LOSPA IS PEDICLE SCREW (MONOAXIAL & POLYAXIAL), LOSPA IS ROD- STRAIGHT (STANDARD), LOSPA IS ROD- PRE BENT (STANDARD & BU

K132644 · Corentec Co., Ltd. · MNI · Sep 19, 2013 · Orthopedic

Device Facts

• Record ID: K132644
• Device Name: LOSPA IS PEDICLE SCREW (MONOAXIAL & POLYAXIAL), LOSPA IS ROD- STRAIGHT (STANDARD), LOSPA IS ROD- PRE BENT (STANDARD & BU
• Applicant: Corentec Co., Ltd.
• Product Code: MNI · Orthopedic
• Decision Date: Sep 19, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LOSPA IS Spinal Systems are 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). When used as an anterior screw fixation system, the LOSPA IS Spinal Systems are indicated for patients with degenerative disc disease which is defined as back pain of the discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, pseudarthrosis, or revision of failed fusion attempts.

Device Story

Pedicle screw spinal system for immobilization and stabilization of thoracic, lumbar, and sacral spine segments. Components include monoaxial/polyaxial pedicle screws, straight/prebent rods, and rod links. Rods available in 5.5mm diameter; configurations include standard and bullet-nosed ends to facilitate soft tissue navigation. Materials include titanium alloy (ASTM F 136) and CoCrMo alloy (ASTM F 1537). System is non-sterile; requires hospital-based sterilization. Used by surgeons in clinical/OR settings to treat spinal instabilities, deformities, and degenerative disc disease. Provides mechanical support to spinal segments to facilitate fusion. Benefits include structural stabilization of the spine in patients with acute/chronic conditions.

Clinical Evidence

Bench testing only. Static and dynamic mechanical testing performed in accordance with ASTM F1717 and ASTM F1798 standards to evaluate structural integrity and performance compared to predicate devices.

Technological Characteristics

Components: Pedicle screws (4.0-8.5mm diameter, 20-55mm length), straight/prebent rods (5.5mm diameter), rod links. Materials: Titanium alloy (ASTM F 136), CoCrMo alloy (ASTM F 1537). Mechanical fixation via pedicle screws and rods. Non-sterile, requires hospital sterilization. No software or electronic components.

Indications for Use

Indicated for skeletally mature patients requiring spinal immobilization/stabilization as an adjunct to fusion for thoracic, lumbar, and sacral spine conditions including severe spondylolisthesis (L5-S1), degenerative spondylolisthesis with neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudarthrosis, spinal stenosis, and failed previous fusion.

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

• AEGIS & AEGIS II Spinal Systems (K092076)
• Synergy VLS (K974749, K081952)
• Moss Miami (K022623, K964024)
• OPTIMA (K031585, K071880)
• Rogozinski Spinal Rod System (K983904)
• APEX Spine System CoCr Rods (K102488)
• Firebird Cobalt Chrome Rod (K092624)
• EXPEDIUM Spine System (K130877)

Submission Summary (Full Text)

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# 510(K) SUMMARY Corentec Co., Ltd. LOSPA IS Spinal System 22nd Aug, 2013

SEP 19 2013

# ADMINISTRATIVE INFORMATION

| Manufacturer | Corentec Co., Ltd. |
|------------------|---------------------------------------------------|
| | 247 Giro-ri, Ipjang-myeon, Seobuk-Gu |
| | Cheonan-si, Chungchongnam-do, 331-822 South Korea |
| | Telephone: [phone] |
| | Fax: [phone] |
| Official Contact | J.S. Daniel |
| | Project Engineer/Manager - RA & QA |
| | Corentec Co., Ltd |
| | 8th Chungho Tower, 748-1 Banpo 1 Dong |
| | Seocho Gu, Seoul. Korea 137-040 |
| | Ph: [phone] |
| | Fax: [phone] |
| | Email: [e-mail] |

# DEVICE NAME AND CLASSIFICATION

| Trade/Proprietary Name: | LOSPA IS Spinal System |
|-----------------------------|---------------------------------|
| Common Name: | Pedicle Screw Spinal System |
| Classification Regulations: | 21 CFR 888.3070 |
| Regulatory Class: | Class II |
| Product Codes: | MNI, MNH, KWQ |
| Classification Panel: | Orthopedic Products Panel |
| Reviewing Branch: | Posterior Spinal Devices Branch |

#### INTENDED USE

The LOSPA IS Spinal Systems are 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,

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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; spinal tumor; and failed previous fusion (pseudarthrosis).

When used as an anterior screw fixation system, the LOSPA IS Spinal Systems are indicated for patients with degenerative disc disease which is defined as back pain of the discogenic origin with degeneration of the disc confirmed by history and radiographic studies, Spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, pseudarthrosis. or revision of failed fusion attempts.

#### DEVICE DESCRIPTION

・

LOSPA IS Spinal System cleared under K092076 is modified for inclusion of 5.5 diameter rods. The rod link (type -B) & pedicle screws are also modified to include 5.5 diameter rods. The rods are available in straight and pre bent configurations for optimal anatomical adjustment. The rod ends are either flat or bullet nosed. The bullet nose might eases navigation through soft tissue. The subject and predicate devices are similar in design, material, specification and manufacturing and are not altered and remain the same as discussed in K092076. Only the prebent rod is additionally available in CoCrMo alloy. The set screw used in the pedicle screw in is the same as approved in K092076, made up of Ti alloy (ASTM F 136) and can be used with both 5.5 mm and 6.0 mm rod system.

The LOSPA IS spinal system is this submission comprises of the following components,

- A. Pedicle Screws (Monoaxial & Polyaxial), standard and guided types, with screw diameters from 4.0 mm to 8.5 mm and length ranging from 20 mm to 55 mm. made up of Titanium Alloy (ASTM F 136).
- B. Straight Rods of diameter of 5.5 mm (Standard) made up of Titanium Alloy (ASTM F 136).
- C. Prebent Rods of diameter 5.5 mm (Standard & Bullet types) made up of Titanium . Alloy (ASTM F 136) & CoCr (ASTM F 1537)
- D. Rod link 5.5 (Type B) made up of Titanium Alloy (ASTM F 136).

All the components are manufactured from medical grade titanium alloy (ASTM F 136) & CoCrMo alloy (ASTM F 1537).

#### SUBSTANTIAL EQUIVALENCE

The LOSPA IS Spinal System is similar to the 510(k) cleared devices as mentioned below with respect to indications, design, operating principles and material.

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- AEGIS & AEGIS II Spinal Systems (Renamed as LOSPA IS Spinal System) . cleared under K092076, manufactured by Corentec Co., Ltd.
- Synergy VLS cleared under K974749 (& K081952), manufactured by Biomet . Spine (Interpore Cross International)
- Moss Miami cleared under K022623(& K964024). manufactured by DePuy . Acromed ·
- OPTIMA cleared under K031585 (& K071880), manufactured by U & 1 . Corporation.
- Rogozinski Spinal Rod System, cleared under K983904, manufactured by United ● States Surgical Corporation
- APEX Spine System CoCr Rods, cleared under K102488, manufactured by o SpineCraft,LLC
- Firebird Cobalt Chrome Rod, cleared under K092624, manufactured by . Blackstone Medical. Inc.
- EXPEDIUM Spine System. cleared under K130877. manufactured by DePuy .

## PERFORMANCE DATA

Corentec's LOSPA IS Spinal System modified components were subjected to a series of testing protocols to document the performance of the components to demonstrate substantial equivalence. The performance testing was conducted as per international standards, ASTM F1717 & ASTM F1798. The static and dynamic testing results demonstrated that the subject device performed either similar or better than comparable predicate devices, there by establishing substantial equivalence for performance.

## STERILIZATION & PACKAGING

Similar to the predicate devices, the LOSPA 1S Spinal System components are supplied non sterile. Hence all implants and instruments used in the surgery must be sterilized by the hospital, prior to use, as mentioned in the IFU.

Any differences in technological characteristic between the subject and predicate devices do not raise new issues of safety or efficacy. Overall. the LOSPA IS Spinal Systems has the following similarities to the predicate devices:

- Has the same intended use. .
- Use the same operating principles. .
- Incorporate the same basic designs, o
- Incorporate same/similar materials, and .
- Has similar packaging materials and processes. .

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's name around the perimeter. In the center of the logo is an abstract symbol that resembles a person with outstretched arms. The logo is black and white.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

September 19, 2013

Corentec Company, Limited Mr. J.S. Daniel Project Engineer / Manager - RA & QA 8th Chungho Tower, 748-1 Banpo 1 Dong Seocho Gu. Seoul 137-040 South Korea

Re: K132644

Trade/Device Name: LOSPA IS Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI, MNH, KWQ Dated: August 23, 2013 Received: August 26, 2013

Dear Mr. Daniel:

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

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#### Page 2 - Mr. J.S. Daniel

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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 Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm1.

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

510(k) Number (if known): K132644

Device Name: LOSPA IS Spinal System

The LOSPA IS Spinal Systems are 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 turnor; and failed previous fusion (pseudarthrosis).

When used as an anterior screw fixation system, the LOSPA IS Spinal Systems are indicated for patients with degenerative disc disease which is defined as back pain of the discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scollosis, kyphosis, lordosis, tumor, pseudarthrosis, or revision of failed fusion attempts.

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

Over-The Counter Use: (Per 21 CFR 801 Subpart C)

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

Concurrence of Center for Devices and Radiological Health (CDRH)

# Colin O'Neill

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K132644