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The Arthrex Corkscrew Family of Suture Anchors has been previously cleared in 510(k) K003817, K003227, K043337, and K050358. These suture anchors are intended for fixation of suture(soft tissue) to bone in the shoulder, foot/ankle, hip, knee, hand/wrist, elbow, and pelvis in, but not limited to, the following procedures:

Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament /Tendon Repair, Bunionectomy . .
Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Iliotibial Band Tenodesis.

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction.

Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Elbow: Collateral Ligament Reconstruction, Lateral Epicondylitis repair.

Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility of intrinsic sphincter deficiency.

Hip: Capsular repair, acetabular labral repair.

The Arthrex PushLock™, previously cleared under 510(k) K051219, is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, hip, and pelvis in the following procedures:

Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Shoulder: Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction

Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Elbow: collateral Ligament Reconstruction, Lateral Epicondylitis repair.

Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency.

Hip: Capsular repair, acetabular labral repair.

The Arthrex Tak™ Family, previously cleared under 510(k)s K971723, K000506, and K050749, is intended to be used for suture or tissue fixation in the foot, ankle, knee, hip, hand, wrist, elbow, shoulder, and in select maxillofacial applications. Specific indications are listed below and are size appropriate per patient needs:

Skull: Stabilization and fixation of oral cranio-maxillofacial skeletal bone. mandible and maxillofacial bones, Lateral Canthoplasty, Repair of Nasal Vestibular Stenosis, Brow Lift, Temporomandibular Joint (TMJ) reconstruction. soft tissue attachment to the parietal temporal ridge, frontal, zygoma, and perioorbital bones of the skull

Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Elbow: Reconstruction

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

Hand/Wrist: Scapholunate Ligament Reconstruction. Carpal Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis

Bladder Neck Suspension for female urinary incontinence due to Pelvis: urethral hypermobility or intrinsic sphincter deficiency.

Hip: Capsular repair, acetabular labral repair.

The Arthrex Families which are part of this expanded indications submission are as follows: Arthrex Bio-Corkscrew and Corkscrew Arthrex Bio-Corkscrew FT and Corkscrew FT Arthrex PushLock Arthrex Tak Family

These implants are comprised of titanium alloy, poly (L-lactide) or PLLA, poly (Llactide-Co-D, L-lactide) or PLDLA, and Polyaryletherketone or (PEEK). They are offered in several different shapes and sizes. They are offered sterile.

This 510(k) premarket notification is for an expanded indication for the Arthrex PushLock, Tak, and Corkscrew products. Therefore, the information provided focuses on demonstrating substantial equivalence to predicate devices for the new indications rather than establishing new acceptance criteria and conducting studies against them.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

There is no table of acceptance criteria or reported device performance for the Arthrex PushLock, Tak, and Corkscrew products in the provided 510(k) summary (K061863). This submission is for an expanded indication for already cleared devices. The acceptance criteria for these devices would have been established during their original 510(k) clearances (K003817, K003227, K043337, K050358 for Corkscrew; K051219 for PushLock; K971723, K000506, K050749 for Tak Family).

The current submission hinges on demonstrating substantial equivalence to existing predicate devices for the new indications of hip capsular repair and acetabular labral repair. The performance criteria for these new indications are implicitly met by showing equivalence to the predicate devices, which are already deemed safe and effective for similar uses.

The predicate device for the hip labral repair indication is identified as K053344, Smith & Nephew BioRaptor 2.9 mm and TwinFix Ti 2.8 & 3.5 mm implants. The performance of the Arthrex devices for these new indications would be considered acceptable if they are deemed substantially equivalent to the Smith & Nephew devices.

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

The provided document does not mention any sample sizes used for a test set or data provenance because this is a 510(k) submission for new indications based on substantial equivalence to predicate devices, not a de novo submission requiring extensive new clinical trial data. Instead, the focus is on comparing the characteristics of the Arthrex devices to the predicate devices, particularly for the new hip indications. This typically involves:

• Dimensional comparisons: Ensuring the sizes and designs are comparable.
• Material comparisons: Confirming the materials (titanium alloy, PLLA, PLDLA, PEEK) are acceptable and similar to the predicate.
• Mechanical testing data (if any was submitted): To demonstrate comparable strength, pull-out strength, or other relevant biomechanical properties for the intended use, although the document does not explicitly detail such testing for this particular submission.

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

Not applicable. As this is a substantial equivalence submission, there is no "test set" in the context of clinical studies requiring expert ground truth establishment for performance evaluation. The "ground truth" for the predicate devices' safety and effectiveness has already been established through their prior clearances and clinical use.

4. Adjudication Method for the Test Set:

Not applicable. No test set requiring adjudication is mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This is not a study involving human readers or AI assistance. It's a regulatory submission for expanded indications of medical devices based on substantial equivalence.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:

Not applicable. This is not a study of an algorithm or AI.

7. Type of Ground Truth Used:

The "ground truth" for this submission is the established safety and effectiveness of the predicate devices (Smith & Nephew BioRaptor and TwinFix Ti implants for hip labral repair), as determined by their previous 510(k) clearances and accepted clinical performance. The Arthrex devices are being presented as having sufficiently similar characteristics and intended use to the predicates for the new indications.

8. Sample Size for the Training Set:

Not applicable. This is not an AI/ML device, so there is no training set.

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

Not applicable. As there is no training set.

In summary, the provided document K061863 is a 510(k) premarket notification seeking clearance for expanded indications for existing Arthrex medical devices (suture anchors). It operates on the principle of "substantial equivalence" to predicate devices already on the market. Therefore, it does not involve the type of acceptance criteria, clinical studies, or data provenance usually associated with proving performance for novel devices or AI algorithms. The "proof" is the detailed comparison of the new indications' intended use and the device characteristics to those of the legally marketed predicate devices.

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