SMARTLOC SPINAL FIXATION SYSTEM

K111883 · A-Spine Asia, Co., Ltd. · MNI · Oct 18, 2011 · Orthopedic

Device Facts

• Record ID: K111883
• Device Name: SMARTLOC SPINAL FIXATION SYSTEM
• Applicant: A-Spine Asia, Co., Ltd.
• Product Code: MNI · Orthopedic
• Decision Date: Oct 18, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SmartLoc™ is a spinal fixation system intended to provide immobilization and stabilization of thoracic, lumbar, and sacral spinal segments as an adjunct to fusion. When used as posterior, pedicle screw fixation, the system is intended for the treatment of severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients. In addition, when used as a pedicle screw fixation system in the non-cervical posterior spine (T1 to S2), the system is intended for the treatment of the following acute and chronic instabilities or deformities: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion in skeletally mature patients. When used as a posterior, non-cervical, hook and/or sacral/iliac fixation system (i.e., non-pedicle screw), the SmartLoc™ is intended for the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (as conformed by patient history and radiographic studies), spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, lordosis, spinal stenosis, spinal tumor, pseudarthrosis and failed previous fusion.

Device Story

SmartLoc™ is a spinal fixation system comprising rods, monoaxial/polyaxial pedicle screws, hooks, and transverse connectors with locking set screws. Used by surgeons in clinical settings to provide immobilization and stabilization of thoracic, lumbar, and sacral spinal segments as an adjunct to fusion. Components are selected based on patient anatomy to address spinal instabilities or deformities. System provides mechanical support to the spine, facilitating fusion and potentially reducing pain or neurologic impairment associated with spinal conditions.

Clinical Evidence

Bench testing only. Static compression bending, torsion, and dynamic compression bending performed per ASTM F1717. Results demonstrate mechanical performance equivalent or superior to predicate devices.

Technological Characteristics

Titanium alloy (Ti-6Al-4V) per ISO 5832-3 / ASTM F136. Rod-based fixation system with monoaxial/polyaxial pedicle screws, hooks, and transverse connectors. Mechanical stabilization principle.

Indications for Use

Indicated for skeletally mature patients requiring immobilization/stabilization of thoracic, lumbar, and sacral spinal segments as an adjunct to fusion. Treats severe spondylolisthesis (grades 3-4) at L5-S1 (pedicle screw) and various acute/chronic instabilities including degenerative spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, lordosis, spinal stenosis, spinal tumor, pseudarthrosis, failed fusion, and degenerative disc disease.

Regulatory Classification

Identification

(1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.

Special Controls

*Classification.* (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards; (ii) Compliance with mechanical testing standards; (iii) Compliance with biocompatibility standards; and (iv) Labeling that contains these two statements in addition to other appropriate labeling information: “Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.” “Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.” (2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls: (i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use. (ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant. (iii) Device components must be demonstrated to be biocompatible. (iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments. (v) Labeling must include the following: (A) A clear description of the technological features of the device including identification of device materials and the principles of device operation; (B) Intended use and indications for use, including levels of fixation; (C) Identification of magnetic resonance (MR) compatibility status; (D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and (E) Detailed instructions of each surgical step, including device removal. (3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls: (i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate. (ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.

Predicate Devices

• CD HORIZON® (K031655/K041460)
• Moss Miami (K992168/K022623)
• Synergy VLS (K950099/K974749)
• Optima™ (K024096/K031585/K051971)
• flamenco (K102853)

Submission Summary (Full Text)

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K111883 Page 1 of 2

OCT 1 8 2011

Image /page/0/Picture/2 description: The image contains the logo for A-Spine. The logo features a stylized letter "A" with the word "spire" written in cursive within the letter. To the right of the "A" is the text "A-SPINE" in a bold, sans-serif font. The logo has a professional and modern look.

| 510(k) Summary | |
|-----------------------|-------------------------------------------------------------------|
| Date: | 28 June 2011 |
| Sponsor: | A-SPINE ASIA CO., LTD. |
| | 11F., No. 1, Aly. 30, Ln. 358, Ruiguang Rd., Neihu District, |
| | Taipei, Taiwan |
| | Phone: [phone] |
| | Fax: [phone] |
| Contact Person: | Frank Hsu |
| | A-SPINE ASIA CO., LTD. |
| | 11F., No. 1, Aly. 30, Ln. 358, Ruiguang Rd., Neihu District, |
| | Taipei, Taiwan |
| | [e-mail] |
| | Phone: [phone] |
| | Fax: [phone] |
| Proposed Trade Name: | SmartLoc™ spinal fixation system |
| Device Classification | Class II |
| Classification Name: | Pedicle screw spinal system & Spinal interlaminal fixation |
| | orthosis |
| Regulation: | 888.3070 & 888.3050 |
| Device Product Code: | MNI/MNH & KWP |
| Device Description: | The SmartLoc™ consists of rods, monoaxial and polyaxial |
| | pedicle screws, hooks and transverse connectors with locking |
| | set screws. The components are available in various sizes to |
| | accommodate differing patient anatomy. Rods are available in |
| | one diameter and a variety of lengths. Monoaxial and polyaxial |
| | screws are available in a variety of diameter-length |
| | combinations. Hooks are offered in a variety shapes and |
| | sizes. |
| Intended Use: | The SmartLoc™ is a spinal fixation system intended to provide |
| | immobilization and stabilization of thoracic, lumbar, and sacral |
| | spinal segments as an adjunct to fusion. When used as |
| | posterior, pedicle screw fixation, the system is intended for the |
| | treatment of severe spondylolisthesis (grades 3 and 4) of the |
| | L5-S1 vertebra in skeletally mature patients. In addition, when |
| | used as a pedicle screw fixation system in the noncervical |
| | posterior spine (T1 to S2), the system is intended for the |
| | treatment of the following acute and chronic instabilities or |

SmartLoc™

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. .

| | deformities: degenerative spondylolisthesis with objective<br>evidence of neurologic impairment, fracture, dislocation,<br>spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor,<br>pseudarthrosis and failed previous fusion in skeletally mature<br>patients. When used as a posterior, non-cervical, hook and/or<br>sacral/iliac fixation system (i.e., non-pedicle screw), the<br>SmartLoc™ is intended for the treatment of the following acute<br>and chronic instabilities or deformities: degenerative disc<br>disease (as conformed by patient history and radiographic<br>studies), spondylolisthesis, fracture, dislocation, scoliosis,<br>kyphosis, lordosis, spinal stenosis, spinal tumor,<br>pseudarthrosis and failed previous fusion. |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Materials: | The SmartLoc™ components are manufactured from titanium<br>alloy (Ti-6Al-4V) as described by ISO 5832-3 / ASTM F136. |
| Predicate Devices: | CD HORIZON® (K031655/K041460)<br>Moss Miami (K992168/K022623)<br>Synergy VLS (K950099/K974749)<br>Optima™ (K024096/K031585/K051971)<br>flamenco (K102853) |
| Technological<br>Characteristics: | The SmartLoc™ possesses the same technological<br>characteristics as the predicate devices. These include basic design (rod-based fixation system having monoaxial<br>and polyaxial pedicle screws and various hook shapes and<br>sizes), material (titanium alloy), sizes (rod and screw sizes are encompassed by those offered by the predicate systems) and intended use (as described above). The fundamental scientific technology of the SmartLoc™ is<br>the same as previously cleared devices. |
| Performance Data: | Static compression bending and torsion, and dynamic<br>compression bending of the worst case SmartLoc™ construct<br>was performed according to ASTM F1717. The mechanical<br>test results demonstrated that SmartLoc™ performs as well as<br>or better than the predicate devices. |

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol resembling a bird or abstract human figure with outstretched arms.

OCT 1 8 2011

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

A-Spine Asia, Co., LTD. % Mr. Frank Hsu 11F., No. 1, Aly. 30, Ln. 358 Ruiguang Rd., Neihu District, Taipei Taiwan

Re: K111883

Trade/Device Name: SmartLoc" spinal fixation system Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal ssytem Regulatory Class: II Product Code: MNI, MNH, KWP Dated: September 14, 2011 Received: September 15, 2011

Dear Mr. Hsu:

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

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Page 2 - Mr. Frank Hsu

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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Eunel Keith

ForMark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

510(k) Number:_K111883

Device Name: SmartLoc™ spinal fixation system Indications for Use:

The SmartLoc™ is a spinal fixation system intended to provide immobilization and stabilization of thoracic, lumbar, and sacral spinal segments as an adjunct to fusion. When used as posterior, pedicle screw fixation, the system is intended for the treatment of severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients. In addition, when used as a pedicle screw fixation system in the non-cervical posterior spine (T1 to S2), the system is intended for the treatment of the following acute and chronic instabilities or deformities: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, spinal tumor, pseudarthrosis and failed previous fusion in skeletally mature patients. When used as a posterior, non-cervical, hook and/or sacral/iliac fixation system (i.e., nonpedicle screw), the SmartLoc™ is intended for the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (as conformed by patient history and radiographic studies), spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, fordosis, spinal stenosis, spinal tumor, pseudarthrosis and failed previous fusion.

Prescription Use X (21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

SmartLoc™

KIII883 510(k) Number___

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