(20 days)
Not Found
No
The summary describes a mechanical implant (a knotless anchor) and its physical properties and testing. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as an "implantable... anchor designed to secure soft tissue to bone," indicating its direct role in reattaching soft tissue to bone in procedures like rotator cuff repair and biceps tenodesis, which are therapeutic interventions.
No
This device is an anchor used to reattach soft tissue to bone, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a "one piece implantable cannulated, threaded anchor" made of PEEK material, which is a physical hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the reattachment of soft tissue to bone in surgical procedures (specifically rotator cuff and biceps tenodesis). This is a therapeutic/surgical intervention, not a diagnostic test performed on samples from the body.
- Device Description: The device is an implantable anchor made of PEEK material. This is a physical implant used to secure tissue, not a reagent, instrument, or system used to examine specimens from the human body.
- Lack of IVD Characteristics: The description 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 to repair anatomical structures.
N/A
Intended Use / Indications for Use
The Healix Knotless™ Anchor is indicated for use in the following procedures for reattachment of soft tissue to bone:
Shoulder
- . Rotator Cuff
- Biceps Tenodesis
Product codes (comma separated list FDA assigned to the subject device)
MAI, HWC
Device Description
The proposed DePuy Mitek's Healix Knotless™ PEEK Anchor is a one piece implantable cannulated, threaded anchor designed to secure soft tissue to bone. The anchor is provided loaded on a disposable inserter driver device. The proposed anchor is offered in one size. The proposed DePuy Mitek's Healix Knotless™ Anchor is molded with PEEK (Polyetheretherketone) material.
The proposed DePuy Mitek's Healix Knotless™ PEEK Anchor will be provided in one size with outer diameter of 4.75mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder
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)
Product Design Verification and Design Validation activities, such as, Insertion Torque, Anchor Pullout (at T=0), and Torque to Failure were performed on the proposed implant device.
Results of performance and safety testing have demonstrated that the proposed device is substantially equivalent to the predicate devices.
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.
K112249 DePuy Mitek's Healix Knotless™ BR Anchor, K103712 DePuy Mitek's Gryphon PEEK Anchor, KO61863 Arthrex PushLock Anchors
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
HEALIX KNOTLESS™ PEEK ANCHOR PRODUCT: SUBMISSION DATE: NOVEMBER 28", 2011 SUBMISSION LABE: SPECIAL
ATTACHMENT 1
Continues ...
5 I O(k) SUMMARY - Healix KnotlerJ™ Anchor
DEVICE DESCRIPTION
The proposed DePuy Mitek's Healix Knotless™ PEEK Anchor is a one piece implantable cannulated, threaded anchor designed to secure soft tissue to bone. The anchor is provided loaded on a disposable inserter driver device. The proposed anchor is offered in one size. The proposed DePuy Mitek's Healix Knotless™ Anchor is molded with PEEK (Polyetheretherketone) material.
The proposed DePuy Mitek's Healix Knotless™ PEEK Anchor will be provided in one size with outer diameter of 4.75mm.
INDICATIONS FOR USE
The Healix Knotless™ Anchor is indicated for use in the following procedures for reattachment of soft tissue to bone:
Shoulder
- . Rotator Cuff
- Biceps Tenodesis ●
TECHNOLOGICAL CHARACTERSTICS
- The technological characteristics in terms of product design and performance specification; the . proposed DePuy Mitek's Healix Knotless™ PEEK Anchor is substantially equivalent to the predicate DePuy Mitek's Healix Knotless™ BR Anchor, DePuy Mitek's Gryphon PEEK Anchor (K103712) and Arthrex PushLock Anchor (K061863).
- The technological characteristics as it relate to the product design, material specifications, . packaging, indications for use and sterilization method; the proposed Healix Knotless™ Anchor is substantially equivalent to the predicate devices.
The PEEK material utilized in the construct of the proposed device is identical utilized in manufacturing of currently marketed DePuy Mitek's Gryphon PEEK Anchors (K103712).
NONCLINICAL TESTING
Product Design Verification and Design Validation activities, such as, Insertion Torque, Anchor Pullout (at T=0), and Torque to Failure were performed on the proposed implant device.
SAFETY AND PERFORMANCE
Results of performance and safety testing have demonstrated that the proposed device is substantially equivalent to the predicate devices.
Based on the indications for use, technological characteristics, and comparison to predicate devices, the proposed DePuy Mitek's Healix Knotless™ PEEK Anchor has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.
1
Image /page/1/Picture/1 description: The image shows the DePuy Mitek Inc. logo with the tagline "never stop moving". The logo is black and white and features the DePuy name in a bold, sans-serif font. Below the name is the text "Mitek Inc." and "a Johnson & Johnson company" in a smaller font. The tagline is in a cursive font and is located to the right of the logo.
PRODUCT: HEALIX KNOTLESS™ PEEK ANCHOR SUBMISSION DATE: NOVEMBER 28™, 2011 SUBMISSION TYPE: SPECIAL ---------
ATTACHMENT 1
5 I O(k) SUMMARY - Healix Knotlers™ Anchor
SUBMITTER'S NAME AND ADDRESS
DePuy Mitek, Inc. a Johnson & Johnson company 325 Paramount Drive Raynham, MA 02767
CONTACT PERSON
Deep Pal Senior Regulatory Affairs Specialist TELEPHONE 508-828-3359
| 508-628-5555 | |
|---|---|
| FACSIMILE | 508-977-6911 |
| dpal3@its.jnj.com | |
| DATE PREPARED | November 10th, 2011 |
NAME OF MEDICAL DEVICE
COMMON/USUAL NAME . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Suture Anchor
TRADE NAME/PROPRIETARY NAME - NAME - NAME - NAME - SE MA Healix Knotless™ PEEK Anchor
SUBSTANTIAL EQUIVALENCE
The proposed Healix Knotless™ Anchor is substantially equivalent to the following devices.
- · K112249 DePuy Mitek's Healix Knotless™ BR Anchor
- · K103712 DePuy Mitek's Gryphon PEEK Anchor
- · KO61863 Arthrex PushLock Anchors
FDA PRODUCT CODE
MAI, HWC
DEVICE CLASSIFICATION
These types of Anchor devices were originally classified as a Class II medical device by the Orthopedic Review Panel; regulated as 21 CFR 888.3040 Smooth or threaded metallic bone fixation fastener.
FDA PRODUCT CODE: MAI, HWC
COMMON CLASSIFICATION NAME: Screw, Fixation, Bone
2
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, with stylized lines representing its wings and body.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DePuy Mitek, Incorporated a Johnson & Johnson Company % Deep Pal Senior Regulatory Affairs Specialist 325 Paramount Drive Raynham, Massachusetts 02767
DEC 2 0 2011
Re: K113534
Trade/Device Name: Healix Knotless™ PEEK Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MAI, HWC Dated: November 28, 2011 Received: November 30, 2011
Dear Deep Pal:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
forth in the quality systems (OS) 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Erine Keith
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K113534 (111)
| PRODUCT: | HEALIX KNOTLESS PEEK ANCHOR |
|---|---|
| SUBMISSION DATE: | NOVEMBER 28 TH , 2011 |
| SUBMISSION TYPE: | SPECIAL |
ATTACHMENT 2
INDICATIONS FOR USE
| 510(k) Number (if known): | K113534 |
|---|---|
| --------------------------- | --------- |
Device Names: Healix Knotless
TM PEEK Anchor
Indications for Use: The Healix Knotless
TM Anchor is indicated for use in the following procedures for reattachment of soft tissue to bone:
Shoulder
- Rotator Cuff
- Biceps Tenodesis
| 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)
Page 1 of ____
for Mark Melkerson
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
| 510(k) Number | K113534 |
|---|---|
| --------------- | --------- |
.
: