(118 days)
No
The device description and performance studies focus on the mechanical properties and materials of a suture-anchor, with no mention of AI or ML.
No
The device is a suture-anchor used for soft tissue fixation to bone, designed for structural repair, not for treating a disease or condition in a therapeutic manner.
No
The device is a suture-anchor used for soft tissue fixation to bone during surgical repairs (e.g., Bankart Repair, SLAP Lesion Repair). It is an implantable device designed for treatment, not for diagnosing conditions or diseases.
No
The device description clearly states it is a suture-anchor made of physical materials (PEEK or Biocryl Rapide) with preloaded suture, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for surgical fixation of soft tissue to bone in the shoulder and hip. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a suture-anchor, a physical implant used during surgery.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a patient's health. This device does not perform any such diagnostic testing.
The information clearly describes a surgical implant used for structural support within the body, which falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Gryphon Anchor w/ProKnot Technology is indicated for followings.
Shoulder: Bankart Repair, SLAP Lesion Repair, Capsular Shift or Capsulolabral Reconstruction
Hip: Capsular Repair, Acetabular Labral Repair
Product codes (comma separated list FDA assigned to the subject device)
MAI, MBI
Device Description
The proposed device is a suture-anchor to be used for soft tissue fixation to bone. The Gryphon Anchor is a cannulated, ribbed anchor, made of either non-absorbable PEEK (Polyetheretherketone) or absorbable Biocryl® RapideTM (composite of β-TCP and PLGA copolymer). Size #1 blue Permacord™ suture (UHMWPE braided suture) is preloaded on the anchor. The suture incorporates a pre-tied sliding knot (ProKnot knot). The Permacord suture is a non-absorbable suture that conforms to USP except for oversized diameter. The device is provided as sterile; the device is for single patient use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Hip
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)
Non-clinical Testing
Fixation strength testing, suture knot strength testing and suture fray testing were conducted and the data were compared with the data of the predicate devices. The data demonstrated substantial equivalence of product performance. The proposed device has raised no new issue of safety and efficacy. Suture testing on the Permacord suture was also conducted per USP.
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.
K132241, K100012, K090124, K103712
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
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
K140643 Page 1/2
0 DePuv Synthes
MITEK SPORTS MEDICINE PANIES OF Goknomagehauen
JUI 0882014
510(k) SUMMARY GRYPHON™ ANCHOR w/PROKNOT™ TECHNOLOGY
| Date Summary
| Prepared | May 2, 2014 |
|---|---|
| Submitter's | |
| Name and | |
| Address | DePuy Mitek |
| a Johnson & Johnson company | |
| 325 Paramount Drive | |
| Raynham, MA 02767 | |
| Contact Person | Yayoi Fujimaki |
| Regulatory Affairs Senior Associate | |
| DePuy Mitek | |
| a Johnson & Johnson company | |
| 325 Paramount Drive | |
| Raynham, MA 02767, USA | |
| Telephone: 508-828-3541 | |
| Facsimile: 508-977-6911 | |
| e-mail: yfujima1@its.jnj.com | |
| Name of the | |
| Device | Trade Name: GRYPHON™ Anchor w/PROKNOTT™ Technology |
| Common Name: fastener, fixation, biodegradable, soft tissue | |
| Device | |
| Classification | MAI - Single/multiple component metallic bone fixation appliances and |
| accessories, classified as Class II, regulated per 21 CFR 888.3030. | |
| MBI - Smooth or threaded metallic bone fixation fastener, classified as Class | |
| II, regulated per 21 CFR 888.3040. | |
| Orthopedic panel | |
| Predicate | |
| Device | The proposed device is substantially equivalent to: |
| GRYPHON™ Anchor w/PROKNOTT™ Technology (K132241); | |
| GRYPHON BR Anchor (K100012, K090124); | |
| GRYPHON PEEK Anchor (K103712). | |
| The following predicate devices were referenced: | |
| Healix Advance Anchor w/Permacord suture (K133794); | |
| Force Fiber Blue Polyethylene Non-Absorbable Surgical Suture (K092533, | |
| Teleflex Medical Incorporated) | |
| Indications for | |
| Use | Shoulder: Bankart Repair, SLAP Lesion Repair, Capsular Shift or Capsulolabral |
| Reconstruction | |
| Hip: Capsular Repair, Acetabular Labral Repair | |
| Device | |
| Description | The proposed device is a suture-anchor to be used for soft tissue fixation to |
| bone. The Gryphon Anchor is a cannulated, ribbed anchor, made of either non- | |
| absorbable PEEK (Polyetheretherketone) or absorbable Biocryl® RapideTM | |
| (composite of β-TCP and PLGA copolymer). Size #1 blue Permacord™ suture | |
| (UHMWPE braided suture) is preloaded on the anchor. The suture incorporates | |
| a pre-tied sliding knot (ProKnot knot). The Permacord suture is a non- | |
| absorbable suture that conforms to USP except for oversized diameter. The | |
| device is provided as sterile; the device is for single patient use only. | |
| Comparison of | |
| Technological | |
| Characteristics | The anchors are existing Gryphon anchors. The blue #1 Permacord suture is |
| made from the same materials as the blue #2 Permacord suture that is used for | |
| the Healix Advance Anchor w/Permacord suture. No other new technological | |
| characteristics are introduced to the proposed device compared with the | |
| predicate device. Fixation strength testing ensured substantial equivalence of | |
| device performance. No new issue of safety and efficacy has been raised. | |
| Safety and | |
| Performance | Non-clinical Testing |
| Fixation strength testing, suture knot strength testing and suture fray testing were | |
| conducted and the data were compared with the data of the predicate devices. | |
| The data demonstrated substantial equivalence of product performance. The | |
| proposed device has raised no new issue of safety and efficacy. Suture testing on | |
| the Permacord suture was also conducted per USP. | |
| Substantial | |
| Equivalence | Based on technological characteristics comparison and performance evaluation, |
| the proposed device is concluded to be substantially equivalent to the predicate | |
| device. |
1
(0) DePuy Synthes
mitek sports medicine COMPRMICS OF Specifican Coknova
2
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 8, 2014
DePuy Mitek Ms. Yayoi Fujimaki Senior Regulatory Affairs Associate 325 Paramount Drive Raynham, Massachusetts 02767
Re: K140643
Trade/Device Name: Gryphon Anchor w/ProKnot Technology Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and Accessories Regulatory Class: Class II Product Code: MAI, MBI Dated: June 3, 2014 Received: June 5, 2014
Dear Ms. Fujimaki:
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
3
Page 2 - Ms. Yayoi Fujimaki
device-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" (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 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 yours, Lori A. Wigqins
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known)
Device Name Gryphon Anchor w/ProKnot Technology
Indications for Use (Describe)
Gryphon Anchor w/ProKnot Technology is indicated for followings.
Shoulder: Bankart Repair, SLAP Lesion Repair, Capsular Shift or Capsulolabral Reconstruction Hip: Capsular Repair, Acetabular Labral Repair
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)
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices
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