(28 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 and Apollo XT Suture Anchors: Shoulder (Rotator Cuff Repair, 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), Knee (Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis), Elbow (Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction), Hip (Capsular Repair, Acetabular Labral Repair).
Indications - Apollo Labral Suture Anchor: Shoulder (Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular 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 - Apollo Lateral Anchor: Shoulder (Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction), Wrist/Hand (Scapholunate Ligament Reconstruction, Ulnar/Radial Collateral Ligament Reconstruction), Foot/Ankle (Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair/Reconstruction, Hallux Valgus Reconstruction, Mid and Forefoot Reconstruction), Elbow (Biceps Tendon Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair (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 –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, Extra-capsular 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, Rotator 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/reconstructions, 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, Tendon transfers).
Indications –Titan Mini-Interference Screws: The Titan Mini-Interference Screws are intended to be used for fixation of tissue, including ligament or tendon to bone, or a bone/tendon to bone. The Mini-Interference 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, Illiotibial 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, Carpometalcarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, Tendon transfer in the hand/wrist, Lateral Epicondylitis repair).
Apollo Family: The Apollo Medial Suture Anchor, XT Suture Anchor, Lateral Anchor, and Labral Suture Anchor 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 Mini-Interference 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 (6AI4V) per ASTM F136, or PEEK (Zeniva ZA-500) per ASTM F2026 from Solvay Advanced Polymers.
Here's a breakdown of the requested information based on the provided text.
This document is a 510(k) premarket notification for a medical device called the "Apollo Suture Anchor System and Titan Screws." It's primarily concerned with demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a standalone study of its performance in a clinical setting against a gold standard.
Therefore, the typical acceptance criteria and study data associated with AI/software devices (e.g., sensitivity, specificity, clinical outcome measures) are not directly applicable or present in this type of regulatory submission. This submission focuses on demonstrating the device is as safe and effective as a previously cleared device.
However, I can extract the relevant information regarding performance testing that was done to support the safety and effectiveness for this type of device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Measured Performance) | Reported Device Performance (Reference Standard/Predicate) |
|---|---|
| Axial Pull-Out (comparison to predicate) | Confirmed that modifications did not introduce new risks when compared to the predicate device. |
| Insertion Torque (comparison to predicate) | Confirmed that modifications did not introduce new risks when compared to the predicate device. |
Explanation: The "acceptance criteria" here are not numerical thresholds for clinical performance or diagnostic accuracy. Instead, the acceptance criterion for this 510(k) submission is that the modified device performs comparably to the predicate device and that the modifications (adding a 3rd suture portal) do not introduce new risks. The reported device performance is that this comparison was confirmed through mechanical testing.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a number of devices or cases. The testing conducted was "Axial Pull-Out and Insertion Torque per ASTM F543-7 testing." ASTM F543-7 is a standard test method, but the specific number of samples tested by Valeris Medical is not provided in this summary.
- Data Provenance: Not applicable in the context of clinical data provenance (country of origin, retrospective/prospective). This refers to mechanical testing data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a surgical implant (suture anchor and screws). The "ground truth" for its performance is assessed via engineering and mechanical testing standards (ASTM F543-7) rather than expert consensus on medical images or clinical outcomes.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods are typically relevant for studies involving human interpretation or clinical outcomes. The testing here is mechanical.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This document does not describe an AI/software device or a clinical study involving human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluation in this context is established by validated mechanical testing standards (ASTM F543-7). This standard provides methods for determining the axial pull-out and insertion torque of metallic bone screws. The goal was to show that the modified device's performance aligned with these established standards and did not significantly differ from the predicate device.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/machine learning device that requires a training set.
Summary of the Study Discussed in the Document:
The study described is a performance testing study.
- Purpose: To confirm that a modification (addition of a 3rd suture portal) to the Apollo Suture Anchor System and Titan Screws did not introduce new risks compared to the predicate device.
- Methodology: Axial Pull-Out and Insertion Torque testing was conducted according to ASTM F543-7.
- Conclusion: The testing confirmed that the modification did not introduce any new risks, supporting the substantial equivalence of the subject device to the predicate device (K133036).
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 10, 2014
Valeris Medical % Ms. Cheryl Wagoner Principal Consultant Wagoner Consulting LLC P O Box 15729 Wilmington, North Carolina 28408
Re: K142230
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: August 8, 2014 Received: August 13, 2014
Dear Ms. Wagoner,
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, listing 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 of medical device-related
{1}------------------------------------------------
adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K142230
Device Name:
Apollo Suture Anchor System and Titan Screws
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 and Apollo XT Suture Anchors | |
|---|---|
| The Apollo Medial Suture Anchor and Apollo XT Suture Anchors are intended for: | |
| Shoulder | |
| Rotator Cuff Repair | |
| 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 | |
| Knee | |
| Medial Collateral Ligament Repair | |
| Lateral Collateral Ligament Repair | |
| Posterior Oblique Ligament Repair | |
| Illiotibial Band Tenodesis | |
| Elbow | |
| Biceps Tendon Reattachment | |
| Ulnar or Radial Collateral Ligament Reconstruction | |
| Hip | |
| Capsular Repair | |
| Acetabular Labral Repair | |
| Indications - Apollo Labral Suture Anchor | |
| Shoulder | |
| Rotator Cuff Repair | |
| Bankart Repair | |
| SLAP Lesion Repair | |
| Biceps Tenodesis | |
| Acromio-Clavicular Separation Repair | |
| Deltoid Repair | |
| Capsular Shift or Capsulolabral Reconstruction | |
| Indications - Apollo Lateral Anchor | |
| The Apollo Lateral Anchor is indicated for: | |
| Shoulder | |
| Rotator Cuff Repair | |
| Bankart Repair | |
| SLAP Lesion Repair | |
| Biceps Tenodesis | |
| Acromio-Clavicular Separation Repair | |
| Deltoid Repair | |
| Capsular Shift or Capsulolabral Reconstruction | |
| Wrist/Hand | |
| Scapholunate Ligament Reconstruction | |
| Ulnar/Radial Collateral Ligament Reconstruction | |
| Foot/Ankle | |
| Lateral Stabilization | |
| Medial Stabilization | |
| Achilles Tendon Repair/Reconstruction | |
| Hallux Valgus Reconstruction | |
| Mid and Forefoot Reconstruction | |
| Elbow | |
| Biceps Tendon Reconstruction | |
| Ulnar or Radial Collateral Ligament Reconstruction | |
| Lateral Epicondylitis Repair (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 |
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| Wrist | |
|---|---|
| [ Scapholunate Ligament Reconstruction | |
| Elbow | |
| Biceps Tendon Reattachment | |
| □ Ulnar or Radial Collateral Ligament Reconstruction | |
| Hip | |
| □ Capsular Repair | |
| ■ Acetabular Labra1 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 Medials Obliquus Muscle Advancement | |
| Indications -Interference Screws | Indications -Titan Mini-Interference Screws |
| The Titan Interference Screws are indicated for thereattachment of liqament, tendon, soft tissue, or bone to | The Titan Mini-Interference Screws are intended to beused for fixation of tissue, including ligament or tendon to |
| bone during cruciate ligament reconstruction surgeries of | bone, or a bone/tendon to bone. See below for specific |
| the knee. All screws with a diameter of 9 mm or less and a | indications. |
| length of 23 mm or less are also intended for the use in the | The Mini-Interference Screws are intended to provide soft |
| following procedures: | tissue reattachment (i.e. fixation of ligament and tendon |
| Knee | graft tissue).See below for specific indications. |
| ACL repairs | Shoulder |
| □ PCL repairs□ Extra-capsular repairs | □ Capsular stabilization |
| o Medial collateral ligament | o Bankart repair |
| o Lateral collateral ligament | o Anterior shoulder instability |
| o Posterior oblique ligament | o SLAP lesion repairs |
| □ Patellar realignment and tendon repairs | o Capsular shift of capsulolabral reconstructions |
| o Vastus medialis oliquous advancement | _ Acromioclavicular separation repairs |
| ■ Iliotibial band tenodes is | □ Deltoid repairs |
| ■ Rotator cuff tear repairs | |
| Shoulder□ Capsular stabilization | ■ Biceps tenodesis |
| o Bankart repair | Foot and Ankle |
| o Anterior shoulder instability | ■ Hallux valgus reconstruction |
| o SLAP lesion repairs | □ Medial stabilization |
| o Capsular shift of capsulolabral reconstructions | □ Lateral stabilization |
| □ Acromioclavicularseparation repairs | _ Achilles Tendon Repair |
| □ De ltoid re pairs | ■ Midfoot reconstructions |
| ■ Rotator cuff tear repairs | _ Metatarsal ligament repair |
| □ Biceps tenodesis | ■ Bunionectomy |
| ■ Flexor Hullucis Longus for Achilles Tendon | |
| Foot and Ankle | reconstruction |
| □ Hallux valgus repairs■ Medial or lateral instability repairs/reconstructions | □ Tendon transfers in the foot and ankle |
| □ Achilles tendon repairs/reconstructions | |
| Midfoot reconstructions | Knee |
| □ Metatars al ligament/tendon repairs/recons tructions | □ Medial Collateral Ligament Repair |
| ■ Bunionectomy | Lateral Collateral Ligament Repair |
| ■ Flexor Hullucis Longus | ■ Patellar Tendon Repair |
| □ Tendon transfers | □ Posterior Oblique Ligament Repair |
| Elbow, Wrist, and Hand | Illiotibial Band Tenodesis |
| □ Biceps tendon reattachment | Posterior Cruciate Ligament Repair |
| □ Ulnar or radial collateral ligament reconstructions | Elbow |
| ■ Lateralepicondylitis repair | _ Biceps tendon reattachmentUlnar or radial collateral ligament reconstruction |
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| □ Scapholunate ligament reconstruction□ Tendon transfers | Wrist and Hand□ Scapholunate Ligament Reconstruction□ Ulnar 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 |
|---|---|
| -------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
Prescription Use ________________________________________________(21 CFR 801 Subpart (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)
{5}------------------------------------------------
510(k) Summary
(as required by 21 CFR 807.92)
| Submitter | Valeris Medical |
|---|---|
| Address | 200 Cobb Pkwy NBuilding 200, Suite 210Marietta, GA 30062 |
| Telephone | 888-404-3980 Ext 101 |
| Fax | 678-669-2188 |
| Contact Person | Daniel LanoisGeneral Manager |
|---|---|
| Address | Valeris Medical200 Cobb Pkwy NBuilding 200, Suite 210Marietta, GA 30062 |
| Telephone | 888-404-3980 Ext 101 |
| Fax | 678-669-2188 |
| daniel@valerismedical.com |
Date Prepared August 8, 2014
| Trade Name | Apollo Suture Anchor System and Titan Screws |
|---|---|
| Common Name | Screw, Fixation, Bone |
| Panel Code | Orthopaedics/87 |
| Classification Name | Smooth or threaded metallic bone fixation fastener |
| Class | Class II |
| Regulation Number | 21 CFR 888.3040 |
| Product Code | MBI |
| Name of Predicate Device | 510(k) # | Manufacturer |
|---|---|---|
| Apollo Suture Anchor System and Titan Screws | K133036 | Amendia (transferred product to Valeris Medical) |
| Description | Apollo FamilyThe Apollo Medial Suture Anchor, XT Suture Anchor, Lateral Anchor, andLabral Suture Anchor are delivery systems for anchors for use in fixationof ligament, tendon, bone, or soft tissue to bone in knee, shoulder,foot/ankle, elbow, and hand/wrist procedures. These anchors consist ofcannulated anchors with integrated suture attachment or separate suturepunch eyelet. The Anchors are provided loaded on individual inserterswith and without integrated sutures, sterile, for single use only. | |
| Titan FamilyThe Titan Interference and Mini-Interference Screws are interferencescrews for use in fixation of ligament, tendon, bone, or soft tissue to bonein knee, shoulder, foot/ankle, elbow, and hand/wrist procedures. Thescrews are provided sterile, for single use only. | ||
| Screw and anchor implants are made from either a titanium alloy (6AI4V)per ASTM F136, or PEEK (Zeniva ZA-500) per ASTM F2026 fromSolvay Advanced Polymers. |
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| Indications andIntended Use | The Apollo Suture Anchors and Titan Screws are indicated for usein fixation of ligament, tendon, bone, or soft tissue to bone in knee,shoulder, foot/ankle, elbow, and hand/wrist procedures. Thescrews are intended for use in the following procedures: |
|---|---|
| --------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Indications - Apollo Medial Suture Anchor and Apollo XT Suture Anchors |
|---|
| The Apollo Medial Suture Anchor and Apollo XT Suture Anchors are intended for: |
| Shoulder | |
|---|---|
| ☐ Rotator Cuff Repair | |
| ☐ 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 | |
| Knee | |
| ☐ Medial Collateral Ligament Repair | |
| ☐ Lateral Collateral Ligament Repair | |
| ☐ Posterior Oblique Ligament Repair | |
| ☐ Illiotibial Band Tenodesis | |
| Elbow | |
| ☐ Biceps Tendon Reattachment | |
| ☐ Ulnar or Radial Collateral Ligament Reconstruction | |
| Hip | |
| ☐ Capsular Repair | |
| ☐ Acetabular Labral Repair |
| Indications - Apollo Lateral Anchor |
|---|
| The Apollo Lateral Anchor is indicated for: |
| Shoulder | |
|---|---|
| ☐ Rotator Cuff Repair | |
| ☐ Bankart Repair | |
| ☐ SLAP Lesion Repair | |
| ☐ Biceps Tenodesis | |
| ☐ Acromio-Clavicular Separation Repair | |
| ☐ Deltoid Repair | |
| ☐ Capsular Shift or Capsulolabral Reconstruction | |
| Wrist/Hand | |
| ☐ Scapholunate Ligament Reconstruction | |
| ☐ Ulnar/Radial Collateral Ligament Reconstruction | |
| Foot/Ankle | |
| ☐ Lateral Stabilization | |
| ☐ Medial Stabilization | |
| ☐ Achilles Tendon Repair/Reconstruction | |
| ☐ Hallux Valgus Reconstruction | |
| ☐ Mid and Forefoot Reconstruction | |
| Elbow | |
| ☐ Biceps Tendon Reconstruction | |
| ☐ Ulnar or Radial Collateral Ligament Reconstruction | |
| ☐ Lateral Epicondylitis Repair (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 Anchor |
|---|
| -------------------------------------------------- |
| Shoulder | |
|---|---|
| ☐ Rotator Cuff Repair | |
| ☐ Bankart Repair | |
| ☐ SLAP Lesion Repair | |
| ☐ Biceps Tenodesis | |
| ☐ Acromio-Clavicular Separation Repair | |
| ☐ Deltoid Repair | |
| ☐ Capsular Shift or Capsulolabral Reconstruction | |
| Wrist | |
| ☐ Scapholunate Ligament Reconstruction | |
| Elbow | |
| ☐ Biceps Tendon Reattachment | |
| ☐ Ulnar or Radial Collateral Ligament Reconstruction | |
| Hip | |
| ☐ Capsular Repair | |
| ☐ Acetabular Labral Repair |
{7}------------------------------------------------
| 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 –Titan Mini-Interference Screws | |
| The Titan Interference Screws are indicated for thereattachment of ligament, tendon, soft tissue, or bone to | The Titan Mini-Interference Screws are intended to beused for fixation of tissue, including ligament or tendon to | |
| bone during cruciate ligament reconstruction surgeries of | bone, or a bone/tendon to bone. See below for specific | |
| the knee. All screws with a diameter of 9 mm or less and a | indications. | |
| length of 23 mm or less are also intended for the use in the | The Mini-Interference Screws are intended to provide soft | |
| following procedures: | tissue reattachment (i.e. fixation of ligament and tendon | |
| Knee | graft tissue).See below for specific indications. | |
| ☐ ACL repairs | Shoulder | |
| ☐ PCL repairs | ☐ Capsular stabilization | |
| ☐ Extra-capsular repairs | o Bankart repair | |
| o Medial collateral ligament | o Anterior shoulder instability | |
| o Lateral collateral ligament | o SLAP lesion repairs | |
| o Posterior oblique ligament | o Capsular shift of capsulolabral reconstructions | |
| ☐ Patellar realignment and tendon repairs | ☐ Acromioclavicular separation repairs | |
| o Vastus medialis oliquous advancement | ☐ Deltoid repairs | |
| ☐ Iliotibial band tenodesis | ☐ Rotator cuff tear repairs | |
| Shoulder | ☐ Biceps tenodesis | |
| ☐ 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 | |
| ☐ Acromioclavicular separation repairs | ☐ Midfoot reconstructions | |
| ☐ Deltoid repairs | ☐ Metatarsal ligament repair | |
| ☐ Rotator cuff tear repairs | ☐ Bunionectomy | |
| ☐ Biceps tenodesis | ☐ Flexor Hullucis Longus for Achilles Tendonreconstruction | |
| Foot and Ankle | ☐ Tendon transfers in the foot and ankle | |
| ☐ Hallux valgus repairs | ||
| ☐ Medial or lateral instability repairs/reconstructions | Knee | |
| ☐ Achilles tendon repairs/reconstructions☐ Midfoot reconstructions | ☐ Medial Collateral Ligament Repair | |
| ☐ Metatarsal ligament/tendon repairs/reconstructions | ☐ Lateral Collateral Ligament Repair | |
| ☐ Bunionectomy | ☐ Patellar Tendon Repair | |
| ☐ Flexor Hullucis Longus | ☐ Posterior Oblique Ligament Repair | |
| ☐ Tendon transfers | ☐ Illiotibial Band Tenodesis | |
| Elbow, Wrist, and Hand | ☐ Posterior Cruciate Ligament Repair | |
| ☐ Biceps tendon reattachment | Elbow | |
| ☐ Ulnar or radial collateral ligament reconstructions | ☐ Biceps tendon reattachment | |
| ☐ Lateral epicondylitis repair | ☐ Ulnar or radial collateral ligament reconstruction | |
| ☐ Scapholunate ligament reconstruction | ||
| ☐ Tendon transfers | Wrist and Hand | |
| ☐ Scapholunate Ligament Reconstruction | ||
| ☐ Ulnar Collateral Ligament Reconstruction | ||
| ☐ Radial Collateral Ligament Reconstruction | ||
| ☐ Carpometalcarpal joint arthroplasty (basal thumb jointarthroplasty) | ||
| ☐ Carpal Ligament Reconstructions and repairs | ||
| ☐ Tendon transfer in the hand/wrist | ||
| ☐ Lateral Epicondylitis repair |
{8}------------------------------------------------
| TechnologicalCharacteristicsand SubstantialEquivalence | Documentation was provided to demonstrate that the Subject device, Apollo Suture Anchor System and Titan Screws is substantially equivalent to the Predicate Apollo Suture Anchor System and Titan Screws (K133036), The Subject device is substantially equivalent to the predicate device in intended use, indications for use, materials, technological characteristics, and labeling. |
|---|---|
| -------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Performance Data | Axial Pull-Out and Insertion Torque per ASTM F543-7 testing wereconducted to confirm that the modification to add a 3rd suture portal didnot introduce any new risk. |
|---|---|
| Conclusion | Based on the indications for use, technological characteristics, materials,and comparison to predicate devices, the Subject Apollo Suture AnchorSystem and Titan Screws has been shown to be substantially equivalentto legally marketed predicate devices, and is safe and effective for itsintended use. |
§ 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.