SECULOK™ ACP System

K190053 · U&I Corporation · KWQ · Feb 1, 2019 · Orthopedic

Device Facts

• Record ID: K190053
• Device Name: SECULOK™ ACP System
• Applicant: U&I Corporation
• Product Code: KWQ · Orthopedic
• Decision Date: Feb 1, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SECULOK™ ACP System is intended for anterior vertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications: · Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration disc confirmed by patient history and radiographic studies): - · Spondylolisthesis - · Trauma (including fractures, dislocation) - · Spinal stenosis - Tumors - · Deformity (defined as scoliosis, kyphosis, or lordosis - · Pseudoarthrosis - · Failed previous fusion WARNING: The device is not approved for screw attachment or the posterior elements (nedicles) of the cervical, thoracic or lumbar spine.

Device Story

SECULOK™ ACP System consists of titanium alloy bone plates and screws; used for anterior cervical spine fixation (C2-T1). Implanted by surgeons via anterior approach to provide temporary stabilization during fusion. Device components are single-use. Modification from predicate (K182055) involves plate width. System provides mechanical support to vertebral bodies; aids in spinal fusion development; benefits patients by stabilizing spine during healing process.

Clinical Evidence

Bench testing only. Mechanical performance verified via static compression bending, static torsion, and compression bending fatigue tests per ASTM F1717. Results met acceptance criteria of predicate device (K182055).

Technological Characteristics

Materials: Titanium alloy (Ti-6Al-4V ELI) per ASTM F136. Components: Bone plates and screws. Mechanical testing: ASTM F1717 (static compression, torsion, fatigue). Single-use. No software or electronic components.

Indications for Use

Indicated for patients requiring anterior vertebral screw fixation of the cervical spine (C2-T1) for temporary stabilization during fusion. Applicable for degenerative disc disease, spondylolisthesis, trauma (fractures/dislocation), spinal stenosis, tumors, deformity (scoliosis, kyphosis, lordosis), pseudoarthrosis, and failed previous fusion. Contraindicated for posterior element (pedicle) attachment.

Regulatory Classification

Identification

A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.

Predicate Devices

• SECULOK™ ACP System (K182055)
• ASPIRON™ ACP System (K131200, K140234)

Submission Summary (Full Text)

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February 1, 2019

U&I Corporation Kwang-Eun Song Regulatory Affairs Specialist 20. Sandan-ro 76beon-gil(Rd) Uijeongbu-si, Gyeonggi-do 11781 KOREA

Re: K190053

Trade/Device Name: SECULOK™ ACP System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: January 8, 2019 Received: January 11, 2019

Dear Kwang-Eun Song:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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) K190053

111,000

Device Name SECULOK™ ACP System

#### Indications for Use (Describe)

The SECULOK™ ACP System is intended for anterior vertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:

· Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration disc confirmed by patient history and radiographic studies):

- · Spondylolisthesis
- · Trauma (including fractures, dislocation)
- · Spinal stenosis
- Tumors
- · Deformity (defined as scoliosis, kyphosis, or lordosis
- · Pseudoarthrosis
- · Failed previous fusion

WARNING: The device is not approved for screw attachment or the posterior elements (nedicles) of the cervical, thoracic or lumbar spine.

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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## 6. 510(k) Summary

| Manufacturer: | U & I Corporation<br>20, Sandan-ro 76beon-gil(Rd), Uijeongbu-si, Gyeonggi-do,<br>11781, Korea, |
|-------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| Sponsor: | U & I Corporation<br>20, Sandan-ro 76beon-gil(Rd), Uijeongbu-si, Gyeonggi-do,<br>11781, Korea, |
| Sponsor Contact: | Kwang-Eun Song, Regulatory Affairs Specialist<br>[phone]<br>[e-mail] |
| Date Prepared: | January 08, 2019 |
| Device Name: | Trade Name: SECULOKTM ACP System |
| Classification Name: | Spinal Intervertebral Body Fixation Orthosis |
| Common Name: | Anterior Cervical Plate |
| Product Code: | KWQ |
| Predicate Devices: | |
| Primary - SECULOKTM ACP System (K182055)<br>Secondary - ASPIRONTM ACP System (K131200, K140234) | |

## Description of Device:

The SECULOK™ ACP System consists of a variety of shapes and sizes of bone plates, screws and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. All implant components are made from titanium alloy (Ti-6AI-4V ELI) in accordance with ASTM F136. All implants are single use only. The width of plates of to the proposed SECULOK™ ACP System was modified compared to the prior devices (K182055).

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## Indications For Use:

The SECULOK™ ACP System is intended for anterior vertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:

- . Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration disc confirmed by patient history and radiographic studies);
- Spondylolisthesis O
- Trauma (including fractures, dislocation)
- Spinal stenosis O
- O Tumors
- O Deformity (defined as scoliosis, kyphosis, or lordosis)
- O Pseudoarthrosis
- Failed previous fusion

WARNING: The device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

#### Substantial Equivalence:

SECULOK™ ACP System is substantially equivalent to SECULOK™ ACP System (K182055) and ASPIRON™ ACP System (K131200, K140234) in design, material, mechanical performance, function and intended use.

- 1. Comparison Technological Characteristics
The predicate and proposed devices have the similar intended use and basic fundamental scientific technology and share the following similarities;

- The similar indications for use
- O Similar design features
- Incorporate the same materials O
- The equivalent mechanical performance

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### 2. Performance evaluation

The SECULOK™ ACP System was evaluated in a non clinical setting (bench testing) to verify that the data of the proposed devices meet the acceptance criteria of the prior devices (K182055) and no new safety and efficiency issues were raised with this device.

The following tests were performed same as test methods and parameters of the prior system (K182055):

- (1) Static compression bending test according to ASTM F1717
- (2) Static torsion test according to ASTM F1717
- (3) Compression bending fatigue test according to ASTM F1717

The mechanical performance of the proposed devices met the acceptance criteria of the predicate devices (K182055).

The SECULOK™ ACP System is substantially equivalent to predicate devices.

#### 3. Conclusion

The data and information provided in this submission support the conclusion that the SECULOK™ ACP System is substantially equivalent to predicate devices with respect to indications for use and technological characteristics.