← Product Code [NKB](/productcode/NKB) · K262712

# Duet™ Spinal Fixation System (K262712)

_Duet Spine Holdings, LLC · NKB · Sep 30, 2026 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K262712

## Device Facts

- **Applicant:** Duet Spine Holdings, LLC
- **Product Code:** [NKB](/productcode/NKB.md)
- **Decision Date:** Sep 30, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.3070
- **Device Class:** Class 2
- **Review Panel:** Orthopedic
- **Attributes:** Therapeutic

## Indications for Use

The Duet™ spinal fixation construct is intended to provide immobilization and stabilization of a single spinal segment in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of lumbar and sacral spine from L1-S1: degenerative disk disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spinal stenosis; pseudoarthrosis; and failed previous fusion.

## Device Story

Duet™ Spinal Fixation System; spinal fixation device for lumbar/sacral spine (L1-S1). Dual screw system; eliminates need for standard pedicle rods. Components: halo-screw, sphere screw, set screw. Manufactured from Ti-6Al-4V ELI. Used by surgeons to provide supplemental fixation at 1-level spinal segment. Immobilizes/stabilizes segment as adjunct to fusion. Mechanical construct provides structural support.

## Clinical Evidence

No clinical data. Bench testing only. Previous static and dynamic compression bending and static torsion testing per ASTM F1717 demonstrated sufficient strength for intended use.

## Technological Characteristics

Material: Ti-6Al-4V ELI. Components: halo-screw, sphere screw, set screw. Mechanism: dual screw system for spinal fixation without rods. Standards: ASTM F1717 (mechanical testing).

## Regulatory Identification

(1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.

## Special Controls

*Classification.* (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
 “Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.

## Predicate Devices

- Duet™ Spinal Fixation System ([K253169](/device/K253169.md))

## Submission Summary (Full Text)

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**U.S. FOOD & DRUG**
ADMINISTRATION

September 30, 2026

Duet Spine Holdings, LLC
% Hannah Taggart
Engineer & Regulatory Specialist
ATS Colorado Springs
4628 Northpark Dr.
Colorado Springs, Colorado 80918

Re: K262712

Trade/Device Name: Duet™ Spinal Fixation System
Regulation Number: 21 CFR 888.3070
Regulation Name: Thoracolumbosacral pedicle screw system
Regulatory Class: Class II
Product Code: NKB
Dated: July 31, 2026
Received: July 31, 2026

Dear Hannah Taggart:

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.

Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls),

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

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K262712 - Hannah Taggart

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ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).

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 Management System Regulation (QMSR) (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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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Sincerely,

# COLIN O'NEILL -S FDA

Colin O'Neill, M.B.E.

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

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# 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. | K262712 | ?  |
| --- | --- | --- |
|  Please provide the device trade name(s). |   | ?  |
|  Duet™ Spinal Fixation System  |   |   |
|  Please provide your Indications for Use below. |   | ?  |
|  The Duet™ spinal fixation construct is intended to provide immobilization and stabilization of a single spinal segment in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of lumbar and sacral spine from L1-S1: degenerative disk disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spinal stenosis; pseudoarthrosis; and failed previous fusion.  |   |   |
|  Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ?  |
|  Please select the age group(s) for which the device(s) is to be used. | ☐ Neonates/Newborns (Birth to < 29 days old) ☐ Infants (29 days old to < 2 years old) ☐ Children (2 years old to < 12 years old) ☐ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) | ?  |

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K262712
Page 1 of 2

# 510(K) SUMMARY

![img-0.jpeg](img-0.jpeg)

|  Submitter's Name: | Duet Spine Holdings, LLC  |
| --- | --- |
|  Submitter's Address: | P.O Box 420 Winona Lake, IN 46590  |
|  Submitter's Telephone: | 901-647-1064  |
|  Contact Person: | Hannah Taggart, MS ATS Colorado Springs 719- 457-1152 htaggart@atslab.com  |
|  Date Summary was Prepared: | July 30, 2026  |
|  Trade or Proprietary Name: | Duet™ Spinal Fixation System  |
|  Device Classification Name: | Thoracolumbosacral Pedicle Screw System  |
|  Classification & Regulation #: | Class II per 21 CFR §888.3070  |
|  Product Code: | NKB  |
|  Classification Panel: | Orthopedic – Spinal (DHT6B)  |

# DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The Duet™ Spinal Fixation System is a spinal fixation device intended to immobilize and stabilize a spinal segment as an adjunct to fusion in the lumbar and sacral regions of the spine. The Duet™ Spinal Fixation System is a dual screw system that eliminates the need for standard pedicle system rods. All components of the Duet™ Spinal Fixation System are manufactured from Ti-6Al-4V ELI.

The Duet™ Spinal Fixation System construct of three components: halo-screw, sphere screw, and set screw. Both screws are offered in various lengths to accommodate individual patient anatomy. The Duet™ Spinal Fixation System is intended to be used at 1-level of the spinal segment to provide supplemental fixation.

# INDICATIONS FOR USE

The Duet™ spinal fixation construct is intended to provide immobilization and stabilization of a single spinal segment in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of lumbar and sacral spine from L1-S1: degenerative disk disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spinal stenosis; pseudoarthrosis; and failed previous fusion. 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 identical between the subject and predicates:

# TECHNOLOGICAL CHARACTERISTICS

- Indications for Use
- Materials of manufacture
- Structural support mechanism

Predicate Devices

|  510k Number | Trade or Proprietary or Model Name | Manufacturer | Product Code | Predicate Type  |
| --- | --- | --- | --- | --- |
|  K253169 | Duet™ Spinal Fixation System | Box Spine, LLC | NKB | Primary  |

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There are no differences between the subject and predicate devices which raise questions for the safety and efficacy of the subject devices.

# PERFORMANCE DATA

The Duet™ Spinal Fixation System was previously tested in the following test modes:

- Static and dynamic compression bending testing per ASTM F1717
- Static torsion testing per ASTM F1717

The Duet™ Spinal Fixation System remains unchanged since the original clearance therefore no additional testing was conducted for this submission. The results of this non-clinical testing show that the strength of the Duet™ Spinal Fixation 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 Duet™ Spinal Fixation System is substantially equivalent to the predicate device.

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**Source:** [https://fda.innolitics.com/device/K262712](https://fda.innolitics.com/device/K262712)

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