(24 days)
Not Found
No
The 510(k) summary describes a mechanical suture anchor and suture system for soft tissue fixation. There is no mention of any software, algorithms, or data processing capabilities that would suggest the use of AI or ML. The device description focuses on the materials and mechanical function of the anchor and sutures.
No
The device is an anchor with sutures used for soft tissue to bone fixation, which is a medical intervention, but it does not directly treat a disease or condition in the same way a 'therapeutic device' typically implies (e.g., drug delivery, pain relief, or active therapy). Its purpose is to physically secure tissue, facilitating healing, but not providing therapy itself.
No
The device is a surgical anchor with sutures used for soft tissue to bone fixation, not for generating diagnostic information or images.
No
The device description clearly states it is a threaded suture anchor made of physical materials (Biocryl Rapide® and PEEK) and includes a disposable inserter assembly, indicating it is a hardware device.
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 about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description and intended use of the HEALIX ADVANCE Anchor with DYNA+TAPE Sutures clearly state that it is a surgical implant used for soft tissue to bone fixation within the body. It is a physical device used during surgery, not a test performed on a sample outside the body.
The information provided about the device's function, materials, and surgical applications confirms it is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The HEALIX ADVANCE Anchor with DYNA+TAPE Sutures is indicated for use in soft tissue to bone fixation in association with post-operative immobilization as follows:
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 Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
Hip: Capsular Repair, Acetabular Labral Repair
Product codes
MBI, MAI
Device Description
The HEALIX ADVANCE Anchor with DYNA+TAPE Sutures is a threaded suture anchor preloaded on a disposable inserter assembly intended for soft tissue fixation with one strand of #2 DYNACORD Suture and one strand of PERMATAPE Suture to bone. HEALIX ADVANCE with DYNA+TAPE Anchors are available in absorbable Biocryl Rapide® (BR) and non-absorbable PEEK materials. The HEALIX ADVANCE with DYNA+TAPE Sutures 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)
Verification activities were performed on the proposed device and / or its predicates. Performance testing included evaluation of fixation strength following cyclic loading.
The proposed device has been determined to be non-pyrogenic per the requirements set forth in ANSI/AAMI ST-72:2011, United States Pharmacopeia (USP), and European Pharmacopeia (EP) using the bacterial endotoxin testing (BET) method.
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 HEALIX ADVANCE with DYNA+TAPE Anchors has shown to be substantially equivalent to the predicate devices under the Federal Food, Drug and Cosmetic Act.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services - USA logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Medos International SARL % Ashley Goncalo Project Manager - Regulatory Affairs DePuy Synthes Mitek, a Johnson and Johnson Company 325 Paramount Drive Raynham, Massachusetts 02767
Re: K191483
Trade/Device Name: HEALIX ADVANCE™ Anchor with DYNA+TAPE™ Sutures Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI, MAI Dated: June 3, 2019 Received: June 4, 2019
Dear Ashley Goncalo:
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.
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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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Laurence D. Coyne, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K191483
Device Name
HEALIX ADVANCE™ Anchor with DYNA+TAPE™ Sutures
Indications for Use (Describe)
The HEALIX ADVANCE Anchor with DYNA+TAPE Sutures is indicated for use in soft tissue to bone fixation in association with post-operative immobilization as follows:
Shoulder: Rotator Cuff Repair, Bankart 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 Collateral Ligament Reconstruction , 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(K) SUMMARY
HEALIX ADVANCE™ Anchor with DYNA+TAPE™ Sutures
| Submitter's
Name and
Address | DePuy Synthes Mitek Sports Medicine
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767
On behalf of:
Medos International SARL
Chemin-Blanc 38, Le Locle Neuchatel
CH 2400, Switzerland |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Ashley Goncalo
Project Manager, Regulatory Affairs
DePuy Synthes Mitek Sports Medicine
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767
Telephone: 508-977-3907
Email: agoncalo@its.jnj.com |
| Name of Medical
Device | Proprietary Name: HEALIX ADVANCE Anchor with DYNA+TAPE Sutures
a) HEALIX ADVANCE BR Anchor with DYNA+TAPE
Sutures
b) HEALIX ADVANCE PEEK Anchor with
DYNA+TAPE Sutures
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 HEALIX ADVANCE Anchor with DYNA+TAPE Sutures is substantially
equivalent to the predicates:
• K170639 - HEALIX ADVANCE Anchor with PERMATAPE™ Suture
(Primary)
• K173859 - HEALIX ADVANCE Anchor with DYNACORD™ Suture |
| Device
Classification | a) HEALIX ADVANCE BR Anchor with DYNA+TAPE Sutures 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. |
| | b) HEALIX ADVANCE PEEK Anchor with DYNA+TAPE Sutures 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 HEALIX ADVANCE Anchor with DYNA+TAPE Sutures is a threaded
suture anchor preloaded on a disposable inserter assembly intended for soft tissue
fixation with one strand of #2 DYNACORD Suture and one strand of
PERMATAPE Suture to bone. HEALIX ADVANCE with DYNA+TAPE
Anchors are available in absorbable Biocryl Rapide® (BR) and non-absorbable
PEEK materials. The HEALIX ADVANCE with DYNA+TAPE Sutures is
provided sterile and is for single use only. |
| Technological
Characteristics | The proposed HEALIX ADVANCE Anchor with DYNA+TAPE Sutures has the
same anchor materials, design, principle of operation, intended use, sterilization
method, and shelf life, as the predicate HEALIX ADVANCE with DYNACORD
Anchors (K173859) and the predicate HEALIX ADVANCE with PERMATAPE
Anchors (K170639). The PERMATAPE Suture, which is preloaded on the
proposed anchor, is identical to the PERMATAPE Suture which is preloaded on
the predicate HEALIX ADVANCE with PERMATAPE Suture (K170639).
The DYNACORD Suture, which is preloaded on the proposed anchor, is identical
to the suture that is pre-loaded on the predicate HEALIX ADVANCE with
DYNACORD Suture (K173859). |
| Indications for
Use | The HEALIX ADVANCE Anchor with DYNA+TAPE Sutures is indicated for use
in soft tissue to bone fixation in association with post-operative immobilization as
follows:
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 Collateral Ligament Reconstruction,
Radial Collateral Ligament Reconstruction
Hip: Capsular Repair, Acetabular Labral Repair |
| Non-clinical
Testing | Verification activities were performed on the proposed device and / or its
predicates. Performance testing included evaluation of fixation strength following
cyclic loading. |
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The proposed device has been determined to be non-pyrogenic per the requirements set forth in ANSI/AAMI ST-72:2011, United States Pharmacopeia (USP), and European Pharmacopeia (EP) using the bacterial endotoxin testing (BET) method.