APOLLO SUTURE ANCHOR SYSTEM AND TITAN SCREWS

K133036 · Amendia, Inc. · MBI · Mar 6, 2014 · Orthopedic

Device Facts

• Record ID: K133036
• Device Name: APOLLO SUTURE ANCHOR SYSTEM AND TITAN SCREWS
• Applicant: Amendia, Inc.
• Product Code: MBI · Orthopedic
• Decision Date: Mar 6, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

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: [List of specific anatomical repairs including rotator cuff, Bankart, SLAP, biceps tenodesis, ligament reconstructions, and tendon repairs across the specified joints].

Device Story

Apollo Suture Anchor System and Titan Screws are orthopedic fixation implants; used for reattaching ligament, tendon, or soft tissue to bone. Implants consist of cannulated anchors with integrated suture attachment or separate eyelets and interference/tenodesis screws. Used in knee, shoulder, foot/ankle, elbow, and hand/wrist surgeries. Implants provided sterile for single-use. Surgeon inserts anchors/screws into bone to secure soft tissue or grafts. Provides mechanical fixation to facilitate healing. Benefits include stabilization of tissue during orthopedic reconstruction procedures.

Clinical Evidence

Bench testing only. Performance testing included axial pullout, axial push out, insertion torque, and torque to failure tests per ASTM F543-07. Results demonstrated substantial equivalence to predicate devices.

Technological Characteristics

Materials: Titanium alloy (6Al4V) per ASTM F136 or PEEK (Zeniva ZA-500) per ASTM F2026. Design: Cannulated anchors and interference/tenodesis screws. 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. Applicable to patients requiring surgical repair of soft tissue or bone, including rotator cuff, Bankart, SLAP, biceps tenodesis, ligament reconstructions, and tendon repairs.

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

• Smith and Nephew Biosure PK Interference Screw (K083635)
• DePuy Mitek Healix PEEK Anchor (K120449)
• Biomet PEEK Allthread Knotless Suture Anchor (K071569)
• Biomet Hitch PEEK Anchor (K060693)
• Arthrex Tenodesis Screw (K041356)

Submission Summary (Full Text)

{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<br>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 |
| <input type="checkbox"/> Rotator Cuff Repair | <input type="checkbox"/> Rotator Cuff Repair |
| <input type="checkbox"/> Bankart Repair | <input type="checkbox"/> Bankart Repair |
| <input type="checkbox"/> SLAP Lesion Repair | <input type="checkbox"/> SLAP Lesion Repair |
| <input type="checkbox"/> Biceps Tenodesis | <input type="checkbox"/> Biceps Tenodesis |
| <input type="checkbox"/> AcormieClavicular Separation Repair | <input type="checkbox"/> AcormieClavicular Separation Repair |
| <input type="checkbox"/> Deltoid Repair | <input type="checkbox"/> Deltoid Repair |
| <input type="checkbox"/> Capisular Shift or Capsulolabral Reconstruction | <input type="checkbox"/> Capisular Shift or Capsulolabral Reconstruction |
| Foot/Ankle | Wrist/Hand |
| <input type="checkbox"/> Lateral Stabilization | <input type="checkbox"/> Scapholunate Ligament Reconstruction |
| <input type="checkbox"/> Medial Stabilization | <input type="checkbox"/> Ulnar/Radial Collateral Ligament Reconstruction |
| <input type="checkbox"/> Achilles Tendon Repair | |
| Knee | Foot/Ankle |
| <input type="checkbox"/> Medial Collateral Ligament Repair | <input type="checkbox"/> Lateral Stabilization |
| <input type="checkbox"/> Lateral Collateral Ligament Repair | <input type="checkbox"/> Medial Stabilization |
| <input type="checkbox"/> Posterior Oblige Ligament Repair | <input type="checkbox"/> Achilles Tendon Repair/Reconstruction |
| <input type="checkbox"/> Illiotibial Band Tenodesis | <input type="checkbox"/> Hallux Valgus Reconstruction |
| Elbow | <input type="checkbox"/> Midand Forefoot Reconstruction |
| <input type="checkbox"/> Biceps Tendon Reattachment | Elbow |
| • Ulnar or Radial Collateral Ligament Reconstruction | <input type="checkbox"/> Biceps Tendon Reconstruction |
| Hip | <input type="checkbox"/> Ulnar or Radial Collateral Ligament Reconstruction |
| <input type="checkbox"/> Capsular Repair | <input type="checkbox"/> Lateral Epicondylitis Repair (PEEK Anchor Only) |
| <input type="checkbox"/> Acetabular Labral Repair | Knee |
| | <input type="checkbox"/> Medial Collateral Ligament Repair |
| | <input type="checkbox"/> Lateral Collateral Ligament Repair |
| | <input type="checkbox"/> Posterior Oblique Ligament Repair |
| | <input type="checkbox"/> Joint Capsule Closure |
| | <input type="checkbox"/> Iliotibial Band Tenodesis |
| | <input type="checkbox"/> 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 | |
| | |
| <b>Wrist</b> | |
| ☐ Scapholunate Ligament Reconstruction | |
| | |
| <b>Elbow</b> | |
| ☐ Biceps Tendon Reattachment | |
| ☐ Ulnar or Radial Collateral ligament Reonstruction | |
| | |
| <b>Hip</b> | |
| ☐ Capsular Repair | |
| ☐ Acetabular Labral Repair | |
| | |
| <b>Knee</b> | |
| ☐ 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 | |
| <b>Indications -Interference Screws</b> | <b>Indications -Tenodesis Screws</b> |
| 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<br>mm or less are also intended for the use in the following | The Tenodesis Screws are intended to provide soft tissue<br>reattachment (i.e. fixation of ligament and tendon graft tissue). |
| procedures: | See below for specific indications. |
| <b>Knee</b> | <b>Shoulder</b> |
| ☐ 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 |
| <b>Shoulder</b> | |
| ☐ Capsular stabilization | <b>Foot and Ankle</b> |
| 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 |
| <b>Foot and Ankle</b> | |
| ☐ Hallux valgus repairs | |
| ☐ Medial or lateral instability repairs/reconstructions | <b>Knee</b> |
| ☐ Achilles tendon repairs/reconstructions | ☐ Medial Collateral Ligament Repair<br>☐ Lateral Collateral Ligament Repair |
| ☐ Midfoot reconstructions | |

{3}------------------------------------------------

| <label>☐ Metatarsal ligament/tendon repairs/reconstructions</label> | <label>☐ Patellar Tendon Repair</label> |
|----------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| <label>☐ Bunionectomy</label> | <label>☐ Posterior Oblique Ligament Repair</label> |
| <label>☐ Flexor Hullucis Longus</label> | <label>☐ Iliotibial Band Tenodesis</label> |
| <label>☐ Tendon transfers</label> | <label>☐ Posterior Cruciate Ligament Repair</label> |
| <b>Elbow, Wrist, and Hand</b> | <b>Elbow</b> |
| <label>☐ Biceps tendon reattachment</label> | <label>☐ Biceps tendon reattachment</label> |
| <label>☐ Ulnar or radial collateral ligament reconstructions</label> | <label>☐ Ulnar or radial collateral ligament reconstruction</label> |
| <label>☐ Lateral epicondylitis repair</label> | |
| <label>☐ Scapholunate ligament reconstruction</label> | <b>Wrist and Hand</b> |
| <label>☐ Tendon transfers</label> | <label>☐ Scapholunate Ligament Reconstruction</label> |
| | <label>☐ Thar Collateral Ligament Reconstruction</label> |
| | <label>☐ Radial Collateral ligament Reconstruction</label> |
| | <label>☐ Carpometalcarpal joint arthroplasty (basal thumb joint arthroplasty)</label> |
| | <label>☐ Carpal Ligament Reconstructions and repairs</label> |
| | <label>☐ Tendon transfer in the hand/wrist</label> |
| | <label>☐ Lateral Epicondylitis repair</label> |

## 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 [phone] or [phone] 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 [phone] or [phone] 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<br>The Apollo Medial Suture Anchor is intended for:<br>Shoulder<br>☐ Rotator Cuff Repair<br>☐ Bankart Repair<br>☐ SLAP Lesion Repair<br>☐ Biceps Tenodesis<br>☐ AcormieClavicular Separation Repair<br>☐ Deltoid Repair<br>☐ Capisular Shift or Capsulolabral Reconstruction<br>Foot/Ankle<br>☐ Lateral Stabilization<br>☐ Medial Stabilizatio<br>☐ Achilles Tendon Repair<br>Knee<br>☐ Medial Collateral Ligament Repair<br>☐ Lateral Collateral Ligament Repair<br>☐ Posterior Oblique Ligament Repair<br>☐ Iliotibial Band Tenodesis<br>Elbow<br>☐ Biceps Tendon Reattachment<br>• Ulnar or Radial Collateral Ligament Reconstruction<br>Hip<br>☐ Capsular Repair<br>☐ Acetabular Labral Repair | Indications - Apollo Lateral Anchor<br>The Apollo Lateral Anchor is Indicated for:<br>Shoulder<br>☐ Rotator Cuff Repair<br>☐ Bankart Repair<br>☐ SLAP Lesion Repair<br>☐ Biceps Tenodesis<br>☐ AcormieClavicular Separation Repair<br>☐ Deltoid Repair<br>☐ Capisular Shift or Capsulolabral Reconstruction<br>Wrist/Hand<br>☐ Scapholunate Ligament Reconstruction<br>☐ Ulnar/Radial Collateral Ligament Reconstruction<br>Foot/Ankle<br>☐ Lateral Stabilization<br>☐ Medial Stabilizatio<br>☐ Achilles Tendon Repair/Reconstruction<br>☐ Hallux Valgus Reconstruction<br>☐ Midland Forefoot Reconstruction<br>Elbow<br>☐ Biceps Tendon Reconstruction<br>☐ Ulnar or Radial Collateral Ligament Reconstruction<br>☐ Lateral Epicondylitis Repai(PEEK Anchor Only)<br>Knee<br>☐ Medial Collateral Ligament Repair<br>☐ Lateral Collateral Ligament Repair<br>☐ Posterior Oblique Ligament Repair<br>☐ Joint Capsule Closure<br>☐ Iliotibial Band Tenodesis<br>☐ Patellar Ligament/Tendon Repair |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications - Apollo Labral Suture Tac Shoulder<br>☐ Rotator Cuff Repair<br>☐ Bankart Repair<br>☐ SLAP Lesion Repair<br>☐ Biceps Tenodesis<br>☐ AcormieClavicular Separation Repair<br>☐ Deltoid Repair<br>☐ Capisular Shift or Capsulolabral Reconstruction<br>Wrist<br>☐ Scapholunate Ligament Reconstruction<br>Elbow<br>☐ Biceps Tendon Reattachment<br>☐ Ulnar or Radial Collateral Ligament Reconstruction<br>Hip<br>☐ Capsular Repair<br>☐ 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 |