(110 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and biocompatibility of a suture anchor, with no mention of AI or ML.
Yes
The device is a suture-anchor used for soft tissue fixation to bone, which is a therapeutic intervention for conditions like Bankart Repair or SLAP Lesion Repair.
No
This device is a suture-anchor used for soft tissue fixation to bone during surgical repairs (e.g., Bankart Repair, SLAP Lesion Repair). It is a therapeutic device, not a diagnostic one, as it directly treats a condition rather than identifying or analyzing it.
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:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states the device is a "suture-anchor to be used for soft tissue fixation to bone" for procedures like Bankart Repair, SLAP Lesion Repair, and Capsular Repair in the shoulder and hip. This is a surgical implant used directly within the body during a procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on in vitro testing.
Therefore, this device falls under the category of a surgical implant or medical device used for fixation, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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, HWC
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 Biocry18 Rapide "(composite of ß-TCP and PLGA copolymer). Orthocord suture (absorbable polydioxanone (PDS®) and non-absorbable polyethylene braided composite suture) is preloaded on the anchor. The suture incorporates a pre-tied sliding knot (ProKnot knot). 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
Performance requirement of the proposed device is to secure soft tissue to bone to heal. Fixation force testing was conducted under in vitro condition throughout two times of healing period, and substantial equivalence of fixation performance to the predicate device has been confirmed. Material biocompatibility has been also confirmed. The proposed device raises no new issue of safety and efficacy.
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.
BIORAPTOR® Knotless Suture Anchor (K121018, K093428), GRYPHON™ P BR Anchor (K090124, K100012), GRYPHON™ PEEK Anchor (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.
Not Found
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
K132241 (1/2)
MITER SPORTS MEDIC
NOV - 5 2013
510(k) SUMMARY GRYPHON™ ANCHOR w/PROKNOT™ TECHNOLOGY
| Date Summary
| Prepared | July 17, 2013 | |
|---|---|---|
| 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: yfujimal@its.jnj.com | ||
| Name of | ||
| Medical Device | Trade Name: | |
| GRYPHON™ Anchor w/PROKNOT™ Technology | ||
| fastener, fixation, biodegradable, soft tissue | ||
| Common Name: | ||
| Device | ||
| Classification | MAI - Single/multiple component metallic bone fixation appliances and | |
| 미 | ||
| accessories, classified as Class II, regulated per 21 CFR 888.3030. | ||
| HWC - Smooth or threaded metallic bone fixation fastener, Classified as | ||
| ● | ||
| Class II, regulated per CFR 888.3040. | ||
| Orthopedic panel | ||
| 요 | ||
| Predicate | ||
| Device | BIORAPTOR® Knotless Suture Anchor (K121018, K093428) | |
| 트 | ||
| GRYPHON™ P BR Anchor (K090124, K100012) | ||
| 다 | ||
| GRYPHON™ PEEK Anchor (K103712) | ||
| E | ||
| 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 Biocry18 Rapide " | ||
| (composite of ß-TCP and PLGA copolymer). Orthocord suture (absorbable | ||
| polydioxanone (PDS®) and non-absorbable polyethylene braided composite | ||
| suture) is preloaded on the anchor. The suture incorporates a pre-tied sliding | ||
| knot (ProKnot knot). The device is provided as sterile; the device is for single | ||
| patient use only. |
1
( ) DePuy Synthes MITEK SPORTS MEDICINE
comments or folonion gobseries
1
| Comparison of
Technological
Characteristics | Substantial equivalence to the predicate devices has been justified by similarity
of indications, design, material, operation principle and device performance data.
Performance testing ensured that there is no new issue of safety and efficacy. |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Safety and
Performance | Non-clinical Testing
Performance requirement of the proposed device is to secure soft tissue to bone
to heal. Fixation force testing was conducted under in vitro condition throughout
two times of healing period, and substantial equivalence of fixation performance
to the predicate device has been confirmed. Material biocompatibility has been
also confirmed. The proposed device raises no new issue of safety and efficacy. |
| Substantial
Equivalence | Based on technological characteristics comparison and performance evaluation,
the proposed device is concluded to be substantially equivalent to the predicate
devices. |
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of an eagle or bird-like figure, with three curved lines extending from its body.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 5, 2013
DePuy Mitek, a Johnson and Johnson company Ms. Yavoi Fujimaki Regulatory Affairs Senior Associate 325 Paramount Drive Raynham, Massachusetts 02767
- Re: K132241
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, HWC Dated: September 25, 2013 Received: September 26, 2013
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-interstatecommerce 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Erin詞為Keith
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
DePuySynthes
MITEK SPORTS MEDICINE
Indications for Use
510(k) Number (if known): K132241
Device Name: GRYPHON™ ANCHOR w/PROKNOT™ TECHNOLOGY
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
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use __
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices
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