(161 days)
The Apollo Suture Anchors and Titan Screws are indicated for use in fixation of ligament, tendon, bone, or soft tissue to bone in knee, shoulder, foot/ankle, elbow, and hand/wrist procedures. The screws are intended for use in the following procedures:
Indications - Apollo Medial Suture Anchor: Shoulder (Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, AcormieClavicular Separation Repair, Deltoid Repair, Capisular Shift or Capsulolabral Reconstruction), Foot/Ankle (Lateral Stabilization, Medial Stabilizatio, Achilles Tendon Repair), Knee (Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis), Elbow (Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction), Hip (Capsular Repair, Acetabular Labral Repair).
Indications - Apollo Lateral Anchor: Shoulder (Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, AcormieClavicular Separation Repair, Deltoid Repair, Capisular Shift or Capsulolabral Reconstruction), Wrist/Hand (Scapholunate Ligament Reconstruction, Ulnar/Radial Collateral Ligament Reconstruction), Foot/Ankle (Lateral Stabilization, Medial Stabilizatio, Achilles Tendon Repair/Reconstruction, Hallux Valgus Reconstruction, Midland Forefoot Reconstruction), Elbow (Biceps Tendon Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repai(PEEK Anchor Only)), Knee (Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Joint Capsule Closure, Iliotibial Band Tenodesis, Patellar Ligament/Tendon Repair).
Indications - Apollo Labral Suture Tac Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromioclavicular Separation Repair, Deltoid Repair, Capisular Shift or Capsulolabral Reconstruction. Wrist: Scapholunate Ligament Reconstruction. Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction. Hip: Capsular Repair, Acetabular Labral Repair. Knee: Extracapsular Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Joint Capsule Closure, Iliotibial Band Tenodesis Reconstruction, Patellar ligament/Tendon Repair, Vastus Medialis Obliquus Muscle Advancement.
Indications – Interference Screws: The Titan Interference Screws are indicated for the reattachment of ligament, tendon, soft tissue, or bone to bone during cruciate ligament reconstruction surgeries of the knee. All screws with a diameter of 9 mm or less and a length of 23 mm or less are also intended for the use in the following procedures: Knee (ACL repairs, PCL repairs, Extracapsular repairs, Medial collateral ligament, Lateral collateral ligament, Posterior oblique ligament, Patellar realignment and tendon repairs, Vastus medialis oliquous advancement, Iliotibial band tenodesis), Shoulder (Capsular stabilization (Bankart repair, Anterior shoulder Instability, SLAP lesion repairs, Capsular shift of capsulolabral reconstructions), Acromioclavicular separation repairs, Deltoid repairs, Rotor cuff tear repairs, Biceps tenodesis), Foot and Ankle (Hallux valgus repairs, Medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon repairs/reconstruions, Bunionectomy, Flexor Hullucis Longus, Tendon transfers), Elbow, Wrist, and Hand (Biceps tendon reattachment, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair, Scapholunate ligament reconstruction, Tendo transfers).
Indications – Tenodesis Screws: The Titan Tenodesis Screws are intended to be used for fixation of tissue, including ligament or tendon to bone, or a bone/tendon to bone. The Tenodesis Screws are intended to provide soft tissue reattachment (i.e. fixation of ligament and tendon graft tissue). See below for specific indications. Shoulder (Capsular stabilization (Bankart repair, Anterior shoulder instability, SLAP lesion repairs, Capsular shift of capsulolabral reconstructions), Acromioclavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs, Biceps tenodesis), Foot and Ankle (Hallux valgus reconstruction, Medial stabilization, lateral stabilization, Achilles Tendon Repair, Midfoot reconstructions, Metatarsal ligament repair, Bunionectomy, Flexor Hullucis Longus for Achilles Tendon reconstruction, Tendon transfers in the foot and ankle), Knee (Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Posterior Cruciate Ligament Repair), Elbow (Biceps tendon reattachment, Ulnar or radial collateral ligament reconstruction), Wrist and Hand (Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, Tendon transfer irthe hand/wrist, Lateral Epicondylitis repair).
The Apollo Medial Suture Anchor, Lateral Anchor, and Suture Tac Delivery Systems are delivery systems for anchors for use in fixation of ligament, tendon, bone, or soft tissue to bone in knee, shoulder, foot/ankle, elbow, and hand/wrist procedures. These anchors consist of cannulated anchors with integrated suture attachment or separate suture punch eyelet. The Anchors are provided loaded on individual inserters with and without integrated sutures, sterile, for single use only.
The Titan Interference and Tenodesis Screws are interference screws for use in fixation of ligament, tendon, bone, or soft tissue to bone in knee, shoulder, foot/ankle, elbow, and hand/wrist procedures. The screws are provided sterile, for single use only.
Screw and anchor implants are made from either a titanium alloy (6Al4V) per ASTM F136, or PEEK (Zeniva ZA-500) per ASTM F2026 from Solvay Advanced Polymers.
Here's an analysis of the provided text regarding the acceptance criteria and study for Amendia's Apollo Suture Anchor and Titan Screws:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not contain explicit, quantitative acceptance criteria in the typical sense (e.g., "device must achieve X % accuracy," or "strength must exceed Y N"). Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices through performance testing. The reported device performance is that it met this standard.
| Acceptance Criteria Type | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Substantial equivalence in axial pullout, axial push out, insertion torque, and torque to failure as per ASTM F543-07 to predicate devices. | "Side-by-side testing to predicate devices was completed with test results demonstrating that the Apollo Suture Anchor System and Titan Screws are substantially equivalent to the predicate devices" in axial pullout, axial push out, insertion torque, and torque to failure tests per ASTM F543-07. |
| Indications for Use | Substantial equivalence of intended use/indications compared to predicate devices. | "The Apollo Suture Anchor System and Titan Screws are substantially equivalent to the predicate devices in regards to... Indications for Use." The specific indications are listed extensively in the document. |
| Materials | Substantial equivalence of materials used compared to predicate devices. | "The Apollo Suture Anchor System and Titan Screws are substantially equivalent to the predicate devices in regards to... Materials." (Implied to be titanium alloy (6Al4V) per ASTM F136, or PEEK (Zeniva ZA-500) per ASTM F2026, as described for the device). |
| Mechanism of Action | Substantial equivalence of mechanism of action compared to predicate devices. | "The Apollo Suture Anchor System and Titan Screws are substantially equivalent to the predicate devices in regards to... Mechanism of action." |
| Dimensions | Substantial equivalence of dimensions compared to predicate devices. | "The Apollo Suture Anchor System and Titan Screws are substantially equivalent to the predicate devices in regards to... Dimensions." |
| Safety and Efficacy | No new types of safety or efficacy issues compared to predicate devices. | "There are no significant differences in technological characteristics compared to the predicate device that would raise any new types of safety or efficacy issues." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document simply states "side-by-side testing to predicate devices was completed." It does not specify the sample size for the test set for any of the performance tests (axial pullout, axial push out, insertion torque, and torque to failure).
- Data Provenance: The document does not specify the country of origin or whether the data was retrospective or prospective. Since it's mechanical testing of physical implants, "provenance" in the context of patient data (country, retrospective/prospective) isn't directly applicable here. The data would be generated from laboratory testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided in the document. The "ground truth" for this device's performance testing is based on standardized mechanical engineering tests (ASTM F543-07) comparing the device to predicate devices, not on expert clinical interpretation of patient data.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving human interpretation or subjective assessments, not for objective mechanical performance tests.
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 and not provided. This device is a surgical implant (suture anchor and screws) and not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies involving human readers and AI assistance are irrelevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable and not provided. This device is a physical surgical implant and does not involve any algorithm or AI.
7. The Type of Ground Truth Used
The "ground truth" for this submission is:
- Standardized Mechanical Test Results: Specifically, compliance with ASTM F543-07 for axial pullout, axial push out, insertion torque, and torque to failure.
- Comparison to Predicate Device Performance: The primary ground truth is the performance data generated for the predicate devices, against which the new device's performance is compared to demonstrate substantial equivalence.
8. The Sample Size for the Training Set
This information is not applicable and not provided. This device is a physical implant and does not involve machine learning or AI, so there is no training set in the computational sense.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided, for the same reasons as #8.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.