ANAX OCT Spinal System

K150570 · U&I Corporation · NKG · Jun 3, 2015 · Orthopedic

Device Facts

• Record ID: K150570
• Device Name: ANAX OCT Spinal System
• Applicant: U&I Corporation
• Product Code: NKG · Orthopedic
• Decision Date: Jun 3, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3075
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

ANAX™ OCT Spinal System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. ANAX™ OCT Spinal System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. In order to achieve additional levels of fixation, ANAX™ OCT Spinal System may be connected to Perfix™ Spinal System and ANAXIN 5.5 Spinal System rods with the rod connectors. Transition rods with differing diameters may also be used to connect ANAX™ OCT Spinal System to Perfix™ Spinal System and ANAX™ 5.5 Spinal System.

Device Story

ANAX™ OCT Spinal System is a posterior spinal fixation system used by surgeons to stabilize the craniocervical junction, cervical spine, and upper thoracic spine. The system comprises polyaxial screws, polyaxial shank screws, hooks, rods, set screws, transverse links, and occipital plates. Components are implanted during spinal surgery to provide rigid immobilization, promoting fusion or restoring spinal integrity in tumor cases. The system is compatible with Perfix™ and ANAX™ 5.5 spinal systems via rod connectors. It is a mechanical implant system; no software or AI components are involved. Benefits include stabilization of spinal segments, reduction of pain, and correction of deformities.

Clinical Evidence

Bench testing only. No clinical data provided. Mechanical performance was validated using worst-case constructs tested per ASTM F2706 (occipito-cervical), ASTM F1717 (thoracic), and ASTM F1798 (subassembly). Tests included static compression bending, static torsion, and axial compression/torsion fatigue testing, as well as axial and torque gripping capacity tests. All results met acceptance criteria.

Technological Characteristics

System components fabricated from medical grade titanium alloy (ASTM F136). Includes polyaxial screws, hooks, rods, set screws, transverse links, and occipital plates. Features self-tapping polyaxial screws. Non-sterile, single-use implants. Specialized surgical instruments made of surgical grade stainless steel. Mechanical fixation principle. No software, electronics, or energy sources.

Indications for Use

Indicated for patients with acute/chronic instabilities of the craniocervical junction, cervical spine (C1-C7), and thoracic spine (T1-T3) requiring immobilization as an adjunct to fusion. Conditions include traumatic fractures/dislocations, instability/deformity, pseudarthrosis, cervical tumors, and degenerative disease (radiculopathy, myelopathy, discogenic pain, facet instability). Also indicated for spinal column integrity restoration in patients with advanced cervical tumors where fusion is not feasible due to limited life expectancy.

Regulatory Classification

Identification

Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

Special Controls

*Classification.* Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use. (2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant. (3) Device components must be demonstrated to be biocompatible. (4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments. (5) Labeling must include the following: (i) A clear description of the technological features of the device including identification of device materials and the principles of device operation; (ii) Intended use and indications for use including levels of fixation; (iii) Device specific warnings, precautions, and contraindications that include the following statements: (A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies ( *e.g.,* CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.” (iv) Identification of magnetic resonance (MR) compatibility status; (v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and; (vi) Detailed instructions of each surgical step, including device removal.

Predicate Devices

• VERTEX ® Reconstruction System (K143471)

Reference Devices

• VERTEX SELECT® Reconstruction System (K123656, K110522)
• Synapse System (K133698)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three faces in profile, stacked on top of each other.

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

June 3, 2015

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

Re: K150570

Trade/Device Name: ANAX™ OCT Spinal System Regulatory Class: Unclassified Product Code: NKG, KWP Dated: March 2, 2015 Received: March 6, 2015

Dear Mr. Kim:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Young-Geun Kim

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/Resourcesfor You/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) K150570

Device Name ANAXTM OCT Spinal System

#### Indications for Use (Describe)

ANAX "MOCT Spinal System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. ANAX™ OCT Spinal System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, ANAX™ OCT Spinal System may be connected to Perfix™ Spinal System and ANAXIN 5.5 Spinal System rods with the rod connectors. Transition rods with differing diameters may also be used to connect ANAX™ OCT Spinal System to Perfix™ Spinal System and ANAX™ 5.5 Spinal System.

| Type of Use (Select one or both, as applicable) |
|---------------------------------------------------------------------------------------------------------------------------------|
| <div><span style="font-size:12px"><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</span></div> |
| <div><span style="font-size:12px"><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</span></div> |

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### 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 Specialist<br>[phone] (ext.619)<br>[e-mail] |
| Date Prepared: | June 02, 2015 |
| Device Name: | ANAX™ OCT Spinal System |
| Classification Name: | Unclassified |
| Common Name: | Occipito-cervico-thoracic spinal fixation system |
| Product Code: | NKG, KWP |
| Primary Predicate<br>Device: | VERTEX ® Reconstruction System (K143471) |
| Reference Devices: | VERTEX SELECT® Reconstruction System (K123656,<br>K110522)<br>Synapse System (K133698) |

### Description of Device:

ANAX™ OCT Spinal System is manufactured by U&I corporation. ANAX™ OCT Spinal System is for fixation the Cervicocranium (Occiput/C2), the true subaxial region (C3/C6), and the cervicothoracic junction (C7 to T2) by one system. The ANAX™ OCT Spinal System consists of polyaxial screws, polyaxial shank screws, hooks, rods, set screws, transverse(cross) links and occipital plate. Connectors are also provided for surgical convenience. ANAX™OCT Spinal System allows surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The singleuse ANAX™ OCT Spinal System components are supplied as non- sterile and are

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fabricated from medical grade titanium alloy (ASTM F136). All polyaxial screws have self-tapping function in the ANAX™ OCT Spinal System. Specialized instruments made from surqical instrument grade stainless steel are available for the application and removal of the ANAX™ OCT Spinal System implants.

## Indications for Use:

ANAX™OCT Spinal System is intended to provide immobilization of spinal segments as an adiunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine(C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g.pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. ANAX™OCT Spinal System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, ANAX™OCT Spinal System may be connected to Perfix™ Spinal System and ANAX™5.5 Spinal System rods with the rod connectors. Transition rods with differing diameters may also be used to connect ANAX™OCT Spinal System to Perfix™ Spinal System and ANAX™ 5.5 Spinal System.

# Substantial Equivalence:

ANAX™ OCT Spinal System is substantially equivalent to VERTEX® Reconstruction System (K143471) in design, material, mechanical performance, function and intended use.

Comparison Technological Characteristics

The predicate and proposed device has the similar intended use, basic fundamental scientific technology, and the following similarities;

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

### Summary of Performance Data:

The mechanical performance of ANAX™ OCT Spinal System met the acceptance criteria which have been established from the predicate device.

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### Performance Testing

ANAX™ OCT Spinal System was tested in a non-clinical setting (bench testing) to assess that no new safety and efficiency issues were raised with this device. All tests met all acceptance criteria and that verifies performance of the ANAX™ OCT Spinal System is substantially equivalent to predicate devices.

The following tests were performed:

- 1) Worst case constructs of the occipito-cervical portion of ANAX™ OCT Spinal System were tested per ASTM F2706.
- . Static compression bending test
- . Static torsion test
- Axial compression fatique test
- Axial torsion fatigue test
- 2) Worst case constructs of the thoracic portion of the ANAX™ OCT Spinal System were tested per ASTM F1717.
- Static compression bending test .
- . Static torsion test
- Axial compression fatique test
- Axial torsion fatique test
- 3) Worst case of subassembly of the ANAX™ OCT Spinal System were tested per ASTM F1798.
- Axial gripping capacity test ●
- . Axial torque gripping capacity test

# Conclusion:

The mechanical testing and published literature support the conclusion that the ANAX™ OCT Spinal System is substantially equivalent to predicate device with respect to indications for use and technological characteristics.