Gemini-C Hybrid Cervical Interbody System

K170844 · Osseus Fusion Systems, LLC · ODP · Jul 3, 2017 · Orthopedic

Device Facts

• Record ID: K170844
• Device Name: Gemini-C Hybrid Cervical Interbody System
• Applicant: Osseus Fusion Systems, LLC
• Product Code: ODP · Orthopedic
• Decision Date: Jul 3, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Gemini-C Hybrid Cervical Interbody System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels within the cervical spine at disc levels from C2 to T1. Degenerative disc disease (DDD) is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. This device is intended for use with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation (i.e. anterior cervical plate such as the White Pearl Preferred Angle Anterior Cervical Plate). Patients should have had at least six weeks of non-operative treatment prior to treatment with intervertebral cages.

Device Story

Intervertebral body fusion device; maintains disc space distraction; used in cervical spine (C2-T1). Configurations: PEEK, Titanium alloy, or Hybrid PEEK/Titanium. Hollow center for bone graft placement. Used by surgeons in clinical settings; requires supplemental fixation (anterior cervical plate). Provides structural support to facilitate fusion; benefits patients with degenerative disc disease by stabilizing spinal segments.

Clinical Evidence

No clinical studies were performed. Evidence is based on non-clinical bench testing including static/dynamic compression, compression shear, torsion, subsidence, and expulsion testing.

Technological Characteristics

Materials: SOLVAY ZENIVA ZA-500 PEEK (ASTM F2026), Ti-6Al-4V ELI (ASTM F136), Tantalum (ASTM F560), Stainless steel (ASTM F899). Form factor: Interbody cage with hollow center. Mechanical testing per ASTM F2077 and F2267.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous cervical levels (C2-T1). DDD defined as discogenic neck pain with radiographic degeneration. Requires at least six weeks of prior non-operative treatment. Contraindicated in patients without skeletal maturity or those not requiring intervertebral fusion.

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

• CONSTRUX Mini PEEK Ti Spacer System (K150619)
• Crystal Cervical Cage (K073351)
• Endoskeleton® TC (K100889)
• BAK/Cervical Interbody Fusion (P980048)
• Fusion Advantage Interbody Cages (K083425)
• Brantigan I/F Cage (P960025)
• LDR Spine Cervical Interbody Fusion System (K091088)
• Nanovis FortiCore™ (K140280)
• 4-Webb Cervical STS Interbody Fusion Device (K121741)

Submission Summary (Full Text)

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Public Health Service

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

Osseus Fusion Systems, LLC % Mr. J.D. Webb The OrthoMedix Group, Inc. 1001 Oakwood Blvd Round Rock, Texas 78681

July 3, 2017

Re: K170844

Trade/Device Name: Gemini-C Hybrid Cervical Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: June 5, 2017 Received: June 7, 2017

Dear Mr. Webb:

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-

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

K170844

Page 1 of 1

#### 510(k) Number (if known)

#### K170844

Device Name

Gemini-C Hybrid Cervical Interbody System

#### Indications for Use (Describe)

The Gemini-C Hybrid Cervical Interbody System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels within the cervical spine at disc levels from C2 to T1. Degenerative disc disease (DDD) is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. This device is intended for use with autogenous bone graft and/or allograft comprised of cancellous bone graft and supplemental fixation (i.e. anterior cervical plate such as the White Pearl Preferred Angle Anterior Cervical Plate). Patients should have had at least six weeks of non-operative treatment prior to treatment with intervertebral cages.

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

ا Prescription Use (Part 21 CFR 801 Subpart D)

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

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

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## 510(k) Summary: Gemini-C Hybrid Cervical Interbody System

| Date Prepared | June 5, 2017 |
|------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted By | Osseus Fusion Systems, LLC<br>2703 Mockingbird Lane, Suite 102<br>Dallas, TX 75235<br>214-395-0100 Tele<br>email: [e-mail] |
| Primary Contact | J.D. Webb<br>1001 Oakwood Blvd<br>Round Rock, TX 78681<br>512-388-0199 Tele<br>e-mail: [e-mail] |
| Trade Name | Gemini-C Hybrid Cervical Interbody System |
| Common Name | intervertebral body fusion device |
| Classification Name | Intervertebral body fusion device - cervical |
| Class | II |
| Product Code | ODP |
| CFR Section | 21 CFR section 888.3080 |
| Device Panel | Orthopedic |
| Primary Predicate<br>Device | • CONSTRUX Mini PEEK Ti Spacer System (K150619) |
| Additional Predicate<br>Devices | • Crystal Cervical Cage (K073351)<br>• Endoskeleton® TC (K100889)<br>• BAK/Cervical Interbody Fusion (P980048)<br>• Fusion Advantage Interbody Cages, (K083425)<br>• Brantigan I/F Cage (P960025)<br>• LDR Spine Cervical Interbody Fusion System (K091088)<br>• Nanovis FortiCore™ (K140280)<br>• 4-Webb Cervical STS Interbody Fusion Device (K121741) |
| Device Description | The Osseus Fusion Systems' Gemini-C Hybrid Cervical Interbody System is used to<br>maintain disc space distraction in skeletally mature adults requiring intervertebral body<br>fusion. This system includes three design configurations: 1) PEEK, 2) Titanium alloy (Ti-<br>6Al-4V ELI), and 3) Hybrid PEEK/Titanium alloy. The implants are available in a range of<br>footprints and heights to suit the individual pathology and anatomical conditions of the<br>patient. The implants have a hollow center to allow placement of bone graft. |
| Materials | • SOLVAY ZENIVA ZA-500 PEEK (ASTM F2026)<br>• Ti-6A-4V ELI (ASTM F136)<br>• Tantalum (ASTM F560)<br>• Stainless steel (ASTM F899) |
| Substantial<br>Equivalence Claimed<br>to Predicate Devices | The Gemini-C Hybrid Cervical Interbody System is substantially equivalent to the<br>predicate devices in terms of intended use, design, materials used, mechanical safety and<br>performances. |
| Indications for Use | The Gemini-C Hybrid Cervical Interbody System is indicated for intervertebral body fusion<br>procedures in skeletally mature patients with degenerative disc disease (DDD) at one or<br>two contiguous levels within the cervical spine at disc levels from C2 to T1. Degenerative<br>disc disease (DDD) is defined as neck pain of discogenic origin with degeneration of the<br>disc confirmed by patient history and radiographic studies. This device is intended for use<br>with autogenous bone graft and/or allograft comprised of cancellous and/or<br>corticocancellous bone graft and supplemental fixation (i.e. anterior cervical plate such as<br>the White Pearl Preferred Angle Anterior Cervical Plate). Patients should have had at least<br>six weeks of non-operative treatment prior to treatment with intervertebral cages. |
| Non-clinical Test<br>Summary | The following analyses were conducted:<br>• Static and dynamic compression (ASTM F2077)<br>• Static and dynamic compression shear (ASTM F2077)<br>• Static and dynamic torsion (ASTM F2077)<br>• Subsidence (ASTM F2267)<br>• Expulsion testing (ASTM Draft Standard F-04.25.02.02)<br><br>The results of these evaluations indicate that the Gemini-C Hybrid Cervical Interbody<br>System is equivalent to predicate devices. |
| Clinical Test<br>Summary | No clinical studies were performed |
| Conclusions: Non-<br>clinical and Clinical | Osseus Fusion Systems, LLC considers the Gemini-C Hybrid Cervical Interbody System<br>to be equivalent to the predicate devices listed above. This conclusion is based upon the<br>similarities between the Gemini-C and predicates in terms of principles of operation,<br>technology, materials, and indications for use. |

In accordance with 21 CFR 807.92 of the Federal Code of Regulations

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