The INNOVASIS® Excella® Spinal System, when used for pedicle screw fixation is intended only for patients: a) Having severe spondylolisthesis (Grade 3 & 4) at the L5-S1 joint; b) Who are receiving fusion using autogenous bone graft only; c) Who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and d) Who are having the device removed after the development of a solid fusion mass.

The INNOVASIS® Excella® Spinal System, when used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic deformities of the thoracic, lumbar, and sacral spine: i. Degenerative spondylolisthesis with objective evidence of neurologic impairment; Fracture; Dislocation; iii. iv. Scoliosis; V. Kyphosis; Spinal tumor; and vi. vii. Previous failed fusion (pseudoarthrosis).

The INNOVASIS® Excella® Spinal System, when used for anterolateral non-pedicle fixation, is intended for the following indications: i. Degenerative disc disease* ii . Spinal stenosis; iii. Spondylolisthesis; Pseudoarthrosis V. vi. Tumor vii. Trauma (i.e. fracture or dislocation); and iv. Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis); viii. Previous failed fusion. *(defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies).

The INNOVASIS® Excella® Spinal System, when used for posterior non-pedicle screw fixation to the noncervical spine, is intended for the following indications: i. Degenerative disc disease; ii. Spinal stenosis; iii. Spondylolisthesis; V. Pseudoarthrosis Tumor: vi. vii. Trauma (i.e. fracture or dislocation); iv. Spinal deformities (i.e. scoliosis, kyphosis and/or lordosis); viii. Previous failed fusion. *(defined as back pain of disogenic origin with degenerative disc confirmed by patient history and radiographic studies).

Device Description

The Excella IIM Spinal System consists of 6AL-4V Titanium alloy implants meant to be used in a system. The single use devices are offered in a variety of different lengths ranging from 25mm to 60mm as well as the following diameters, 4.75mm, 5.5mm, 6.5mm and 7.5mm, 8.5mm-and are sold non-sterile. The Excella II implants are cannulated and feature a multi-axial joint for free motion of the screw head to allow the physician greater flexibility when placing the screws, including use of a minimally invasive surgical procedure. The bone thread portion of the screws features a self-tapping, double lead with an aggressive thread.

The Excella II system utilizes 5.5mm Titanium rods in various lengths from 35mm to 460mm (straight) or 35mm to 85mm (bent). The rods are placed in the head of the screws and the system is locked in place with Titanium locking caps. The locking caps design includes a threaded locking screw attached to an alignment cap. Each locking cap includes a buttress thread design for axial strength and to prevent screw loosening. The alignment cap is attached to the bottom of the locking screw and rotates about the radial axis. This cap is intended to aid the alignment of the locking cap during insertion. The alignment cap also improves the rotational stiffness at the rod to locking cap interface.

The Excella II system also has available alignment caps with extended length head (reduction head) that can be broken off after installation. The available lengths go from 5 inches (12.7mm) to 4.72 inches (120mm). Primarily used in scoliosis correction, the reduction head allows easier use of longer rods that may be difficult to place in the standard head due to the anatomy of the patient and the curvature of the spine needing correction. A retaining ring is provided to prevent splay of the reduction head while tightening down the rod. Once the locking screw has been tightened in place, the ring is removed and the added length on the alignment cap can be broken off at a tab, resulting in a final profile and assembly that is identical to a standard screw and locking cap assembly.

The cross connectors come in various adjustable lengths and allow for variation in perpendicular placement on two rods. Each cross connector features a clamping mechanism to grip the rods and stabilize the relation between the rods.

The implants are machined from Medical Grade Titanium (6AL-4V) per ASTM F136-02a.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Innovasis Excella II Spinal System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria as might be seen for novel devices or PMAs. As such, the information you've requested regarding acceptance criteria and performance studies in the context of AI/software device evaluation (e.g., sample sizes, expert ground truth, MRMC studies) is largely not applicable to this document.

The "studies" performed for this submission are mechanical tests of the physical implant, and the "acceptance criteria" are the ability to perform in accordance with its intended use, based on these tests and comparison to a predicate device.

Here's an analysis of the provided text in relation to your request, highlighting what is and isn't present:

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

The document does not present specific quantitative acceptance criteria and device performance in a table format as would be expected for a software/AI clinical trial. Instead, it relies on demonstrating substantial equivalence through adherence to recognized ASTM standards and material specifications.

Acceptance Criteria (Implied)	Reported Device Performance
Material Specifications:
Biocompatible materials	Use of biocompatible materials with a proven history of acceptable performance.
Adherence to ASTM F136-02a for Medical Grade Titanium (6AL-4V)	Material selection with certifications to ASTM F136. Additional biocompatibility testing verification (LAL, MEM analysis).
Mechanical Performance:
Ability to perform in accordance with intended use (spinal fixation)	Performance testing per ASTM F543 (Standard Specification and Test Methods for Metallic Medical Bone Screws), ASTM F1717-09 (Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model), and ASTM F1798-97 (Reapproved 2008) (Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants) for:
- Static Compression Bend	- (Indicates satisfactory performance)
- Static Torsion	- (Indicates satisfactory performance)
- Dynamic Compression Bend	- (Indicates satisfactory performance)
- Axial Pullout Strength	- (Indicates satisfactory performance)
- Torque to Failure	- (Indicates satisfactory performance)
- Axial, Flexion and Torsional Grip	- (Indicates satisfactory performance)
Manufacturing & Design:
Dimension verification to design	Dimension verification (inspection) to the design.
Process verification and validation	Process verification and validation.
Product verification and validation	Product verification and validation.
Physician evaluation	Physician evaluation.
Calibrated inspection systems	Calibrated inspection systems.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document as it pertains to a mechanical device and not a data-driven AI/software study. "Sample size" in this context would refer to the number of implants tested mechanically, but specific numbers for each test are not given, only the standards applied. The tests are non-clinical (physical testing of the device itself) and not related to patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and therefore not provided. Ground truth for mechanical devices is established through adherence to engineering specifications and performance against recognized standards, not expert consensus on medical images or patient outcomes. The document mentions "Physician evaluation" but does not detail how this was conducted or for what specific purpose related to "ground truth" and test sets.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and therefore not provided. Adjudication methods are relevant for clinical studies involving disagreement among human reviewers, which is not the type of study described here.

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

An MRMC study is not applicable and was not done. This type of study is for evaluating the impact of AI on human reader performance, which is completely outside the scope of a 510(k) for a spinal implant.

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

A standalone performance study is not applicable and was not done. This device is a physical pedicle screw system, not an algorithm.

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

The "ground truth" for this device's performance is implicit in its ability to meet established engineering standards (ASTM F543, F1717, F1798) for mechanical strength, fatigue, and material composition. There is no biological or interpretative ground truth involved in its evaluation for substantial equivalence.

8. The sample size for the training set

This information is not applicable and therefore not provided. There is no "training set" as this is not an AI/machine learning device.

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

This information is not applicable and therefore not provided. There is no "training set" and therefore no ground truth established for it.

Summary

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1.0 510(k) Summary Prepared October 5, 2010 Company: Innovasis, Inc. 614 E. 3900 South Salt Lake City, UT 84107 Marshall C. McCarty Contact: OCT 7 2010 Phone: (801) 261-2236 mmccarty@innovasis.com Trade Name: Excella® Spinal System Excella-M Excella-P Excella II™ Common Name: Pedicle Screw Spinal System Classification: Regulation No.: 21CFR 888.3050, 3060. Class II Regulation No .: 21CFR 888.3070, Class III Product Code: NKB, KWP, KWQ, MNI, MNH Review Panel: Orthopedic Applicable Standards: ASTM F543-07 Standard Specification and Test . Methods for Metallic Medical Bone Screws. ASTM F1717-09 Standard Test Methods for Spinal . Implant Constructs in a Vertebrectomy Model ASTM F1798-97(Reapproved 2008) Standard Guide . for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants ASTM F2193-02(Reapproved 2007) Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System Substantially Excella® Spinal System Equivalent Device: K071921 Device Description: The Excella IIM Spinal System consists of 6AL-4V Titanium alloy implants meant to be used in a system. The single use devices are offered in a variety of different

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K1022-18

lenaths ranging from 25mm to 60mm as well as the following diameters, 4.75mm, 5.5mm, 6.5mm and 7.5mm, 8.5mm-and are sold non-sterile. The Excella II implants are cannulated and feature a multi-axial joint for free motion of the screw head to allow the physician greater flexibility when placing the screws, including use of a minimally invasive surgical procedure. The bone thread portion of the screws features a self-tapping, double lead with an aggressive thread.

(Non-clinical)--Performance testing per ASTM F543, Performance Data: F1717 and F1798 for Static Compression Bend, Static Torsion and Dynamic Compression Bend, Axial Pullout Strength, Torque to Failure, Axial, Flexion and Torsional Grip indicates that the Excella II Spinal System is capable of performing in accordance with its intended use.

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K102248

Materials:	The implants are machined from Medical Grade Titanium(6AL-4V) per ASTM F136-02a.
------------	--------------------------------------------------------------------------------------

The intended use is the same as the predicate Excella® Intended Use: Spinal System (K071921). The Innovasis Excella II™ Spinal System is intended for use in the non-cervical area of the spine.

Indications for Use: The intended use is the same as the predicate Excella® Spinal System (K071921).

The Excella Pedicle Screw System, when used for pedicle screw fixation is intended only for patients:

a) Having severe spondylolisthesis (Grade 3 & 4) at the L5-S1 joint;
b) Who are receiving fusion using autogenous bone graft only;
c) Who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and
d) Who are having the device removed after the development of a solid fusion mass.

The Excella Pedicle Screw System, when used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adiunct to fusion, in treatment of the following acute and chronic deformities of the thoracic, lumbar, and sacral spine:

a) Degenerative spondvlolisthesis with objective evidence of neurologic impairment;
b) Fracture:
c) Dislocation;
d) Scoliosis;
e) Kyphosis;
Spinal tumor; and ﮯ
g) Previous failed fusion (pseudoarthrosis).

The Excella Pedicle Screw System, when used for anterolateral non-pedicle fixation, is intended for the following indications:

a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies);
b) Spinal stenosis;
c) Spondylolisthesis;
d) Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis);
e) Pseudoarthrosis;
c Tumor:
g) Trauma (i.e. fracture or dislocation); and

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K10aa48?

h) Previous failed fusion.
The Excella Pedicle Screw System, when used for posterior non-pedicle screw fixation to the non-cervical spine, is intended for the following indications:
a) Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies);
b) Spinal stenosis;
Spondylolisthesis; c)
d) Spinal deformities (i.e. scoliosis, kyphosis and/or lordosis);
e) Pseudoarthrosis;
Tumor: ()
g) Trauma (i.e. fracture or dislocation);
h) Previous failed fusion.

Contraindications (Exclusions for Use): .

a.) Morbid obesity
b.) Mental illness
c.) Alcoholism or drug abuse
d.) Pregnancy
e.) Metal sensitivity / allergies
f.) Severe osteopenia
g.) Active infection near the surgical site
h.) Patients unwilling or unable to follow post-operative care instructions

Basis for Substantial

Equivalence:

The Excella II Spinal System has been subjected to risk analysis, engineering analysis and testing to recognized standards and has been shown to be substantially equivalent to the predicate device, K071921, Excella Spinal System.

Design configurations are substantially equivalent.

Applied mechanical loads are substantially equivalent.

Product sizes and shapes are substantially equivalent.

Materials used are equivalent.

Biocompatibility requirements are equivalent.

Manufacturing and processing methods are substantially equivalent.

Training of Physicians and Representatives is substantially equivalent.

Indications for Use are equivalent.

Shelf life is equivalent.

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K102248

Summary of Safety

And Effectiveness:

And Effectiveness: The Innovasis Excella II Spinal System is shown to be safe and effective for use as a polyaxial pedicle screw system and in the indications associated with device product codes KWP, MNH, MNI and NKB.

Safety: The following have been performed to ensure the safety of the product:

Use of biocompatible materials that have a proven history of acceptable performance.

Material selection with certifications to ASTM F136.

Additional biocompatibility testing verification (LAL, MEM analysis)

Mechanical testing performed to applicable ASTM standards.

Effectiveness: The following have been performed to ensure the effectiveness of the product:

Dimension verification (inspection) to the design.

Process verification and validation.

Product verification and validation.

Physician evaluation

Calibrated inspection systems.

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Image /page/5/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird with outstretched wings, depicted in a simple, flowing design.

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

OCT 7 2010

Innovasis, Inc. % Mr. Marshall C. McCarty Manager QA/RA 614 East 3900 South Salt Lake City, Utah 84107

Re: K102248

Trade/Device Name: Excella II Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH, KWP, KWQ Dated: September 10, 2010 Received: September 13, 2010

Dear Mr. McCarty:

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

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Page 2- Mr. Marshall C. McCarty

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 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/CDRH/CDRHOffices/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/ResourcesforYou/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mark N. Melkers 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 Statement

510(k) Number:

Device Name: Excella® Spinal System

Indications for Use:

The Innovasis® Excella® Spinal System is intended for use in the non-cervical area of the spine.

i. Degenerative spondylolisthesis with objective
- evidence of neurologic impairment;
· Fracture;
Dislocation; iii.
iv. Scoliosis;
V. Kyphosis;
Spinal tumor; and vi.
vii. Previous failed fusion (pseudoarthrosis).

Prescription Use (21 CFR 801 Subpart D) 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

510(k) Number K102248

Page 1 of 2

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The INNOVASIS® Excella® Spinal System, when used for anterolateral non-pedicle fixation, is intended for the following indications:

i. Degenerative disc disease*
ii . Spinal stenosis;
iii. Spondylolisthesis;

Pseudoarthrosis V.

vi. Tumor
vii. Trauma (i.e. fracture or dislocation); and
iv. Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis);
viii. Previous failed fusion.

*(defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies).

The INNOVASIS® Excella® Spinal System, when used for posterior non-pedicle screw fixation to the noncervical spine, is intended for the following indications:

i. Degenerative disc disease;
ii. Spinal stenosis;
iii. Spondylolisthesis;
V. Pseudoarthrosis
Tumor: vi.
vii. Trauma (i.e. fracture or dislocation);
iv. Spinal deformities (i.e. scoliosis, kyphosis and/or lordosis); viii. Previous failed fusion. *(defined as back pain of disogenic origin with degenerative disc confirmed by patient history and radiographic studies).

Prescription Use (21 CFR 801 Subpart D) 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

KIO 2248 510(k) Number.

Page 2 of 2

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.