The HD LifeSciences Cervical IBFD System is indicated for use anterior cervical intervertebral body fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) at a single level from C2 to T1. Patients should have received 6 weeks of nonoperative treatment prior to treatment with the device is indicated to be used with allograft bone comprised of cancellous and/or corticocancellous bone. The HD LifeSciences Cervical IBFD System requires additional supplemental fixation cleared for the cervical spine.

Device Description

The HD LifeSciences Cervical IBFD System consists of interbody fusion cages made from Ti-6Al-4V implant-grade titanium using additive manufacturing technology. The titanium takes the form of a highly porous core which is surrounded at the cephalad and caudal ends by protective solid titanium endplates. The implant is anatomic in shape and has teeth to ensure placement is maintained after implantation.

AI/ML Overview

The provided text describes a medical device, the HD LifeSciences Cervical IBFD System, and its substantial equivalence to predicate devices, focusing on its mechanical performance. However, it does not include information on acceptance criteria for a study, reported device performance metrics in relation to those criteria, or details regarding study design, sample sizes, expert involvement, or ground truth establishment.

Therefore, I cannot provide the requested information based on the provided text. The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence through technological characteristics and performance testing against industry standards for mechanical strength, rather than a clinical study evaluating diagnostic or treatment efficacy.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health and Human Services logo. The logo on the right is the FDA logo, which includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.

HD LifeSciences LLC John Sullivan Director of Operations 38 Montvale Ave Ste 380 Stoneham. Massachusetts 02180

Re: K180364

Trade/Device Name: HD LifeSciences Cervical IBFD System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: April 24, 2018 Received: June 19, 2018

Dear Mr. Sullivan:

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. Iisting 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.

June 27, 2018

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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 comprehensive regulatory information about mediation-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Melissa Hall-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

Food and Drug Administration

Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

510(k) Number (if known) K180364

Device Name HD LifeSciences Cervical IBFD System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Submitter's Name	HD LifeSciences LLC
Submitter's Address	38 Montvale Ave Ste 380Stoneham, MA 02180
Company Contact Person	John Sullivan602-234-4321
Contact Person	John Sullivan602-234-4321johnsullivan@hdlifesciences.com
Date Summary wasPrepared	07 February 2018
Trade or Proprietary Name	HD LifeSciences Cervical IBFD System
Common or Usual Name	Intervertebral Fusion Device, Cervical
Classification	Class II per 21 CFR §888.3080
Product Code	ODP
Classification Panel	Division of Orthopedic Devices

510(K) SUMMARY

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The implants of the HD LifeSciences Cervical IBFD System are offered in a variety of lengths, widths and cross sectional geometries to accommodate patient anatomy and surgical approach. The implants are provided sterile, in validated sterile packaging, and are one-time use only.

INDICATIONS FOR USE

The HD LifeSciences Cervical IBFD System is indicated for use anterior cervical intervertebral body fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) at a single level from C2 to T1. Patients should have received 6 weeks of non-operative treatment prior to treatment with the device is indicated to be used with allograft bone comprised of cancellous and/or corticocancellous bone. The HD LifeSciences Cervical IBFD System requires additional supplemental fixation cleared for the cervical spine.

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TECHNOLOGICAL CHARACTERISTICS

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

. Indications for Use
Materials of Manufacture
Principles of Operation
. Implant Dimensions

Table 5-1: Predicate Devices

510kNumber	Trade or Proprietary or Model Name	Manufacturer	PredicateType
K120275	ACIS	Synthes	Primary
K171496	Tritanium® C Anterior Cervical Cage	Stryker	Additional
K162264	Cascadia Interbody System	K2M	Additional
K170676	HD Lumbar Interbody System	HD LifeSciences LLC	Additional

Performance Data

The HD LifeSciences Cervical IBFD System has been tested in the following test modes:

Static axial compression per ASTM F2077 ●
. Static torsion per ASTM F2077
. Dynamic axial compression per ASTM F2077
Dynamic torsion per ASTM F2077 ●
Static subsidence per ASTM F2267
Static expulsion per ASTM F04.25.02.02 ●

The results of this non-clinical testing show that the strength of the HD LifeSciences Cervical IBFD System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the HD LifeSciences Cervical IBFD System is substantially equivalent to the predicate device.

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.