PathLoc-SI Joint Fusion System

K153656 · L&K BIOMED Co., Ltd. · OUR · Nov 14, 2016 · Orthopedic

Device Facts

• Record ID: K153656
• Device Name: PathLoc-SI Joint Fusion System
• Applicant: L&K BIOMED Co., Ltd.
• Product Code: OUR · Orthopedic
• Decision Date: Nov 14, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

PathLoc-SI Joint Fusion System comprises titanium alloy (Ti-6Al-4V ELI) bone screws of varying diameters, lengths (30-70mm), and thread configurations; includes arch screws, locking screws, and washers. Arch screws implanted in bone to facilitate autograft insertion; self-tapping flutes center screws for insertion. Used by surgeons in clinical settings for sacroiliac joint fusion. System provides mechanical fixation to stabilize the joint, promoting fusion. Benefits include stabilization of joint disruptions and degenerative conditions.

Clinical Evidence

Bench testing only. Performance data includes torsional testing, axial pullout testing, driving torque testing (insertion/removal) per ASTM F543-13, and static/fatigue bending strength testing per ASTM F2193-14.

Technological Characteristics

Material: Ti-6Al-4V ELI (ASTM F136). Components: Arch screws, locking screws, washers. Features: Self-tapping flutes, cannulated design, various lengths (30-70mm). Mechanical fixation principle. Class II device.

Indications for Use

Indicated for patients requiring sacroiliac joint fusion due to sacroiliac joint disruptions or degenerative sacroiliitis.

Regulatory Classification

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.

Predicate Devices

• Dyna Locking Cannulated Screw (K112240)
• Synthes 6.5mm Cannulated Screw (K021932)
• SILEX SACROILIAC JOINT FUSION SYSTEM (K123702)
• LIFE SPINE SACROILIAC JOINT FIXATION SYSTEM (K141246)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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. [phone] e-mail: [e-mail] 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<br>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)

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

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| neck fractures;<br>intercondylar femur<br>fractures; SI joint<br>disruptions; and<br>subtalar arthrodeses. | used and a guided<br>system may be<br>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.