ZSFab Lumbar Interbody System

K252610 · Zsfab, Inc. · MAX · Nov 25, 2025 · Orthopedic

Device Facts

• Record ID: K252610
• Device Name: ZSFab Lumbar Interbody System
• Applicant: Zsfab, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: Nov 25, 2025
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ZSFab Lumbar Interbody System is intended for lumbar interbody fusion. The devices are indicated for use at one or two contiguous levels in the lumbar spine from L2-S1, in skeletally mature patients who have had at least six months of non-operative treatment. The ZSFab Lumbar Interbody System is indicated to treat lumbar degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by imaging studies (radiographs, CT, MRI). Additionally, the ZSFab Lumbar Interbody System can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The ZSFab lumbar Interbody System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone and/or demineralized allograft bone with bone marrow aspirate to facilitate fusion and to be used with supplemental fixation cleared for use in the lumbosacral spine.

Device Story

Additively manufactured titanium interbody fusion implants; solid frame with lattice structures; central cavity for bone graft. Used for surgical stabilization of lumbar spine; implanted by surgeons. Implants feature teeth on endplates; available in various heights, lengths, widths, and lordotic angles to match patient anatomy. Used with autogenous/allogeneic bone graft and supplemental fixation. Benefits include spinal fusion in patients with degenerative disc disease or scoliosis.

Clinical Evidence

Bench testing only. Mechanical evaluation performed per ASTM F2077, including axial compression, compression shear, and expulsion testing. No clinical data provided.

Technological Characteristics

Material: Titanium alloy Ti-6Al-4V ELI per ASTM F3001. Additively manufactured. Features: Solid frame with lattice structures (850μm-1180μm pores) and endplate teeth (620μm-710μm pores). Supplied sterile. Mechanical testing per ASTM F2077.

Indications for Use

Indicated for skeletally mature patients requiring lumbar interbody fusion at one or two contiguous levels (L2-S1). Treats degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis, and degenerative scoliosis. Requires six months of prior 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

• ZSFab Lumbar Interbody System (K242734)
• ZSFab Lumbar Interbody System (K221858)
• TiGer Shark System (K172816)
• Aleutian IBF System (K133614)

Submission Summary (Full Text)

{0}

FDA U.S. FOOD & DRUG ADMINISTRATION

November 25, 2025

ZSFab, Inc.
% Nathan Wright
Engineer & Regulatory Specialist
Applied Technical Services (Empirical Technologies)
4628 Northpark Drive
Colorado Springs, Colorado 80918

Re: K252610
Trade/Device Name: ZSFab Lumbar Interbody System
Regulation Number: 21 CFR 888.3080
Regulation Name: Intervertebral Body Fusion Device
Regulatory Class: Class II
Product Code: MAX
Dated: November 10, 2025
Received: November 10, 2025

Dear Nathan Wright:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

{1}

K252610 - Nathan Wright
Page 2

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

{2}

K252610 - Nathan Wright
Page 3

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

{3}

ZSFab Lumbar Interbody System
K252610
Page 1 of 1

| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This
textbox will be left blank for original applications/submissions. | K252610 | ? |
| Please provide the device trade name(s). | | ? |
| ZSFab Lumbar Interbody System | | |
| Please provide your Indications for Use below. | | ? |
| The ZSFab Lumbar Interbody System is intended for lumbar interbody fusion. The devices are indicated for
use at one or two contiguous levels in the lumbar spine from L2-S1, in skeletally mature patients who have
had at least six months of non-operative treatment. The ZSFab Lumbar Interbody System is indicated to
treat lumbar degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the
involved spinal level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc
confirmed by imaging studies (radiographs, CT, MRI). Additionally, the ZSFab Lumbar Interbody System
can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The ZSFab lumbar
Interbody System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous
and/or corticocancellous bone and/or demineralized allograft bone with bone marrow aspirate to facilitate
fusion and to be used with supplemental fixation cleared for use in the lumbosacral spine. | | |
| Please select the types of uses (select one or both, as
applicable). | ☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |

{4}

K252610 - 510(K) SUMMARY
K252610
Page 1 of 2

| Submitter’s Name: | ZSFab, Inc. |
| --- | --- |
| Submitter’s Address: | 96 Clematis Avenue, Suite 2F
Waltham, Massachusetts 02453 |
| Submitter’s Telephone: | 617-468-8665 |
| Contact Person: | Nathan Wright, MS, RAC
Empirical Technologies (an ATS Company)
1-719-351-0248
[e-mail] |
| Date Summary was Prepared: | November 10, 2025 |
| Trade or Proprietary Name: | ZSFab Lumbar Interbody System |
| Device Classification Name: | Intervertebral Fusion Device with Bone Graft, Lumbar |
| Classification & Regulation #: | Class II per 21 CFR §888.3080 |
| Product Code: | MAX |
| Classification Panel: | Orthopedic – Spinal Devices |

## DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The ZSFab Lumbar Interbody System includes additively manufactured interbody fusion devices for lumbar implantation. The implants are designed as a solid frame that includes lattice structures to provide surgical stabilization of the spine. The lattices have near-elliptical pores with axis lengths of 850μm to 1180μm. The endplates are featured with teeth design and stochastic lattice structures with average pore size of 620μm to 710μm. Each lumbar interbody has a central cavity for 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. The implants are additively manufactured from titanium alloy Ti-6Al-4V ELI per ASTM F3001 and supplied sterile.

The purpose of this 510(k) is to introduce a line extension of the P-TLIF configuration with additional sizes.

## INDICATIONS FOR USE

The ZSFab Lumbar Interbody System is intended for lumbar interbody fusion. The devices are indicated for use at one or two contiguous levels in the lumbar spine from L2-S1, in skeletally mature patients who have had at least six months of non-operative treatment. The ZSFab Lumbar Interbody System is indicated to treat lumbar degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by imaging studies (radiographs, CT, MRI). Additionally, the ZSFab Lumbar Interbody System can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The ZSFab lumbar Interbody System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone and/or demineralized allograft bone with bone marrow aspirate to facilitate fusion and to be used with supplemental fixation cleared for use in the lumbosacral spine.

## 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. Specifically, the following characteristics are similar between the subject and predicates:

1 | Page

{5}

K252610
Page 2 of 2

- Indications for Use
- Structure and Function
- Material of Manufacture
- Size Options
- Manufacturing and Biocompatibility
- Sterility

## Predicate Devices

| 510k Number | Trade or Proprietary or Model Name | Manufacturer | Predicate Type |
| --- | --- | --- | --- |
| K242734 | ZSFab Lumbar Interbody System | ZSFab, Inc. | Primary |
| K221858 | ZSFab Lumbar Interbody System | ZSFab, Inc. | Additional |
| K172816 | TiGer Shark System | Choice Spine, LP | Additional |
| K133614 | Aleutian IBF System | K2M, Inc. | Additional |

## PERFORMANCE DATA

The subject ZSFab Lumbar Interbody System was evaluated through finite element under ASTM F2077 axial compression and compression shear loading conditions and tested in dynamic axial compression and compression shear to verify that the mechanical testing under of the ZSFab Lumbar Interbody System under K242734 was the worst-case compared to subject implants. The subject ZSFab Lumbar Interbody System was also tested in expulsion.

## CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the subject ZSFab Lumbar Interbody System is substantially equivalent to the predicate devices.

2 | Page