(116 days)
No
The summary describes a mechanical suture anchor and its material properties, with no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device, Gryphon T and P BR Anchors, is an absorbable suture anchor used in various orthopedic repairs (e.g., rotator cuff repair, ligament repair). These repairs address injuries or conditions to restore or improve function, which is the definition of a therapeutic device.
No
The device is a surgical anchor used for tissue fixation to bone, not for diagnosing medical conditions. Its intended uses listed are all related to surgical repair and reconstruction.
No
The device description clearly states it is a physical implant (absorbable suture anchors) made of "Biocryl Rapide" material, preloaded on a disposable inserter assembly. This is a hardware device, not software.
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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the Gryphon T and P BR Anchors are absorbable suture anchors intended for the fixation of suture to bone during surgical procedures in various anatomical locations (Shoulder, Foot/Ankle, Knee, Elbow, Hip). This is a surgical implant used in vivo (within the body), not a test performed in vitro (outside the body).
- Lack of IVD Characteristics: The document does not mention any analysis of biological samples, detection of biomarkers, or diagnostic purposes.
Therefore, the Gryphon T and P BR Anchors are medical devices used for surgical repair, not IVDs.
N/A
Intended Use / Indications for Use
- Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction;
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair;
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis;
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction;
Hip: Capsular repair, acetabular labral repair.
Product codes (comma separated list FDA assigned to the subject device)
MAI
Device Description
The proposed Gryphon T and P BR Anchors are absorbable suture anchors manufactured of “Biocryl Rapide” material. The anchor comes preloaded on a disposable inserter assembly and is intended for fixation of size #2 suture to bone. The suture option is provided without needles. The Gryphon T and P BR Anchors are provided as size 3.0 mm. Each Gryphon T or P BR Anchor is provided sterile and 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, Foot/Ankle, Knee, Elbow, 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)
Results of performance and safety testing have demonstrated that the proposed devices are suitable for their intended use.
Verification of the Gryphon BR Anchors includes pull-out performance testing of the sample anchors under real-time aged conditions out to 26 weeks to show that the device meets its product specifications.
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
§ 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
SECTION 2 – 510(k) SUMMARY
APR-30 2010
| Submitter's Name and Address: | DePuy Mitek
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767 |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Ruth Forstadt
Regulatory Affairs Manager
DePuy Mitek, Inc.
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767, USA
Telephone: 508-977-3988
Facsimile: 508-977-6955
e-mail: rforstad@its.jnj.com |
| Name of Medical Device | Classification Name: Single/multiple component metallic bone fixation appliances and accessories
Common/Usual Name: Bone Anchor
Proprietary Name: Gryphon T and P BR Anchors |
| Substantial Equivalence | The proposed Gryphon T and P BR Anchors are substantially equivalent to:
K090124 Gryphon P BR Anchor (March 11, 2009); K073412 Gryphon BR and Healix BR Anchors (January 17, 2008). The proposed Gryphon T and P BR Anchors are also similar to:
K071481 Healix PEEK Anchor (August 09, 2007) |
| Device Classification | These devices carry an FDA product code MAI and are classified as single/multiple component metallic bone fixation appliances and accessories under 21 CFR 888.3030. |
| Device Description | The proposed Gryphon T and P BR Anchors are absorbable suture anchors manufactured of “Biocryl Rapide” material. The anchor comes preloaded on a disposable inserter assembly and is intended for fixation of size #2 suture to bone. The suture option is provided without needles. The Gryphon T and P BR Anchors are provided as size 3.0 mm. Each Gryphon T or P BR Anchor is provided sterile and is for single patient use only. |
| Indications for Use | The proposed Gryphon T and P BR Anchors are intended for:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction;
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair;
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis;
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction;
Hip: Capsular repair, acetabular labral repair. |
| Safety and Performance | Results of performance and safety testing have demonstrated that the proposed devices are suitable for their intended use.
Verification of the Gryphon BR Anchors includes pull-out performance testing of the sample anchors under real-time aged conditions out to 26 weeks to show that the device meets its product specifications.
Based on the indications for use, technological characteristics, and comparison to the predicate devices, the proposed Gryphon T and P BR Anchors have shown to be substantially equivalent to the predicate devices under the Federal Food, Drug and Cosmetic Act. |
Confidential
ﺘﻌﻠﻴﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪ
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DePuy Mitek % Ruth Forstadt Regulatory Affiars Manager 325 Paramount Drive Raynham, MA 02767
APR 3 0 2010
Re: K100012
Trade/Device Name: Gryphon T and P BR Anchors Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: MAI Dated: April 26, 2010 Received: April 27, 2010
Dear Ms. Forstadt:
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.
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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. Ruth Forstadt
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Barbara BucheuD
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K100012 (pg 1/1)
Indications for Use
510(k) Number (if known):
Device Name: Gryphon T and P BR Anchors
Indications for Use:
- Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction;
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair;
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis;
Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction; Elbow:
Hip: Capsular repair, acetabular labral repair.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Smith for nxn
(Division Sign-Off)
Division of Surgical, Orthope and Restorative Devices
Page 1 of 1
510(k) Number K110012
Premarket Notification - Traditional Gryphon T and P BR Anchors - Hip Indication