ASPIRON ACP SYSTEM

K140234 · U&I Corp. · KWQ · Jun 2, 2014 · Orthopedic

Device Facts

• Record ID: K140234
• Device Name: ASPIRON ACP SYSTEM
• Applicant: U&I Corp.
• Product Code: KWQ · Orthopedic
• Decision Date: Jun 2, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ASPIRON™ ACP System is intended for anterior inter-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 fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine,

Device Story

ASPIRON™ ACP System comprises titanium alloy (Ti-6Al-4V ELI) bone plates and screws; used for anterior inter-vertebral fixation of cervical spine (C2-T1). System provides temporary stabilization during fusion. Components are anodized (5% phosphoric acid). Type 2 screws feature full-length threading for insertion. Device used by surgeons in clinical settings via anterior approach. Output is mechanical fixation of vertebral bodies. Benefits include spinal stabilization for various pathologies. Single-use only.

Clinical Evidence

Bench testing only. Compression bending fatigue testing performed per ASTM F1717 to verify mechanical performance equivalence to predicate devices. No clinical data provided.

Technological Characteristics

Materials: Titanium alloy (Ti-6Al-4V ELI) per ASTM F136. Surface treatment: Anodized (5% phosphoric acid, pH 1.5). Components: Bone plates and screws. Mechanical testing: ASTM F1717 compression bending fatigue. Single-use.

Indications for Use

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

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

• Maxima™ Anterior Cervical Plate System (K061002)
• Blackstone™ III° Anterior Cervical Plating System (K012184)
• ZEPHIR™ Anterior Cervical Plate System (K994239)
• Venture™ Anterior Cervical Plate System (K061274)
• INDUS™ INVUE Anterior Cervical Plate System (K121060)
• ASPIRON™ ACP System (K131200)

Submission Summary (Full Text)

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# JUN 0 2 2014

### 6. 510(k) Summary

| Manufacturer: | U & I Corporation<br>20, Sandan-ro 76beon-gil(Rd), Uijeongbu-si, Gyeonggi-do,<br>Korea, 480-859 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | U & I Corporation<br>20, Sandan-ro 76beon-gil(Rd), Uijeongbu-si, Gyeonggi-do,<br>Korea, 480-859 |
| Sponsor Contact: | Young-Geun Kim, Regulatory Affairs Assistant<br>[phone] (ext.619)<br>[e-mail] |
| Date Prepared: | February 18, 2014 |
| Device Name: | Trade Name: ASPIRON™ ACP System |
| Submission Purpose: | To expand the ASPIRON™ ACP System to include shorter<br>plate sizes and introduce new types of bone screw |
| Classification Name: | Spinal Intervertebral Body Fixation Orthosis, per 21 CFR<br>888.3060 |
| Common Name: | Anterior Cervical Plate |
| Product Code: | KWQ |
| Predicate Devices: | Maxima™ Anterior Cervical Plate System (K061002)<br>Blackstone™ III° Anterior Cervical Plating System (K012184)<br>ZEPHIR™ Anterior Cervical Plate System (K994239)<br>Venture™ Anterior Cervical Plate System(K061274)<br>INDUS™ INVUE Anterior Cervical Plate System (K121060)<br>ASPIRON™ ACP System (K131200) |

#### Description of Device:

The ASPIRON™ ACP System consists of a variety of shapes and sizes of bone plates, screws and associated instruments. Fixation is provided by bone screws i inserted into the vertebral body of the cervical spine using an anterior approach. All implant components are made from titanium alloy (Ti-6Al-4V ELI) in accordance with ASTM F136. The main plate and screws are anodized according to the internal process (5% Phospheric acid solution under pH 1.5). The same anodizing process is also applied to the conventional ASPIRON™ ACP System(K131200) and

ASPIRON™ ACP System

Image /page/0/Picture/7 description: The image shows the logo for USI Corporation. The logo features the letters "U" and "S" stacked on top of each other in a bold, stylized font. To the right of the letters is the word "CORPORATION" in a smaller, sans-serif font. The logo is black and white.

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Maxima(K061002). This material is not compatible with other metal alloys. Stainless steel and titanium implant components should not be used together in a construct. Do not use any of the ASPIRON™ ACP System components with the components from any other system or manufacturer. All implants are single use only. The Type 2 of screws and short plates are added to the conventional ASPIRON™ ACP System in this submission. Type 2 screw has thread until the tip of screw for easy insertion.

#### Intended Use:

The ASPIRON™ ACP System is intended for anterior inter-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 fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine,

#### Substantial Equivalence:

The ASPIRON™ ACP System is substantially equivalent to predicate legally marketed devices in design, material, mechanical performance, function and intended use. The mechanical performance of ASPIRON™ ACP System met the acceptance criteria which have been established from the predicate devices.

**CORPORATION**

ASPIRON™ ACP System

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#### 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 ●
- Similar design features .
- Incorporate the same or similar materials
- The equivalent mechanical performance

#### 2. Performance Testing

The ASPIRON™ ACP System was tested in a non clinical setting (bench testing) to assess that to no new safety and efficiency issues were raised with this device. The testing met all acceptance criteria and verifies that performance of the ASPIRON™ ACP System is substantially equivalent to the predicate devices. The compression bending fatigue test was performed according to ASTM F1717.

#### 3. Conclusion

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

**CORPORATION**

ASPIRON™ ACP System

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

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

June 2, 2014

U & I Corporation Mr. Young-Geun Kim Regulatory Affairs Assistant 20, Sandan-ro, 76beon-gil (Rd) Uiieongbu-si. Gyeonggi-do Republic of Korea 480-859

Re: K140234

Tradc/Device Name: ASPIRON™ ACP System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: April 30. 2014 Received: May 5, 2014

Dear Mr. Kim:

We have reviewed your Section 510(k) premarket notification of intent to market the device indicati We have reviewed your Section 910(x) premained institutially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreative to regary mances promotical Device Amendments, or to
commerce prior to May 28, 1976. the enactment date of the Federal Food. Drug commerce prior to May 28, 1970. Inc. Inc. Inc. Inc. Inc. Inc. Federal Food. Drug.
devices that have been reclassified in accordance with any anyakat annual prolices (PMA) devices that have been reclassified in accordance with the provinsity and Claim (PMA).
and Cosmetic Act (Act) that do not require approval of a premiers of the Act. The and Cosmetic Act (Act) that do not require approvate or visions provisions of the Act. The Act. The You may, therefore, market the Act include requirements for annual registration, listing of
general controls provisions of the Act include requires misbranding and general controls provisions of the Act mender reading mishranding and devices, good manufacturing placece, labeling and provins related to contract liability.
adulteration. Please note: CDRH does not evaluate in the putchful and not mislean adulteration. Please note: CDRF does not evaluate in official and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (see above) mito ends ir regulations affecting your device can be
it may be subject to additional controls. Existing major a 988 . In edition, ED it may be subject to additional controls. LASSME major vegan of 800 to 800 may
found in the Code of Federal Regulations, Title 21. Parts 800 to 808 may found in the Code of I cucral Regulations. The Federal Register,

Please be advised that FDA`s issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuance of a subscribe other requirements of the Act
that FDA has made a determination that your device adverse of the Act that FDA has made a delefinination that your acries by other Federal agencies. You must or any Federal statules and regilantons and innied to: registration and listing (21
comply with all the Act's requirements, including, but limited to: reporting of medical comply with all the Act's requirements. Mchamer of a reporting of medical
CFR Part 807); labeling (2) CFR Part 800); medical device reporting of medical CFR Part 807); labeling (21 CFR Part 801); medical do for the reporting (1)
device-related adverse events) (21 CFR 803): good manufacturing practice requirements as set

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#### Page 2 - Mr. Young-Geun Kim

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality bysteins (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 If you desire specific advice for your do nover Education at its toll-free number [phone] or [phone] or at its Internet address

or [phone] or at its michiet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.html (0) 405P But Illips//www.rda.gov/Mications by reference to premarket notification" (2) CFR Part the regulation entitled, "Misolanding of reference to premainment 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 You may oblain other general information on your respension at its toll-free number [phone] or (301)
Division of Industry and Consumer Education at its toll-free numbe 796-7100 or at its Internet address

/90-7100 or at its internet addition of Resourcesfor You/Industry/default.htm.

Sincerely yours,

# 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 Statement

K140234 510(k) Number (if known): -

Device Name: ASPIRON™ ACP System

#### Indications for Use:

The ASPIRON™ ACP System is intended for anterior inter-vertebral screw fixation of the cervical The ASPIRON - ACP System is indicated for temporary stabilization of the anterior spine during spirie at levels C2-11. The System is indication for sewith the following indications:

- Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration . Degenerative U.S. alocuse (to y and radiographic studies);
- Spondylolisthesis
- Trauma (including fractures, dislocation)
- Spinal stenosis
- Tumors
- Turnors
Deformity (defined as scoliosis, kyphosis, or lordosis)
- 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.

Over-The-Counter Use Prescription Use X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE, CDRH)

Anton E. Dmitriev, PhD Division of Orthopedia Devices

**CORPORATION**