(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.
{0}------------------------------------------------
510(k) SUMMARY Amendia's Apollo Suture Anchor and Titan Screws
| Date: | September 11, 2013 |
|---|---|
| Contact: | Daniel Lanois, General Manager |
| Trade Name: | Apollo Suture Anchor System and Titan Screws |
| Common Name: | Screw, Fixation, Bone |
| Product Class: | Class II |
| Classification: | 21 CFR §888.3040 - Smooth or threaded metallic bone fixationfastener |
| Product Code: | MBI |
| Panel Code: | 87 |
Name/Address of Sponsor
Amendia, LLC 1755 West Oak Pkwy Marietta, GA 30062 770-575-5200
Purpose:
The purpose of this submission is clearance of the Apollo Suture Anchor System and Titan Screws as a new medical device that is substantially equivalent to the predicate device.
Device Description
Apollo Family
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.
Titan Family
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.
{1}------------------------------------------------
Predicate Device
The Apollo Suture Anchor System and Titan Screws are substantially equivalent to Smith and Nephew Biosure PK Interference Screw (K083635), the DePuy Mitek Healix PEEK Anchor (K120449), the Biomet PEEK Allthread Knotless Suture Anchor and Hitch PEEK Anchor (K071569 and K060693), and the Arthrex Tenodesis Screw (K041356).
Intended Use / Indications for Use
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 | Indications - Apollo Lateral Anchor |
|---|---|
| The Apollo Medial Suture Anchor is intended for: | The Apollo Lateral Anchor is indicated for: |
| Shoulder | Shoulder |
| Rotator Cuff Repair | Rotator Cuff Repair |
| Bankart Repair | Bankart Repair |
| SLAP Lesion Repair | SLAP Lesion Repair |
| Biceps Tenodesis | Biceps Tenodesis |
| AcormieClavicular Separation Repair | AcormieClavicular Separation Repair |
| Deltoid Repair | Deltoid Repair |
| Capisular Shift or Capsulolabral Reconstruction | Capisular Shift or Capsulolabral Reconstruction |
| Foot/Ankle | Wrist/Hand |
| Lateral Stabilization | Scapholunate Ligament Reconstruction |
| Medial Stabilization | Ulnar/Radial Collateral Ligament Reconstruction |
| Achilles Tendon Repair | |
| Knee | Foot/Ankle |
| Medial Collateral Ligament Repair | Lateral Stabilization |
| Lateral Collateral Ligament Repair | Medial Stabilization |
| Posterior Oblige Ligament Repair | Achilles Tendon Repair/Reconstruction |
| Illiotibial Band Tenodesis | Hallux Valgus Reconstruction |
| Elbow | Midand Forefoot Reconstruction |
| Biceps Tendon Reattachment | Elbow |
| • Ulnar or Radial Collateral Ligament Reconstruction | Biceps Tendon Reconstruction |
| Hip | Ulnar or Radial Collateral Ligament Reconstruction |
| Capsular Repair | Lateral Epicondylitis Repair (PEEK Anchor Only) |
| Acetabular Labral Repair | 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
{2}------------------------------------------------
| ☐ 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 Reonstruction | |
| 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 Medias Obliquus Muscle Advancement | |
| Indications -Interference Screws | Indications -Tenodesis Screws |
| The Titan Interference Screws are indicated for the | The Titan Tenodesis Screws are intended to be used for fixation |
| reattachment of ligament, tendon, soft tissue, or bone to bone | of tissue, including ligament or tendon to bone, or a |
| during cruciate ligament reconstruction surgeries of the knee. | bone/tendon to bone. See below for specific indications. |
| All screws with a diameter of 9 mm or less and a length of 23mm or less are also intended for the use in the following | The Tenodesis Screws are intended to provide soft tissuereattachment (i.e. fixation of ligament and tendon graft tissue). |
| procedures: | See below for specific indications. |
| Knee | Shoulder |
| ☐ ACL repairs | ☐ Capsular stabilization |
| ☐ PCL repairs | o Bankart repair |
| o Extracapsular repairs | o Anterior shoulder instability |
| o Medial collateral ligament | o SLAP lesion repairs |
| o Lateral collateral ligament | o Capsular shift of capsulolabral reconstructions |
| o Posterior oblique ligament | ☐ Acromioclavicular separation repairs |
| o Patellar realignment and tendon repairs | ☐ Deltoid repairs |
| o Vastus medialis oliquous advancement | ☐ Rotator cuff tear repairs |
| ☐ Iliotibial band tenodesis | ☐ Biceps tenodesis |
| Shoulder | |
| ☐ Capsular stabilization | Foot and Ankle |
| o Bankart repair | ☐ Hallux valgus reconstruction |
| o Anterior shoulder instability | ☐ Medial stabilization |
| o SLAP lesion repairs | ☐ Lateral stabilization |
| o Capsular shift of capsulolabral reconstructions | ☐ Achilles Tendon Repair |
| o Acromioclavicular separationrepairs | ☐ Midfoot reconstructions |
| ☐ Deltoid repairs | ☐ Metatarsal ligament repair |
| ☐ Rotator cuff tear repairs | ☐ Bunionectomy |
| ☐ Biceps tenodesis | ☐ Flexor Hullucis Longus for Achilles Tendon reconstruction |
| ☐ Tendon transfers in the foot and ankle | |
| Foot and Ankle | |
| ☐ Hallux valgus repairs | |
| ☐ Medial or lateral instability repairs/reconstructions | Knee |
| ☐ Achilles tendon repairs/reconstructions | ☐ Medial Collateral Ligament Repair☐ Lateral Collateral Ligament Repair |
| ☐ Midfoot reconstructions |
{3}------------------------------------------------
| ☐ Metatarsal ligament/tendon repairs/reconstructions | ☐ Patellar Tendon Repair |
|---|---|
| ☐ Bunionectomy | ☐ Posterior Oblique Ligament Repair |
| ☐ Flexor Hullucis Longus | ☐ Iliotibial Band Tenodesis |
| ☐ Tendon transfers | ☐ Posterior Cruciate Ligament Repair |
| Elbow, Wrist, and Hand | Elbow |
| ☐ Biceps tendon reattachment | ☐ Biceps tendon reattachment |
| ☐ Ulnar or radial collateral ligament reconstructions | ☐ Ulnar or radial collateral ligament reconstruction |
| ☐ Lateral epicondylitis repair | |
| ☐ Scapholunate ligament reconstruction | Wrist and Hand |
| ☐ Tendon transfers | ☐ Scapholunate Ligament Reconstruction |
| ☐ Thar Collateral Ligament Reconstruction | |
| ☐ Radial Collateral ligament Reconstruction | |
| ☐ Carpometalcarpal joint arthroplasty (basal thumb joint arthroplasty) | |
| ☐ Carpal Ligament Reconstructions and repairs | |
| ☐ Tendon transfer in the hand/wrist | |
| ☐ Lateral Epicondylitis repair |
Performance Data:
Performance testing included axial pullout, axial push out, insertion torque, and torque to failure tests per ASTM F543-07. 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.
Summary:
The Apollo Suture Anchor System and Titan Screws are substantially equivalent to the predicate devices in regards to:
- . Indications for Use
- . Materials
- Mechanism of action . .
- . Dimensions
There are no significant differences in technological characteristics compared to the predicate device that would raise any new types of safety or efficacy issues.
{4}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 6, 2014
Amendia, LLC % Dr. Richard Jansen, Pharm. D. President Silver Pine Consulting 13540 Guild Ave. Apple Valley, Minnesota 55124
Re: K133036
Trade/Device Name: Apollo Suture Anchor System and Titan Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: January 17, 2014 Received: February 14, 2014
Dear Dr. Jansen,
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. The general controls provisions of the Act include requirements for annual registration. Ilsting 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.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
{5}------------------------------------------------
Page 2 - Dr. Richard Jansen
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Vincen詞Devlin -S
- for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{6}------------------------------------------------
Indications for Use Statement
510(k) Number (if known): K133036 Device Name: Apollo Suture Anchor System and Titan Screws
Intended Use / Indications for Use
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 AnchorThe Apollo Medial Suture Anchor is intended for:Shoulder☐ Rotator Cuff Repair☐ Bankart Repair☐ SLAP Lesion Repair☐ Biceps Tenodesis☐ AcormieClavicular Separation Repair☐ Deltoid Repair☐ Capisular Shift or Capsulolabral ReconstructionFoot/Ankle☐ Lateral Stabilization☐ Medial Stabilizatio☐ Achilles Tendon RepairKnee☐ Medial Collateral Ligament Repair☐ Lateral Collateral Ligament Repair☐ Posterior Oblique Ligament Repair☐ Iliotibial Band TenodesisElbow☐ Biceps Tendon Reattachment• Ulnar or Radial Collateral Ligament ReconstructionHip☐ Capsular Repair☐ Acetabular Labral Repair | Indications - Apollo Lateral AnchorThe Apollo Lateral Anchor is Indicated for:Shoulder☐ Rotator Cuff Repair☐ Bankart Repair☐ SLAP Lesion Repair☐ Biceps Tenodesis☐ AcormieClavicular Separation Repair☐ Deltoid Repair☐ Capisular Shift or Capsulolabral ReconstructionWrist/Hand☐ Scapholunate Ligament Reconstruction☐ Ulnar/Radial Collateral Ligament ReconstructionFoot/Ankle☐ Lateral Stabilization☐ Medial Stabilizatio☐ Achilles Tendon Repair/Reconstruction☐ Hallux Valgus Reconstruction☐ Midland Forefoot ReconstructionElbow☐ 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☐ AcormieClavicular Separation Repair☐ Deltoid Repair☐ Capisular Shift or Capsulolabral ReconstructionWrist☐ Scapholunate Ligament ReconstructionElbow☐ Biceps Tendon Reattachment☐ Ulnar or Radial Collateral Ligament ReconstructionHip☐ Capsular Repair☐ Acetabular Labral Repair |
{7}------------------------------------------------
КІЗЗОЗЕ
| 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 | Indications – Tenodesis Screws |
| The Titan Interference Screws are indicated for the | The Titan Tenodesis Screws are intended to be used for fixation |
| reattachment of ligament, tendon, soft tissue, or bone to bone | of tissue, including ligament or tendon to bone, or a |
| during cruciate ligament reconstruction surgeries of the knee. | bone/tendon to bone. See below for specific indications. |
| All screws with a diameter of 9 mm or less and a length of 23 | The Tenodesis Screws are intended to provide soft tissue |
| mm or less are also intended for the use in the following | reattachment (i.e. fixation of ligament and tendon graft tissue). |
| procedures: | See below for specific indications. |
| Knee | Shoulder |
| ACL repairs | Capsular stabilization |
| PCL repairs | o Bankart repair |
| o Extracapsular repairs | o Anterior shoulder instability |
| o Medial collateral ligament | o SLAP lesion repairs |
| o Lateral collateral ligament | o Capsular shift of capsulolabral reconstructions |
| o Posterior oblique ligament | Acromioclavicular separation repairs |
| Patellar realignment and tendon repairs | Deltoid repairs |
| o Vastus medialis oliquous advancement | Rotator cuff tear repairs |
| Iliotibial band tenodesis | Biceps tenodesis |
| Shoulder | Foot and Ankle |
| Capsular stabilization | Hallux valgus reconstruction |
| o Bankart repair | Medial stabilization |
| o Anterior shoulder Instability | lateral stabilization |
| o SLAP lesion repairs | Achilles Tendon Repair |
| o Capsular shift of capsulolabral reconstructions | Midfoot reconstructions |
| Acromioclavicular separation repairs | Metatarsal ligament repair |
| Deltoid repairs | Bunionectomy |
| Rotor cuff tear repairs | Flexor Hullucis Longus for Achilles Tendon reconstruction |
| Biceps tenodesis | Tendon transfers in the foot and ankle |
| Foot and Ankle | Knee |
| Hallux valgus repairs | Medial Collateral Ligament Repair |
| Medial or lateral instability repairs/reconstructions | Lateral Collateral Ligament Repair |
| Achilles tendon repairs/reconstructions | Patellar Tendon Repair |
| Midfoot reconstructions | Posterior Oblique Ligament Repair |
| Metatarsal ligament/tendon repairs/reconstruions | Iliotibial Band Tenodesis |
| Bunionectomy | Posterior Cruciate Ligament Repair |
| Flexor Hullucis Longus | Elbow |
| Tendon transfers | Biceps tendon reattachment |
| Elbow, Wrist, and Hand | Ulnar or radial collateral ligament reconstruction |
| Biceps tendon reattachment | Wrist and Hand |
| Ulnar or radial collateral ligament reconstructions | Scapholunate Ligament Reconstruction |
| Lateral epicondylitis repair | Ulnar Collateral Ligament Reconstruction |
| Scapholunate ligament reconstruction | Radial Collateral Ligament Reconstruction |
| Tendo transfers | Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty) |
| Carpal Ligament Reconstructions and repairs | |
| Tendon transfer irthe hand/wrist | |
| Lateral Epicondylitis repair |
____ Prescription Use _______________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
.
Over-The-Counter Use _ AND/OR
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Casey L. Hanley Ph.D. |
|---|
| Division of Orthopedic Devices |
§ 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.