DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) Cage

K162220 · Dio Medical Co., Ltd. · ODP · Nov 21, 2016 · Orthopedic

Device Facts

• Record ID: K162220
• Device Name: DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) Cage
• Applicant: Dio Medical Co., Ltd.
• Product Code: ODP · Orthopedic
• Decision Date: Nov 21, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DIO Medical IVA (ACIF) Cage is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-TI disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage. The DIO Medical IVA (PLIF, TLIF, DLIF and ALIF) Cage is indicated for intervertebral body fusion of the lumbar spine, L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at one or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

Device Story

Intervertebral body fusion device (cage) used to facilitate spinal fusion; implanted by surgeons in clinical settings. Device acts as structural spacer between vertebrae; filled with autograft to promote bone growth. Requires supplemental fixation hardware. Benefits include stabilization of spinal segments and relief of discogenic pain. Device is passive implant; no electronic or software components.

Clinical Evidence

Bench testing only. Device underwent static and dynamic axial compression, static and dynamic torsion, static compression shear, and subsidence testing per ASTM F2077 and ASTM F2267 standards.

Technological Characteristics

Materials: PEEK and Tantalum. Principle: Intervertebral body fusion spacer. Form factor: Various heights, lengths, and widths. Energy source: None (passive implant). Sterilization: Not specified.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-C3 to C7-T1) with radicular symptoms (requiring 6 weeks non-operative treatment) or lumbar spine (L2-S1) with up to Grade 1 spondylolisthesis (requiring 6 months 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

• Galaxy PEEK Cage (K122872)
• Synster Cage (K111820)
• VENUS Lumbar Intervertebral Body Fusion Cage System (K110783, K120063, K121096)
• Innesis PEEK Cage (K120464)
• AnyPlus PEEK Cage (K131612, K153517)

Submission Summary (Full Text)

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

November 21, 2016

DIO Medical Co., Ltd % Mr. Paul Speidel Senior Regulatory and Quality Consultant ROMIS Inc. 110 Haverhill Road, Suite 526 Amesbury, MA 01913

Re: K162220

Trade/Device Name: DIO Medical IVA (ACIF, DLIF, PLIF, TLIF, ALIF) Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP, MAX Dated: September 9, 2016 Received: September 12, 2016

Dear Mr. Speidel:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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,

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) K162220

#### Device Name

DIO Medical IVA (ACIF, DLIF, PLIF, TLIF, ALIF) Cage

#### Indications for Use (Describe)

The DIO Medical IVA (ACIF) Cage is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-TI disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radio raphic studies. The device is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage.

The DIO Medical IVA (PLIF, TLIF, DLIF and ALIF) Cage is indicated for intervertebral body fusion of the lumbar spine, L2 to S1, in skeletally mature patients who have had six months of non-overative treatment. The device is intended for use at one or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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### 510(k) SUMMARY

### DIO Medical Co., Ltd's IVA Cage

## Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

DIO Medical Co., Ltd Sung Hee-Lee 101-105 Megacenter, SK Technopark 124 Sagimakgol-ro, Jungwon-gu Seongnam-si Gyeonggi-do, South Korea

Phone: [phone] Fax: [phone]

Contact Person: Sung Hee-Lee

Date Prepared: November 10, 2016

### Name of Device and Name/Address of Sponsor

DIO Medical IVA (ACIF, DLIF, PLIF, TLIF, ALIF) Cage

DIO Medical Co., Ltd Sung Hee-Lee 101-105 Megacenter, SK Technopark 124 Sagimakgol-ro, Jungwon-gu Seongnam-si Gyeonggi-do, South Korea

### Common or Usual Name

Intervertebral Body Fusion Device

### Classification Name, Product Code, Regulation Number and Class

Intervertebral Body Fusion Device, Cervical (Product Code ODP) 21 CFR 888.3080 Class II Intervertebral Body Fusion Device, Lumbar (Product Code MAX) 21 CFR 888.3080 Class II

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## Predicate Devices

- o Primary
- K122872 Galaxy PEEK Cage (Dio Medical Co., Ltd)
- · Additional
- K111820 Synster Cage (BM Korea Co., Ltd) -
- K110783, K120063, K121096 VENUS Lumbar Intervertebral Body Fusion Cage -System (L&K Biomed Co.)
- -K120464 Innesis PEEK Cage (BK Meditech Co.)
- K131612, K131612, K153517 AnyPlus PEEK Cage (GS Medical Co., Ltd.) -

# Intended Use / Indications for Use

# Indications for Use:

The DIO Medical IVA (ACIF) Cage is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-TI disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The DIO Medical IVA (PLIF, TLIF, DLIF and ALIF) Cage is indicated for intervertebral body fusion of the lumbar spine, L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at one or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

# Intended Use:

The DIO Medical IVA (ACIF, PLIF, TLIF, DLIF and ALIF) Cage are intended for intervertebral body fusion in skeletally mature patients. The intended operation of this device is concentrated around the C2-C3, C7-Tl, and L2-S1 region of the spine. The device is designed for use with supplemental fixation and with autograft to facilitate fusion in the vertebrae.

# Technological Characteristics

The DIO Medical IVA (ACIF, PLIF, TLIF, DLIF and ALIF) Cage consists of PEEK+Tantalum which is identical to its predicate devices. All of the heights, lengths, and widths are within range covered by its predicate devices.

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### Performance Data

The DIO Medical IVA (ACIF) Cage device underwent testing according to ASTM F2077, specifically static and dynamic axial compression testing, static and dynamic torsion testing, static compression shear testing; and subsidence testing according to ASTM F2267.

The DIO Medical IVA (PLIF, TLIF, DLIF and ALIF) Cage device underwent testing according to ASTM F2077. specifically static and dynamic axial compression testing. static torsion testing, static compression shear testing; and subsidence testing according to ASTM F2267.

## Substantial Equivalence

The DIO Medical IVA (ACIF, PLIF, TLIF, DLIF and ALIF) Cage is as safe and effective as the Galaxy PEEK Cage (DIO Medical Co., Ltd), SYNSTER Caqe (BM Korea Co., Ltd), VENUS Lumbar Intervertebral Body Fusion Cage System (L&K Biomed Co.), the Innesis PEEK Cage (BK Meditech Co.) and the AnyPlus PEEK Cage (GS Medical Co., Ltd.). The DIO Medical IVA (ACIF, PLIF, TLIF, DLIF and ALIF) Cage has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the DIO Medical IVA (ACIF, PLIF, TLIF, DLIF and ALIF) Cage and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the DIO Medical IVA (ACIF, PLIF, TLIF, DLIF and ALIF) Cage is as safe and effective as the Galaxy PEEK Cage (DIO Medical Co., Ltd), SYNSTER Cage (BM Korea Co., Ltd), VENUS Lumbar Intervertebral Body Fusion Cage System (L&K Biomed Co.), the Innesis PEEK Cage (BK Meditech Co.) and the AnyPlus PEEK Cage (GS Medical Co., Ltd.). Thus, the DIO Medical IVA (ACIF, PLIF, TLIF, DLIF and ALIF) Cage is substantially equivalent.