Apollo Suture Anchor System and Titan Screws
Device Facts
| Record ID | K142230 |
|---|---|
| Device Name | Apollo Suture Anchor System and Titan Screws |
| Applicant | Valeris Medical |
| Product Code | MBI · Orthopedic |
| Decision Date | Sep 10, 2014 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 888.3040 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
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: [List of specific procedures for Medial, XT, Labral, Lateral, Interference, and Mini-Interference anchors/screws].
Device Story
System comprises cannulated suture anchors and interference screws for soft tissue-to-bone fixation. Anchors/screws provided sterile, single-use, loaded on inserters. Used by orthopedic surgeons in clinical/OR settings for various joint repairs (knee, shoulder, foot/ankle, elbow, hand/wrist). Device provides mechanical fixation to facilitate healing; output is the physical stabilization of tissue. No AI/ML or software involved.
Clinical Evidence
Bench testing only. Axial pull-out and insertion torque testing per ASTM F543-7 conducted to validate the addition of a 3rd suture portal.
Technological Characteristics
Materials: Titanium alloy (6Al4V) per ASTM F136 or PEEK (Zeniva ZA-500) per ASTM F2026. Design: Cannulated anchors/screws with integrated suture attachment or separate punch eyelet. Sterilization: Sterile, single-use. No software or electronic components.
Indications for Use
Indicated for fixation of ligament, tendon, bone, or soft tissue to bone in knee, shoulder, foot/ankle, elbow, and hand/wrist procedures. Specific procedures include rotator cuff, Bankart, SLAP, biceps tenodesis, AC separation, deltoid, capsular, ligamentous, and tendon repairs/reconstructions, as well as bunionectomy and arthroplasty.
Regulatory Classification
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.
Predicate Devices
- Apollo Suture Anchor System and Titan Screws (K133036)
Submission Summary (Full Text)
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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 | |
| <div style="display:flex; align-items:center;"><input type="checkbox"/> Rotator Cuff Repair</div> | |
| <div style="display:flex; align-items:center;"><input type="checkbox"/> Bankart Repair</div> | |
| <div style="display:flex; align-items:center;"><input type="checkbox"/> SLAP Lesion Repair</div> | |
| <div style="display:flex; align-items:center;"><input type="checkbox"/> Biceps Tenodesis</div> | |
| <div style="display:flex; align-items:center;"><input type="checkbox"/> Acromio-Clavicular Separation Repair</div> | |
| <div style="display:flex; align-items:center;"><input type="checkbox"/> Deltoid Repair</div> | |
| <div style="display:flex; align-items:center;"><input type="checkbox"/> Capsular Shift or Capsulolabral Reconstruction</div> | |
| Foot/Ankle | |
| <div style="display:flex; align-items:center;"><input type="checkbox"/> Lateral Stabilization</div> | |
| <div style="display:flex; align-items:center;"><input type="checkbox"/> Medial Stabilization</div> | |
| <div style="display:flex; align-items:center;"><input type="checkbox"/> Achilles Tendon Repair</div> | |
| Knee | |
| <div style="display:flex; align-items:center;"><input type="checkbox"/> Medial Collateral Ligament Repair</div> | |
| <div style="display:flex; align-items:center;"><input type="checkbox"/> Lateral Collateral Ligament Repair</div> | |
| <div style="display:flex; align-items:center;"><input type="checkbox"/> Posterior Oblique Ligament Repair</div> | |
| <div style="display:flex; align-items:center;"><input type="checkbox"/> Illiotibial Band Tenodesis</div> | |
| Elbow | |
| <div style="display:flex; align-items:center;"><input type="checkbox"/> Biceps Tendon Reattachment</div> | |
| <div style="display:flex; align-items:center;"><input type="checkbox"/> Ulnar or Radial Collateral Ligament Reconstruction</div> | |
| Hip | |
| <div style="display:flex; align-items:center;"><input type="checkbox"/> Capsular Repair</div> | |
| <div style="display:flex; align-items:center;"><input type="checkbox"/> Acetabular Labral Repair</div> | |
| Indications - Apollo Labral Suture Anchor | |
| Shoulder | |
| <div style="display:flex; align-items:center;"><input type="checkbox"/> Rotator Cuff Repair</div> | |
| <div style="display:flex; align-items:center;"><input type="checkbox"/> Bankart Repair</div> | |
| <div style="display:flex; align-items:center;"><input type="checkbox"/> SLAP Lesion Repair</div> | |
| <div style="display:flex; align-items:center;"><input type="checkbox"/> Biceps Tenodesis</div> | |
| <div style="display:flex; align-items:center;"><input type="checkbox"/> Acromio-Clavicular Separation Repair</div> | |
| <div style="display:flex; align-items:center;"><input type="checkbox"/> Deltoid Repair</div> | |
| <div style="display:flex; align-items:center;"><input type="checkbox"/> Capsular Shift or Capsulolabral Reconstruction</div> | |
| Indications - Apollo Lateral Anchor | |
| The Apollo Lateral Anchor is indicated for: | |
| Shoulder | |
| <div style="display:flex; align-items:center;"><input type="checkbox"/> Rotator Cuff Repair</div> | |
| <div style="display:flex; align-items:center;"><input type="checkbox"/> Bankart Repair</div> | |
| <div style="display:flex; align-items:center;"><input type="checkbox"/> SLAP Lesion Repair</div> | |
| <div style="display:flex; align-items:center;"><input type="checkbox"/> Biceps Tenodesis</div> | |
| <div style="display:flex; align-items:center;"><input type="checkbox"/> Acromio-Clavicular Separation Repair</div> | |
| <div style="display:flex; align-items:center;"><input type="checkbox"/> Deltoid Repair</div> | |
| <div style="display:flex; align-items:center;"><input type="checkbox"/> Capsular Shift or Capsulolabral Reconstruction</div> | |
| Wrist/Hand | |
| <div style="display:flex; align-items:center;"><input type="checkbox"/> Scapholunate Ligament Reconstruction</div> | |
| <div style="display:flex; align-items:center;"><input type="checkbox"/> Ulnar/Radial Collateral Ligament Reconstruction</div> | |
| Foot/Ankle | |
| <div style="display:flex; align-items:center;"><input type="checkbox"/> Lateral Stabilization</div> | |
| <div style="display:flex; align-items:center;"><input type="checkbox"/> Medial Stabilization</div> | |
| <div style="display:flex; align-items:center;"><input type="checkbox"/> Achilles Tendon Repair/Reconstruction</div> | |
| <div style="display:flex; align-items:center;"><input type="checkbox"/> Hallux Valgus Reconstruction</div> | |
| <div style="display:flex; align-items:center;"><input type="checkbox"/> Mid and Forefoot Reconstruction</div> | |
| Elbow | |
| <div style="display:flex; align-items:center;"><input type="checkbox"/> Biceps Tendon Reconstruction</div> | |
| <div style="display:flex; align-items:center;"><input type="checkbox"/> Ulnar or Radial Collateral Ligament Reconstruction</div> | |
| <div style="display:flex; align-items:center;"><input type="checkbox"/> Lateral Epicondylitis Repair (PEEK Anchor Only)</div> | |
| Knee | |
| <div style="display:flex; align-items:center;"><input type="checkbox"/> Medial Collateral Ligament Repair</div> | |
| <div style="display:flex; align-items:center;"><input type="checkbox"/> Lateral Collateral Ligament Repair</div> | |
| <div style="display:flex; align-items:center;"><input type="checkbox"/> Posterior Oblique Ligament Repair</div> | |
| <div style="display:flex; align-items:center;"><input type="checkbox"/> Joint Capsule Closure</div> | |
| <div style="display:flex; align-items:center;"><input type="checkbox"/> Iliotibial Band Tenodesis</div> | |
| <div style="display:flex; align-items:center;"><input type="checkbox"/> Patellar Ligament/Tendon Repair</div> | |
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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 the<br>reattachment of liqament, tendon, soft tissue, or bone to | The Titan Mini-Interference Screws are intended to be<br>used 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).<br>See below for specific indications. |
| ACL repairs | Shoulder |
| □ PCL repairs<br>□ 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<br>□ 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<br>■ 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 reattachment<br>Ulnar or radial collateral ligament reconstruction |
| | |
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| □ Scapholunate ligament reconstruction<br>□ Tendon transfers | <b>Wrist and Hand</b><br>□ Scapholunate Ligament Reconstruction<br>□ Ulnar Collateral Ligament Reconstruction<br>□ Radial Collateral Ligament Reconstruction<br>□ Carpometalcarpal joint arthroplasty (basal thumb joint arthroplasty)<br>□ Carpal Ligament Reconstructions and repairs<br>□ Tendon transfer in the hand/wrist<br>□ 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)
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### 510(k) Summary
#### (as required by 21 CFR 807.92)
| Submitter | Valeris Medical |
|-----------|------------------------------------------------------------------|
| Address | 200 Cobb Pkwy N<br>Building 200, Suite 210<br>Marietta, GA 30062 |
| Telephone | 888-404-3980 Ext 101 |
| Fax | 678-669-2188 |
| Contact Person | Daniel Lanois<br>General Manager |
|----------------|-------------------------------------------------------------------------------------|
| Address | Valeris Medical<br>200 Cobb Pkwy N<br>Building 200, Suite 210<br>Marietta, GA 30062 |
| Telephone | 888-404-3980 Ext 101 |
| Fax | 678-669-2188 |
| email | 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 Family<br>The Apollo Medial Suture Anchor, XT Suture Anchor, Lateral Anchor, and<br>Labral Suture Anchor are delivery systems for anchors for use in fixation<br>of ligament, tendon, bone, or soft tissue to bone in knee, shoulder,<br>foot/ankle, elbow, and hand/wrist procedures. These anchors consist of<br>cannulated anchors with integrated suture attachment or separate suture<br>punch eyelet. The Anchors are provided loaded on individual inserters<br>with and without integrated sutures, sterile, for single use only. | |
| | Titan Family<br>The Titan Interference and Mini-Interference Screws are interference<br>screws for use in fixation of ligament, tendon, bone, or soft tissue to bone<br>in knee, shoulder, foot/ankle, elbow, and hand/wrist procedures. The<br>screws are provided sterile, for single use only. | |
| | Screw and anchor implants are made from either a titanium alloy (6AI4V)<br>per ASTM F136, or PEEK (Zeniva ZA-500) per ASTM F2026 from<br>Solvay Advanced Polymers. | |
{6}------------------------------------------------
| Indications and<br>Intended Use | The Apollo Suture Anchors and Titan Screws are indicated for use<br>in fixation of ligament, tendon, bone, or soft tissue to bone in knee,<br>shoulder, foot/ankle, elbow, and hand/wrist procedures. The<br>screws are intended for use in the following procedures: |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <b>Indications - Apollo Medial Suture Anchor and Apollo XT Suture Anchors</b> |
|--------------------------------------------------------------------------------|
| The Apollo Medial Suture Anchor and Apollo XT Suture Anchors are intended for: |
| <b>Shoulder</b> | |
|------------------------------------------------------|--|
| ☐ Rotator Cuff Repair | |
| ☐ Bankart Repair | |
| ☐ SLAP Lesion Repair | |
| ☐ Biceps Tenodesis | |
| ☐ Acromio-Clavicular Separation Repair | |
| ☐ Deltoid Repair | |
| ☐ Capsular Shift or Capsulolabral Reconstruction | |
| <b>Foot/Ankle</b> | |
| ☐ Lateral Stabilization | |
| ☐ Medial Stabilization | |
| ☐ Achilles Tendon Repair | |
| <b>Knee</b> | |
| ☐ Medial Collateral Ligament Repair | |
| ☐ Lateral Collateral Ligament Repair | |
| ☐ Posterior Oblique Ligament Repair | |
| ☐ Illiotibial Band Tenodesis | |
| <b>Elbow</b> | |
| ☐ Biceps Tendon Reattachment | |
| ☐ Ulnar or Radial Collateral Ligament Reconstruction | |
| <b>Hip</b> | |
| ☐ Capsular Repair | |
| ☐ Acetabular Labral Repair | |
| <b>Indications - Apollo Lateral Anchor</b> |
|---------------------------------------------|
| The Apollo Lateral Anchor is indicated for: |
| <b>Shoulder</b> | |
|------------------------------------------------------|--|
| ☐ Rotator Cuff Repair | |
| ☐ Bankart Repair | |
| ☐ SLAP Lesion Repair | |
| ☐ Biceps Tenodesis | |
| ☐ Acromio-Clavicular Separation Repair | |
| ☐ Deltoid Repair | |
| ☐ Capsular Shift or Capsulolabral Reconstruction | |
| <b>Wrist/Hand</b> | |
| ☐ Scapholunate Ligament Reconstruction | |
| ☐ Ulnar/Radial Collateral Ligament Reconstruction | |
| <b>Foot/Ankle</b> | |
| ☐ Lateral Stabilization | |
| ☐ Medial Stabilization | |
| ☐ Achilles Tendon Repair/Reconstruction | |
| ☐ Hallux Valgus Reconstruction | |
| ☐ Mid and Forefoot Reconstruction | |
| <b>Elbow</b> | |
| ☐ Biceps Tendon Reconstruction | |
| ☐ Ulnar or Radial Collateral Ligament Reconstruction | |
| ☐ Lateral Epicondylitis Repair (PEEK Anchor Only) | |
| <b>Knee</b> | |
| ☐ Medial Collateral Ligament Repair | |
| ☐ Lateral Collateral Ligament Repair | |
| ☐ Posterior Oblique Ligament Repair | |
| ☐ Joint Capsule Closure | |
| ☐ Iliotibial Band Tenodesis | |
| ☐ Patellar Ligament/Tendon Repair | |
| <b>Indications - Apollo Labral Suture Anchor</b> |
|--------------------------------------------------|
|--------------------------------------------------|
| <b>Shoulder</b> | |
|------------------------------------------------------|--|
| ☐ Rotator Cuff Repair | |
| ☐ Bankart Repair | |
| ☐ SLAP Lesion Repair | |
| ☐ Biceps Tenodesis | |
| ☐ Acromio-Clavicular Separation Repair | |
| ☐ Deltoid Repair | |
| ☐ Capsular Shift or Capsulolabral Reconstruction | |
| <b>Wrist</b> | |
| ☐ Scapholunate Ligament Reconstruction | |
| <b>Elbow</b> | |
| ☐ Biceps Tendon Reattachment | |
| ☐ Ulnar or Radial Collateral Ligament Reconstruction | |
| <b>Hip</b> | |
| ☐ 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 | | |
| <b>Indications –Interference Screws</b> | | <b>Indications –Titan Mini-Interference Screws</b> |
| The Titan Interference Screws are indicated for the<br>reattachment of ligament, tendon, soft tissue, or bone to | | The Titan Mini-Interference Screws are intended to be<br>used 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).<br>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 Tendon<br>reconstruction |
| Foot and Ankle | | ☐ Tendon transfers in the foot and ankle |
| ☐ Hallux valgus repairs | | |
| ☐ Medial or lateral instability repairs/reconstructions | | Knee |
| ☐ Achilles tendon repairs/reconstructions<br>☐ 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 joint<br>arthroplasty) |
| | | ☐ Carpal Ligament Reconstructions and repairs |
| | | ☐ Tendon transfer in the hand/wrist |
| | | ☐ Lateral Epicondylitis repair |
{8}------------------------------------------------
| Technological<br>Characteristics<br>and Substantial<br>Equivalence | 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. |
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| Performance Data | Axial Pull-Out and Insertion Torque per ASTM F543-7 testing were<br>conducted to confirm that the modification to add a 3rd suture portal did<br>not introduce any new risk. |
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| Conclusion | Based on the indications for use, technological characteristics, materials,<br>and comparison to predicate devices, the Subject Apollo Suture Anchor<br>System and Titan Screws has been shown to be substantially equivalent<br>to legally marketed predicate devices, and is safe and effective for its<br>intended use. |
