GRAVITY™ Soft Tissue Repair System

K170642 · Wrightmedicaltechnologyinc · GAT · Aug 22, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K170642
• Device Name: GRAVITY™ Soft Tissue Repair System
• Applicant: Wrightmedicaltechnologyinc
• Product Code: GAT · General, Plastic Surgery
• Decision Date: Aug 22, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5000
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

GRAVITY™ Plantar Plate Repair System: - Distal metatarsal osteotomy (screw) - Plantar plate repair (suture) GRAVITY™ Needle Driver: - Approximation of soft tissues, including the use of allograft tissue for orthopedic surgeries

Device Story

GRAVITY™ Soft Tissue Repair System comprises UHMWPE sutures and ASTM F136 titanium alloy screws; includes needle driver device for suture delivery. Used in orthopedic surgical settings by surgeons for plantar plate repair, distal metatarsal osteotomy, and soft tissue approximation. System provided sterile with disposable instruments. Operates as mechanical fixation and soft tissue approximation tool; surgeon manually manipulates needle driver and screws to secure tissue or bone. Output is physical stabilization of surgical site. Benefits include simplified delivery of suture and fixation hardware during orthopedic procedures.

Clinical Evidence

No clinical trials performed. Substantial equivalence supported by a comprehensive clinical literature review regarding the free strand suture indications and bench performance testing demonstrating equivalent construct tensile strength.

Technological Characteristics

Materials: UHMWPE suture, ASTM F136 titanium alloy screws. System includes disposable instruments. Sterile packaging. Mechanical fixation and soft tissue approximation. No software or electronic components.

Indications for Use

Indicated for patients undergoing orthopedic surgeries requiring distal metatarsal osteotomy, plantar plate repair, or soft tissue approximation, including the use of allograft tissue.

Regulatory Classification

Identification

Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.

Special Controls

*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.

Predicate Devices

• FORCE FIBER POLYETHYLENE NONABSORBABLE (K063778)
• FORCE FIBER POLYETHYLENE NONABSORBABLE (K092533)
• CHARLOTTE Snap-Off Screws (K133713)

Reference Devices

• G-FORCE Ti Anchor System (K141011)

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/0/Picture/12 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 right, resembling a bird-like shape.

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

Wright Medical Technology, Inc. Mr. Michael Mullins Regulatory Affairs Specialist 1023 Cherry Road Memphis. Tennessee 38117

August 22, 2017

Re: K170642

Trade/Device Name: GRAVITY™ Soft Tissue Repair System Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: Class II Product Code: GAT, HWC Dated: July 18, 2017 Received: July 20, 2017

Dear Mr. Mullins:

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

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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 (DICE) 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 (DICE) 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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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement on last page.

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

## Indications for Use

510(k) Number (if known) K170642

Device Name GRAVITY™ Soft Tissue Repair System

Indications for Use (Describe) The GRAVITY™ Soft Tissue Repair Systems are indicated for the following:

GRAVITY™ Plantar Plate Repair System:

- Distal metatarsal osteotomy (screw)
• Plantar plate repair (suture)

GRAVITY™ Needle Driver:

· Approximation of soft tissues, including the use of allograft tissue for orthopedic surgeries

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

X 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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Image /page/4/Picture/0 description: The image shows an address. The address is 1023 Cherry Road, Memphis, TN 38117, USA. The text is in a light gray color.

901 867 9971 800 238 7117 wright.com

Image /page/4/Picture/2 description: The image shows the Wright logo. The logo consists of two overlapping geometric shapes in red and orange, followed by the word "WRIGHT" in red, and the words "FOCUSED EXCELLENCE" in gray below the word "WRIGHT". The logo is simple and modern, and the colors are bright and eye-catching.

## 510(K) SUMMARY

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 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the GRAVITY™ Soft Tissue Repair System.

| (a)(1). Submitted By: | Wright Medical Technology, Inc.<br>1023 Cherry Road<br>Memphis, TN 38117 |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | August 17, 2017 |
| Contact Person: | Michael Mullins<br>Regulatory Affairs Specialist<br>Office - [phone]<br>Fax - [phone] |
| (a)(2). Proprietary Name: | GRAVITY™ Soft Tissue Repair System |
| Common Name: | -Suture, Nonabsorbable, Synthetic,<br>Polyethylene<br>-Screw, Fixation, Bone |
| Classification Name and Reference: | -21 CFR 878.5000 - Class II<br>-21 CFR 888.3030 - Class II |
| Device Product Code, Device Panel: | -GAT - General<br>-HWC - Orthopedic |
| (a)(3). Predicate Device: | Primary- K063778: FORCE FIBER<br>POLYETHYLENE NONABSORBABLE<br>Primary- K092533: FORCE FIBER<br>POLYETHYLENE NONABSORBABLE<br>Secondary- K133713: CHARLOTTE Snap-Off<br>Screws<br>Reference- K141011: G-FORCE Ti Anchor<br>System |
| (a)(4). Device Description | |

## The GRAVITY™ Soft Tissue Repair System is available in two offerings: the plantar plate repair system (suture, screws, and accessories) and the Needle Driver Device (free strand suture). The subject device is composed UHMWPE suture and ASTM F136 Titanium alloy screws. The system is conveniently sterile packed with disposable instruments.

Attachment 2-1

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## (a)(5). INTENDED USE

GRAVITY™ Soft Tissue Repair Systems are indicated for the following: GRAVITY™ Plantar Plate Repair System

- Distal metatarsal osteotomy (screw)
- · Plantar plate repair (suture)

## GRAVITY™ Needle Driver:

· Approximation of soft tissues, including the use of allograft tissue for orthopedic surgeries

## (a)(6). Technological Characteristics Comparison

The subject GRAVITY™ Soft Tissue Repair System is technologically equivalent to the primary predicates in material and design with differences being that the subject is preloaded on a needle driver device and has a different needle design. The snap-off screws are identical in material and design to their respective predicate. There are no technological characteristic differences between the subject and predicate snap-off screws.

## (b)(1). Substantial Equivalence - Non-Clinical Evidence

Performance testing and analysis demonstrated substantial equivalence in construct tensile strength to the reference predicate.

#### (b)(2). Substantial Equivalence - Clinical Evidence

A comprehensive clinical literature review was completed and used to support the subject free strand suture indications for use.

#### (b)(3). Substantial Equivalence - Conclusions

The design characteristics of the subject system do not raise any new types of questions of safety or effectiveness. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate device.