Chiral Surgical Pedicle Screw System

K181995 · Chiral Surgical · NKB · Sep 20, 2018 · Orthopedic

Device Facts

• Record ID: K181995
• Device Name: Chiral Surgical Pedicle Screw System
• Applicant: Chiral Surgical
• Product Code: NKB · Orthopedic
• Decision Date: Sep 20, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Chiral Surgical Pedicle Screw System is a posterior non-cervical pedicle screw system intended for use as an adjunct to fusion in patients with degenerative spondylolisthesis (Grade 3 and 4) with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis) of the lumbosacral spine vertebra and implants are removable after the attainment of a solid fusion. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment.

Device Story

Top-loading posterior spinal fixation system; consists of pedicle screws, rods, nuts, and transverse connectors. Used by surgeons to build spinal implant constructs to stabilize and promote fusion in the lumbosacral spine. Implants are non-sterile, single-use, and removable after solid fusion. Provides mechanical stabilization of the spine.

Clinical Evidence

Bench testing only. Testing included static axial compression, static torsion, and dynamic axial compression bending per ASTM F1717 to 5,000,000 cycles.

Technological Characteristics

Top-loading posterior spinal fixation system. Materials: Titanium alloy (Ti-6Al-4V ELI) per ASTM F136 or Cobalt Chrome per ASTM F1537. Non-sterile, single-use. Mechanical stabilization via pedicle screws, rods, nuts, and transverse connectors.

Indications for Use

Indicated for skeletally mature patients with degenerative spondylolisthesis (Grade 3-4) with neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, or pseudarthrosis of the lumbosacral spine requiring fusion. Requires 6 months of prior non-operative treatment.

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

• 4CIS VANE Spine System (K121615)
• SYNERGY Spinal System (K973836)
• TSRH Spinal System (K103049)

Submission Summary (Full Text)

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September 20, 2018

Chiral Surgical % Meredith Lee May, MS, RAC Vice President Empirical Consulting, LLC 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K181995

Trade/Device Name: Chiral Surgical Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB Dated: July 26, 2018 Received: July 26, 2018

Dear Ms. May:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Ronald P. Jean -S

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement on last page.

510(k) Number (if known) K181995 Device Name Chiral Surgical Pedicle Screw System

Indications for Use (Describe)

The Chiral Surgical Pedicle Screw System is a posterior non-cervical pedicle screw system intended for use as an adjunct to fusion in patients with degenerative spondylolisthesis (Grade 3 and 4) with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis) of the lumbosacral spine vertebra and implants are removable after the attainment of a solid fusion. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| <span> <span style="font-family: Arial, sans-serif;"> <span style="font-size: 10pt;"> Prescription Use (Part 21 CFR 801 Subpart D) </span> </span> </span> | <span> <span style="font-family: Arial, sans-serif;"> <span style="font-size: 10pt;"> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> </span> |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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# 5.510(K) SUMMARY

| Submitter's Name: | Chiral Surgical |
|----------------------------|--------------------------------------------------------------------------------------------------|
| Submitter's Address: | 17310 Red Hill Ave, STE 335<br>Irvine, CA 92614 |
| Submitter's Telephone: | [phone] |
| Contact Person: | Meredith Lee May MS, RAC<br>Empirical Consulting<br>719.337.7579<br>[e-mail] |
| Date Summary was Prepared: | 26-Jul-18 |
| Trade or Proprietary Name: | Chiral Surgical Pedicle Screw System |
| Common or Usual Name: | Thoracolumbosacral pedicle screw system |
| Classification: | Class II per 21 CFR §888.3070 |
| Product Code: | NKB |
| Classification Panel: | Posterior Spine Devices Branch (PSDB) |

## DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The Chiral Surgical Pedicle Screw System is a top-loading multiple component, posterior spinal fixation system which consists of pedicle screws, rods, nuts, and a transverse (cross) connectors. The Chiral Surgical Pedicle Screw System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. Chiral Surgical Pedicle Screw System implant components are supplied non-sterile are single use and are fabricated from titanium alloy (Ti-6A1-4V ELI) that conforms to ASTM F136 or Cobalt Chrome that conforms to ASTM F1537. Various sizes of these implants are available.

### INDICATIONS FOR USE

The Chiral Surgical Pedicle Screw System is a posterior non-cervical pedicle screw system intended for use as an adjunct to fusion in patients with degenerative spondylolisthesis (Grade 3 and 4) with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis) of the lumbosacral spine vertebra and implants are removable after the attainment of a solid fusion. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment.

### 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:

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

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| 510k Number | Trade or Proprietary or<br>Model Name | Manufacturer | Predicate<br>Type |
|-------------|---------------------------------------|---------------------------------|-------------------|
| K121615 | 4CIS VANE Spine System | Solco Biomedical Co.,<br>Ltd. | Primary |
| K973836 | SYNERGY Spinal System | Cross Medical<br>Products, Inc. | Additional |
| K103049 | TSRH Spinal System | Medtronic Sofarnor<br>Danek USA | Additional |

Table 5-1 Predicate Devices

### PERFORMANCE DATA

The Chiral Surgical Pedicle Screw System has been tested in the following test modes:

- Static axial compression per ASTM F1717
- Static torsion per ASTM F1717 ●
- Dynamic axial compression bending per ASTM F1717 to estimate the maximum run out load value at 5 000 000 cycles

The results of this non-clinical testing show that the strength of the Chiral Surgical Pedicle Screw System is substantially equivalent to legally marketed predicate devices.

### CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the Chiral Surgical Pedicle Screw System is substantially equivalent to the predicate device.