The Intra-Lock Bone Fixation System is indication and fixation of bone graft, bone filling materials, and/or barrier membranes used to regenerate bone in the oral cavity.

Device Description

The Intra-Lock Bone Fixation System consists of titanium alloy self-tapping screws, which are tapered and have a minimum diameter of 1.5mm with lengths of 3mm, 6mm, 7mm, 8mm, 9mm, 10mm and 11mm and a maximum diameter of 2.0mm with lengths of 4mm, 5mm, 9mm, 11mm, 13mm, and 15mm. Tenting screws are also available in the 1.5 mm diameter. The spacer part of the tenting screws is available in 2mm, 6mm, 8mm and 10mm lengths. The screws are manufactured using Ti-6Al-4V alloy (ASTM F-136) and adhere to standards tested under ASTM F-543. This system also includes accessories used to fixate the screws, membranes or bone graft to the host bone including a tapered driver, and a cassette. The screws are designed for removal from the patient after such time when sufficient bone regeneration is demonstrated. The devices are sold non-sterile. Single-use only.

AI/ML Overview

The provided text is a 510(k) summary for the Intra-Lock Bone Fixation System. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting standalone performance studies or clinical trials with acceptance criteria for the new device itself.

Therefore, many of the requested elements about acceptance criteria, sample sizes, ground truth establishment, expert adjudication, or MRMC studies are not applicable and not found within this document. This is typical for 510(k) submissions where reliance on predicate device performance and non-clinical testing for equivalence is key.

However, I can extract information regarding non-clinical performance data and the reason for the absence of clinical data.

Section 1: Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission primarily focused on demonstrating substantial equivalence to a predicate, the document does not present "acceptance criteria" in the traditional sense of a performance study for the new device with specific statistical targets (e.g., sensitivity, specificity). Instead, the performance is evaluated against established standards to show that the new device is as safe and effective as the predicate.

The non-clinical performance tests conducted are:

Acceptance Criteria / Test	Reported Device Performance
Torsion Testing (ASTM F543)	All tested Unifix screws yielded and fractured, whereas the predicate screw head stripped. (This indicates the subject device performed acceptably, though the exact "acceptance criteria" for this comparison aren't quantified beyond observing behavior.)
Axial Pullout Testing (ASTM F543)	No failures of the test specimen were observed. The screw pulled out of the bone foam.
Driving Torque Testing (ASTM F543)	No failures were observed; the screw pulled from the foam block.
Cleaning and Sterilization Testing (ISO 17665-1:2006(R)2013)	The Intra-Lock Bone Fixation System Kit can be steam sterilized to a sterility assurance level of at least 10^-6.
Biocompatibility (ISO 10993)	Not conducted for the implant as materials and manufacturing are identical to previously cleared devices (K130140, K103194). Not conducted for instruments as patient contact materials (medical grade 455 and 7-14 stainless steel) are well-known to be biocompatible.

Section 2: Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated for each mechanical test. The document mentions "All tested Unifix screws" for torsion testing, implying a sufficient number for the test.
Data Provenance: This refers to non-clinical performance data generated by the manufacturer, Intra-Lock International, Inc. It is not patient or human-derived data, so terms like "country of origin" or "retrospective/prospective" are not applicable in this context.

Section 3: Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

Not applicable. For mechanical and sterilization tests, ground truth is established by engineering standards (e.g., ASTM F-543, ISO 17665-1) and internal quality control, not by human experts adjudicating clinical outcomes.

Section 4: Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving reader disagreement. For non-clinical, objective tests, the results of the test itself determine the outcome.

Section 5: If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No. An MRMC study was not done. This device is a bone fixation system, not an imaging or diagnostic AI device that would typically undergo MRMC studies.

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

Not applicable. This device is a physical medical device (screws), not an algorithm or AI software. Therefore, standalone performance in the context of AI is not relevant.

Section 7: The type of ground truth used

For mechanical tests: Engineering specifications and standards (e.g., ASTM F543).
For sterilization: Industry standards (ISO 17665-1).
For biocompatibility: Benchmarking against previously cleared devices and accepted biocompatibility of materials (ISO 10993-1).

Section 8: The Sample Size for the Training Set

Not applicable. This product is a physical bone fixation system, not a machine learning or AI algorithm that requires a "training set."

Section 9: How the Ground Truth for the Training Set Was Established

Not applicable. As stated above, there is no training set for this type of device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized eagle. To the right of that is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with "ADMINISTRATION" underneath.

Intra-Lock International, Inc.

October 26, 2017

Mary L. Jean Regulatory Affairs Manager 6560 West Rogers Circle Bldg. 24 Boca Raton, Florida 33487

Re: K171831

Trade/Device Name: Intra-Lock Bone Fixation System Regulation Number: 21 CFR 872.4880 Regulation Name: Intraosseous Fixation Screw Or Wire Regulatory Class: Class II Product Code: DZL Dated: September 21, 2017 Received: September 27, 2017

Dear Mary L. Jean:

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 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);

{1}------------------------------------------------

Page 2 - Mary Jean

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 contact the Division of Industry and Consumer Education (DICE) 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. 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 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 Industry and Consumer Education (DICE) 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.

Mary S. Runner -S

for

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K171831

Device Name Intra-Lock Bone Fixation System

Indications for Use (Describe)

The Intra-Lock Bone Fixation System is indication and fixation of bone graft, bone filling materials, and/or barrier membranes used to regenerate bone in the oral cavity.

Type of Use (Select one or both, as applicable)

∑ Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary

Intra-Lock Bone Fixation System

K171831

1. Submission Sponsor

Intra-Lock International, Inc.

6560 West Rogers Circle

Bldg. 24

Boca Raton

FL 33487

United States of America

Office Phone: (561) 447.8282

Contact: Mary L. Jean

Title: Regulatory Affairs Manager

2. Date Prepared

10/26/17

3. Device Identification

Trade/Proprietary Name:	Intra-Lock Bone Fixation System
Common/Usual Name:	Bone Fixation System
Classification Name:	Intraosseous Fixation Screw or Wire
Regulation Number:	21 CFR 872.4880
Product Code:	DZL
Device Class:	Class II
Classification Panel:	Dental

4. Legally Marketed Predicate Device(s)

K093719, Pro-Fix Precision Fixation System, OSTEOGENICS BIOMEDICAL, INC. (Primary predicate)

{4}------------------------------------------------

K073342, Salvin Dental Specialties Fixation Screw System, Salvin Dental Specialties,

Inc. (Reference Device)

K130140, Intra-Lock OP Dental Implant, Intra-Lock International (Reference Device)

K103194, Intra-Lock Dental Implant with Blossom, Intra-Lock International (Reference Device)

5. Indication for Use Statement

The Intra-Lock Bone Fixation System is indicated for the stabilization of bone graft, bone filling materials, and/or barrier membranes used to regenerate bone in the oral cavity.

6. Device Description

7. Substantial Equivalence Discussion

The following table compares the Intra-Lock Bone Fixation System to the predicate device with respect to indications for use, principles of operation, technological characteristics, and performance testing. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence. The subject device does not raise any new issues of safety or effectiveness based on the similarities to the predicate device.

Manufacturer	Intra-LockInternational, Inc.	OSTEOGENICSBIOMEDICAL, INC.	Device Comparison
Trade Name	Intra-Lock BoneFixation System	Pro-Fix Precision FixationSystem
510(k) Number		K093719
Product Code	DZL	DZL	Same
Regulation Number	21 CFR 872.4880	21 CFR 872.4880	Same
Regulation Name	Intraosseous FixationScrew or Wire	Intraosseous FixationScrew or Wire	Same
Manufacturer	Intra-LockInternational, Inc.	OSTEOGENICSBIOMEDICAL, INC.	Device Comparison
Trade Name	Intra-Lock BoneFixation System	Pro-Fix Precision FixationSystem
Indications for Use	The Intra-Lock BoneFixation System isindicated for thestabilization and fixationof bone grafts, bonefilling materials, and / orbarrier membranes usedto regenerate bone inthe oral cavity.	The Pro-Fix PrecisionFixation System is usedto stabilize, fixate and/orsupport bone grafts,bone filling materials andor barrier membranesused for the regenerationof bone in the oral cavity	Same
Mechanism of Action	Self-tappingconfiguration (MICROBLOSSOM) incorporatesat least one cuttingsurface on each threadwith self-tapping tip.Screw threads enablesthe implant tocontinually slice throughthe bone with increasedefficiency and minimalforce.	Membrane Fixationscrews and Tentingscrews are designed witha self-drilling tip allowspenetration throughcortical bone without theuse of a mallet or theneed for drilling pilotholes.Bone Fixation screws aredesigned with finer pitch,self-tapping threads thatgive the screws greaterclamping force whileusing less driver torque.	Similar
TechnologyOverview	Self-tappingSquare HeadConfiguration3mm – 15mm Screwlengths1.5mm - 2.0mm Screwdiameter	Self-drillingSelf-tappingCross Head Configuration3mm, 8mm, 10mm,12mm, 14mm Screwlengths1.5mm Screw diameter	Similar
Anatomical Location	Maxilla or mandible	Maxilla or mandible	Same
Material	Titanium alloy Ti-6Al-4V(ASTM F-136)	Titanium alloy Ti-6Al-4V(ASTM F-136)	Same
Manufacturer	Intra-LockInternational, Inc.	OSTEOGENICSBIOMEDICAL, INC.	Device Comparison
Trade Name	Intra-Lock BoneFixation System	Pro-Fix Precision FixationSystem
Sterile	Steam Sterilization byEnd-User	Steam Sterilization byEnd-User	Same
Single-Use	Yes	Yes	Same
Shelf Life	N/A	N/A	Same
Complies with ISO10993-1	Yes	Yes	Same

Table 5A - Comparison of Characteristics

{5}------------------------------------------------

{6}------------------------------------------------

8. Non-Clinical Performance Data

As part of demonstrating safety and effectiveness of Intra-Lock Bone Fixation System and in showing substantial equivalence to the predicate devices that are subject to these 510(k) submissions, Intra-Lock Bone Fixation System completed a number of non-clinical performance tests. The Intra-Lock Bone Fixation System meets all the requirements for overall design, sterilization, and biocompatibility results confirming that the design output meets the design inputs and specifications for the device.

Biocompatibility testing per ISO 10993 was not conducted for the Intra-Lock Bone Fixation implant because the materials and manufacturing methods are identical those used in the Intra-Lock OP Dental Implant (K130140) and the anodization process is identical to that used in the Intra-Lock Dental Implant with Blossom (K103194). All Intra-Lock products are manufactured at Intra-Lock Manufacturing. Biocompatibility testing per ISO 10993-1 was not conducted for the Intra-Lock Bone Fixation instruments because their patient contact materials are medical grade 455 and 7-14 stainless steel which is well-known to be biocompatible in the intended applications

The Intra-Lock Bone Fixation System passed all the mechanical testing in accordance with ASTM F543-13 shown below to support substantial equivalence of the subject device:

Torsion Testing - All tested Unifix screws vielded and fractured whereas the predicate screw head stripped.
Axial Pullout Testing - No failures of the test specimen were observed. The screw pulled out of the bone foam
Driving Torque Testing - No failures were observed; the screw pulled from the foam block
Cleaning and Sterilization Testing - Concluded that the Intra-Lock Bone Fixation System Kit can be steam sterilized to a sterility assurance level of at least 10 $ per ISO 17665-1:2006(R)2013.

{7}------------------------------------------------

9. Clinical Performance Data

There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with proven safety and efficacy for the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.

10. Statement of Substantial Equivalence

By definition, a device is substantially equivalent to a predicate device has the same intended use and the same technological characteristics as the previously cleared predicate device. Or the device has the same intended use and different technological characteristics that can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise additional questions regarding its safety and effectiveness as compared to the predicate device(s).

The Intra-Lock Bone Fixation System, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate device(s).

Regulation Number and Section

§ 872.4880 Intraosseous fixation screw or wire.

(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.