The ACTIVE TM Screw Bone Screw is intended for implantation into prepared bone during orthopaedic surgery when the surgeon determines the need for additional fixation: bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.

The ACTIVE™ Screw Bone Screw is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.

Device Description

The ACTIVE ™ Screw Bone Screws subjected to this premarket notification are 4.5 mm diameter screws available in 5 mm length increments from 20 to 50 mm. The screws are manufactured from titanium alloy and have an expandable thread crest. The implants are single use only devices.

The ACTIVE ™ Screw Bone Screw consists of a screw shank in conjunction with a spiral helical thread crest component. With the spiral helical thread component, the screw has the ability to expand an additional 1 mm after implantation.

The ACTIVE TM Screw Bone Screw is made of wrought titanium 6AI-4V ELI (ASTM F136) and is available in a 4.5 mm diameter size from 20 mm to 50 mm and will be provided non-sterile, and is to be steam sterilized by the end user. Resterilization of screws upon contamination is not recommended.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the "ACTIVE™ Screw Bone Screw" and contains information about its performance testing. However, it does not present acceptance criteria in a quantitative, pass/fail manner with specific numerical targets. Instead, it describes general compliance with existing standards and acceptable results.

Here's a breakdown of the information based on the request:

1. Table of Acceptance Criteria and Reported Device Performance

As specific numerical acceptance criteria are not explicitly stated in the document, I will infer them from the reported testing methods and positive outcomes.

Acceptance Criteria (Inferred)	Reported Device Performance
Mechanical Strength & Performance
Torsional strength comparable to and exceeding minimum required values for comparable screws of the same size per ASTM F543-07 (Method A1).	Exceeded the minimum required values for comparable screws of the same size.
Breaking angle comparable to and exceeding minimum required values for comparable screws of the same size per ASTM F543-07 (Method A1).	Exceeded the minimum required values for comparable screws of the same size.
Acceptable axial pullout strength.	"The results were acceptable."
Acceptable torque in/torque out performance.	"The results were acceptable."
Interaction with Bone
Forces exerted on bone after implantation of helical thread crest are physiologically safe.	"The forces were found to be physiologically safe to the bone."
Damage from removal of thread crest component does not exceed damage from removal of a traditional (predicate) bone screw.	"The damage generated by the removal of the thread crest component did not exceed damage resulting from the removal of a traditional (predicate) bone screw."
Overall function as intended.	"In all instances, the ACTIVE™ Screw Bone Screw functioned as intended."
Biocompatibility
Manufactured from a biocompatible material (wrought titanium 6Al-4V ELI (ASTM F136)).	Manufactured from wrought titanium 6Al-4V ELI (ASTM F136). (This is a material property that implies biocompatibility based on common surgical practice and standards).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not explicitly state the specific number of screws or tests conducted for each performance evaluation (torsion, pullout, torque in/out, bone interaction). It refers to "testing" as a general activity.
Data Provenance: The studies were pre-clinical bench tests. The data is generated from laboratory testing of the device itself, not from human subjects or retrospective/prospective clinical data. Therefore, notions of "country of origin of the data" or "retrospective/prospective" do not apply in the typical sense; the tests were conducted by the manufacturer, Intelligent Implant Systems, LLC.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This question is not applicable to the type of safety and effectiveness testing described in the document. The "ground truth" for mechanical testing is established by engineering standards (e.g., ASTM F543-07) and objective physical measurements rather than expert consensus on medical images or diagnoses.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods like "2+1" or "3+1" are relevant for clinical studies where subjective assessments (e.g., image interpretation) require reconciliation; this document describes objective mechanical performance testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This question is not applicable. The device described is a bone screw, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or evaluation of AI assistance for human readers is irrelevant to this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable. The device is a physical bone screw, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for these performance tests is based on:

Engineering Standards: Specifically, ASTM F543-07 for bone screw testing methods.
Physical Measurements: Objective measurements of torsional strength, breaking angle, axial pullout strength, and force exerted.
Comparative Performance to Predicate Devices: Damage from removal was compared directly to that of "traditional (predicate) bone screw[s]."

8. The Sample Size for the Training Set

This question is not applicable. As a physical medical device (bone screw), there is no "training set" in the context of machine learning or AI models. Performance is evaluated through physical testing.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable, as there is no training set for this device.

Summary

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K121682(Y3)

ОСТ 4 2012

510(k) SUMMARY

Intelligent Implant Systems's ACTIVE™ Screw Bone Screw

Company Name:	Intelligent Implant Systems, LLC
	3300 International Airport Drive, Suite 1100
	Charlotte, NC 28208
	(704) 424-1009
	(704) 424-1011 (fax)

510(k) Contact:	Michael Nutt
	Chief Operations Officer
	(704) 424-1009

Date Prepared:	August 30, 2012
Proprietary Name:	ACTIVETM Screw Bone Screw
Common Name:	Bone Screw
Classification:	21 CFR 888.3040 - Class II
Device Product Code:	HWC: Screw, Fixation Bone
	87 Orthopedics
Predicate Devices:	K961157 - Whiteside Biomechanics Cancellous BoneScrew, K102429, K112772 - Wright Medical TechnologyORTHOLOCTM Bone Screws, K061621 - Synthes (USA)6.5 mm Cancellous Screws

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Device Description:

Intended Use / Indications for Use

The ACTIVE™ Screw Bone Screw is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.

Technological Characteristics

Performance Data

Torsion testing was conducted according to the standard bone screw testing method (Method A1 in ASTM F543-07) and the torsional strength and breaking angle exceeded the minimum required values for comparable screws of the same size. In addition, axial pullout strength testing and torque in/ torque out testing were conducted on the ACTIVE™ Screw Bone Screw and the results were acceptable.

Additional evaluation and testing was undertaken to determine the forces exerted on the bone after implantation of the helical thread crest component and the damage that the removal of the thread crest component may inflict on the surrounding bone. The forces were found to be physiologically safe to the bone and the damage generated by the removal of the thread crest component did not exceed damage resulting from the removal of a traditional (predicate) bone screw.

In all instances, the ACTIVE™ Screw Bone Screw functioned as intended and the testing results observed were acceptable.

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Substantial Equivalence

The ACTIVE ™ Screw Bone Screw is substantially equivalent in design and function to the bone screws marketed by Wright Medical Technology (K102429, K112772), Whiteside Biomechanics (K961157), and Synthes (USA) (K061621). Like the predicate devices, the subject screw is composed of titanium alloy and is used in the same applications where the surgeon determines the need for additional fixation.

Substantial equivalence is shown through mechanical testing, materials information, and comparison of design characteristics. The results show that the subject ACTIVETM Screw Bone Screw can be expected to perform at least as well as the legally marketed predicate ORTHOLOC™ Bone screws, Whiteside Biomechanics Bone Screws, and Synthes (USA) Cancellous Screws

The performance data demonstrate the ACTIVE ™ Screw Bone Screw is as safe and effective as the predicate devices. The ACTIVE ™ Screw Bone Screw has the same or similar intended uses and indications, technological characteristics, and principles of operation as its predicate devices. The differences between the ACTIVE ™ Screw Bone Screw and its predicate devices raise no new issues of safety or effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three swooping lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

OCT 4 2012

Intelligent Implant Systems, LLC % Mr. Michael J. Nutt Chief Operating Officer 3300 International Airport Drive, Suite 100 Charlotte, North Carolina 28208

Re: K121682

Trade/Device Name: Active Bone Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: August 30, 2012 Received: August 31, 2012

Dear Mr. Nutt:

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

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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,

sincerely yours,

for

J. N. Mall

Mark N. Melker Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): K121682

Device Name: ACTIVETM Screw Bone Screw

Intended Use:

Indications for Use:

The ACTIVE™ Screw Bone Screw is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

K121682 510(k) Number

Regulation Number and Section

§ 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.