ChanPin Pedicle Screw Spinal System

K251251 · Chanpin Medtak Co., Ltd. · NKB · Jun 9, 2026 · Orthopedic

Device Facts

• Record ID: K251251
• Device Name: ChanPin Pedicle Screw Spinal System
• Applicant: Chanpin Medtak Co., Ltd.
• Product Code: NKB · Orthopedic
• Decision Date: Jun 9, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The CHANPIN Pedicle Screw Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to thoracolumbosacral fusion for the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: A.Degenerative disc disease (defined as discogenic back pain with disc degeneration confirmed by medical history and radiographic studies) B.Spondylolisthesis C.Trauma D.Tumors E.Spinal stenosis F.Spinal deformities or curvatures (e.g., scoliosis, kyphosis, and/or lordosis) G.Failed previous fusion H.Pseudarthrosis The CHANPIN Pedicle Screw Spinal System is intended for adult patients only.

Device Story

ChanPin Pedicle Screw Spinal System comprises pedicle screws, rods, set screws, and hooks; available in EZ Spine, EZ MIS, and EZ MIS Plus series. Designed for surgical immobilization and stabilization of thoracic, lumbar, and sacral spinal segments. Used by surgeons in clinical settings as an adjunct to thoracolumbosacral fusion. Components provide mechanical support to spinal segments to facilitate fusion in patients with instabilities or deformities. System performance validated via mechanical bench testing.

Clinical Evidence

No clinical data provided; substantial equivalence supported by non-clinical bench testing.

Technological Characteristics

Components manufactured from titanium alloy (Ti-6Al-4V) per ASTM F136 and ISO 5832-3. System includes pedicle screws, rods, set screws, and hooks. Mechanical testing performed per ASTM F1717-21 (static/dynamic compression bending, static torsion) and ASTM F543-17 (twisting and pullout strength).

Indications for Use

Indicated for skeletally mature adult patients requiring immobilization and stabilization of thoracic, lumbar, and sacral spinal segments as an adjunct to fusion for degenerative disc disease, spondylolisthesis, trauma, tumors, spinal stenosis, spinal deformities (scoliosis, kyphosis, lordosis), failed previous fusion, or pseudarthrosis.

Regulatory Classification

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

• NOVA Minimally Invasive System (K182416)

Submission Summary (Full Text)

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

June 9, 2026

ChanPin MedTak Co., Ltd.
Che-Yung Kuan
R&D Manager
7F., No. 168, Lide St., Zhonghe Dist.
New Taipei City 235, Taiwan (R.O.C.)
New Taipei City, 235
Taiwan

Re: K251251

Trade/Device Name: ChanPin Pedicle Screw Spinal System
Regulation Number: 21 CFR 888.3070
Regulation Name: Thoracolumbosacral Pedicle Screw System
Regulatory Class: Class II
Product Code: NKB, KWP
Dated: May 11, 2026
Received: May 11, 2026

Dear Che-Yung Kuan:

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 20903
www.fda.gov

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K251251 - Che-Yung Kuan

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(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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), 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 ([e-mail]) or phone [phone] or 301-796-7100).

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K251251 - Che-Yung Kuan

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Sincerely,

**EILEEN
CADEL-S** for

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. | K251251 | ? |
| --- | --- | --- |
| Please provide the device trade name(s). | | ? |
| ChanPin Pedicle Screw Spinal System | | |
| Please provide your Indications for Use below. | | ? |
| The CHANPIN Pedicle Screw Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to thoracolumbosacral fusion for the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: A.Degenerative disc disease (defined as discogenic back pain with disc degeneration confirmed by medical history and radiographic studies) B.Spondylolisthesis C.Trauma D.Tumors E.Spinal stenosis F.Spinal deformities or curvatures (e.g., scoliosis, kyphosis, and/or lordosis) G.Failed previous fusion H.Pseudarthrosis The CHANPIN Pedicle Screw Spinal System is intended for adult patients only. | | |
| 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) | ? |

© 2014, 2015, 2016, 2017, 2018

2014.05.01

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K251251

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ChanPin MedTak Co., Ltd.

ChanPin Pedicle Screw Spinal System

### 510(k) SUMMARY

**Type of Submission:** Traditional

**Date of Summary:** 2026.05.11

**Submitter:** ChanPin MedTak Co., Ltd.

**Address:** 7F., No. 168, Lide St., Zhonghe Dist., New Taipei

City 235, Taiwan (R.O.C.)

**Phone:** [phone] ext 102

**Contact:** Mr. Che-Yung Kuan

**Email** [e-mail]

**Identification of the Device:**

**Proprietary/Trade Name:** ChanPin Pedicle Screw Spinal System

**Regulation Description:** Thoracolumbosacral pedicle screw system

**Review Panel:** Orthopedic

**Regulation Number:** 21 CFR 888.3070

**Product Code:** NKB

**Device Class:** Class II

**Secondary Regulation** Spinal interlaminal fixation orthosis.

**Description:** Secondary Regulation 21 CFR 888.3050

**Number:**

**Secondary Product Code:** KWP

**Device Class:** Class II

**Identification of the Predicate Device:**

**Predicate Device Name:** NOVA Minimally Invasive System

**Model Number:** N/A

**510(k) Number:** K182416

**Manufacturer:** BAUI BIOTECH CO., LTD.

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K251251

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ChanPin MedTak Co., Ltd.

ChanPin Pedicle Screw Spinal System

Regulation Number: 21 CFR 888.3070

Product Code: NKB

Device Class: Class II

## Indications for Use of the Device

The CHANPIN Pedicle Screw Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to thoracolumbosacral fusion for the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine:

A. Degenerative disc disease (defined as discogenic back pain with disc degeneration confirmed by medical history and radiographic studies)
B. Spondylolisthesis
C. Trauma
D. Tumors
E. Spinal stenosis
F. Spinal deformities or curvatures (e.g., scoliosis, kyphosis, and/or lordosis)
G. Failed previous fusion
H. Pseudarthrosis

The CHANPIN Pedicle Screw Spinal System is intended for adult patients only.

## Device Description

The ChanPin Pedicle Screw System includes three series: EZ Spine, EZ MIS, and EZ MIS Plus, specifically designed to accommodate various forms of spinal surgeries and meet diverse clinical needs. The system consists of primary components such as pedicle screws, rods, set screws, and hooks. All series are available in multiple sizes to address different surgical requirements and patient conditions. All components are manufactured from

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K251251

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ChanPin MedTak Co., Ltd.

ChanPin Pedicle Screw Spinal System

titanium alloy (Ti-6Al-4V) compliant with ASTM F136 and ISO 5832-3 standards.

## Non-clinical Testing

A series of safety and performance tests were conducted on the subject device.

- Performance tests

- Static and dynamic axial compression bending (ASTM F1717-21)
- Static torsion (ASTM F1717-21)
- Twisting strength (ASTM F543-17 Annex A1)
- Pullout strength (ASTM F543-17 Annex A3)

All the test results demonstrate ChanPin Pedicle Screw Spinal System is substantially equivalent to the predicate device.

## Clinical Testing

No clinical test data was used to support the decision of substantial equivalence.

## Substantial Equivalence Determination

ChanPin Pedicle Screw Spinal System is substantially equivalent in intended use, principles of operation, safety and performance to the cleared NOVA Minimally Invasive System (K182416). Differences between the devices cited in this section do not raise any new issue of substantial equivalence.

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K251251

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ChanPin MedTak Co., Ltd.

ChanPin Pedicle Screw Spinal System

## Similarity and Difference

The subject device has similar indications for use/intended use and principle of operation as the predicate device.

The differences between the subject device and the predicate device are diameter and length of Poly-axial Screws. The subject device has tested safety and performance tests and the results were complied with the test requests. Therefore, the differences between subject device and predicate device did not raise any problems of safety or effectiveness. The subject device is substantially equivalent to the predicate device in intended use, main materials, safety and performance claims.

## Conclusion

After analyzing non-clinical laboratory studies and safety testing data, it can be concluded that ChanPin Pedicle Screw Spinal System is substantially equivalent to the predicate device.