(28 days)
No
The 510(k) summary describes a mechanical suture anchor and suture system, with no mention of AI or ML in the intended use, device description, or performance studies.
Yes.
The device is intended for the repair and reconstruction of soft tissues to bone in various anatomical locations, which are therapeutic medical procedures.
No
The device is described as a "push-in suture anchor... intended for fixation of soft tissue to bone," indicating it is a surgical implant for repair, not a diagnostic tool used to identify or characterize medical conditions.
No
The device description clearly states it is a "push-in suture anchor preloaded on a disposable inserter assembly," indicating it is a physical medical device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a surgical implant for fixing soft tissue to bone in various anatomical locations (Shoulder, Foot/Ankle, Knee, Elbow, Hip). This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The description details a "push-in suture anchor preloaded on a disposable inserter assembly." This is a physical device used in surgery, not a reagent, instrument, or system intended for use in vitro to examine specimens from the human body.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
The device is a surgical implant used for repair and reconstruction, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The GRYPHON® BR Anchor with DYNACORD™ Suture is 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 |
The GRYPHON® PEEK Anchor with DYNACORD™ Suture is intended for:
| Shoulder: | Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid
Repair, Capsular Shift or Capsulolabral Reconstruction |
|-------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Foot/Ankle: | Lateral Stabilization, Medial Stabilization |
| Knee: | Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament
Repair, Iliotibial Band Tenodesis |
| Elbow: | Ulnar or Radial Collateral Ligament Reconstruction |
| Hip: | Capsular Repair, Acetabular Labral Repair |
Product codes
MAI, MBI
Device Description
The GRYPHON® Anchor with DYNACORD™ Suture is a push-in suture anchor
preloaded on a disposable inserter assembly intended for fixation of soft tissue to
bone. The GRYPHON® Anchors with DYNACORD™ Suture are available in
absorbable BR and non-absorbable PEEK materials. The GRYPHON® Anchors with
DYNACORD™ is provided sterile and is for single 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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing has been performed on the proposed device and / or its
predicates. Performance testing included anchor fixation testing and in-vitro testing.
Safety evaluations were conducted to address sterility, packaging, shelf-life testing.
Bacterial endotoxin testing has been completed on representative device and results
have demonstrated that the proposed devices meet the endotoxin limits.
Results of performance testing have demonstrated that the proposed devices are
suitable for their intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
August 3, 2018
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
Medos International SARL % Tatyana Korsunsky Regulatory Affairs Technical Manager DePuy Mitek, a Johnson & Johnson company 325 Paramount Drive Raynham, Massachusetts 02767
Re: K181809
Trade/Device Name: GRYPHON® Anchors with DYNACORD™ Suture 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: July 3, 2018 Received: July 6, 2018
Dear Ms. Korsunsky:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Sarah B. Nelson -S
For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181809
Device Name
GRYPHON® Anchors with DYNACORD™ Suture
Indications for Use (Describe)
The GRYPHON® BR Anchor with DYNACORD™ Suture is 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 |
The GRYPHON® PEEK Anchor with DYNACORD™ Suture is intended for:
| Shoulder: | Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid
Repair, Capsular Shift or Capsulolabral Reconstruction |
|-------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Foot/Ankle: | Lateral Stabilization, Medial Stabilization |
| Knee: | Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament
Repair, Iliotibial Band Tenodesis |
| Elbow: | Ulnar or Radial Collateral Ligament 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)
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510(k) SUMMARY
GRYPHON® Anchors with DYNACORD™ Suture
510k Document Number: K181809
Date Prepared: July 30th, 2018
| Submitter's
Name and
Address | DePuy Mitek
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767 |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Tatyana Korsunsky
Regulatory Affairs Technical Manager
DePuy Mitek, Inc.
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767, USA
Telephone: 508-828-3122
e-mail: tkorsuns@its.jnj.com |
| Name of
Medical Device | Proprietary Name: GRYPHON® Anchor with DYNACORD™ Suture:
a) GRYPHON® BR Anchor with DYNACORD™ Suture
b) GRYPHON® PEEK Anchor with DYNACORD™ Suture
Classification Name: a) Single/multiple component metallic bone fixation
appliances and accessories
b) Smooth or threaded metallic bone fixation fasteners
Common Name: Suture Anchor |
| Substantial
Equivalence | The GRYPHON® Anchors with DYNACORD™ Suture are substantially equivalent
to:
K141259 GRYPHON® Anchors with PERMACORD™ Suture Reference devices: K173859 HEALIX ADVANCE™ Anchors with DYNACORD™ Suture |
| Device
Classification | > GRYPHON® BR Anchor with DYNACORD™ Suture is classified as:
Single/multiple component metallic bone fixation appliances and accessories,
classified as Class II, product code MAI, regulated under 21 CFR 888.3030.
GRYPHON® PEEK Anchor with DYNACORD™ Suture is classified as:
Smooth or threaded metallic bone fixation fasteners, classified as Class II,
product code MBI, regulated under 21 CFR 888.3040 |
| Device
Description | The GRYPHON® Anchor with DYNACORD™ Suture is a push-in suture anchor
preloaded on a disposable inserter assembly intended for fixation of soft tissue to
bone. The GRYPHON® Anchors with DYNACORD™ Suture are available in
absorbable BR and non-absorbable PEEK materials. The GRYPHON® Anchors with
DYNACORD™ is provided sterile and is for single use only. |
| Technological
Characteristics | The proposed GRYPHON® Anchors with DYNACORD™ Suture has the same
anchor materials, design, principle of operation, as well as device assembly,
sterilization method, and shelf life, as predicate GRYPHON® Anchors with
PERMACORD™ Suture (K141259). The DYNACORD™ Suture component is a
non-absorbable suture that conforms to USP, except for oversized diameter. The
DYNACORD™ Suture is designed to resist laxity and minimize gap formation, by
maintaining approximation force (compression). DYNACORD™ Suture on the
GRYPHON® Anchors is the same as the DYNACORD™ Suture on reference
predicate HEALIX ADVANCE™ Anchors with DYNACORD™ Suture
(K173859). |
| Indications for
Use | GRYPHON® BR Anchors with DYNACORD™ Suture are indicated 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
GRYPHON® PEEK Anchors with DYNACORD™ Suture are indicated for:
Shoulder: Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-
Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral
Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair,
Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Elbow: Ulnar or Radial Collateral Ligament Reconstruction
Hip: Capsular Repair, Acetabular Labral Repair. |
4
5
| Non clinical
Testing | Non-clinical testing has been performed on the proposed device and / or its
predicates. Performance testing included anchor fixation testing and in-vitro testing.
Safety evaluations were conducted to address sterility, packaging, shelf-life testing.
Bacterial endotoxin testing has been completed on representative device and results
have demonstrated that the proposed devices meet the endotoxin limits. |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Safety and
Performance | Results of performance testing have demonstrated that the proposed devices are
suitable for their intended use. Based on similarities in the indications for use,
technological characteristics, and performance in comparison to the predicate
devices, the proposed GRYPHON® Anchors with DYNACORD™ Suture has shown
to be substantially equivalent to the predicate devices under the Federal Food, Drug
and Cosmetic Act. |