Who is the manufacturer of ChoiceSpine Blackhawk Ti Cervical Spacer System?

Choice Spine, LLC filed the 510(k) submission for ChoiceSpine Blackhawk Ti Cervical Spacer System (K223869).

What is the FDA product code for ChoiceSpine Blackhawk Ti Cervical Spacer System?

OVE. It is classified under 21 CFR 888.3080 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for ChoiceSpine Blackhawk Ti Cervical Spacer System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for ChoiceSpine Blackhawk Ti Cervical Spacer System?

ChoiceSpine Tomcat Cervical Spacer System (K170953); ChoiceSpine Blackhawk Cervical Spacer System (K203311).

Who can help prepare an FDA 510(k) submission like ChoiceSpine Blackhawk Ti Cervical Spacer System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ChoiceSpine Blackhawk Ti Cervical Spacer System

K223869 · Choice Spine, LLC · OVE · Sep 14, 2023 · Orthopedic

Device Facts

Record ID	K223869
Device Name	ChoiceSpine Blackhawk Ti Cervical Spacer System
Applicant	Choice Spine, LLC
Product Code	OVE · Orthopedic
Decision Date	Sep 14, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3080
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Blackhawk Ti Cervical Spacer System is a stand-alone anterior cervical interbody fusion device indicated for use in a skeletally mature patient with degenerative disease (DDD) with accompanying radicular symptoms at one level from C2-T1. 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. Ti Cervical Spacer System is to be used with autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, to facilitate fusion.

Device Story

Stand-alone anterior cervical interbody fusion device; titanium alloy (Ti-6Al-4V ELI) cage; nitinol locking clips; two internal titanium bladed anchors; titanium locking cam. Implanted via anterior cervical approach; used to facilitate fusion in DDD patients. Surgeon-operated; provides stabilization via internal bladed anchors that lock on deployment. Chamber filled with autogenous/allogenic bone graft. Provides mechanical support to intervertebral space; intended to reduce need for supplemental fixation, though surgeon may add if necessary. Benefits patient by restoring disc height and promoting fusion.

Clinical Evidence

Bench testing only. Included static subsidence (ASTM F2267-04), dynamic axial compression, dynamic compression-shear, and dynamic torsion (ASTM F2077-18). Cadaveric range-of-motion testing compared subject device to previously cleared stand-alone device, confirming equivalent stabilization performance.

Technological Characteristics

3D-printed titanium alloy (Ti-6Al-4V ELI, ASTM F3001/F136) spacer; nitinol (ASTM F2063) locking clips; titanium alloy (ASTM F136) anchors and cam. Provided sterile (gamma radiation, SAL 10-6). Instruments provided non-sterile (steam sterilized).

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) and radicular symptoms at one level from C2-T1, following six weeks of failed 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

ChoiceSpine Tomcat Cervical Spacer System (K170953)
ChoiceSpine Blackhawk Cervical Spacer System (K203311)

Related Devices

K203311 — ChoiceSpine Blackhawk Ti Cervical Spacer System · Choice Spine, LLC · May 10, 2021
K231763 — Stable-C Interbody System · Nexus Spine, LLC · Aug 21, 2023
K171489 — Acapella Cervical Spacer System · Choicespine, LP · Oct 23, 2017
K181295 — Genesys Spine AIS-C Cervical Stand-Alone System · Genesys Spine · Aug 29, 2018
K163474 — CAVUX CervicalCage-L SA System · Providence Medical Technology, Inc. · Mar 10, 2017

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. September 14, 2023 ChoiceSpine, LLC Kim Finch Director of Regulatory Affairs 400 Erin Drive Knoxville, Tennessee 37919 Re: K223869 Trade/Device Name: ChoiceSpine Blackhawk Ti Cervical Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE Dated: August 17, 2023 Received: August 18, 2023 Dear Kim Finch: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 {1}------------------------------------------------ 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. 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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Katherine D. Kavlock -S for Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K223869 Device Name ChoiceSpine Blackhawk Ti Cervical Spacer System #### Indications for Use (Describe) The Blackhawk Ti Cervical Spacer System is a stand-alone anterior cervical interbody fusion device indicated for use in a skeletally mature patient with degenerative disease (DDD) with accompanying radicular symptoms at one level from C2-T1. 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. Ti Cervical Spacer System is to be used with autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, to facilitate fusion. 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) | ☐ | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "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." {3}------------------------------------------------ # 510(k) Summary | Date: Sponsor: | September 11, 2023 ChoiceSpine, LLC 400 Erin Drive Knoxville, TN 37919 | |----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Phone: Fax: Contact Person: | 865-246-3333 865-246-3334 Kim Finch, Director of Regulatory Affairs | | Proposed Proprietary Trade Name: | ChoiceSpine Blackhawk™ Ti Cervical Spacer System | | Product Class: | Class II | | Classification Name: | ChoiceSpine Blackhawk™ Ti Cervical Spacer System 888.3080 - Intervertebral Fusion Device with Integrated Fixation, Cervical | | Device Product Code: | ChoiceSpine Blackhawk™ Ti Cervical Spacer System OVE | | Purpose of Submission: | The purpose is to modify our existing ChoiceSpine Blackhawk™ Ti Cervical Spacer System (K203311). Modifying the intended use to include stand-alone indication and updating the labeling. | | Device Description: | The Blackhawk™ Ti Cervical Spacer System is a stand-alone anterior cervical interbody device consisting of a titanium alloy (Ti-6Al-4V ELI) implant cage per ASTM F3001, nitinol internal locking components per ASTM F2063, two internal titanium alloy (Ti-6Al-4V ELI) anchors per ASTM F136, and a titanium alloy (Ti- 6Al-4V ELI) locking cam per ASTM F136. They are intended for use as interbody fusion devices and are offered in a variety of heights, footprints, and lordotic angles to accommodate varying anatomical conditions. The device features a chamber intended to be filled with autogenous bone and/or allogenic bone graft material. The Blackhawk™ Ti Cervical Spacer System is used with two internal bladed anchors that lock on deployment and provide additional fixation. | | | The integrated fixation anchors may not provide adequate stability for all situations. The surgeon should consider the appropriate fixation required for each patient and determine if additional supplemental fixation (e.g., an anterior plate, posterior pedicle screws) may be needed. | | Indications for Use: | The Blackhawk™ Ti Cervical Spacer System is a stand-alone anterior cervical interbody fusion device indicated for use in a skeletally mature patient with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the | | | disc conformed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Blackhawk™ Ti Cervical Spacer System is to be used with autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, to facilitate fusion. | | Materials: | The Blackhawk™ Ti Cervical Spacer System implants are composed of a titanium alloy (Ti-6Al- 4V ELI per ASTM F3001, Class C) implant spacer, nitinol (per ASTM F2063) internal locking clips, titanium alloy (Ti-6Al-4V ELI per ASTM F136) anchors, and a titanium alloy (Ti-6Al-4V ELI per ASTM F136) locking cam. The implant body, cam, and anchors are composed of Titanium alloy Ti-6Al-4V per ASTM F136/F3001, which has a long history of safe and effective use in orthopedic implants. The locking clips are composed of nitinol per ASTM F2063, which has a long history of safe and effective use in orthopedic implants. The Blackhawk™ Ti Cervical Spacer System implants will be provided sterile. Instruments will be provided non-sterile but will be steam sterilized before use. The instrumentation is made from 17-4 Stainless Steel (ASTM F899/A693), 465 Stainless Steel (ASTM F899), titanium alloy (Ti-6Al-4V ELI Grade 5 per ASTM F136), and polyphenylsulfone (Radel R5000 Series). | | Predicate Devices: | Primary Predicate: ChoiceSpine Tomcat™ Cervical Spacer System (K170953) Additional Predicates: ChoiceSpine Blackhawk™ Cervical Spacer System (K203311) | | Non-clinical Testing: | Static subsidence per ASTM F2267-04 Expulsion (standard N/A) Dynamic axial compression per ASTM F2077-18 Dynamic compression-shear per ASTM F2077-18 Dynamic torsion per ASTM F2077-18 ROM Cadaveric testing of the Tomcat & Blackhawk Ti Implants | | Technological Characteristics: | The implants proposed in this submission are similar to the predicate devices in the principle of operation, indications for use, stabilization method, anatomic location and approach, product code and classification, and biocompatibility. | | | The subject device has similar geometry and identical footprints as the primary predicate (Tomcat Cervical Spacer System). The subject device's spacer component is made out of titanium alloy whereas the primary predicate's spacer component is made out of PEEK. The anchor components of the subject devices are made out of the same titanium alloy. The primary predicate Tomcat is secured by two screws with an internal locking mechanism, whereas the Blackhawk Ti has two bladed anchors secured with a titanium cam lock and locking clips that are deployed in an equivalent fashion. | | | The Blackhawk Ti Cervical Spacer is a 3D printed device and manufacturing process remains unchanged since initially cleared under K203311. | {4}------------------------------------------------ {5}------------------------------------------------ ### Substantial Equivalence Conclusion: Cadaveric range of motion testing was performed comparing the design to a previously cleared standalone device. The results demonstrate the subject device is substantially equivalent to the predicate devices in safety, effectiveness, and performance. While the designs are different, the mechanical strength and stabilization performance are equivalent as demonstrated through ASTM F2077 and ASTM F2267 testing and cadaveric testing. The subject device is provided sterile and are processed at the same supplier as previously cleared Blackhawk Ti K203311. ChoiceSpine's sterilization process has been validated through gamma validation and distribution testing and the results demonstrate that the predetermined acceptance criteria were met. The minimum radiation dose of 25kGy was sufficient to meet a sterilization assurance level (SAL) of 106 and the package system remained intact while also maintaining the hermetic barrier.