PathLoc-SI Joint Fusion System

K181600 · L&K BIOMED Co., Ltd. · OUR · Jul 16, 2018 · Orthopedic

Device Facts

• Record ID: K181600
• Device Name: PathLoc-SI Joint Fusion System
• Applicant: L&K BIOMED Co., Ltd.
• Product Code: OUR · Orthopedic
• Decision Date: Jul 16, 2018
• Decision: SESE
• Submission Type: Special
• 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 sacroiliitis.

Device Story

PathLoc-SI Joint Fusion System is a metallic bone fixation system for sacroiliac joint fusion. Device consists of arch screws, locking screws, and washers. Arch screws are implanted into bone to facilitate autograft insertion; locking screws provide fixation, optionally with washers. Self-tapping flutes assist in screw centering and insertion. System accommodates variations in patient anatomy through multiple diameters and lengths. Used by surgeons in clinical settings to stabilize the sacroiliac joint, promoting fusion to alleviate pain and instability associated with joint disruptions or degenerative sacroiliitis.

Clinical Evidence

No clinical data. Performance testing was limited to bench testing per ASTM F543-13 (torsional, axial pullout, and driving torque tests) and ASTM F2193-14 (static and fatigue bending strength of metallic spinal screws).

Technological Characteristics

Constructed from Titanium-6Aluminum-4Vanadium ELI (ASTM F136). System includes arch screws, locking screws, and washers. Features self-tapping flutes. Mechanical fixation device; no energy source or software components.

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

• PathLoc-SI Joint Fusion System (K153656)

Submission Summary (Full Text)

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July 16, 2018

L&K BIOMED Co., Ltd. Ms. Jihyeon Seo Regulatory Affairs Associate #201, 202 16-25, Dongbaekjungang-ro 16 beon-gil Giheung-gu, Yongin-si, Gyeonggi-do, 17015 KOREA

Re: K181600

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: June 15, 2018 Received: June 18, 2018

Dear Ms. Seo:

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);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Ronald P. Jean -S

for 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) K181600

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 sacroiliitis.

| 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, 17015, Korea Phone: [phone] e-mail: [e-mail] Contact Person: Jihyeon Seo Date prepared: June 15th, 2018
#### 2. Device Identification

| Trade Name | PathLoc-SI Joint Fusion System |
|---------------------|-----------------------------------------------------------------------|
| Common Name | Sacroiliac Joint Fixation / Sacroiliac Joint Fusion |
| Product Code | OUR |
| Regulatory Class | II |
| Classification Name | 21 CFR 888.3040 Smooth or threaded metallic bone<br>fixation fastener |

#### 3. Purpose of 510(k)

The L&K BIOMED Co. Ltd. hereby submits this special 510(k): to register additional size and additional components of the PathLoc-SI Joint Fusion System

#### Predicate or legally marketed devices which are substantially equivalent 4.

- Primary Predicate(unmodified device): K153656 PathLoc-SI Joint Fusion 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 on its own
- · Self-tapping flute centers screw for easy insertion

## Materials:

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

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#### Indication for Use 6.

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

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

The PathLoc-SI Joint Fusion System is considered substantially equivalent to the unmodified device (PathLoc-SI Joint Fusion System, K153656). They are similar in design and have the same material, and the same indications for use.

| | Subject Device | Predicate Device<br>(unmodified) |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | PathLoc-SI Joint Fusion<br>System | PathLoc-SI Joint Fusion<br>System |
| Manufacturer | L&K BIOMED Co.,Ltd. | L&K BIOMED Co.,Ltd. |
| Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
| 510(K) No | | K153656 |
| Product Code | OUR | OUR |
| Regulation<br>No. | 21CFR888.3040 | 21CFR888.3040 |
| Class | Class II | Class II |
| Intended Use | The PathLoc-SI Joint Fusion<br>System is intended for<br>sacroiliac joint fusion for<br>conditions including sacroiliac<br>joint disruptions and<br>degenerative sacroililtis. | The PathLoc-SI Joint Fusion<br>System is intended for<br>sacroiliac joint fusion for<br>conditions including sacroiliac<br>joint disruptions and<br>degenerative sacroililtis. |

#### Performance Testing 8.

ASTM F543-13 Standard

- । Torsional test
- Axial pullout test -
- Driving torque test(Insertion/Removal) -

ASTM F2193-14 Standard

- Static and fatigue bending strength of metallic spinal screw -
#### 9. Conclusion

The PathLoc-SI Joint Fusion System is substantially equivalent to the unmodified device (K153656)