When used as a pedicle screw fixation system, the NuVasive Armada Spinal System is 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 posterior thoracic, lumbar, and sacral spine:

Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
Degenerative spondylolisthesis with objective evidence of neurologic impairment
Fracture
Dislocation
Scoliosis
Kyphosis
Spinal tumor and/or
Failed previous fusion (pseudoarthrosis)

The NuVasive Armada Spinal System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants after attainment of a solid fusion.

When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the NuVasive Armada Spinal System is also intended for the following indications:

Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
Spinal stenosis
Spondylolisthesis
Spinal deformities
Fracture
Pseudoarthosis
Tumor resection and/or
Failed previous fusion

When used as a pedicle screw fixation system, the NuVasive Precept Spinal System is 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 posterior thoracic, lumbar, and sacral spine:

Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
Degenerative spondylolisthesis with objective evidence of neurologic impairment
Fracture
Dislocation
Scoliosis
Kyphosis
Spinal tumor and/or
Failed previous fusion (pseudoarthrosis)

The NuVasive Precept Spinal System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants after attainment of a solid fusion.

When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the NuVasive Precept Spinal System is also intended for the following indications:

Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
Spinal stenosis
Spondylolisthesis
Spinal deformities
Fracture
Pseudoarthosis
Tumor resection and/or
Failed previous fusion

When used as a pedicle screw fixation system, the NuVasive SpheRx Spinal System is 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 posterior thoracic, lumbar, and sacral spine:

Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
Degenerative spondylolisthesis with objective evidence of neurologic impairment
Fracture
Dislocation
Scoliosis
Kyphosis
Spinal tumor and/or
Failed previous fusion (pseudoarthrosis)

The NuVasive SoheRx Spinal System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants after attainment of a solid fusion.

When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the NuVasive SpheRx Spinal System is also intended for the following indications:

Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
Spinal stenosis
Spondylolisthesis
Spinal deformities
Fracture
Pseudoarthosis
Tumor resection and/or
Failed previous fusion

Device Description

The NuVasive Polyaxial Screws are part of the following NuVasive systems: Precept (K102514), Armada (K092287), and SpheRx PPS (K090981) that consist of a variety of polyaxial screws, reduction screws, offset connectors, rods, locking nuts, and transverse connectors. Implant components can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the patient. This 510(k) is for the modification to a component used in the assembly of tulip to screw shanks of polyaxial screws.

AI/ML Overview

The provided text is a 510(k) Summary for NuVasive Polyaxial Spinal Screws. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing de novo acceptance criteria for a new type of device or conducting studies to prove a device meets specific clinical performance metrics. Therefore, many of the requested elements for an acceptance criteria study (e.g., sample size, number of experts for ground truth, MRMC studies) are not applicable to this type of regulatory submission.

The device being described is a medical implant (polyaxial spinal screws), not a software or AI-based diagnostic/detection device. The "performance data" section refers to mechanical testing of the physical hardware, not clinical performance or diagnostic accuracy.

Here's an attempt to answer the questions based on the provided text, highlighting where the information is not applicable due to the nature of the submission:

NuVasive Polyaxial Spinal Screws 510(k) Summary Analysis

1. A table of acceptance criteria and the reported device performance

For this medical implant, "acceptance criteria" are equivalent to demonstrating that the device meets or exceeds the mechanical performance of predicate devices as per specific ASTM standards and internal tests.

Acceptance Criteria (Mechanical Testing Standard)	Reported Device Performance
Static and Dynamic Flexion-Extension Moment Testing per ASTM F1798	"meet or exceed the performance of the predicate devices"
Tulip Pull-off	"meet or exceed the performance of the predicate devices"
Tension-Torsion	"meet or exceed the performance of the predicate devices"

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes (number of screws or test repetitions) used for each mechanical test. The data provenance is internal laboratory testing and comparisons to predicate device data, rather than clinical patient data. Therefore, country of origin or retrospective/prospective classification is not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. "Ground truth" in the context of mechanical testing refers to the physical properties and performance measured against engineering standards, not expert clinical interpretation of data.

4. Adjudication method for the test set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where expert consensus is needed to establish ground truth from subjective interpretations. For mechanical testing, the results are quantitative and directly measured.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a physical medical device (spinal screws), not an AI-assisted diagnostic or interpretation tool. Therefore, MRMC studies and "human readers" are irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance of this device is established by engineering standards and mechanical test results. The performance is compared against the known performance of predicate devices. There is no expert consensus, pathology, or outcomes data involved in this specific performance assessment for a 510(k) submission focused on substantial equivalence through mechanical testing.

8. The sample size for the training set

Not applicable. There is no concept of a "training set" for physical device mechanical testing. The tests are designed to evaluate the physical properties and performance of the manufactured device.

9. How the ground truth for the training set was established

Not applicable. As there is no training set, there is no ground truth to establish for it.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a stylized leaf-like shape on the left, followed by the word "NUVASIVE" in a bold, sans-serif font. Below the word "NUVASIVE" is the tagline "Speed of Innovation" in a smaller font. The logo is simple and modern, and the tagline suggests that Nuvasive is a company that is focused on innovation.

510(k) Summary

In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR $807.92. the following summary of information is provided:

AUG 2 4 2012

Submitted by: Elias Ketchum Senior Regulatory Affairs Associate NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 320-4588 Fax: (858) 320-4688

Date Prepared: August 21, 2012

B. Device Name

	Trade or Proprietary Name: NuVasive® Polyaxial Spinal Screws
Common or Usual Name:	Pedicle Screw System
Classification Name:	Pedicle Screw Spinal System, Spinal Interlaminal FixationOrthosis, Spinal Intervertebral Body Fixation orthosis
Device Class:	Class III
Classification:	§888.3050, §888.3060, §888.3070
Product Code:	NKB, KWP, MNI, MNH, KWQ

C. Predicate Devices

The subject NuVasive Polyaxial Spinal Screws are substantially equivalent to the Precept™ (K102514), Armada® (K092287), and SpheRx® PPS (K090981) Systems currently distributed commercially in the U.S. by NuVasive.

. D. Device Description

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Image /page/1/Picture/0 description: The image shows the Nuvasive logo. The logo consists of a stylized graphic element on the left, followed by the word "NUVASIVE" in bold, sans-serif font. Below "NUVASIVE" is the tagline "Speed of Innovation" in a smaller font size. The overall design is clean and modern.

E. Intended Use

NuVasive® Armada® Spinal System

1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
Degenerative spondylolisthesis with objective evidence of neurologic impairment 2.
1. Fracture
Dislocation 4.
స్ Scoliosis
1. Kyphosis
1. Spinal tumor and/or
1. Failed previous fusion (pseudoarthrosis)

When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the NuVasive Armada Spinal System is also intended for the following indications:

1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
1. Spinal stenosis
1. Spondylolisthesis
1. Spinal deformities
1. Fracture
1. Pseudoarthosis
1. Tumor resection and/or
1. Failed previous fusion

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Image /page/2/Picture/1 description: The image contains the logo for Nuvasive. The logo consists of a stylized graphic element on the left, followed by the word "NUVASIVE" in capital letters. Below the word "NUVASIVE" is the tagline "Speed of Innovation" in a smaller font size.

NuVasive® Precept™ Spinal System

1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
1. Degenerative spondylolisthesis with objective evidence of neurologic impairment
1. Fracture
1. Dislocation
1. Scoliosis
1. Kyphosis
1. Spinal tumor and/or
1. Failed previous fusion (pseudoarthrosis)

When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the NuVasive Precept Spinal System is also intended for the following indications:

1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
1. Spinal stenosis
1. Spondylolisthesis
1. Spinal deformities
1. Fracture
1. Pseudoarthosis
1. Tumor resection and/or
1. Failed previous fusion

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a stylized leaf-like shape on the left, followed by the word "NUVASIVE" in bold, sans-serif font. Below the word "NUVASIVE" is the tagline "Speed of Innovation" in a smaller font.

SpheRx® PPS System

1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
Degenerative spondylolisthesis with objective evidence of neurologic impairment 2.
1. Fracture
1. Dislocation
1. Scoliosis
Kyphosis 6.
Spinal tumor and/or 7.
Failed previous fusion (pseudoarthrosis) 8.

When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the NuVasive SpheRx Spinal System is also intended for the following indications:

1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
1. Spinal stenosis
Spondylolisthesis 3.
1. Spinal deformities
1. Fracture
1. Pseudoarthosis
1. Tumor resection and/or
1. Failed previous fusion

F. Technological Characteristics

As was established in this submission, the subject NuVasive Polyaxial Spinal Screws are substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent and have the same technological characteristics to its predicate devices through comparison in areas including design, intended use, material composition, function, and range of sizes.

{4}------------------------------------------------

G. Performance Data

Nonclinical testing was performed to demonstrate that the subject NuVasive® Polyaxial Spinal Screws are substantially equivalent to other predicate devices. The following testing was performed:

. Static and dynamic flexion-extension moment testing per ASTM F1798
. Tulip pull-off
Tension-torsion .

The results of these studies showed that the subject NuVasive Polyaxial Spinal Screws meet or exceed the performance of the predicate devices, and the device was therefore found to be substantially equivalent.

H. Conclusions

Based on the indications for use, technological characteristics, performance testing, and comparison to predicate devices, the subject NuVasive Polyaxial Spinal Screws have been shown to be substantially equivalent to legally marketed predicate devices, and safe and effective for its intended use.

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Image /page/5/Picture/1 description: The image is a seal for the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

AUG 2 4 2012

NuVasive, Incorporated % Mr. Elias Ketchum Senior Regulatory Affairs Associate 7475 Lusk Boulevard San Diego, California 92121

Re: K121619

Trade/Device Name: NuVasive Polyaxial Spinal Screws (Precept, Armada, and SpheRx Systems)

Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, KWP, MNI, MNH, KWQ Dated: July 26, 2012 Received: July 27, 2012

Dear Mr. Ketchum:

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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

{6}------------------------------------------------

Page 2 - Mr. Elias Ketchum

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,
Mark Millerson

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

Enclosure

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Indications for Use

510(k) Number (if known): K121619

NuVasive® SpheRx® PPS System Device Name:____

Indications For Use:

1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
1. Degenerative spondylolisthesis with objective evidence of neurologic impairment
1. Fracture
1. Dislocation
1. Scollosis
1. Kyphosis
. 7. Spinal tumor and/or
1. Failed previous fusion (pseudoarthrosis)

The NuVasive SpheRx Spinal System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants after attainment of a solid fusion.

When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the NuVasive SpheRx Spinal System is also intended for the following indications:

1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
Spinal stenosis 2.
1. Spondylolisthesis
1. Spinal deformities
1. Fracture

Prescription Use

1. Pseudoarthosis
1. Tumor resection and/or

1. Failed previous fusion
  (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

K121614 510(k) Number_

Page 1 of 3

{8}------------------------------------------------

Indications for Use

510(k) Number (if known): K121619

NuVasive® Armada® Spinal System Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
Degenerative spondylolisthesis with objective evidence of neurologic impairment 2.
1. Fracture
1. Dislocation
Scoliosis 5.
1. Kyphosis
1. Spinal tumor and/or
1. Failed previous fusion (pseudoarthrosis)

When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the NuVasive Armada Spinal System is also intended for the following indications:

Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the ﮩﮯ disc confirmed by patient history and radiographic studies)
Spinal stenosis 2.
1. Spondylolisthesis
Spinal deformities ব :
1. Fracture
1. Pseudoarthosis
Tumor resection and/or 7.

Failed previous fusion 8.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

K121619 510(k) Number_

Page 2 of 3

{9}------------------------------------------------

Indications for Use

510(k) Number (if known): K121619

Device Name:

Indications For Use:

1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
1. Degenerative spondylolisthesis with objective evidence of neurologic impairment
1. Fracture
Dislocation 4.
1. Scoliosis
1. Kyphosis
1. Spinal tumor and/or
1. Failed previous fusion (pseudoarthrosis)

When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the NuVasive Precept Spinal System is also intended for the following indications:

1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
1. Spinal stenosis
1. Spondylolisthesis
1. Spinal deformities
1. Fracture
1. Pseudoarthosis
Tumor resection and/or 7.
8 Failed previous fusion

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

KIZI619 510(k) Number_

Page 3 of 3

Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
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.
(b)
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.