The NEO Pedicle Screw System™, when used as a posterior pedicle screw system, is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. The system is intended for posterior, non-cervical fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (scoliosis, kyphosis), tumor, pseudarthrosis, and/or failed previous fusion.

When used in conjunction with BonOs® Inject Cement, the NEO Pedicle Screw System™ is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. NEO Pedicle Screws augmented with BonOs® Inject Cement are for use with 5 mm to 8 mm screw diameters at spinal levels (thoracic and lumbar T1 to L5) where the structural integrity of the spine is not severely compromised.

BonOs® Inject

BonOs® Inject bone cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using vertebroplasty or balloon kyphoplasty procedure.

When used in conjunction with NEO Pedicle Screw System™ BonOs® Inject is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. NEO Pedicle Screws augmented with BonOs® Inject Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

Device Description

BonOs® Iniect

BonOs® Iniect is a radiopaque, iniectable bone cement for use in spine surgery like percutaneous vertebral augmentation during vertebroplasty or kyphoplasty. It is a twocomponent system consisting of a powder and a liguid. Methylmethacrylate polymer is the primary constituent of the powder component. Zirconium dioxide is added as radiopacifier. Methylmethacrylate monomer is the primary constituent of the liquid component. Mixing the two separate sterile components, initially an injectable paste is produced which can be transferred into a syringe and which then can be injected under slight pressure into the vertebral body. After curing of the bone cement by exothermic polymerization it stabilizes the vertebral lesions and vertebral compression fractures.

NEO Pedicle Screw System™

The NEO Pedicle Screw System™ has been optimized and consists of 27 pedicle and 8 iliac screws, rods and connectors which are available in different sizes. The system includes a reduced optimized trav of instruments providing options for open and MIS surgical techniques. The implants are all delivered sterile and ready to use. The relevant instruments are mainly delivered as single use, disposable and delivered sterile, just a few optional instruments are reusable and delivered non-sterile.

All the system components are made of materials compliant with ASTM and/or ISO standards. Screws and rods are made of titanium-alloy (Ti-6AI-4VELI) and comply with ISO 5832-3 or ASTM-F136. The screws are made out of a titanium alloy and delivered pre-mounted to a screw extender including a tissue dilator and sterile. The rods are made out of a titanium alloy or cobalt chrome alloy CoCrMo (ISO 5832-12, ASTM F1537) and delivered sterile, Connectors are made out of titanium alloy and delivered sterile.

The pedicle screws are offered in diameters of 4.5 – 8.0 mm and lengths of 25 - 55 mm. Illiac screws are offered in diameters of 8.0 mm and 10.0 mm and lengths of 70 – 100 mm. Three different types of rods are available: pre-bent, straight or special bent rod for S1/L5. All rods have a diameter of 5.5 mm. Pre-bent rods are offered in lengths of 35 – 100 mm, straight rods in lengths from 30 - 500 mm and the special-bent rod in either 30 or 40 mm length.

The NEO Pedicle Screw System™ provides immobilization and stabilization of spinal seqments in skeletally mature patients as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The system can be used via an open or minimally invasive posterior approach. lliac screws shall be placed via Sacral Alar Iliac (SAI) and/or Posterior Superior Illiac Spine (PSIS) approach. The size and form of the device is adjusted to the morphology of the body and the surgical technique.

AI/ML Overview

The provided text is an FDA 510(k) clearance letter and a 510(k) summary for a medical device called the "NEO Pedicle Screw System™" and "BonOs® Inject Bone Cement." This document details the administrative information, device description, indications for use, and a summary of performance data to support substantial equivalence to a predicate device.

However, the document specifies that "No clinical studies were conducted." This means that the information requested regarding acceptance criteria for a study proving device performance (especially for AI/algorithm-based devices), sample size for test and training sets, expert involvement, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment cannot be provided from this document.

The performance data mentioned in the document are limited to non-clinical testing, primarily focusing on mechanical performance, biological evaluation, and MRI compatibility. These types of tests are used to demonstrate that changes to the device (like new components or size extensions) do not negatively impact its existing, cleared performance characteristics, and that it is substantially equivalent to the predicate device.

Therefore, I cannot populate the requested table or answer the specific questions related to the acceptance criteria and study that proves the device meets the acceptance criteria in the context of an AI/algorithm-driven device's performance study, as this submission is for a physical orthopedic implant system, not a software or AI product requiring such a study.

Here's what can be inferred from the document regarding "acceptance criteria" and "proof" in the context of this device:

The "acceptance criteria" for the modifications introduced in this 510(k) submission are implicitly met if the device demonstrates substantial equivalence to its predicate device. This is primarily demonstrated through:

Mechanical Performance: Meeting the requirements for pedicle screw spinal systems according to relevant ASTM and ISO standards (e.g., ASTM F1717 for dynamic compression bending). The document states: "Non-clinical performance testing demonstrate that the NEO Pedicle Screw System™ meets the requirements for Pedicle screw spinal systems according to Spinal System 510(k)s Guidance for Industry and FDA Staff Document issued on: May 3, 2004 and is substantially equivalent to its predicate devices."
Biological Evaluation: Compliance with ISO 10993-1 series for the new components.
MRI Compatibility: Meeting standards like ASTM F2052-15, ASTM F2182-11a, and ASTM F2119-07 (R2013).
Functionality: Internal validation confirming new components function as intended.

Table of Acceptance Criteria (Implicit for a Mechanical Device) and Reported Performance:

Acceptance Criteria Category	Specific Acceptance Criteria (Implicit from Submission)	Reported Device Performance (as stated in the document)
Mechanical Performance	Meets requirements of relevant standards (e.g., ASTM F1717 for dynamic compression bending for spinal systems).	"Finite element analysis and engineering rationales were performed to justify that the subject components do not represent a new worst case for mechanical performance. Additionally, the new axial connector was included in a construct tested according to ASTM F1717 for dynamic compression bending." "Mechanical testing also confirmed that the conical press-fit connection between the ball attachment and the 10.0 mm diameter iliac screw thread is sufficiently strong through measurement of the torque resistance of the assembled screw." "Results of these evaluations demonstrate substantially equivalent mechanical performance."
Biocompatibility	New components comply with ISO 10993-1 series.	"Biological evaluation has been performed for the new 10.0 mm diameter iliac screws of the modified NEO Pedicle Screw System™ in accordance with the ISO 10993-1 series."
Cleaning & Sterilization	Validation performed for new components.	"A new cleaning and sterilization validation has been performed for the new 10.0 mm diameter iliac screws."
MRI Compatibility	Evaluated against ASTM F2052-15, F2182-11a, F2119-07 (R2013).	"The new system components have been evaluated in regards to Magnetic field interactions ASTM F2052-15, MRI-related heating ASTM F2182-11a and Artifacts ASTM F2119-07 (R2013). Non-clinical testing demonstrated that the entire family of the NEO Pedicle Screw System™ is MRI conditional. The previous conclusions and MR conditional K222256 remain valid."
Functional Performance (Internal)	New axial connectors function as intended.	"An internal validation of the new axial connectors of the modified NEO Pedicle Screw System™ was performed and confirmed they function as intended."
Overall Equivalence	Demonstrated substantial equivalence to the predicate device in terms of intended use, material, design, and function.	"Based on the indications for use, technological characteristics, and comparison to predicate device, the subject modified BonOs® Inject Bone Cement, NEO Pedicle Screw System™ has been shown to be substantially equivalent to the currently cleared predicate device."

Regarding the specific questions about an AI/algorithm performance study:

Sample size for the test set and data provenance: Not applicable. No clinical or external algorithm performance test set was used.
Number of experts used to establish the ground truth and qualifications: Not applicable.
Adjudication method for the test set: Not applicable.
MRMC comparative effectiveness study: Not applicable.
Standalone (algorithm only without human-in-the-loop performance) study: Not applicable.
Type of ground truth used: Not applicable. Ground truth for a physical device is often demonstrated by meeting design specifications and performance under defined test conditions (e.g., material strength and fatigue testing).
Sample size for the training set: Not applicable. This is not an AI/ML device.
How the ground truth for the training set was established: Not applicable.

In summary, the provided document is for a traditional mechanical medical device, not an AI/ML powered one. Therefore, the specific criteria and study details requested, which are pertinent to AI/ML device evaluations, are not present in this submission. The "proof" for this device's acceptance rests on its demonstration of substantial equivalence to a predicate device through non-clinical laboratory testing.

Summary

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December 23, 2024

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below.

Neo Medical SA % Dawn Balazs-Metz Senior Consultant meditec Consulting GmbH Obermoosstrasse 23 Berne, BE 3067 Switzerland

Re: K243693

Trade/Device Name: NEO Pedicle Screw System™ Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB, PML, NDN Dated: November 25, 2024 Received: November 29, 2024

Dear Dawn Balazs-Metz:

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" (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).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 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-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (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-device-advicecomprehensive-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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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Sincerely, EILEEN Digitally signed by CADEL EILEEN -၇ 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

Submission Number (if known)

K243693

Device Name

NEO Pedicle Screw System TM

Indications for Use (Describe)

NEO Pedicle Screw System™

BonOs® Inject

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

Prescription Use (Part 21 CFR 801 Subpart D)

ver-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary

In accordance with 21 CFR 807.92 the following information is provided for the BonOs® Inject Bone Cement, NEO Pedicle Screw System™.

ADMINISTRATIVE INFORMATION

Date prepared	November 25, 2024
Submission type	Special 510(k)
Purpose of 510(k)	Modification to currently marketed NEO Pedicle ScrewSystem™, New system component - axial connectors, LineExtension - 10.0 mm diameter iliac screws and 150 mmconnectors, announcement of minor modifications to the devicesince the last clearance (K222256)
Submitter	Neo Medical S.A.Route de Lausanne 157 A1096 Villette (Lavaux), Switzerland
Official Correspondent	Dawn Balazs-MetzSenior consultant, meditec Consulting GmbHPhone +41 79 772 5540Email balazs-metz@meditec-consulting.ch
US agent	Richie Robel, confinis corporationPhone +1 716 867-2417Email Richie.Robel@confinis.com

DEVICE NAME AND CLASSIFICATION

Trade name	1) BonOs® Inject Bone Cement,2) NEO Pedicle Screw System™
Common name	1) PMMA bone cement for vertebroplasty2) Pedicle Screw System
Regulation number,Regulation name,Regulatory class, ProductCodes	1) BonOs® Inject Bone Cement21 CFR 888.3027Polymethylmethacrylate (PMMA) bone cementClass IIPML, NDN
	2) NEO Pedicle Screw System™21 CFR 888.3070Thoracolumbosacral pedicle screw systemClass IINKB

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PRIMARY PREDICATE DEVICE

BonOs® Inject Bone Cement, NEO Pedicle Screw System™ (K222256)

INDICATIONS FOR USE

NEO Pedicle Screw System™

The NEO Pedicle Screw System™, when used as a posterior pedicle screw system, is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. The system is intended for posterior, non-cervical fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (scoliosis, kyphosis, and/or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.

BonOs® Inject

When used in coniunction with NEO Pedicle Screw System™ BonOs® Inject is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. NEO Pedicle Screws auqmented with BonOs® Inject Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

DEVICE DESCRITION

1) BonOs® Iniect

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2) NEO Pedicle Screw System™

SUMMARY OF TECHNOLOGICAL CHARACTERISTICS AND COMPARISON TO PREDICATE DEVICE

The modified NEO Pedicle Screw System™ is substantially equivalent to it's the currently cleared device in terms of intended use, material, design, mechanical properties and function. Non-clinical performance testing demonstrate that the NEO Pedicle Screw System™ meets the requirements for Pedicle screw spinal systems according to Spinal System 510(k)s Guidance for Industry and FDA Staff Document issued on: May 3, 2004 and is substantially equivalent to its predicate devices.

SUMMARY OF PERFORMANCE DATA

Finite element analysis and engineering rationales were performed to justify that the subject components do not represent a new worst case for mechanical performance. Additionally, the new axial connector was included in a construct tested according to ASTM F1717 for dynamic compression bending. Mechanical testing also confirmed that the conical press-fit connection between the ball attachment and the 10.0 mm diameter illac screw thread is sufficiently strong through measurement of the torque resistance of the assembled screw. Results of these evaluations demonstrate substantially equivalent mechanical performance.

Biological evaluation has been performed for the new 10.0 mm diameter iliac screws of the modified NEO Pedicle Screw System™ in accordance with the ISO 10993-1 series. A new cleaning and sterilization validation has been performed for the new 10.0 mm diameter illiac screws.

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The new system components have been evaluated in regards to Magnetic field interactions ASTM F2052-15, MRI-related heating ASTM F2182-11a and Artifacts ASTM F2119-07 (R2013). Non-clinical testing demonstrated that the entire family of the NEO Pedicle Screw System™ is MRI conditional. The previous conclusions and MR conditional K222256 remain valid.

An internal validation of the new axial connectors of the modified NEO Pedicle Screw System™ was performed and confirmed they function as intended.

No clinical studies were conducted.

CONCLUSION

Based on the indications for use, technological characteristics, and comparison to predicate device, the subject modified BonOs® Inject Bone Cement, NEO Pedicle Screw System™ has been shown to be substantially equivalent to the currently cleared predicate device.

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.