(161 days)
Not Found
No
The device description and intended use are solely focused on the physical components (suture anchors and screws) and their surgical application for tissue fixation. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device, consisting of suture anchors and screws, is used for fixation of ligament, tendon, bone, or soft tissue to bone in various surgical procedures, which directly addresses medical conditions and aims to restore function or treat injury.
No
This device is described as an implantable screw and anchor system for the fixation of ligament, tendon, bone, or soft tissue to bone, primarily used in orthopedic surgical procedures. Its intended use is therapeutic (fixation), not diagnostic.
No
The device description clearly states that the device consists of physical components: "cannulated anchors with integrated suture attachment or separate suture punch eyelet" and "interference screws". These are hardware components, not software.
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 taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Description: The description clearly states that the Apollo Suture Anchors and Titan Screws are implants made from titanium alloy or PEEK. They are used for the fixation of tissues like ligament, tendon, bone, or soft tissue to bone during surgical procedures. This is a direct surgical intervention within the body.
- Intended Use/Indications for Use: The indications list various surgical procedures in specific anatomical locations (knee, shoulder, foot/ankle, etc.) where these implants are used to repair or reconstruct damaged tissues. This is a therapeutic use, not a diagnostic one.
The device is a surgical implant used for structural support and fixation within the body, which falls under the category of medical devices, but not specifically In Vitro Diagnostic devices.
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
The Apollo Medial Suture Anchor is intended for:
Shoulder
Rotator Cuff Repair
Bankart Repair
SLAP Lesion Repair
Biceps Tenodesis
AcormieClavicular Separation Repair
Deltoid Repair
Capisular Shift or Capsulolabral Reconstruction
Foot/Ankle
Lateral Stabilization
Medial Stabilizatio
Achilles Tendon Repair
Knee
Medial Collateral Ligament Repair
Lateral Collateral Ligament Repair
Posterior Oblique Ligament Repair
Iliotibial Band Tenodesis
Elbow
Biceps Tendon Reattachment
Ulnar or Radial Collateral Ligament Reconstruction
Hip
Capsular Repair
Acetabular Labral Repair
Indications - Apollo Lateral Anchor
The Apollo Lateral Anchor is Indicated for:
Shoulder
Rotator Cuff Repair
Bankart Repair
SLAP Lesion Repair
Biceps Tenodesis
AcormieClavicular Separation Repair
Deltoid Repair
Capisular Shift or Capsulolabral Reconstruction
Wrist/Hand
Scapholunate Ligament Reconstruction
Ulnar/Radial Collateral Ligament Reconstruction
Foot/Ankle
Lateral Stabilization
Medial Stabilizatio
Achilles Tendon Repair/Reconstruction
Hallux Valgus Reconstruction
Midland Forefoot Reconstruction
Elbow
Biceps Tendon Reconstruction
Ulnar or Radial Collateral Ligament Reconstruction
Lateral Epicondylitis Repai(PEEK Anchor Only)
Knee
Medial Collateral Ligament Repair
Lateral Collateral Ligament Repair
Posterior Oblique Ligament Repair
Joint Capsule Closure
Iliotibial Band Tenodesis
Patellar Ligament/Tendon Repair
Indications - Apollo Labral Suture Tac Shoulder
Rotator Cuff Repair
Bankart Repair
SLAP Lesion Repair
Biceps Tenodesis
Acromioclavicular Separation Repair
Deltoid Repair
Capisular Shift or Capsulolabral Reconstruction
Wrist
Scapholunate Ligament Reconstruction
Elbow
Biceps Tendon Reattachment
Ulnar or Radial Collateral ligament Reonstruction
Hip
Capsular Repair
Acetabular Labral Repair
Knee
Extracapsular Repair
Medial Collateral Ligament Repair
Lateral Collateral Ligament Repair
Posterior Oblique Ligament Repair
Joint Capsule Closure
Iliotibial Band Tenodesis Reconstruction
Patellar ligament/Tendon Repair
Vastus Medias Obliquus Muscle Advancement
Indications -Interference Screws
The Titan Interference Screws are indicated for the reattachment of ligament, tendon, soft tissue, or bone to bone during cruciate ligament reconstruction surgeries of the knee.
All screws with a diameter of 9 mm or less and a length of 23 mm or less are also intended for the use in the following procedures:
Knee
ACL repairs
PCL repairs
Extracapsular repairs
Medial collateral ligament
Lateral collateral ligament
Posterior oblique ligament
Patellar realignment and tendon repairs
Vastus medialis oliquous advancement
Iliotibial band tenodesis
Shoulder
Capsular stabilization
Bankart repair
Anterior shoulder instability
SLAP lesion repairs
Capsular shift of capsulolabral reconstructions
Acromioclavicular separationrepairs
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/reconstruions
Bunionectomy
Flexor Hullucis Longus
Tendon transfers
Elbow, Wrist, and Hand
Biceps tendon reattachment
Ulnar or radial collateral ligament reconstructions
Lateral epicondylitis repair
Scapholunate ligament reconstruction
Tendo transfers
Indications -Tenodesis Screws
The Titan Tenodesis Screws are intended to be used for fixation of tissue, including ligament or tendon to bone, or a bone/tendon to bone. See below for specific indications.
The Tenodesis Screws are intended to provide soft tissue reattachment (i.e. fixation of ligament and tendon graft tissue). See below for specific indications.
Shoulder
Capsular stabilization
Bankart repair
Anterior shoulder instability
SLAP lesion repairs
Capsular shift of capsulolabral reconstructions
Acromioclavicular separation repairs
Deltoid repairs
Rotator cuff tear repairs
Biceps tenodesis
Foot and Ankle
Hallux valgus reconstruction
Medial stabilization
Lateral stabilization
Achilles Tendon Repair
Midfoot reconstructions
Metatarsal ligament repair
Bunionectomy
Flexor Hullucis Longus for Achilles Tendon reconstruction
Tendon transfers in the foot and ankle
Knee
Medial Collateral Ligament Repair
Lateral Collateral Ligament Repair
Patellar Tendon Repair
Posterior Oblique Ligament Repair
Iliotibial Band Tenodesis
Posterior Cruciate Ligament Repair
Elbow
Biceps tendon reattachment
Ulnar or radial collateral ligament reconstruction
Wrist and Hand
Scapholunate Ligament Reconstruction
Ulnar Collateral Ligament Reconstruction
Radial Collateral Ligament Reconstruction
Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)
Carpal Ligament Reconstructions and repairs
Tendon transfer irthe hand/wrist
Lateral Epicondylitis repair
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The Apollo Medial Suture Anchor, Lateral Anchor, and Suture Tac Delivery Systems are delivery systems for anchors for use in fixation of ligament, tendon, bone, or soft tissue to bone in knee, shoulder, foot/ankle, elbow, and hand/wrist procedures. These anchors consist of cannulated anchors with integrated suture attachment or separate suture punch eyelet. The Anchors are provided loaded on individual inserters with and without integrated sutures, sterile, for single use only.
The Titan Interference and Tenodesis Screws are interference screws for use in fixation of ligament, tendon, bone, or soft tissue to bone in knee, shoulder, foot/ankle, elbow, and hand/wrist procedures. The screws are provided sterile, for single use only.
Screw and anchor implants are made from either a titanium alloy (6Al4V) per ASTM F136, or PEEK (Zeniva ZA-500) per ASTM F2026 from Solvay Advanced Polymers.
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)
Performance testing included axial pullout, axial push out, insertion torque, and torque to failure tests per ASTM F543-07. Side-by-side testing to predicate devices was completed with test results demonstrating that the Apollo Suture Anchor System and Titan Screws are substantially equivalent to the predicate devices.
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.
K083635, K120449, K071569, K060693, K041356
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
510(k) SUMMARY Amendia's Apollo Suture Anchor and Titan Screws
| Date: | September 11, 2013 |
|---|---|
| Contact: | Daniel Lanois, General Manager |
| Trade Name: | Apollo Suture Anchor System and Titan Screws |
| Common Name: | Screw, Fixation, Bone |
| Product Class: | Class II |
| Classification: | 21 CFR §888.3040 - Smooth or threaded metallic bone fixation |
| fastener | |
| Product Code: | MBI |
| Panel Code: | 87 |
Name/Address of Sponsor
Amendia, LLC 1755 West Oak Pkwy Marietta, GA 30062 770-575-5200
Purpose:
The purpose of this submission is clearance of the Apollo Suture Anchor System and Titan Screws as a new medical device that is substantially equivalent to the predicate device.
Device Description
Apollo Family
The Apollo Medial Suture Anchor, Lateral Anchor, and Suture Tac Delivery Systems are delivery systems for anchors for use in fixation of ligament, tendon, bone, or soft tissue to bone in knee, shoulder, foot/ankle, elbow, and hand/wrist procedures. These anchors consist of cannulated anchors with integrated suture attachment or separate suture punch eyelet. The Anchors are provided loaded on individual inserters with and without integrated sutures, sterile, for single use only.
Titan Family
The Titan Interference and Tenodesis Screws are interference screws for use in fixation of ligament, tendon, bone, or soft tissue to bone in knee, shoulder, foot/ankle, elbow, and hand/wrist procedures. The screws are provided sterile, for single use only.
Screw and anchor implants are made from either a titanium alloy (6Al4V) per ASTM F136, or PEEK (Zeniva ZA-500) per ASTM F2026 from Solvay Advanced Polymers.
1
Predicate Device
The Apollo Suture Anchor System and Titan Screws are substantially equivalent to Smith and Nephew Biosure PK Interference Screw (K083635), the DePuy Mitek Healix PEEK Anchor (K120449), the Biomet PEEK Allthread Knotless Suture Anchor and Hitch PEEK Anchor (K071569 and K060693), and the Arthrex Tenodesis Screw (K041356).
Intended Use / Indications for Use
The Apollo Suture Anchors and Titan Screws are indicated for use in fixation of ligament, tendon, bone, or soft tissue to bone in knee, shoulder, foot/ankle, elbow, and hand/wrist procedures. The screws are intended for use in the following procedures:
| Indications - Apollo Medial Suture Anchor | Indications - Apollo Lateral Anchor |
|---|---|
| The Apollo Medial Suture Anchor is intended for: | The Apollo Lateral Anchor is indicated for: |
| Shoulder | Shoulder |
| Rotator Cuff Repair | Rotator Cuff Repair |
| Bankart Repair | Bankart Repair |
| SLAP Lesion Repair | SLAP Lesion Repair |
| Biceps Tenodesis | Biceps Tenodesis |
| AcormieClavicular Separation Repair | AcormieClavicular Separation Repair |
| Deltoid Repair | Deltoid Repair |
| Capisular Shift or Capsulolabral Reconstruction | Capisular Shift or Capsulolabral Reconstruction |
| Foot/Ankle | Wrist/Hand |
| Lateral Stabilization | Scapholunate Ligament Reconstruction |
| Medial Stabilization | Ulnar/Radial Collateral Ligament Reconstruction |
| Achilles Tendon Repair | |
| Knee | Foot/Ankle |
| Medial Collateral Ligament Repair | Lateral Stabilization |
| Lateral Collateral Ligament Repair | Medial Stabilization |
| Posterior Oblige Ligament Repair | Achilles Tendon Repair/Reconstruction |
| Illiotibial Band Tenodesis | Hallux Valgus Reconstruction |
| Elbow | Midand Forefoot Reconstruction |
| Biceps Tendon Reattachment | Elbow |
| • Ulnar or Radial Collateral Ligament Reconstruction | Biceps Tendon Reconstruction |
| Hip | Ulnar or Radial Collateral Ligament Reconstruction |
| Capsular Repair | Lateral Epicondylitis Repair (PEEK Anchor Only) |
| Acetabular Labral Repair | Knee |
| Medial Collateral Ligament Repair | |
| Lateral Collateral Ligament Repair | |
| Posterior Oblique Ligament Repair | |
| Joint Capsule Closure | |
| Iliotibial Band Tenodesis | |
| Patellar Ligament/Tendon Repair |
Indications - Apollo Labral Suture Tac Shoulder
Rotator Cuff Repair
Bankart Repair
SLAP Lesion Repair
2
| ☐ Biceps Tenodesis | |
|---|---|
| ☐ Acromioclavicular Separation Repair | |
| ☐ Deltoid Repair | |
| ☐ Capisular Shift or Capsulolabral Reconstruction | |
| Wrist | |
| ☐ Scapholunate Ligament Reconstruction | |
| Elbow | |
| ☐ Biceps Tendon Reattachment | |
| ☐ Ulnar or Radial Collateral ligament Reonstruction | |
| Hip | |
| ☐ Capsular Repair | |
| ☐ Acetabular Labral Repair | |
| Knee | |
| ☐ Extracapsular Repair | |
| ☐ Medial Collateral Ligament Repair | |
| ☐ Lateral Collateral Ligament Repair | |
| ☐ Posterior Oblique Ligament Repair | |
| ☐ Joint Capsule Closure | |
| ☐ Iliotibial Band Tenodesis Reconstruction | |
| ☐ Patellar Ligament/Tendon Repair | |
| ☐ Vastus Medias Obliquus Muscle Advancement | |
| Indications -Interference Screws | Indications -Tenodesis Screws |
| The Titan Interference Screws are indicated for the | The Titan Tenodesis Screws are intended to be used for fixation |
| reattachment of ligament, tendon, soft tissue, or bone to bone | of tissue, including ligament or tendon to bone, or a |
| during cruciate ligament reconstruction surgeries of the knee. | bone/tendon to bone. See below for specific indications. |
| All screws with a diameter of 9 mm or less and a length of 23 | |
| mm or less are also intended for the use in the following | The Tenodesis Screws are intended to provide soft tissue |
| reattachment (i.e. fixation of ligament and tendon graft tissue). | |
| procedures: | See below for specific indications. |
| Knee | Shoulder |
| ☐ ACL repairs | ☐ Capsular stabilization |
| ☐ PCL repairs | o Bankart repair |
| o Extracapsular repairs | o Anterior shoulder instability |
| o Medial collateral ligament | o SLAP lesion repairs |
| o Lateral collateral ligament | o Capsular shift of capsulolabral reconstructions |
| o Posterior oblique ligament | ☐ Acromioclavicular separation repairs |
| o Patellar realignment and tendon repairs | ☐ Deltoid repairs |
| o Vastus medialis oliquous advancement | ☐ Rotator cuff tear repairs |
| ☐ Iliotibial band tenodesis | ☐ Biceps tenodesis |
| Shoulder | |
| ☐ Capsular stabilization | Foot and Ankle |
| o Bankart repair | ☐ Hallux valgus reconstruction |
| o Anterior shoulder instability | ☐ Medial stabilization |
| o SLAP lesion repairs | ☐ Lateral stabilization |
| o Capsular shift of capsulolabral reconstructions | ☐ Achilles Tendon Repair |
| o Acromioclavicular separationrepairs | ☐ Midfoot reconstructions |
| ☐ Deltoid repairs | ☐ Metatarsal ligament repair |
| ☐ Rotator cuff tear repairs | ☐ Bunionectomy |
| ☐ Biceps tenodesis | ☐ Flexor Hullucis Longus for Achilles Tendon reconstruction |
| ☐ Tendon transfers in the foot and ankle | |
| Foot and Ankle | |
| ☐ Hallux valgus repairs | |
| ☐ Medial or lateral instability repairs/reconstructions | Knee |
| ☐ Achilles tendon repairs/reconstructions | ☐ Medial Collateral Ligament Repair |
| ☐ Lateral Collateral Ligament Repair | |
| ☐ Midfoot reconstructions |
3
| ☐ Metatarsal ligament/tendon repairs/reconstructions | ☐ Patellar Tendon Repair |
|---|---|
| ☐ Bunionectomy | ☐ Posterior Oblique Ligament Repair |
| ☐ Flexor Hullucis Longus | ☐ Iliotibial Band Tenodesis |
| ☐ Tendon transfers | ☐ Posterior Cruciate Ligament Repair |
| Elbow, Wrist, and Hand | Elbow |
| ☐ Biceps tendon reattachment | ☐ Biceps tendon reattachment |
| ☐ Ulnar or radial collateral ligament reconstructions | ☐ Ulnar or radial collateral ligament reconstruction |
| ☐ Lateral epicondylitis repair | |
| ☐ Scapholunate ligament reconstruction | Wrist and Hand |
| ☐ Tendon transfers | ☐ Scapholunate Ligament Reconstruction |
| ☐ Thar Collateral Ligament Reconstruction | |
| ☐ Radial Collateral ligament Reconstruction | |
| ☐ Carpometalcarpal joint arthroplasty (basal thumb joint arthroplasty) | |
| ☐ Carpal Ligament Reconstructions and repairs | |
| ☐ Tendon transfer in the hand/wrist | |
| ☐ Lateral Epicondylitis repair |
Performance Data:
Performance testing included axial pullout, axial push out, insertion torque, and torque to failure tests per ASTM F543-07. Side-by-side testing to predicate devices was completed with test results demonstrating that the Apollo Suture Anchor System and Titan Screws are substantially equivalent to the predicate devices.
Summary:
The Apollo Suture Anchor System and Titan Screws are substantially equivalent to the predicate devices in regards to:
- . Indications for Use
- . Materials
- Mechanism of action . .
- . Dimensions
There are no significant differences in technological characteristics compared to the predicate device that would raise any new types of safety or efficacy issues.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 6, 2014
Amendia, LLC % Dr. Richard Jansen, Pharm. D. President Silver Pine Consulting 13540 Guild Ave. Apple Valley, Minnesota 55124
Re: K133036
Trade/Device Name: Apollo Suture Anchor System and Titan Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: January 17, 2014 Received: February 14, 2014
Dear Dr. Jansen,
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading,
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
5
Page 2 - Dr. Richard Jansen
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Vincen詞Devlin -S
- for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use Statement
510(k) Number (if known): K133036 Device Name: Apollo Suture Anchor System and Titan Screws
Intended Use / Indications for Use
The Apollo Suture Anchors and Titan Screws are indicated for use in fixation of ligament, tendon, bone, or soft tissue to bone in knee, shoulder, foot/ankle, elbow, and hand/wrist procedures. The screws are intended for use in the following procedures:
| Indications - Apollo Medial Suture Anchor
The Apollo Medial Suture Anchor is intended for:
Shoulder
☐ Rotator Cuff Repair
☐ Bankart Repair
☐ SLAP Lesion Repair
☐ Biceps Tenodesis
☐ AcormieClavicular Separation Repair
☐ Deltoid Repair
☐ Capisular Shift or Capsulolabral Reconstruction
Foot/Ankle
☐ Lateral Stabilization
☐ Medial Stabilizatio
☐ Achilles Tendon Repair
Knee
☐ Medial Collateral Ligament Repair
☐ Lateral Collateral Ligament Repair
☐ Posterior Oblique Ligament Repair
☐ Iliotibial Band Tenodesis
Elbow
☐ Biceps Tendon Reattachment
• Ulnar or Radial Collateral Ligament Reconstruction
Hip
☐ Capsular Repair
☐ Acetabular Labral Repair | Indications - Apollo Lateral Anchor
The Apollo Lateral Anchor is Indicated for:
Shoulder
☐ Rotator Cuff Repair
☐ Bankart Repair
☐ SLAP Lesion Repair
☐ Biceps Tenodesis
☐ AcormieClavicular Separation Repair
☐ Deltoid Repair
☐ Capisular Shift or Capsulolabral Reconstruction
Wrist/Hand
☐ Scapholunate Ligament Reconstruction
☐ Ulnar/Radial Collateral Ligament Reconstruction
Foot/Ankle
☐ Lateral Stabilization
☐ Medial Stabilizatio
☐ Achilles Tendon Repair/Reconstruction
☐ Hallux Valgus Reconstruction
☐ Midland Forefoot Reconstruction
Elbow
☐ Biceps Tendon Reconstruction
☐ Ulnar or Radial Collateral Ligament Reconstruction
☐ Lateral Epicondylitis Repai(PEEK Anchor Only)
Knee
☐ Medial Collateral Ligament Repair
☐ Lateral Collateral Ligament Repair
☐ Posterior Oblique Ligament Repair
☐ Joint Capsule Closure
☐ Iliotibial Band Tenodesis
☐ Patellar Ligament/Tendon Repair |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications - Apollo Labral Suture Tac Shoulder
☐ Rotator Cuff Repair
☐ Bankart Repair
☐ SLAP Lesion Repair
☐ Biceps Tenodesis
☐ AcormieClavicular Separation Repair
☐ Deltoid Repair
☐ Capisular Shift or Capsulolabral Reconstruction
Wrist
☐ Scapholunate Ligament Reconstruction
Elbow
☐ Biceps Tendon Reattachment
☐ Ulnar or Radial Collateral Ligament Reconstruction
Hip
☐ Capsular Repair
☐ Acetabular Labral Repair | |
7
КІЗЗОЗЕ
| Knee | |
|---|---|
| Extracapsular Repair | |
| Medial Collateral Ligament Repair | |
| Lateral Collateral Ligament Repair | |
| Posterior Oblique Ligament Repair | |
| Joint Capsule Closure | |
| Iliotibial Band Tenodesis Reconstruction | |
| Patellar ligament/Tendon Repair | |
| Vastus Medialis Obliquus Muscle Advancement | |
| Indications – Interference Screws | Indications – Tenodesis Screws |
| The Titan Interference Screws are indicated for the | The Titan Tenodesis Screws are intended to be used for fixation |
| reattachment of ligament, tendon, soft tissue, or bone to bone | of tissue, including ligament or tendon to bone, or a |
| during cruciate ligament reconstruction surgeries of the knee. | bone/tendon to bone. See below for specific indications. |
| All screws with a diameter of 9 mm or less and a length of 23 | The Tenodesis Screws are intended to provide soft tissue |
| mm or less are also intended for the use in the following | reattachment (i.e. fixation of ligament and tendon graft tissue). |
| procedures: | See below for specific indications. |
| Knee | Shoulder |
| ACL repairs | Capsular stabilization |
| PCL repairs | o Bankart repair |
| o Extracapsular repairs | o Anterior shoulder instability |
| o Medial collateral ligament | o SLAP lesion repairs |
| o Lateral collateral ligament | o Capsular shift of capsulolabral reconstructions |
| o Posterior oblique ligament | Acromioclavicular separation repairs |
| Patellar realignment and tendon repairs | Deltoid repairs |
| o Vastus medialis oliquous advancement | Rotator cuff tear repairs |
| Iliotibial band tenodesis | Biceps tenodesis |
| Shoulder | Foot and Ankle |
| Capsular stabilization | Hallux valgus reconstruction |
| o Bankart repair | Medial stabilization |
| o Anterior shoulder Instability | lateral stabilization |
| o SLAP lesion repairs | Achilles Tendon Repair |
| o Capsular shift of capsulolabral reconstructions | Midfoot reconstructions |
| Acromioclavicular separation repairs | Metatarsal ligament repair |
| Deltoid repairs | Bunionectomy |
| Rotor cuff tear repairs | Flexor Hullucis Longus for Achilles Tendon reconstruction |
| Biceps tenodesis | Tendon transfers in the foot and ankle |
| Foot and Ankle | Knee |
| Hallux valgus repairs | Medial Collateral Ligament Repair |
| Medial or lateral instability repairs/reconstructions | Lateral Collateral Ligament Repair |
| Achilles tendon repairs/reconstructions | Patellar Tendon Repair |
| Midfoot reconstructions | Posterior Oblique Ligament Repair |
| Metatarsal ligament/tendon repairs/reconstruions | Iliotibial Band Tenodesis |
| Bunionectomy | Posterior Cruciate Ligament Repair |
| Flexor Hullucis Longus | Elbow |
| Tendon transfers | Biceps tendon reattachment |
| Elbow, Wrist, and Hand | Ulnar or radial collateral ligament reconstruction |
| Biceps tendon reattachment | Wrist and Hand |
| Ulnar or radial collateral ligament reconstructions | Scapholunate Ligament Reconstruction |
| Lateral epicondylitis repair | Ulnar Collateral Ligament Reconstruction |
| Scapholunate ligament reconstruction | Radial Collateral Ligament Reconstruction |
| Tendo transfers | Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty) |
| Carpal Ligament Reconstructions and repairs | |
| Tendon transfer irthe hand/wrist | |
| Lateral Epicondylitis repair |
____ Prescription Use _______________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
.
Over-The-Counter Use _ AND/OR
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Casey L. Hanley Ph.D. |
|---|
| Division of Orthopedic Devices |