GRAVITYTM PEEK-OPTIMA Suture Anchor

K170265 · Wrightmedicaltechnologyinc · MBI · Feb 23, 2017 · Orthopedic

Device Facts

• Record ID: K170265
• Device Name: GRAVITYTM PEEK-OPTIMA Suture Anchor
• Applicant: Wrightmedicaltechnologyinc
• Product Code: MBI · Orthopedic
• Decision Date: Feb 23, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The GRAVITY PEEK-OPTIMA® Suture Anchor System is indicated for use: · In the repair of shoulder instability secondary to Bankart lesion, rotator cuff tear, a slap lesion, acromioclavicular separation, biceps tenodesis, deltoid tear/separation, or capsular shift or capsulolabral reconstruction; • In the repair of elbow instability secondary to biceps tendon detachment, temis elbow, or ulnar or radial collateral tear/ separation; • In the repair of hand/wrist instability secondary to tear or separation of the scapholunate ligament, or radial collateral ligament; • In the repair of knee instability secondary to tear or separation of the medial collateral ligament, patellar tendon, or posterior oblique ligament, or secondary to iliotibial band tenodesis; • In the repair of foot/ankle instability secondary to tear or separation of the Achilization tendons/ligaments, medial stabilization tendons/ligaments, midfoot tendons/ligaments, or metatarsal tendons/ligaments, Tendon reattachments, and ligament reconstructions of the midfoot, forefoot, and hindfoot procedures associated with flatfoot reconstruction, hindfoot deformity, midfoot reconstruction, lateral/medial ankle reconstruction or instability, Hallux Valgus or Varus, and MTP instability including: o Achilles reattachment/reconstruction - o Flexor Digitorum Longus Transfer - o Flexor Hallucis Longus Transfer - o Extensor Hallucis Longus Transfer - o Brostrom Procedures - o Peroneal Tendon Relocation - o Capsule Repair - o Deltoid reconstruction / reattachment - o Plantar Plate Repair - o Spring Ligament Repair

Device Story

Sterile, single-use, hand-held suture anchor system; used by orthopedic surgeons in clinical/surgical settings. Device consists of PEEK-OPTIMA anchors preloaded with non-absorbable polyethylene sutures and needles. Operates by anchoring soft tissue to bone to facilitate healing and stabilization. Output is physical fixation of tissue. Benefits patient by restoring joint stability and structural integrity following injury or surgical reconstruction.

Clinical Evidence

Bench testing only. Pullout strength testing performed to demonstrate equivalence to predicate systems. No clinical data provided.

Technological Characteristics

Sterile, single-use, hand-held bone fixation fastener. Materials: PEEK-OPTIMA and titanium alloy. Includes non-absorbable polyethylene sutures and needles. Mechanical fixation principle.

Indications for Use

Indicated for patients requiring soft tissue-to-bone repair in shoulder, elbow, hand/wrist, knee, and foot/ankle joints. Addresses instability, tears, separations, and ligament/tendon reconstructions (e.g., rotator cuff, Achilles, Brostrom, Hallux Valgus).

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

• G-FORCE® Gen 2 Ti Suture Anchor System (K141011)
• G-FORCE® Ti Suture Anchor System (K100579)
• G-FORCE® Suture Anchor System (K100630)

Submission Summary (Full Text)

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, one behind the other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Wright Medical Technology, Inc. Ms. Tara Conrad Regulatory Affairs Specialist II 1023 Cherry Road Memphis. Tennessee 38117

February 23, 2017

Re: K170265

Trade/Device Name: GRAVITY PEEK-OPTIMA® Suture Anchor System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI, HWC Dated: January 20, 2017 Received: January 27, 2017

Dear Ms. Conrad:

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 (reporting of medical device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

#### 510(k) Number (if known) K170265

#### Device Name

GRAVITY PEEK-OPTIMA® Suture Anchor System

#### Indications for Use (Describe)

The GRAVITY PEEK-OPTIMA® Suture Anchor System is indicated for use:

· In the repair of shoulder instability secondary to Bankart lesion, rotator cuff tear, a slap lesion, acromioclavicular separation, biceps tenodesis, deltoid tear/separation, or capsular shift or capsulolabral reconstruction;

• In the repair of elbow instability secondary to biceps tendon detachment, temis elbow, or ulnar or radial collateral tear/ separation;

• In the repair of hand/wrist instability secondary to tear or separation of the scapholunate ligament, or radial collateral ligament;

• In the repair of knee instability secondary to tear or separation of the medial collateral ligament, patellar tendon, or posterior oblique ligament, or secondary to iliotibial band tenodesis;

• In the repair of foot/ankle instability secondary to tear or separation of the Achilization tendons/ligaments, medial stabilization tendons/ligaments, midfoot tendons/ligaments, or metatarsal tendons/ligaments, Tendon reattachments, and ligament reconstructions of the midfoot, forefoot, and hindfoot procedures associated with flatfoot reconstruction, hindfoot deformity, midfoot reconstruction, lateral/medial ankle reconstruction or instability, Hallux Valgus or Varus, and MTP instability including:

o Achilles reattachment/reconstruction

- o Flexor Digitorum Longus Transfer
- o Flexor Hallucis Longus Transfer
- o Extensor Hallucis Longus Transfer
- o Brostrom Procedures
- o Peroneal Tendon Relocation
- o Capsule Repair
- o Deltoid reconstruction / reattachment
- o Plantar Plate Repair
- o Spring Ligament Repair

Type of Use (Select one or both, as applicable)

|×| Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the GRAVITY™ PEEK-OPTIMA® Suture Anchor System.

| Submitted By: | Wright Medical Technology, Inc. |
|-------------------------------------|---------------------------------------------------------------------------------|
| Date: | February 7, 2017 |
| Contact Person: | Tara Conrad |
| | Regulatory Affairs Specialist II |
| Proprietary Name: | GRAVITY ^TM PEEK-OPTIMA ^® Suture Anchor System |
| Common Name: | Soft Tissue Anchor |
| Classification Name and Reference: | 21 CFR 888.3040 - Smooth or threaded metallic bone fixation fastener - Class II |
| Device Product Code and Panel Code: | Orthopedics/87/MBI/HWC |

Predicate Device:

G-FORCE® Gen 2 Ti Suture Anchor System (K141011) Predicate -G-FORCE® Ti Suture Anchor System (K100579) G-FORCE® Suture Anchor System (K100630)

## DEVICE INFORMATION

### A. DEVICE DESCRIPTION

The GRAVITY " PEEK-OPTIMA® Suture Anchor System is a sterile, single-use, hand-held device intended to aid in the attachment of soft tissue to bone. The GRAVITY™ PEEK-OPTIMA® Suture Anchor System comes preloaded with non-absorbable polyethylene sutures, needles and titanium alloy anchors. The anchors are available in a variety of sizes with correspondingly sized sutures.

## B. INDICATIONS FOR USE

The GRAVITY™ PEEK-OPTIMA® Suture Anchor System is indicated for use:

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- In the repair of shoulder instability secondary to Bankart lesion, rotator cuff tear, a . slap lesion, acromioclavicular separation, biceps tenodesis, deltoid tear/separation, or capsular shift or capsulolabral reconstruction;
- . In the repair of elbow instability secondary to biceps tendon detachment, tennis elbow, or ulnar or radial collateral ligament tear/separation;
- In the repair of hand/wrist instability secondary to tear or separation of the ● scapholunate ligament, ulnar collateral ligament, or radial collateral ligament;
- . In the repair of knee instability secondary to tear or separation of the medial collateral ligament, lateral collateral ligament, patellar tendon, or posterior oblique ligament, or secondary to iliotibial band tenodesis;
- In the repair of foot/ankle instability secondary to tear or separation of the Achilles ● tendon, stabilization tendons/ligaments, midfoot tendons/ligaments, or metatarsal tendons/ligaments, Tendon Transfers, tendon reattachments, and ligament reconstructions of the midfoot, forefoot, and hindfoot procedures associated with flatfoot reconstruction, hindfoot deformity, midfoot reconstruction, lateral/medial ankle reconstruction or instability, Hallux Valgus or Varus, and MTP instability including:
- o Achilles reattachment/reconstruction
- Flexor Digitorum Longus Transfer o
- Flexor Hallucis Longus Transfer o
- Extensor Hallucis Longus Transfer o
- Brostrom Procedures o
- O Peroneal Tendon Relocation
- Capsule Repair o
- Deltoid reconstruction / reattachment о
- Plantar Plate Repair o
- 0 Spring Ligament Repair

## C. SUBSTANTIAL EQUIVALENCE INFORMATION

The indications for use of the GRAVITY™ PEEK-OPTIMA® Suture Anchor System are the same as the predicate G-FORCE® Gen 2 Ti Suture Anchor System. The design characteristics of the subject device do not raise any new types of questions in terms of either safety or effectiveness. Based on the evidence submitted in this 510(k), the subject device can be expected to perform in a manner equal or superior to the predicate device and is substantially equivalent.

## D. PERFORMANCE DATA

Bench testing was used to demonstrate that the pullout strength characteristics of the GRAVITY™ PEEK-OPTIMA® Suture Anchor System are substantially equivalent to the predicate systems. The safety and effectiveness of the GRAVITY "" PEEK-OPTIMA® Suture Anchor System is adequately supported by the pullout testing performed, substantial equivalence information, material biocompatibility assessment, and comparison of design characteristics provided within this premarket notification.