(81 days)
Not Found
No
The 510(k) summary describes a physical implantable device (anchor) and its inserter, with no mention of software, algorithms, or AI/ML capabilities. The performance studies focus on mechanical properties of the anchor.
Yes.
The device is used for "reattachment of soft tissue to bone" in procedures like "Rotator Cuff - Biceps Tenodesis," which directly treats a medical condition or injury.
No
The device is described as an implantable 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 an "implantable cannulated, threaded anchor" made of polymer and TCP, which are physical materials, not software.
Based on the provided information, the Healix Knotless™ Anchor is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the reattachment of soft tissue to bone in surgical procedures (Shoulder - Rotator Cuff - Biceps Tenodesis). This is a therapeutic and structural function within the body.
- Device Description: The device is an implantable anchor made of absorbable materials, designed to secure tissue to bone. This is a physical implant used during surgery.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.) outside the body.
- Providing diagnostic information about a patient's health status.
- Using reagents or assays.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Healix Knotless™ Anchor is a surgical implant used to physically repair tissue within the body.
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 Healix Knotless™ Anchor is a once piece implantable cannulated, threaded anchor rne proposed to secure soft tissue to bone. The anchor is provided loaded on a disposable inserter driver device to seears on the is offered in one size. The proposed Healix Knotless™ Anchor is molded acther The proposable Poly (lactide-co-glycolide) polymer and Tricalcium Phosphate (TCP).
The proposed Healix Knotless™ 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 activities, such as, Insertion Torque, Anchor Pullout (at T=0, 6 and 12 week in-vitro physiological aging), and Torque to Failure were performed on the implant.
Results of performance and safety testing have demonstrated that the proposed device is substantially equivalent to the predicate device.
Based on the indications for use, technological characteristics, and comparison to predicate devices, the proposed Healix Knotless™ Anchor has been shown to be substantially equivalent to predicate device under the Federal Food, Drug and Cosmetic Act.
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.
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
DePuy
Mitek Inc.
• Johnson-Johnson company
never stop moving
PRODUCT: IX KNOTLESS™ ANCHOR SUBMISSION DATE: AUGUST 05 14, 2011 SUBMISSION TYPE: TRADITIONAL
OCT 2 5 2011
ATTACHMENT 1
5 l 0(k) SUMMARY - Healix Knotler/™ 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 |
|---|---|
| FACSIMILE | 508-977-6911 |
| dpal3@its.jnj.com | |
| DATE PREPARED | August 05th, 2011 |
NAME OF MEDICAL DEVICE
COMMON/USUAL NAME Suture Anchor
TRADE NAME/PROPRIETARY NAME
Healix Knotless™ Anchor
SUBSTANTIAL EQUIVALENCE
The proposed Healix Knotless™ Anchor is substantially equivalent to the following devices.
- · KO61863 Arthrex PushLock Anchors
- · K073412 · DePuy Mitek's Gryphon BR Anchor
- K032717, K060830 and K103831
- FDA PRODUCT CODE
MAI, HWC
DEVICE CLASSIFICATION
These types of Interference Screws were originally classified as a Class II medical device by the Orthopedic Review Panel, regulated as 21 CFR 888.3030.
Milagro Interference Screws
FDA PRODUCT CODE: MAI, HWC COMMON CLASSIFICATION NAME: Fastener, fixation, biodegradable, soft tissue
1
KI12249 #/2
Image /page/1/Picture/1 description: The image shows the logo for DePuy Mitek Inc., a Johnson & Johnson company. The logo features a black circle followed by the name "DePuy" in a bold, sans-serif font. Below the name is the text "Mitek Inc." and "a Johnson & Johnson company" in a smaller font. To the right of the logo is the phrase "never stop moving" in a cursive font.
HEALIX KNOTLESS™ ANCHOR SUBMISSION DATE: AUGUST 05™, 2011 SUBMISSION TYPE: TRADITIONAL
ATTACHMENT 1
Continues ...
5 1 0 (k) SUMMARY - Healix Knotler/™ Anchor
DEVICE DESCRIPTION
The proposed Healix Knotless™ Anchor is a once piece implantable cannulated, threaded anchor rne proposed to secure soft tissue to bone. The anchor is provided loaded on a disposable inserter driver device to seears on the is offered in one size. The proposed Healix Knotless™ Anchor is molded acther The proposable Poly (lactide-co-glycolide) polymer and Tricalcium Phosphate (TCP).
The proposed Healix Knotless™ 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 Healix Knotless™ Anchor is substantially equivalent to the predicate Arthrex PushLock Anchor (K061863) except that the proposed Healix Knotless™ Anchor is smaller in length with a different thread profile and has a slot on one side of the anchor wall (Proximal End).
- The technological characteristics as it relate to the product material specifications, packaging, . indications for use and sterilization method; the proposed Healix Knotless™ Anchor is substantially equivalent to the predicate DePuy Mitek's Gryphon BR Anchor (K073412).
The same absorbable Poly (lactide-co-glycolide) polymer and Tricalcium Phosphate (TCP) material is used to manufacture both the predicate (Gryphon BR) and the proposed Healix Knotless™ Anchor.
NONCLINICAL TESTING
Product Design Verification activities, such as, Insertion Torque, Anchor Pullout (at T=0, 6 and 12 week in-vitro physiological aging), and Torque to Failure were performed on the implant.
SAFETY AND PERFORMANCE
Results of performance and safety testing have demonstrated that the proposed device is substantially equivalent to the predicate device.
Based on the indications for use, technological characteristics, and comparison to predicate devices, the proposed Healix Knotless™ Anchor has been shown to be substantially equivalent to predicate device under the Federal Food, Drug and Cosmetic Act.
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 stylized eagle with three stripes representing the three levels of government. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DePuy Mitek, Inc a Johnson & Johnson Company % Deep Pal Senior Regulatory Affairs Specialist 325 Paramount Drive Raynham, Massachusetts 02767
OCT 2 5 2011
Re: K112249
Trade/Device Name: Healix Knotless™ Anchor Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: MAI, HWC Dated: August 5, 2011 Received: August 5, 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 mislcading.
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.
3
Page 2 - Deep Pal
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); 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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Erin d. Keith
Jo Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
"K 112249 (1/1)
ATTACHMENT 2
INDICATIONS FOR USE
| 510(k) Number (if known): | K112249 |
|---|---|
| Device Names: | Healix Knotless™ Anchor |
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
| Prescription Use (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)
Page 1 of _______
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
| 510(k) Number | K112249 |
|---|---|
| --------------- | --------- |
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