EXACTECH CERVICAL SPACER SYSTEM

K141129 · Exactech, Inc. · ODP · Aug 15, 2014 · Orthopedic

Device Facts

• Record ID: K141129
• Device Name: EXACTECH CERVICAL SPACER SYSTEM
• Applicant: Exactech, Inc.
• Product Code: ODP · Orthopedic
• Decision Date: Aug 15, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Exactech Cervical Spacer System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease at one disc level from C2-T1. Degenerative Disc Disease (DDD) is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Exactech Cervical Spacer System is to be used with autogenous bone graft and supplemental fixation (i.e., an anterior cervical plate), and is implanted via an open, anterior approach. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.

Device Story

Exactech Cervical Spacer System is an interbody fusion device for anterior cervical spine surgery. Implant consists of PEEK (polyetheretherketone) cage with tantalum radiographic markers; features internal chamber for autogenous bone graft. Available in various heights, footprints, and lordotic angles to match patient anatomy. Implanted by surgeons via open, anterior approach; requires supplemental fixation (anterior cervical plate). Device provides structural support to facilitate fusion in patients with degenerative disc disease. Benefits include stabilization of spinal segment and promotion of bone fusion.

Clinical Evidence

Bench testing only. Performed static axial compression, static torsion, static subsidence, static expulsion, dynamic axial compression bending fatigue, and dynamic torsion per ASTM F2077-11, ASTM F2267-04, and ASTM F-04.25.02.02 (draft). No clinical data provided.

Technological Characteristics

Anterior cervical interbody spacer composed of PEEK Optima® LT1 with tantalum radiographic markers. Trapezoidal shape. Single-use. Mechanical testing performed per ASTM F2077-11 (static/dynamic compression, torsion), ASTM F2267-04 (subsidence), and ASTM F-04.25.02.02 (expulsion).

Indications for Use

Indicated for anterior cervical interbody fusion in skeletally mature patients with degenerative disc disease (DDD) at one level (C2-T1). Requires six weeks of failed non-operative treatment. Contraindicated for patients without skeletal maturity or those not requiring 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 Spacer System (K121649)
• Copperhead System (K090064)
• AVS AS System (K120486)
• Apache™ Interbody Fusion System (K130317)
• Star Cervical PEEK (K103034)
• Spine MC+ Cervical Cage (K121103)
• Spine MC+ Cervical Cage (K113559)
• Spine MC+ Cervical Cage (K091088)
• Cervical IBFD (K130948)

Submission Summary (Full Text)

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August 15, 2014

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

Exactech, Incorporated % Ms. Meredith L. May, MS, RAC Empirical Consulting, LLC 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K141129

Trade/Device Name: Exactech Cervical Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: July 14, 2014 Received: July 18, 2014

Dear Ms. May:

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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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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| DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration | Form Approved: OMB No. 0910-0120<br>Expiration Date: December 31, 2013 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| See PRA Statement on last page. | |
| <b>Indications for Use</b> | |
| 510(k) Number (if known) | K141129 |
| Device Name | Exactech Cervical Spacer System |
| Indications for Use (Describe) | |
| The Exactech Cervical Spacer System is indicated for anterior cervical interbody fusion<br>procedures in skeletally mature patients with degenerative disc disease at one disc level from<br>C2-T1. Degenerative Disc Disease (DDD) is defined as discogenic pain with degeneration of<br>the disc confirmed by history and radiographic studies. These patients should have had six<br>weeks of non-operative treatment. The Exactech Cervical Spacer System is to be used with<br>autogenous bone graft and supplemental fixation (i.e., an anterior cervical plate), and is<br>implanted via an open, anterior approach. Patients with previous non-fusion spinal surgery at<br>involved level may be treated with the device. | |
| Type of Use (Select one or both, as applicable) | |
| <label><input 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> |
| PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| FOR FDA USE ONLY | |
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | |

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# 5.510(K) SUMMARY

| Submitter's Name: | Exactech |
|----------------------------|--------------------------------------------------------|
| Submitter's Address: | 2320 NW 66th Court |
| | Gainesville, Florida 32653 |
| Submitter's Telephone: | [phone] |
| Contact Person: | Meredith L. May MS, RAC |
| | Empirical Testing Corp. |
| | 719.337.7579 |
| Date Summary was Prepared: | 30 April 2014 |
| Trade or Proprietary Name: | Exactech Cervical Spacer System |
| Common or Usual Name: | Intervertebral Fusion Device With Bone Graft, Cervical |
| Classification: | Class II per 21 CFR §888.3080 |
| Product Code: | ODP |
| Classification Panel: | Division of Orthopedic Devices |

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

Cervical Spacer System implants are anterior cervical interbody devices consisting of a PEEK (polyetheretherkeytone) implant cage with tantalum radiographic markers.

The Cervical Spacer System is intended for use as an interbody fusion device and offered in a variety of heights, footprints, and lordotic angles to accommodate varying anatomical conditions. The devices features a chamber intended to be filled with autogenous bone graft material.

#### INDICATIONS FOR USE

The Exactech Cervical Spacer System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease at one disc level from C2-T1. Degenerative Disc Disease (DDD) is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Exactech Cervical Spacer System is to be used with autogenous bone graft and supplemental fixation (i.e., an anterior cervical plate), and is implanted via an open, anterior approach. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.

The indications for use for the Cervical Spacer System is similar to that of the predicate devices.

### TECHNOLOGICAL CHARACTERISTICS

The Exactech Cervical Spacer System is an anterior cervical interbody composed of the PEEK Optima® LT1 trapezoidal shaped implant with tantalum radiographic markers that is similar to many devices cleared for sale in the United States, including the referenced predicate devices. It is intended for use as an interbody fusion device and is offered in a variety of heights, footprints, and lordotic angles to accommodate varying anatomical conditions. The device features an

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enclosed chamber intended to be filled with autogenous bone graft material. The implants are intended for single use only.

The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically the following characteristics are identical between the subject and predicates:

- Indications for Use
- Materials of manufacture
- Structural support mechanism ●

| 510(k) Number | Trade or Proprietary or Model Name | Manufacturer |
|---------------------------------|-------------------------------------------------------|--------------------|
| K121649 | CONSTRUX™ MINI Spacer System | Orthofix<br>Spinal |
| K090064 | Copperhead System | Eminent Spine |
| K120486 | AVS AS System | Stryker Spine |
| K130317,<br>K103034 | Apache™ Interbody Fusion System Star Cervical<br>PEEK | Genesys Spine |
| K121103,<br>K113559,<br>K091088 | Spine MC+ Cervical Cage | LDR |
| K130948 | Cervical IBFD | Southern Spine |

Table 5-1 Predicate Devices

#### PERFORMANCE DATA

The Cervical Spacer System has been tested in the following test modes:

- Static axial compression per ASTM F2077-11 ●
- Static torsion per ASTM F2077-11
- o Static Subsidence per ASTM F2267-04
- Static Expulsion per ASTM F-04.25.02.02 (draft) ●
- Dynamic axial compression bending fatigue per ASTM F2077-11 ●
- Dynamic Torsion per ASTM F2077-11 ●

The results of this non-clinical testing show that the strength of the Cervical Spacer System is sufficient for its intended use and is substantially equivalent to the legally marketed predicate devices, for which there may be no publically available published performance data.

#### CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the Cervical Spacer System is substantially equivalent to the predicate devices.