(27 days)
Not Found
No
The device description and intended use clearly describe a mechanical suture anchor system for attaching soft tissue to bone. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies are limited to bench testing of pullout strength, further supporting a purely mechanical device.
Yes
The device is described as a "Suture Anchor System" intended to aid in the attachment of soft tissue to bone for the repair of various instabilities and injuries, which directly addresses a health condition.
No
Explanation: The device is described as a "Suture Anchor System" intended to aid in the attachment of soft tissue to bone, used for the repair of instability in various anatomical sites. It is a surgical implant and does not perform any diagnostic functions like detecting, monitoring, or predicting medical conditions.
No
The device description explicitly states it is a "sterile, single-use, hand-held device" and includes physical components like "polyethylene sutures, needles and titanium alloy anchors." This indicates it is a hardware medical device, not software-only.
No, 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 for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The GRAVITY PEEK-OPTIMA® Suture Anchor System is a surgical implant used to attach soft tissue to bone during various orthopedic repair procedures. It is a physical device used in vivo (within the body) during surgery, not a test performed on a sample in vitro (outside the body).
The provided information clearly describes a surgical implant and its intended use in orthopedic repairs, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for 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
Product codes
MBI, HWC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, elbow, hand/wrist, knee, foot/ankle
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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
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 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 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
2
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)
3
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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:
5
- 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.