is relevant for machine learning algorithms, not for the regulatory submission of a physical medical device like a knee prosthesis.

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

• This information is not applicable/not provided for the same reason as point 8.

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