ACIF

K173148 · Coligne AG · ODP · Dec 1, 2017 · Orthopedic

Device Facts

• Record ID: K173148
• Device Name: ACIF
• Applicant: Coligne AG
• Product Code: ODP · Orthopedic
• Decision Date: Dec 1, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The coLigne ACIF system is used to maintain disc space distraction in skeletally mature adults requiring anterior cervical interbody fusion (ACIF).

Device Story

Intervertebral body fusion device; maintains disc space distraction in cervical spine. Implants (ACIF oscar, ACIF oscar dome) feature hollow centers for bone graft placement; available in various footprints/heights. Used by surgeons via anterior approach; requires supplemental fixation. Provides structural support to facilitate fusion in DDD patients. Benefits include stabilization of cervical segments and potential reduction of discogenic pain.

Clinical Evidence

No clinical studies were performed. Evidence is based on non-clinical bench testing including static and dynamic compression (ASTM F2077), static and dynamic torsion (ASTM F2077), and subsidence (ASTM F2267).

Technological Characteristics

Materials: Polyether ketone ether ketone ketone (ASTM F1876-98), carbon filaments, and gold (ASTM B562-95). Form factor: Cervical cage with hollow center for bone graft. Provided non-sterile for single use. Mechanical performance validated per ASTM F2077 and F2267.

Indications for Use

Indicated for skeletally mature patients at one or two contiguous levels of the cervical spine (C2-T1) for fusion in degenerative disc disease (DDD) with discogenic pain confirmed by history and radiography. Requires anterior approach, autogenous/allograft bone graft, and supplemental fixation. Patients must have failed at least six weeks of 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

• DePuy, BENGAL System (K081917)
• Spinal Elements, Crystal Cervical Cage (K073351)
• Zimmer, BAK/C Vista Interbody Fusion (P980048 S3)
• LDR Spine Cervical Interbody Fusion System (K091088)
• Medtronic, Affinity Anterior Cervical Cage (P000028)

Reference Devices

• ostaPek® VBR System (K072326)

Submission Summary (Full Text)

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December 1, 2017

coLigne, AG % Mr. J.D. Webb The OrthoMedix Group, Inc. 1001 Oakwood Blvd. Round Rock, Texas 78681

Re: K173148

Trade/Device Name: ACIF Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: September 25, 2017 Received: September 29, 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 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.

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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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

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)

#### K173148

Device Name

ACIF

#### Indications for Use (Describe)

The ACIF system is indicated for use as an intervertebral body fusion device in skeletally mature patients at one or two contiguous levels of the cervical spine (C2-T1) to facilitate fusion in case of degenerative disc disease (DDD) defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The ACIF implants are placed via an anterior approach using autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft. The ACIF implants are to be used with supplemental fixation. Patients should have at least six weeks of non-operative treatment prior to surgery.

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

| <span style="text-decoration: underline;">Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="font-size: 20px;">☑</span> |
|-----------------------------------------------------------------------------------------------|-----------------------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | <span style="font-size: 20px;">☐</span> |

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## 510(k) Summary: ACIF

| Date Prepared | September 25, 2017 |
|------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted By | Robert Lange<br>coLigne, AG<br>Utoquai 43<br>CH 8008 Zurich<br>Switzerland<br>Telephone: [phone]<br>e-mail: [e-mail] |
| Primary Contact | J.D. Webb<br>1001 Oakwood Blvd<br>Round Rock, TX 78681<br>Telephone: [phone]<br>e-mail: [e-mail] |
| Trade Name | ACIF |
| 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 | DePuy, BENGAL System (K081917) |
| Secondary Predicate<br>Devices | Spinal Elements, Crystal Cervical Cage (K073351)<br>Zimmer, BAK/C Vista Interbody Fusion (P980048 S3)<br>LDR Spine Cervical Interbody Fusion System (K091088)<br>Medtronic, Affinity Anterior Cervical Cage (P000028) |
| Reference Device | ostaPek® VBR System (K072326) |
| Device Description | The coLigne ACIF system are used to maintain disc space distraction in skeletally mature<br>adults requiring anterior cervical interbody fusion (ACIF). This system includes two design<br>configurations: ACIF oscar, and ACIF oscar dome. The implants are available in a range<br>of footprints and heights to suit the individual pathology and anatomical conditions of<br>the patient. The implants have a hollow center to allow placement of bone graft. |
| Materials | Polyether ketone ether ketone ketone (ASTM F1876-98)<br>Fiber carbon filaments<br>Gold (ASTM B562-95) |
| Intended Use | The coLigne ACIF system is used to maintain disc space distraction in skeletally mature<br>adults requiring anterior cervical interbody fusion (ACIF). |
| Substantial<br>Equivalence Claimed<br>to Predicate Devices | The coLigne ACIF system is substantially equivalent to the predicate devices in terms<br>of intended use, design, materials used, mechanical safety and performances. |
| Indications for Use | The ACIF system is indicated for use as an intervertebral body fusion device in skeletally<br>mature patients at one or two contiguous levels of the cervical spine (C2-T1) to facilitate<br>fusion in case of degenerative disc disease (DDD) defined as discogenic pain with<br>degeneration of the disc confirmed by patient history and radiographic studies. The ACIF<br>implants are placed via an anterior approach using autogenous bone graft and/or allograft<br>comprised of cancellous and/or corticocancellous bone graft. The ACIF implants are to be<br>used with supplemental fixation. Patients should have at least six weeks of non-operative<br>treatment prior to surgery. |
| Technological<br>Characteristics | Intended Use<br>The subject ACIF system and all the predicates have similar intended uses.<br>Materials<br>The subject device is composed of the same materials as the reference device.<br>Design Features/Functions<br>The subject ACIF system and cited predicate devices share similar basic design features<br>and functions.<br>Dimensions<br>The subject ACIF system is dimensionally similar to cited predicate devices.<br>Sterilization<br>The subject ACIF system is provided non-sterile and cited predicate devices are sterile<br>and non-sterile for single use only.<br>Performance Specification<br>Mechanical testing confirmed the ACIF system demonstrated equivalent performance to<br>the cited predicate device under the same test conditions. |
| Non-clinical Test<br>Summary | The following analyses were conducted:<br>Static and dynamic compression per ASTM F2077 Static and dynamic torsion per ASTM F2077 Subsidence per ASTM F2267 The results of these evaluations indicate that the coLigne ACIFare equivalent to predicate devices. |
| Clinical Test<br>Summary | No clinical studies were performed |
| Conclusions: Non-<br>clinical and Clinical | coLigne, AG considers the coLigne ACIF Cervical Cages to be equivalent to the<br>predicate devices listed above. This conclusion is based upon the devices' similarities in<br>principles of operation, technology, materials and indications for use |

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

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