(28 days)
Not Found
No
The device description and intended use are for physical implants (suture anchors and screws) and their delivery systems, with no mention of software, data processing, or AI/ML capabilities. The performance studies are mechanical tests.
Yes.
This device is designed for the fixation of biological tissues (ligament, tendon, bone, or soft tissue) to bone, which directly addresses and corrects physiological issues, thereby providing therapeutic benefits.
No
The device, consisting of suture anchors and screws, is intended for the fixation of ligament, tendon, bone, or soft tissue to bone, which is a therapeutic and reconstructive purpose, not for diagnosing conditions.
No
The device description clearly states that the devices are physical implants (suture anchors and screws) made from titanium alloy or PEEK, and are provided sterile for single use. This indicates a hardware medical device, not a software-only one.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description and intended use clearly state that the Apollo Suture Anchors and Titan Screws are surgical implants used for the fixation of tissues (ligament, tendon, bone, soft tissue) to bone during various orthopedic procedures. They are physically implanted into the body.
The device's function is mechanical fixation within the body, not the analysis of biological samples outside the body.
N/A
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 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
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
Extra-capsular repairs
o Medial collateral ligament
o Lateral collateral ligament
o Posterior oblique ligament
Patellar realignment and tendon repairs
o Vastus medialis oliquous advancement
Iliotibial band tenodesis
Shoulder
Capsular stabilization
o Bankart repair
o Anterior shoulder instability
o SLAP lesion repairs
o 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. See below for specific indications.
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
o Bankart repair
o Anterior shoulder instability
o SLAP lesion repairs
o 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
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee, shoulder, foot/ankle, elbow, hand/wrist, Hip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Axial Pull-Out and Insertion Torque per ASTM F543-7 testing were conducted to confirm that the modification to add a 3rd suture portal did not introduce any new risk.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
2
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 |
3
| 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 | |
| reattachment of liqament, tendon, soft tissue, or bone to | The Titan Mini-Interference Screws are intended to be |
| 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). |
| 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 reattachment |
| Ulnar or radial collateral ligament reconstruction | |
4
| □ 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 N |
| Building 200, Suite 210 | |
| Marietta, GA 30062 | |
| Telephone | 888-404-3980 Ext 101 |
| Fax | 678-669-2188 |
| Contact Person | Daniel Lanois
General Manager |
|----------------|-------------------------------------------------------------------------------------|
| Address | Valeris Medical
200 Cobb Pkwy N
Building 200, Suite 210
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 | |
| 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. |
6
| Indications and
Intended 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 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 the | ||
| reattachment of ligament, tendon, soft tissue, or bone to | The Titan Mini-Interference Screws are intended to be | |
| 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). | |
| 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 | |
| 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 | ||
| ☐ 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 | ||
| arthroplasty) | ||
| ☐ Carpal Ligament Reconstructions and repairs | ||
| ☐ Tendon transfer in the hand/wrist | ||
| ☐ Lateral Epicondylitis repair |
8
| Technological
Characteristics
and Substantial
| 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. |
|---|---|
| -------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Performance Data | Axial Pull-Out and Insertion Torque per ASTM F543-7 testing were
conducted to confirm that the modification to add a 3rd suture portal did
not introduce any new risk. |
|------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion | Based on the indications for use, technological characteristics, materials,
and comparison to predicate devices, the Subject Apollo Suture Anchor
System and Titan Screws has been shown to be substantially equivalent
to legally marketed predicate devices, and is safe and effective for its
intended use. |