(173 days)
No
The summary describes a mechanical soft tissue repair system with sutures, screws, and instruments. There is no mention of AI, ML, image processing, or data-driven analysis.
Yes
The device is described as a "Soft Tissue Repair System" used for procedures like "plantar plate repair" and "approximation of soft tissues," which are therapeutic interventions aimed at correcting or alleviating a medical condition.
No
Explanation: The device description and intended use indicate that it is a system for repairing soft tissues and approximates soft tissues during orthopedic surgeries. It does not mention any function related to diagnosing medical conditions.
No
The device description explicitly states it is composed of UHMWPE suture and ASTM F136 Titanium alloy screws, which are hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes surgical procedures for repairing soft tissues (plantar plate repair, distal metatarsal osteotomy, approximation of soft tissues). This is a therapeutic/surgical application, not a diagnostic one.
- Device Description: The device is composed of surgical materials like UHMWPE suture and titanium alloy screws, which are used in the body during surgery, not for testing samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is to physically repair tissue during surgery.
N/A
Intended Use / Indications for Use
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
Product codes (comma separated list FDA assigned to the subject device)
GAT, HWC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 and analysis demonstrated substantial equivalence in construct tensile strength to the reference predicate. A comprehensive clinical literature review was completed and used to support the subject free strand suture indications for use.
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.
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
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
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.(b)
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.
0
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
1
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 (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 (DICE) 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,
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.
1023 Cherry Road
Memphis, TN 38117 |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | August 17, 2017 |
| Contact Person: | Michael Mullins
Regulatory Affairs Specialist
Office - (901) 867-4142
Fax - (901) 867-4190 |
| (a)(2). Proprietary Name: | GRAVITY™ Soft Tissue Repair System |
| Common Name: | -Suture, Nonabsorbable, Synthetic,
Polyethylene
-Screw, Fixation, Bone |
| Classification Name and Reference: | -21 CFR 878.5000 - Class II
-21 CFR 888.3030 - Class II |
| Device Product Code, Device Panel: | -GAT - General
-HWC - Orthopedic |
| (a)(3). Predicate Device: | Primary- K063778: FORCE FIBER
POLYETHYLENE NONABSORBABLE
Primary- K092533: FORCE FIBER
POLYETHYLENE NONABSORBABLE
Secondary- K133713: CHARLOTTE Snap-Off
Screws
Reference- K141011: G-FORCE Ti Anchor
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.