ShurFit CpTi-HA ACIF Interbody Fusion System

K161809 · Precision Spine, Inc. · ODP · Dec 6, 2016 · Orthopedic

Device Facts

• Record ID: K161809
• Device Name: ShurFit CpTi-HA ACIF Interbody Fusion System
• Applicant: Precision Spine, Inc.
• Product Code: ODP · Orthopedic
• Decision Date: Dec 6, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ShurFit CpTi-HA Coated Anterior Cervical Interbody Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. ShurFit Anterior Cervical Interbody Fusion System implants are used to facilitate fusion in the cervical spine and are placed via an anterior approach at the C-3 to C-7 disc levels using autograft bone. Patients should have at least six weeks of non- operative treatment prior to treatment with an intervertebral fusion device. The device should be used with supplemental fixation.

Device Story

Intervertebral body fusion device; provides mechanical support to cervical spine levels C3-C7 during fusion. Implants consist of PEEK (ASTM F2026) cages with Commercially Pure Titanium (CpTi) and Hydroxyapatite (HA) coating on endplates. Implanted via anterior approach by surgeons; packed with autograft bone. Device maintains disc space height and stability until biological fusion occurs. Benefits include stabilization of degenerated disc segments in patients failing conservative therapy.

Clinical Evidence

Bench testing only. Mechanical performance evaluated per ASTM F2077-11, F2267-04, and draft standard F-04.25.02.02 (static/dynamic axial compression, torsion, compression shear, expulsion, subsidence). Coating properties evaluated per ASTM F1147, F1044, F1160, and F1854 (tensile bond strength, shear strength, fatigue, solubility, microstructural analysis).

Technological Characteristics

Material: PEEK Optima LT1 (ASTM F2026). Coating: Commercially Pure Titanium (CpTi) and Hydroxyapatite (HA). Form factor: Interbody cage with various widths, heights, and lengths. Sterilization: Provided sterile. Connectivity: None.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one level (C3-C7). Requires six weeks of prior non-operative treatment. Must be used with autograft bone and supplemental fixation.

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

• Interbody Fusion Device ACIF System (K083118)
• Reliance HA Infused Cervical IBF (K142269)
• Arena-C HA infused Cervical cage (K142026)
• Calix PC Titanium coated Cervical cage (K112036)
• CeSpace Titanium coated Cervical cage (K123909)

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

December 6, 2016

Precision Spine, Inc. Michael C. Dawson, Esq. Sr. Director of Regulatory Affairs 2050 Executive Drive Pearl, Mississippi 39208

Re: K161809

Trade/Device Name: ShurFit CpTi-HA ACIF Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: November 16, 2016 Received: November 21, 2016

Dear Mr. Dawson:

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 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.

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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,

Vincent J. Devlin -S

for 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 | Form Approved: OMB No. 0910-0120 |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Food and Drug Administration | Expiration Date: January 31, 2017 |
| Indications for Use | See PRA Statement on last page. |
| 510(k) Number (if known) | K161809 |
| Device Name | ShurFit CpTi-HA ACIF Interbody Fusion System |
| Indications for Use (Describe) | The ShurFit CpTi-HA Coated Anterior Cervical Interbody Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. ShurFit Anterior Cervical Interbody Fusion System implants are used to facilitate fusion in the cervical spine and are placed via an anterior approach at the C-3 to C-7 disc levels using autograft bone. Patients should have at least six weeks of non- operative treatment prior to treatment with an intervertebral fusion device. The device should be used with supplemental fixation. |
| Type of Use (Select one or both, as applicable) | <label><input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
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| Department of Health and Human Services<br>Food and Drug Administration<br>Office of Chief Information Officer<br>Paperwork Reduction Act (PRA) Staff<br>[e-mail] | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number. " | |
| FORM FDA 3881 (12/13) Page 1 of 1 | PSC Publishing Services [phone] EF |

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Image /page/3/Picture/1 description: The image shows the logo for Precision Spine. The words "PRECISION SPINE" are written in blue font. There is a yellow spine graphic between the two words. There is a blue line above and below the words.

# 510(K) SUMMARY

| Submitter's Name: | Precision Spine, Inc. |
|----------------------------|----------------------------------------------|
| Submitter's Address: | 2050 Executive Drive<br>Pearl, MS 39208 |
| Submitter's Telephone: | 973-455-7150 ext. 128 |
| Contact Person: | Michael C. Dawson |
| Date Summary was Prepared: | June 22, 2016 |
| Trade or Proprietary Name: | ShurFit CpTi-HA ACIF Interbody Fusion System |
| Common or Usual Name: | Intervertebral Body Fusion Device |
| Classification: | Class II per 21 CFR §888.3080 |
| Product Code: | ODP |

#### DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The ShurFit Anterior Cervical Interbody Fusion (ACIF) System consists of implants with various widths, heights and lengths to accommodate individual patient anatomy and graft material size. It is implanted from the anterior approach and packed with autogenous bone graft to facilitate fusion. The device is intended to provide mechanical support to the implanted level until biologic fusion is achieved. All components are manufactured from medical grade polyetheretherketone as described by ASTM F2026, specifically PEEK Optima LT1. The cages are included without a coating (already cleared K083118) or with a CpTi-HA (Commercially Pure Titanium -Hydroxyapatite) coating (this submission).

## CHANGE FROM PREDICATE:

The purpose of this submission is to add CpTi-HA (Commercially Pure Titanium -Hydroxyapatite) coated cages to the ShurFit ACIF Interbody Fusion System cleared in K083118. This submission seeks to add a line of ShurFit ACIF devices that have a coating on their endplates. The coating consists of a commercially pure Titanium (CpTi) based layer with a Hydroxyapatite (HA) layer on top of the CpTi. Precision Spine relies of the Master File of its contract manufacturer, APS Biomaterials Inc. located at 4011 Riverside Drive, Dayton, Ohio, for the composition and other technical characteristics of the HA and the CpTi coating. The coated products will be supplied sterile in validated sterile packaging.

#### INDICATIONS FOR USE

The ShurFit CpTi-HA Coated Anterior Cervical Interbody Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc

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level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. ShurFit Anterior Cervical Interbody Fusion System implants are used to facilitate fusion in the cervical spine and are placed via an anterior approach at the C-3 to C-7 disc levels using autograft bone. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral fusion device. The device should be used with supplemental fixation.

### TECHNOLOGICAL CHARACTERISTICS

The intended use and technological features of the modifications to the components of the ShurFit Anterior Cervical Interbody Fusion System do not substantially differ from the legally marketed predicate devices.

All ShurFit CpTi-HA ACIF Interbody Fusion System components are manufactured from medical grade polyetheretherketone as described by ASTM F2026, specifically PEEK Optima LT1. The coated implants are provided sterile. The subject and predicate devices have identical technological characteristics and differ only in the fact that a CpTi-HA coating has been added and the coated devices will be provided supplied sterile. Additional predicates that contain CpTi or HA are listed below.

| 510k Number | Trade or Proprietary or<br>Model Name | Manufacturer | Primary or<br>Additional |
|-------------|-------------------------------------------|---------------------------------|--------------------------|
| K083118 | Interbody Fusion Device<br>ACIF System | Precision Spine<br>(Spinal USA) | Primary |
| K142269 | Reliance HA Infused<br>Cervical IBF | Reliance<br>Medical<br>Systems | Additional |
| K142026 | Arena-C HA infused<br>Cervical cage | Spine Frontier | Additional |
| K112036 | Calix PC Titanium coated<br>Cervical cage | X Spine | Additional |
| K123909 | CeSpace Titanium coated<br>Cervical cage | Aesculap | Additional |

Table 5-1 Predicate Devices

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The following is a brief summary of non-clinical tests provided to the agency for review:

Mechanical performance of the CpTi-HA coated ShurFit® ACIF System was evaluated under the standards of ASTM F2077-11, F2267-04, and the draft standard F-04.25.02.02. The following properties were tested:

- Static Axial Compression ●
- Dynamic Axial Compression ●
- Static Torsion ●
- Dynamic Torsion ●
- Static Compression Shear ●
- Dynamic Compression Shear
- Static Expulsion
- Static Subsidence

Coating properties were evaluated using the standards ASTM 1147, ASTM F1044, ASTM F1160, and ASTM F1854. The following properties were tested:

- Static Tensile Bond Strength ●
- Static Shear Strength ●
- Shear Fatigue ●
- Solubility and Dissolution ●
- Microstructural and Image Analysis of coated surface ●

Additional information on both the CpTi and the HA coatings can be found in the Master Access File of the coatings vendor, APS Materials.

#### CONCLUSION

The overall technology characteristics and mechanical engineering analysis lead to the conclusion that the ShurFit CpTi-HA ACIF Interbody Fusion System is substantially equivalent to the predicate devices.