Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the mechanical properties and materials of bone screws for sacroiliac joint fusion, with no mention of AI or ML capabilities.

Therapeutic

No.
The device is intended for sacroiliac joint fusion, which is a surgical procedure to stabilize the joint, not directly for therapy. The screws are orthopedic implants used for mechanical stabilization rather than a therapeutic function like drug delivery or energy application.

Diagnostic

No
The device description indicates it is a fusion system consisting of bone screws for sacroiliac joint fusion, which is a treatment and not a diagnostic function.

SaMD (Software as a Medical Device)

No

The device description clearly states it consists of bone screws made of titanium alloy, which are physical hardware components intended for surgical implantation. There is no mention of software as the primary or sole component of the device.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
Device Description: The PathLoc-SI Joint Fusion System is a system of bone screws intended for surgical implantation into the sacroiliac joint. This is a device used within the body for a structural purpose (fusion).
Intended Use: The intended use is for sacroiliac joint fusion, a surgical procedure.
Lack of Diagnostic Information: The description does not mention any testing of samples or providing diagnostic information.

Therefore, based on the provided information, the PathLoc-SI Joint Fusion System is a surgical implant, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The PathLoc-SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroililtis.

Product codes

OUR

Device Description

PathLoc-SI Joint Fusion System consists of different diameter bone screws in various lengths and thread configurations to accommodate variations in patient anatomy. The material is Titanium alloy (Titanium-6Aluminum-4Vanadium ELI, per ASTM F136) approved for medical use.

· Arch Screw will be implanted in patient's bone then autograft will be inserted.
· Locking Screw can be used with washer or can be used solo
· Self-tapping flute centers screw for easy insertion
· Various choice of Screw Length(30,35,40,45,50,55,60,65,70 mm of Length)

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

sacroiliac joint

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Prescription Use

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

ASTM F543-13 Standard

Torsional test .
Axial pullout test .
Driving torque test(Insertion/Removal) i

ASTM F2193-14 Standard

Static and fatigue bending strength of metallic spinal screw -

Key Metrics

Not Found

Predicate Device(s)

K112240, K021932, K123702, K141246

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked on top of each other.

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

November 14, 2016

L&K Biomed Co., Ltd. Yerim An RA Specialist #201, 202 16-25, Dongbaekjungang-ro 16 beon-gil Giheung-gu, Yongin-si, 446-916 Korea

Re: K153656

Trade/Device Name: PathLoc-SI Joint Fusion System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: OUR Dated: October 12, 2016 Received: October 13, 2016

Dear Yerim An:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

1

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 contact the Division of Industry and Consumer Education 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 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 yours,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K153656

Device Name PathLoc-SI Joint Fusion System

Indications for Use (Describe)

The PathLoc-SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroililtis.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) SUMMARY

The following 510(k) summary is being submitted as required by 21 CFR 807.92(a):

1. Submitter: L&K BIOMED Co., Ltd. #201, 202 16-25, Dongbaekjungang-ro 16 beon-gil Giheung-gu, Yongin-si, Gyeonggi-do, 446-916, Korea Phone. 82-2-6717-1985 e-mail: yerim2706@gmail.com Contact Person: Yerim An
  Date prepared: Nov. 11, 2016

Device Identification 2.

Trade Name	PathLoc-SI Joint Fusion System
Common Name	Sacroiliac Joint Fixation / Sacroiliac Joint Fusion
Product Code	OUR
Regulatory Class	II
Classification Name	21CFR888.3040 Smooth or threaded metallic bone
fixation fastener

Purpose of 510(k) 3.

The L&K BIOMED Co.Ltd, here by submits this traditional 510(k): to register our new product PathLoc-Si Joint Fusion System

Predicate or legally marketed devices which are substantially equivalent 4.

Predicate: K112240 Dyna Locking Cannulated Screw .
Additional Predicate: K021932 Synthes 6.5mm Cannulated Screw .
. Additional Predicate: K123702 SILEX SACROILIAC JOINT FUSION SYSTEM
Additional Predicate: K141246 LIFE SPINE SACROILIAC JOINT . FIXATION SYSTEM

Description of the Device 5.

PathLoc-SI Joint Fusion System consists of different diameter bone screws in various lengths and thread configurations to accommodate variations in patient anatomy. The material is Titanium alloy (Titanium-6Aluminum-4Vanadium ELI, per ASTM F136) approved for medical use.

· Arch Screw will be implanted in patient's bone then autograft will be inserted.
· Locking Screw can be used with washer or can be used solo
· Self-tapping flute centers screw for easy insertion
· Various choice of Screw Length(30,35,40,45,50,55,60,65,70 mm of Length)

4

Materials:

Product	Material	Standard
Arch Screw	Ti-6AI-4V ELI	ASTM F136
Locking Screw	Ti-6AI-4V ELI	ASTM F136
Washer	Ti-6AI-4V ELI	ASTM F136

Indication for Use 6.

The PathLoc-SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroililtis.

Comparison of the technological characteristics of the subject and 7. predicate devices

The PathLoc-SI Joint Fusion System is considered substantially equivalent to other legally marketed devices. They are similar in design, material, and indications for use.

| | Subject Device | Primary predicate
device | Additional predicate
device |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | PathLoc-SI Joint
Fusion System | Synthes 6.5mm
Cannulated Screw | Dyna Locking
Cannulated Screwm |
| Manufacturer | L&K BIOMED Co.,Ltd. | Synthes | U & I Corporation |
| Material | Ti-6Al-4V ELI | Stainless steel and
titanium alloy | Ti-6Al-4V ELI |
| 510(K) No | K153656 | K021932 | K112240 |
| Product Code | OUR | HWC, OUR | HWC |
| Regulation
No. | 21CFR888.3040 | 21CFR888.3040 | 21CFR888.3040 |
| Class | Class II | Class II | Class II |
| Intended Use | The PathLoc-SI Joint
Fusion System is
intended for sacroiliac
joint fusion for
conditions including
sacroiliac joint
disruptions and
degenerative
sacroiliitis. | Synthes 6.5mm
Cannulated Screw is
intended for fracture
fixation of large
bones and large
bone fragments,
such as femoral
neck fractures;
slipped capital
femoral epiphyses;
an adjunct to DHS in
basilar neck
fractures; tibial
plateau fractures;
ankle arthrodesis;
pediatric femoral | Intracapsular
fractures of the
femoral neck
Intertrochanteric
fractures of the
femur
Tibial plateau
fractures
Fractures of the
dorsal pelvic ring
Pelvic sacroiliac joint
disruption
Ankle arthrodesis
Other indications
where cancellous
screws are currently |

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| neck fractures;
intercondylar femur
fractures; SI joint
disruptions; and
subtalar arthrodeses. | used and a guided
system may be
beneficial |
|------------------------------------------------------------------------------------------------------------|--------------------------------------------------|

Performance Testing 8.

ASTM F543-13 Standard

Torsional test .
Axial pullout test .
Driving torque test(Insertion/Removal) i

ASTM F2193-14 Standard

Static and fatigue bending strength of metallic spinal screw -

Conclusion 9.

The PathLoc-SI Joint Fusion System is substantially equivalent to legally marketed predicates.