The Healix Knotless™ Anchor is indicated for use in the following procedures for reattachment of soft tissue to bone: Shoulder - Rotator Cuff - Biceps Tenodesis

Device Description

The proposed Healix Knotless™ Anchor is a once piece implantable cannulated, threaded anchor proposed to secure soft tissue to bone. The anchor is provided loaded on a disposable inserter driver device. The proposed Healix Knotless™ Anchor is molded from absorbable 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.

AI/ML Overview

The provided text describes the DePuy Mitek, Inc. Healix Knotless™ Anchor, a medical device intended for reattachment of soft tissue to bone. The submission is a 510(k) premarket notification, which establishes substantial equivalence to predicate devices, rather than proving de novo safety and efficacy through extensive clinical trials with acceptance criteria directly tied to performance metrics in that context. Therefore, the information provided focuses on demonstrating substantial equivalence through nonclinical testing, rather than reporting against specific clinical acceptance criteria in the manner one might expect for a novel therapeutic device.

Here's an analysis based on the provided document:

Table of Acceptance Criteria and Reported Device Performance:

Feature/Requirement	Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance/Comparison to Predicate
Indications for Use	Same or similar to predicate devices.	Indicated for rotator cuff and biceps tenodesis procedures in the shoulder, similar to the predicate devices.
Technological Characteristics (Design)	Substantially equivalent to predicate devices, with documented differences and justification.	Smaller in length than Arthrex PushLock Anchor (K061863), different thread profile, and has a slot on one side of the anchor wall (Proximal End). These differences are mentioned and presumably addressed to ensure substantial equivalency.
Technological Characteristics (Material)	Same or substantially equivalent materials as predicate devices.	Uses the same absorbable Poly (lactide-co-glycolide) polymer and Tricalcium Phosphate (TCP) material as the predicate DePuy Mitek's Gryphon BR Anchor (K073412).
Mechanical Performance: Insertion Torque	Demonstrates appropriate insertion torque for safe and effective use; comparable to predicate or within acceptable industry standards.	Performed. Results demonstrated safety and performance (implying suitability for the intended use and substantial equivalence to predicates). No specific torque values provided.
Mechanical Performance: Anchor Pullout (at T=0, 6, and 12 week in-vitro physiological aging)	Maintains adequate pullout strength over time, comparable to predicate devices or within acceptable industry standards to secure soft tissue to bone.	Performed. Results demonstrated safety and performance (implying suitability for the intended use and substantial equivalence to predicates). No specific pullout values provided.
Mechanical Performance: Torque to Failure	Demonstrates adequate resistance to torque before failure, comparable to predicate devices or within acceptable industry standards.	Performed. Results demonstrated safety and performance (implying suitability for the intended use and substantial equivalence to predicates). No specific torque values provided.
Material Specifications	Meet specified material requirements, comparable to predicate devices.	Substantially equivalent to predicate DePuy Mitek's Gryphon BR Anchor (K073412).
Packaging	Adequate for maintaining sterility and product integrity; comparable to predicate devices.	Substantially equivalent to predicate DePuy Mitek's Gryphon BR Anchor (K073412).
Sterilization Method	Effective in sterilizing the device without compromising material properties; comparable to predicate devices.	Substantially equivalent to predicate DePuy Mitek's Gryphon BR Anchor (K073412).
Overall Safety and Performance	Demonstrate substantial equivalence to legally marketed predicate devices to ensure safety and effectiveness for its intended use.	Results of performance and safety testing have demonstrated that the proposed device is substantially equivalent to the predicate device.

Sample Size used for the test set and the data provenance:
The document mentions "Product Design Verification activities" including Insertion Torque, Anchor Pullout (at T=0, 6 and 12 week in-vitro physiological aging), and Torque to Failure. However, specific sample sizes for these tests are not provided in the summary. The data provenance is described as "in-vitro physiological aging," implying laboratory testing rather than human or animal studies, and thus the concept of "country of origin of the data" in a patient context is not applicable here.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to the type of nonclinical testing described. These were engineering/mechanical tests on the device itself, not evaluations based on expert interpretation of clinical data or images.
Adjudication method for the test set:
This information is not applicable as the tests were nonclinical mechanical property tests, not assessments requiring adjudication of clinical findings or interpretations.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, an MRMC comparative effectiveness study was not done. The submission is for a medical implant (suture anchor) relying on nonclinical bench testing to demonstrate substantial equivalence to existing devices, not a diagnostic or AI-assisted product requiring human reader evaluation.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
No, this is not an artificial intelligence or algorithmic device. It is a physical implantable medical device.
The type of ground truth used:
For the nonclinical tests, the "ground truth" would be the measured physical properties (e.g., actual pullout strength, torque values, material composition) of the device and its predicate devices, as determined by standardized engineering testing methods.
The sample size for the training set:
This information is not applicable as there is no "training set" in the context of a physical medical device undergoing nonclinical bench testing for 510(k) submission.
How the ground truth for the training set was established:
This information is not applicable for the reasons stated above.

Summary

{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
E-MAIL	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
---------------	---------

・・

Regulation Number and Section

§ 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.