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 Description

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.

AI/ML Overview

The provided text is a 510(k) summary for the Exactech Cervical Spacer System, which is an intervertebral body fusion device. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving performance against specific acceptance criteria for a novel AI or medical device with new analytical, clinical, or performance endpoints.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details for a study proving device meets acceptance criteria cannot be extracted from this document. This type of information is typically found in clinical trial reports, analytical validation studies, or detailed performance testing summaries for devices with more complex functionality or novel claims requiring rigorous quantitative assessment against predefined metrics.

Instead, this document provides the following:

1. Device Description and Intended Use:

Device Name: Exactech Cervical Spacer System
Device Type: Anterior cervical interbody devices consisting of a PEEK (polyetheretherkeytone) implant cage with tantalum radiographic markers.
Intended Use: For anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease at one disc level from C2-T1. It is to be used with autogenous bone graft and supplemental fixation (e.g., an anterior cervical plate) via an open, anterior approach.
Degenerative Disc Disease (DDD) Definition: Discogenic pain with degeneration of the disc confirmed by history and radiographic studies, where patients have had six weeks of non-operative treatment.

2. Predicate Devices for Substantial Equivalence:

The Exactech Cervical Spacer System claims substantial equivalence to several legally marketed predicate devices, implying similar technological characteristics, indications for use, and materials of manufacture. The predicate devices listed are:

K121649: CONSTRUX™ MINI Spacer System (Orthofix Spinal)
K090064: Copperhead System (Eminent Spine)
K120486: AVS AS System (Stryker Spine)
K130317, K103034: Apache™ Interbody Fusion System Star Cervical PEEK (Genesys Spine)
K121103, K113559, K091088: Spine MC+ Cervical Cage (LDR)
K130948: Cervical IBFD (Southern Spine)

3. Performance Data (Non-Clinical Testing):

The document mentions that the device underwent non-clinical testing to demonstrate its strength for its intended use and substantial equivalence to predicate devices. The performed tests are:

Static axial compression per ASTM F2077-11
Static torsion per ASTM F2077-11
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 document concludes that 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.

Missing Information:

The document does not provide:

Specific numerical acceptance criteria for each test.
The reported numerical performance values for the Exactech Cervical Spacer System.
The performance values of the predicate devices for direct comparison.
Sample sizes for these mechanical tests.
Any details related to clinical studies, human readers, or methods for establishing ground truth, as these are not relevant for demonstrating substantial equivalence for a mechanical intervertebral fusion device based primarily on non-clinical mechanical testing.

In summary, this document is a regulatory filing focused on demonstrating equivalence through non-clinical mechanical testing and comparison of technological characteristics, not a study evaluating a device against specific clinical or analytical performance acceptance criteria.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, stacked on top of each other. The profiles are rendered in black against a white background.

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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 SERVICESFood and Drug Administration	Form Approved: OMB No. 0910-0120Expiration Date: December 31, 2013
See PRA Statement on last page.
Indications for Use
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 fusionprocedures in skeletally mature patients with degenerative disc disease at one disc level fromC2-T1. Degenerative Disc Disease (DDD) is defined as discogenic pain with degeneration ofthe disc confirmed by history and radiographic studies. These patients should have had sixweeks of non-operative treatment. The Exactech Cervical Spacer System is to be used withautogenous bone graft and supplemental fixation (i.e., an anterior cervical plate), and isimplanted via an open, anterior approach. Patients with previous non-fusion spinal surgery atinvolved level may be treated with the device.
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)
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:	(352) 377-1140
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.

INDICATIONS FOR USE

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	OrthofixSpinal
K090064	Copperhead System	Eminent Spine
K120486	AVS AS System	Stryker Spine
K130317,K103034	Apache™ Interbody Fusion System Star CervicalPEEK	Genesys Spine
K121103,K113559,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.

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
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.(b)
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.