Who is the manufacturer of ZSFab Cervical Interbody System?

Zsfab, Inc. filed the 510(k) submission for ZSFab Cervical Interbody System (K202488).

What is the FDA product code for ZSFab Cervical Interbody System?

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

What is the regulatory pathway for ZSFab Cervical Interbody System?

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

What are the predicate devices for ZSFab Cervical Interbody System?

Cascadia™ Interbody System (K160125).

Who can help prepare an FDA 510(k) submission like ZSFab Cervical Interbody 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.

ZSFab Cervical Interbody System

K202488 · Zsfab, Inc. · ODP · Jan 7, 2021 · Orthopedic

Device Facts

Record ID	K202488
Device Name	ZSFab Cervical Interbody System
Applicant	Zsfab, Inc.
Product Code	ODP · Orthopedic
Decision Date	Jan 7, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3080
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The ZSFab Cervical Interbody System is intended for anterior interbody fusion in skeletally mature patients who have had at least six weeks of non-operative treatment. The ZSFab Cervical Interbody System is indicated to treat cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The ZSFab Cervical Interbody System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone to facilitate fusion and to be used with supplemental fixation cleared for use in the cervical spine.

Device Story

ZSFab Cervical Interbody System consists of additively manufactured titanium alloy interbody fusion implants; designed for surgical stabilization of cervical spine. Implants feature lattice structures with near-elliptical pores (720-760μm minor axis; 1030-1060μm major axis) and central bone graft windows. Available in various heights, widths, and lordotic angles to match patient anatomy. Used by surgeons in clinical settings for anterior interbody fusion; requires concurrent use of autogenous/allogeneic bone graft and supplemental fixation. Implants provide structural support to facilitate spinal fusion, addressing disc degeneration and instability.

Clinical Evidence

Bench testing only. Mechanical performance evaluated per ASTM F2077 (static/dynamic axial compression and torsion) and ASTM F2267 (subsidence). Expulsion testing also performed. Results demonstrate performance substantially equivalent to predicate devices.

Technological Characteristics

Material: Ti-6Al-4V ELI titanium alloy (ASTM F3001). Manufacturing: Additive manufacturing. Design: Lattice structure with near-elliptical pores (720-760μm minor axis; 1030-1060μm major axis). Features: Bone graft window, various heights/widths/lordotic angles. Energy source: N/A (mechanical implant). Connectivity: N/A.

Indications for Use

Indicated for skeletally mature patients with cervical disc degeneration or spinal instability (confirmed by imaging) causing radiculopathy, myelopathy, or pain at C2-T1 levels, following at least 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

Cascadia™ Interbody System (K160125)

Related Devices

K232150 — ZSFab Cervical Interbody System · Zsfab, Inc. · Aug 18, 2023
K191354 — Ti3Z Cervical Interbody System · Zavation Medical Products, LLC · Sep 9, 2019
K252432 — Flex-Z Cervical Cage · Spinepoint, LLC · Mar 25, 2026
K242734 — ZSFab Cervical Interbody System; ZSFab Lumbar Interbody System · Zsfab · Nov 7, 2024
K200458 — Tailored-C Cervical Interbody Fusion System · Bespoke Technologies · Dec 28, 2020

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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. January 7, 2021 ZSFab Inc. % Karen Warden President BackRoads Consulting Inc. 12520 Heath Road Chesterland. Ohio 44026 Re: K202488 Trade/Device Name: ZSFab Cervical Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: December 4, 2020 Received: December 7, 2020 Dear Karen Warden: 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, 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}------------------------------------------------ Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. ## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use 510(k) Number (if known) K202488 Device Name ZSFab Cervical Interbody System Indications for Use (Describe) The ZSFab Cervical Interbody System is intended for anterior interbody fusion in skeletally mature patients who have had at least six weeks of non-operative treatment. The ZSFab Cervical Interbody System is indicated to treat cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The ZSFab Cervical Interbody System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone to facilitate fusion and to be used with supplemental fixation cleared for use in the cervical spine. | 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](mailto: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}------------------------------------------------ ## Section 7 – 510(k) Summary | Date: | 28 August 2020 | |------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Sponsor: | ZSFab Inc. | | | 705 Cambridge St, Suite 1 | | | Cambridge, MA 02141 | | | Office: 213.880.4966 | | Sponsor Contact: | Kai Xu, CTO | | 510(k) Contact: | Karen E. Warden, PhD | | | BackRoads Consulting Inc. | | | PO Box 566 | | | Chesterland, OH 44026 | | | Office: 440.729.8457 | | Proposed Trade Name: | ZSFab Cervical Interbody System | | Common Name: | Cervical interbody fusion device | | Device Classification: | Class II | | Regulation Names, Regulation Numbers, Product Codes: | Intervertebral fusion device with bone graft, 888.3080, cervical, ODP | | Device Description: | The ZSFab Cervical Interbody System includes additively manufactured interbody fusion devices for cervical implantation. The implants are designed with lattice structures to provide surgical stabilization of the spine. The lattices have near-elliptical pores with minor axis length of 720-760μm and major axis length of 1030-1060μm. Each interbody has a bone graft window that can be packed with bone graft material. The implants are available in a variety of height, length, width and lordotic angulation combinations to accommodate the patient specific anatomy and clinical circumstances. | | Indications for Use: | The ZSFab Cervical Interbody System is intended for anterior interbody fusion in skeletally mature patients who have had at least six weeks of non- operative treatment. The ZSFab Cervical Interbody System is indicated to treat cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The ZSFab Cervical Interbody System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone to facilitate fusion and to be used with supplemental fixation cleared for use in the cervical spine. | | Materials: | The ZSFab Cervical Interbody System implants are manufactured from Ti- 6Al-4V ELI titanium alloy (ASTM F3001). | | Primary Predicate: | Cascadia™ Interbody System (K2M Inc. – K160125) | | Performance Data: | Mechanical testing of the worst case ZSFab Cervical Interbody System implant included static and dynamic axial compression and static and dynamic torsion according to ASTM F2077. In addition, subsidence according to ASTM F2267 and expulsion tests were performed. The mechanical test results demonstrate that the ZSFab Cervical Interbody System performance is substantially equivalent to the predicate devices. | | Technological Characteristics: | The ZSFab Cervical Interbody System possesses the same technological characteristics as one or more of the predicate devices. These include: • intended use (as described above) • basic design (additively manufactured structure), • material (titanium alloy) and • sizes (dimensions are comparable to those offered by the predicate systems) The ZSFab Cervical Interbody System is the same as previously cleared devices. | | Conclusion: | The ZSFab Cervical Interbody System possesses the same intended use and technological characteristics as the predicate devices. Therefore the ZSFab Cervical Interbody System is substantially equivalent for its intended use. | {4}------------------------------------------------