LnK Posterior Cervical Fixation System

K143278 · L&K BIOMED Co., Ltd. · KWP · Jul 29, 2015 · Orthopedic

Device Facts

• Record ID: K143278
• Device Name: LnK Posterior Cervical Fixation System
• Applicant: L&K BIOMED Co., Ltd.
• Product Code: KWP · Orthopedic
• Decision Date: Jul 29, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LnK Posterior Cervical Fixation System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies) Spondylolisthesis Spinal stenosis Fracture/dislocation Failed previous fusion Tumors The implants are intended to provide stabilization as an adjunct to fusion when used with autogenous bone graft or allograft following the reduction of fractures/dislocations or trauma in the spine. Hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (CI-T3) spine. The pedicle screws are limited to placement in T1-T3 in treating thoracic conditions only. The pedicle screws are not intended to be placed in or treat conditions involving the cervical spine.

Device Story

Top-loading, posterior spinal fixation system; includes polyscrews, reduction screws, rods (straight, curved, transitional), set screws, and hooks. Used in open surgical approach by surgeons to provide spinal stabilization as adjunct to fusion. Implants stabilize spine following reduction of fractures, dislocations, or trauma. System components are implanted to support bone graft or allograft fusion. Benefits include mechanical stabilization of cervical/upper thoracic spine segments.

Clinical Evidence

Bench testing only. Static compression bending testing performed per ASTM F1717.

Technological Characteristics

Materials: Ti-6Al-4V ELI (ASTM F136) and Cobalt-28Chromium-6Molybdenum-4Vanadium ELI (ASTM F1537). Top-loading, multi-component posterior spinal fixation system. Components include screws, rods, and hooks. No software or electronic components.

Indications for Use

Indicated for patients with DDD, spondylolisthesis, spinal stenosis, fracture/dislocation, failed previous fusion, or tumors in the cervical/upper thoracic (C1-T3) spine. Pedicle screws limited to T1-T3 thoracic conditions only; not for cervical spine use.

Regulatory Classification

Identification

A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.

Predicate Devices

• LnK Posterior Cervical Fixation System (K120879)

Submission Summary (Full Text)

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July 29, 2015

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

L&K BIOMED Company, Limited Ms. Yerim An #201, 202 16-25, Dongbaekjungang-ro 16 beon-gil Giheung-gu, Yongin-si Gyeonggi-do, 446-916 Republic of Korea

Re: K143278

Trade/Device Name: LnK Posterior Cervical Fixation System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP, MNI Dated: July 3, 2015 Received: July 6, 2015

Dear Ms. An:

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

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Page 2 - Ms. Yerim An

(21 CFR Part 807); labeling (21 CFR Part 801); medical device 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 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/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 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) K143278

#### Device Name

LnK Posterior Cervical Fixation System

Indications for Use (Describe)

The LnK Posterior Cervical Fixation System is indicated for the following:

- DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)

- Spondylolisthesis
- Spinal stenosis
- Fracture/dislocation
- Failed previous fusion
- Tumors

The implants are intended to provide stabilization as an adjunct to fusion when used with autogenous bone graft or allograft following the reduction of fractures/dislocations or trauma in the spine.

Hooks and rods are also intended to provide stabilization following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (CI-T3) spine.

The pedicle screws are limited to placement in T1-T3 in treating thoracic conditions only. The pedicle screws are not intended to be placed in or treat conditions involving the cervical 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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## 510(k) SUMMARY

The following 510(k) summary is being submitted as required by 21 CFR 807.92(a):

| 1. | Submitter: | L&K BIOMED Co., Ltd.<br>#201, 202 16-25, Dongbaekjungang-ro 16 beon-gil<br>Giheung-gu, Yongin-si, Gyeonggi-do, 446-916,<br>Korea<br>Phone. [phone]<br>FAX .[phone] |
|----|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Yerim An |
| | Date prepared: | July 24, 2015 |

#### Device Identification 2.

| Trade Name | LnK Posterior Cervical Fixation System |
|---------------------|--------------------------------------------------------------------------------------------------|
| Common Name | Spinal Fixation System |
| Product Code | KWP, MNI |
| Regulatory Class | II |
| Classification Name | 21CFR888.3050 Spinal Interlaminal Fixation Orthosis<br>21CFR888.3070 Pedicle Screw Spinal System |

## 3. Purpose of 510(k)

The L&K BIOMED Co.Ltd, here by submits this traditional 510(k): device modification to request a modification for our LnK Posterior Cervical Fixation System. The modifications are adding sizes and additional components.

## 4. Primary Predicate or legally marketed devices which are substantially equivalent

- Primary predicate: L&K BIOMED Co.,Ltd. / LnK Posterior Cervical Fixation System (K120879)
## 5. Description of the Device

The LnK Posterior Cervical Fixation System is a top-loading, multiple component, posterior (cervical-thoracic) spinal fixation system which consists of polyscrew, Reduction poly screw, partially screw, semi-reduction partially screw, straight rod, curved rod, transitional rod, set screw and hooks that can be used via an open surgical approach.

#### Materials:

| Product | Material | Standard |
|----------------|---------------------------------------------|------------|
| Cervical Screw | Ti-6Al-4V ELI | ASTM F136 |
| Rod | Ti-6Al-4V ELI | ASTM F136 |
| | Cobalt-28Chromium-6Molybdenum-4Vanadium ELI | ASTM F1537 |

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| Hook | Ti-6Al-4V ELI | ASTM F136 |
|-----------|---------------|-----------|
| Set Screw | Ti-6Al-4V ELI | ASTM F136 |

Any implant components other than the rods are not manufactured from cobalt chrome.

#### 6. Indication for use

The LnK Posterior Cervical Fixation System is indicated for the following:

- DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient . history and radiographic studies)
- . Spondylolisthesis
- Spinal stenosis
- Fracture/dislocation
- Failed previous fusion
- . Tumors

The implants are intended to provide stabilization as an adjunct to fusion when used with autogenous bone graft or allograft following the reduction of fractures/dislocations or trauma in the spine.

Hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (CI-T3) spine.

The pedicle screws are limited to placement in T1-T3 in treating thoracic conditions only. The pedicle screws are not intended to be placed in or treat conditions involving the cervical spine.

## 7. Comparison of the technological characteristics of the subject and predicate devices

The LnK Posterior Cervical Fixation System is considered substantially equivalent to other legally marketed devices. They are similar in design, material, and indications for use.

| No | Item | LnK Posterior Cervical Fixation System | LnK Posterior Cervical Fixation System (Primary Predicate) |
|----|---------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Manufacturer | L&K BIOMED Co., Ltd. | L&K BIOMED Co., Ltd. |
| 2 | Material | Ti-6Al-4V ELI and CoCrMo alloy | Ti-6Al-4V ELI |
| 3 | 510(K) number | K143278 | K120879 |
| 4 | Product Code | MNI, KWP | MNI, KWP |
| 5 | Class | ClassIl | ClassIl |
| 6 | Intended Use | The LnK Posterior Cervical<br>Fixation System is indicated for<br>the following:<br>• DDD (neck pain of<br>discogenic origin with<br>degeneration of the disc as<br>confirmed by patient history<br>and radiographic studies) | The LnK Posterior Cervical<br>Fixation System is indicated for<br>the following:<br>• DDD (neck pain of<br>discogenic origin with<br>degeneration of the disc as<br>confirmed by patient history<br>and radiographic studies) |

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| Spondylolisthesis Spinal stenosis Fracture/dislocation Failed previous fusion Tumors The implants are intended to provide stabilization as an adjunct to fusion when used with autogenous bone graft or allograft following the reduction of fractures/dislocations or trauma in the spine. Hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (CI-T3) spine. The pedicle screws are limited to placement in T1-T3 in treating thoracic conditions only. The pedicle screws are not intended to be placed in or treat conditions involving the cervical spine. | Spondylolisthesis Spinal stenosis Fracture/dislocation Failed previous fusion Tumors The implants are intended to provide stabilization as an adjunct to fusion when used with autogenous bone graft or allograft following the reduction of fractures/dislocations or trauma in the spine. Hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (CI-T3) spine. The pedicle screws are limited to placement in T1-T3 in treating thoracic conditions only. The pedicle screws are not intended to be placed in or treat conditions involving the cervical spine. |
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|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

## 8. Performance Data

Static compression bending testing was performed per ASTM F1717.

#### 9. Conclusion

The LnK Posterior Cervical Fixation System is substantially equivalent to legally marketed predicates.