LnK Cervical Interbody Fusion Cage System

K143360 · L&K BIOMED Co., Ltd. · ODP · Apr 3, 2015 · Orthopedic

Device Facts

• Record ID: K143360
• Device Name: LnK Cervical Interbody Fusion Cage System
• Applicant: L&K BIOMED Co., Ltd.
• Product Code: ODP · Orthopedic
• Decision Date: Apr 3, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

LnK Cervical Interbody Fusion Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. LnK Cervical Interbody Fusion Cage System is used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. LnK Cervical Interbody Fusion Cage System is to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

Device Story

Intervertebral body fusion cage; facilitates fusion in cervical spine (C3-C7). Implanted surgically by physician; requires supplemental fixation and autograft bone. Device provides structural support to intervertebral space; promotes bone growth. Available in various sizes/configurations to match patient anatomy. Benefits patient by stabilizing vertebral segment; alleviating radicular symptoms associated with DDD.

Clinical Evidence

Bench testing only. Mechanical performance evaluated per ASTM F2077 (static/dynamic axial compression, compression-shear, torsion, expulsion) and ASTM F2267 (static subsidence). No clinical data presented.

Technological Characteristics

Materials: PEEK-OPTIMA LTI with unalloyed tantalum marker pins. Form factor: Interbody cage in various sizes. Energy source: None (passive implant). Sterilization: Gamma irradiation (ISO 11137).

Indications for Use

Indicated for skeletally mature patients with cervical degenerative disc disease (DDD) and radicular symptoms at one level (C3-C7). Requires autograft bone and supplemental fixation. Contraindicated in patients without 6 weeks of prior non-operative treatment.

Regulatory Classification

Identification

An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.

Special Controls

*Classification.* (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Predicate Devices

• LnK Cervical Interbody Fusion Cage System (K120840)

Submission Summary (Full Text)

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April 3, 2015

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

L&K Biomed Co., Ltd. Ms. Yerim An #201, 202 16-25, Dongbaekjungang-ro 16 beon-gil Giheung-gu, Yongin-si Geyonggi-do, 446-916 Korea

Re: K143360

Trade/Device Name: LnK Cervical Interbody Fusion Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: March 19, 2015 Received: March 23, 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/Resourcesfor You/Industry/default.htm. 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/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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K143360 Page 1 of 1

## Indications for Use Statement

510(k) Number (if known): K143360 Device Name: LnK Cervical Interbody Fusion Cage System

### Indications For Use:

LnK Cervical Interbody Fusion Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. LnK Cervical Interbody Fusion Cage System is used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. LnK Cervical Interbody Fusion Cage System is to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

Prescription Use (Part 21 CER801 Subpart D)

AND/OR

Over-The-Counter Use (21 CER801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (OED)

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## 510(k) SUMMARY

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

| 1. Submitter: | Gook Jin Kang<br>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: | March 19, 2015 |

#### Device Identification 2.

| Trade Name | LnK Cervical Interbody Fusion Cage System | |
|---------------------|------------------------------------------------------|--|
| Common Name | Intervertebral Body Fusion Device | |
| Product Code | ODP | |
| Classification | Class II | |
| Classification Name | Intervertebral body fusion device<br>21 CFR 888.3080 | |

#### Predicate or legally marketed devices which are substantially equivalent 3.

- L&K BIOMED Co., Ltd: LnK Cervical Interbody Fusion Cage System(K120840) .
#### 4. Description of the Device

LnK Cervical Interbody Fusion Cage System intended for use as an interbody fusion cage device and must be used with supplemental fixation. The devices are available in a variety of different sizes and configurations to accommodate anatomical variation in different vertebral levels and/or patient anatomy. The devices are made of PEEK-OPTIMA® LTI with marker pins made of Unalloyed Tantalum.

#### 5. Intended use

LnK Cervical Interbody Fusion Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. LnK Cervical Interbody Fusion Cage System is used to facilitate intervertebral body fusion in

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the cervical spine at the C3 to C7 disc levels using autograft bone. LnK Cervical Interbody Fusion Cage System is to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

| No | Item | LnK Cervical Interbody<br>Fusion Cage System | LnK Cervical Interbody<br>Fusion Cage System<br>(Predicate) |
|----|---------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Manufacturer | L&K BIOMED Co., Ltd. | L&K BIOMED Co., Ltd. |
| 2 | Material | PEEK and Tantalum | PEEK and Tantalum |
| 3 | 510(K) Number | K143360 | K120840 |
| 4 | Product Code | ODP | ODP |
| 5 | Class | ClassII | ClassII |
| 6 | Intended Use | LnK Cervical Interbody<br>Fusion Cage System is<br>indicated for use in skeletally<br>mature patients with<br>degenerative disc disease<br>(DDD) of the cervical spine<br>with accompanying radicular<br>symptoms at one disc level.<br>DDD is defined as discogenic<br>pain with degeneration of the<br>disc confirmed by patient<br>history and radiographic<br>studies. LnK Cervical<br>Interbody Fusion Cage<br>System is used to facilitate<br>intervertebral body fusion in<br>the cervical spine at the C3 to<br>C7 disc levels using autograft<br>bone. LnK Cervical Interbody<br>Fusion Cage System is to be<br>used with supplemental<br>fixation. Patients should have<br>at least six (6) weeks of non-<br>operative treatment prior to<br>treatment with an<br>intervertebral cage | LnK Cervical Interbody<br>Fusion Cage System is<br>indicated for use in skeletally<br>mature patients with<br>degenerative disc disease<br>(DDD) of the cervical spine<br>with accompanying radicular<br>symptoms at one disc level.<br>DDD is defined as discogenic<br>pain with degeneration of the<br>disc confirmed by patient<br>history and radiographic<br>studies. LnK Cervical<br>Interbody Fusion Cage<br>System is used to facilitate<br>intervertebral body fusion in<br>the cervical spine at the C3 to<br>C7 disc levels using autograft<br>bone. LnK Cervical Interbody<br>Fusion Cage System is to be<br>used with supplemental<br>fixation. Patients should have<br>at least six (6) weeks of non-<br>operative treatment prior to<br>treatment with an<br>intervertebral cage |

### 6. Comparison of the technology characteristics of the device to predicate and legally marketed devices

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#### Performance Data 7.

Mechanical performance of additional components of LnK Cervical Interbody Fusion Cage System is same with predicated LnK Cervical Interbody Fusion Cage System(K120840). They are same product in all aspect, except sterilization. Sterilization method is gamma irradiation which is following ISO 11137. It is widely known that gamma irradiation sterilization is not effect on mechanical performance. Therefore, We substitute mechanical test data of additional components of LnK Cervical Interbody Fusion Cage System with it of LnK Cervical Interbody Fusion Cage System(K120840).

The LnK Cervical Interbody Fusion Cage System was tested according to the ASTM F 2077, specifically, Static and Dynamic Axial Compression, Static and Dynamic Compression-Shear Testing, Static and Dynamic Torsion Testing, Expulsion Testing and Static Subsidence testing under Axial Compression, per ASTM F 2267.

#### 8. Conclusion

The additional components of LnK Cervical Interbody Fusion Cage System is substantially equivalent to the device referenced above and is therefore safe and effective for its intended use.