SYNERGY(TM) TI POSTERIOR SPINAL SYSTEM

• K Number: K950099
• Device Name: SYNERGY(TM) TI POSTERIOR SPINAL SYSTEM
• Manufacturer: BUCKMAN CO., INC.
• Date Cleared: 1997-01-16 ( 737 days)
• Product Code: MNH
• Regulation Number: 888.3070
• Type: Traditional
• Panel: Orthopedic
• Reference & Predicate Devices: K901005 , K901587 , K904243 , K914306 , K914966 , K922520 , K923242 , K920116 , K924381 , K922617 , K922767 , K923239 , K923241
• Predicate For: K061774 , K071377 , K090523 , K092420 , K093833 , K100377 , K100409 , K100438 , K100956 , K101278 , K102853 , K110046 , K111115 , K111883 , K113173 , K120074 , K123164 , K130958 , K131810 , K133103 , K133690 , K133746 , K141253 , K153446 , K161225 , K172808 , K181139 , K973836 , K974749 , K980484 , K983353 , K990118 , K241663

Intended Use

The SYNERGY™ Posterior Spinal System, when using the screws as pedicle screws, is intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the screws fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass.

Except for situations where screws are attached to the pedicles of the lumbar and sacral spine via a posterior approach for the treatment of severe spondylolisthesis (Grade 3 and Grade 4) at the L5-S1 vertebral joint, the specific indications for the SYNERGY™ Posterior Spinal System are:

1. Degenerative Disc Disease (as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
2. Idiopathic scoliosis.
3. Kyphotic deformities of the spine.
4. Paralytic scoliosis and/or pelvic obliquity treated in combination with anterior instrumentation.
5. Lordotic deformities of the spine.
6. Neuromuscular scoliosis associated with pelvic obliquity.
7. Vertebral fracture or dislocation.
8. Tumors.
9. Spondylolisthesis.
10. Stenosis.
11. Pseudarthrosis.
12. Unsuccessful previous attempts at spinal fusion.

Device Description

The SYNERGY™ Posterior Spinal System implants are intended to stabilize the spinal operative site during the development of a solid fusion with bone graft, and are intended to be removed after the development of a solid fusion mass. The implantable portions are made from surgical implant grade stainless steel, commercially pure titanium, and titanium alloy meeting ASTM specifications. The surgical instruments are made from 17-4, 420, 440 and 455 series stainless steels (ASTM F-899-84 and A276-91). Established medical grade plastics (Ultem and Radel) are used to construct the handles, cases, etc. The system is made up of INTEGRAL™ screws, spinal hooks, adjustable and fixed transverse connectors, closed and axial rod connectors, lateral connectors, rods, instruments, and sterilization case(s).

AI/ML Overview

This document is a 510(k) Summary of Safety and Effectiveness for the SYNERGY™ Posterior Spinal System. It describes the device, its intended use, indications, contraindications, and comparisons to predicate devices. However, this document does not contain acceptance criteria or detailed study results demonstrating that the device meets specific performance criteria.

Here's why and what information is missing based on your request:

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

• Acceptance Criteria: Not explicitly stated in the document. For a medical device, these would typically include specific performance metrics like strength, fatigue life, corrosion resistance, biocompatibility, etc., often with numerical thresholds or pass/fail conditions.
• Reported Device Performance: The document mentions that the implants are made from materials meeting ASTM specifications and have "excellent strength, fatigue and corrosion resistance characteristics." It also states "mechanical testing" was done, but no specific results or performance values are provided.
  • Missing Information: Quantitative data from mechanical tests (e.g., maximum load at failure, cycles to failure in fatigue tests), specific corrosion rates, or biocompatibility test results.

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

• Sample Size: Not mentioned.
• Data Provenance: Not mentioned. It's implied that "mechanical testing" and "pre-production quality assurance planning and engineering analysis" were performed by CROSS® Medical Products, Inc., but details on where (e.g., country) or how (retrospective/prospective) are absent. This document focuses on the summary of safety and effectiveness based on equivalence, not a detailed research study protocol or results.

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

• Not Applicable. This device is a surgical implant, not a diagnostic or AI-driven device that requires "ground truth" established by human experts in the context of image interpretation or similar tasks. The "truth" for this device lies in its material properties, mechanical performance, and clinical safety/effectiveness for its intended use, typically assessed through engineering tests and clinical experience with predicate devices.

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

• Not Applicable. See point 3.

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 not an AI-assisted diagnostic device.

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

• Not Applicable. This is not an algorithm-based device.

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

• Not Applicable. For a spinal implant, the "ground truth" for proving substantial equivalence primarily relies on:
  • Material Specifications: Adherence to established ASTM standards for surgical implant materials.
  • Mechanical Testing: Demonstrating equivalent (or superior) mechanical properties (strength, fatigue) compared to predicate devices, often simulated or in vitro.
  • Design Similarity: Comparison of features and dimensions to legally marketed predicate devices.
  • Clinical Experience/Literature: Relying on the known safety and effectiveness of the predicate devices for similar indications.
  • The document states "mechanical testing" was performed, and "engineering analysis" was used to establish substantial equivalence.

8. The sample size for the training set:

• Not Applicable. This device does not use a "training set" in the machine learning sense. The "training" for such a device typically refers to the accumulated knowledge and design principles from prior similar devices and material science.

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

• Not Applicable. See point 8.

In summary:

This 510(k) summary is a regulatory document asserting "substantial equivalence" to predicate devices, a common pathway for medical device approval. It focuses on demonstrating that the new device is as safe and effective as existing legally marketed devices, primarily through:

• Similarity in design and intended use.
• Use of well-known, established materials (meeting ASTM specifications).
• Mechanical testing (though no specific results are provided in this summary).
• Comparison of indications and contraindications.

The level of detail requested in your prompt regarding specific acceptance criteria, test set sizes, ground truth establishment, and MRMC studies is typically found in detailed test reports, design verification and validation documents, or clinical study reports, which are part of the full 510(k) submission but are not always included in the publicly available summary documents.

Summary

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JAN | 6 1997

K950099 510(k) Summary of Safety and Effectiveness Information

Regulatory Authority:

Safe Medical Devices Act of 1990, 21 CFR 807.92

Company Name/Contract:

Company:	CROSS® Medical Products, Inc.5161-A Blazer Memorial ParkwayDublin, Ohio 43017-1339Phone: [phone]FAX: [phone]Medical Device EstablishmentRegistration Number: 1526354
Contact:	Regulatory Affairs Department

CROSS® Medical Products, Inc. 5161-A Blazer Memorial Parkway Dublin, Ohio 43017-1339 Phone: [phone] FAX: [phone]

Device Name:

Trade Name:	SYNERGY™ Posterior Spinal System
Common Name:	Posterior Spine ImplantsUniversal Spine System
Classification Name:	Appliance, Fixation, Spinal InterlaminalSpondylolisthesis Spinal Fixation Device System

Establishment Registration:

Number:	1526354
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Classification:

The Orthopedic and Rehabilitation Devices Panel assigned the unique device classification code 87KWP (Interlaminal uses) to this device system. published physical description of these devices is in 21 CFR, 888.3050. addition, they are presently Class II medical devices. Class II medical devices
are subject to Performance Standards. This device is also categorized under
87MNH (Spon

Performance Standards:

Performance Standards applicable to the SYNERGY™ Posterior Spinal System have not been published by FDA. CROSS® Medical Products, Inc. produces this device according to the regulations and standards that are appropriate to the risk that Class II devices reasonably ormance standards, such as materials certifications, in-house SOP's and/or ASTM Standards are utilized as appropriate.

Substantially Equivalent Devices(s);

• TSRH® Spinal System 1. Danek Group K901005, K901587, K904243,
  K914306, K914966, K922520, K923242
• PWB Lumbosacral Spinal System 2. CROSS® Medical K920116, K924381
• Harrington Spine System 3. Zimmer, Inc. Preamendment Device
• Danek/Sofamor Group 4. Dyna-Lok Spine System K922617、K922767、K923239、K923241

Device Description:

Background: This document summarizes safety and 2 seen the SYNERGY™ Posterior Spinal System contained in the 510(k)
Premarket Notification submitted to FDA in support of its substantial equivalence.

Y™ Posterior Spinal System implants are inten at assists normal healing and are not intended to replace normal body structures.

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They are intended to stabilize the spinal operative site during the development of a solid fusion with bone graft, and are intended to be removed after the development of a solid fusion mass.

The implantable portions of the SYNERGY™ Posterior Spinal System are made from surgical implant grade stainless steel, commercially pure titanium, and titanium alloy meeting ASTM specifications.

In the stainless steel system, the screws and set screws are made from 22-13-5 stainless steel (ASTM F-1314) and the balance of the implants are made from 316 LVM stainless steel (F-138-86, grade 2). Stainless steel alloy of these types are particularly well suited for use as surgical implants. In addition to excellent strength, fatigue and corrosion resistance characteristics, it has a long history of use in the human body as an implant material.

In the titanium system the screws, nuts, and set screws are made from 6Al-4V ELI titanium alloy (ASTM F-136-92). The rods are made from 6Al-4V ELI titanium alloy and commercially pure titanium (ASTM F-67-89, Grade 2). Both of these titanium types have excellent strength, fatigue, and corrosion resistance characteristics. Titanium devices are also useful as an alternative to devices made from stainless steel for selected patients with reactions or sensitivity to stainless steel implants. The surface finish of the titanium implants is tiodized type II, type III, and/or satin finished.

CAUTION: Mixing of dissimilar metals can accelerate the corrosion process. The titanium and stainless steel components of the SYNERGY™ Posterior Spinal System should not be used together. No components of the CROSS® Medical - SYNERGY™ Posterior Spinal System should be used with the components from any other system or manufacturer.

The surgical instruments used to assist in the implantation of the system are made from 17-4, 420, 440 and 455 series stainless steels (ASTM F-899-84 and A276-91). Established medical grade plastics (Ultem and Radel) are used to construct the handles, cases, etc.

The SYNERGY™ Posterior Spinal System is made up of the following basic components:

The CROSS ® Medical - SYNERGY ™ Posterior Spinal System posterior application components are grouped as follows :

• 1. INTEGRAL ™ Open, Closed, and Reduction screws, and angled closed, iliac, and variable locking sacral screws with variable locking seats, hex nuts, and set screws. Only the INTEGRAL ™ Open, Closed, Reduction, and Variable Locking screws are intended for pedicle fixation. (See INDICATIONS)
• 2. Open and closed spinal hooks with sliders, c-rings, and set screws.
• 3. Adjustable and fixed transverse connectors with set screws.

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• 4. Closed and Axial rod connectors with set screws.
• 5. Lateral connectors with set screws.
• 6. Rods.
• 7. Instruments
• 8. Sterilization case(s).

Note: While the variable locking screws and some fasteners (nuts and set screws) are used for both the 6.35 mm and 4.75 mm rod sizes, the remaining components are designed for specific rod diameters.

Note: The 5.5 and 8.0 mm diameter INTEGRAL ™ Open and Reduction Screws, as well as the Angled Closed Screws, and Iliac Screws are only for use with the 6.35 mm rod system.

INDICATIONS:

The SYNERGY™ Posterior Spinal System, when using the screws as pedicle screws, is intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the screws fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass.

Except for situations where screws are attached to the pedicles of the lumbar and sacral spine via a posterior approach for the treatment of severe spondylolisthesis (Grade 3 and Grade 4) at the L5-S1 vertebral joint, the specific indications for the SYNERGY™ Posterior Spinal System are:

• 1. Degenerative Disc Disease (as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
• 2. Idiopathic scoliosis.
• 3. Kyphotic deformities of the spine.
• Paralytic scoliosis and/or pelvic obliquity treated in combination with 4. anterior instrumentation.
• 5. Lordotic deformities of the spine.
• 6. Neuromuscular scoliosis associated with pelvic obliquity.
• 7. Vertebral fracture or dislocation.
• 8. Tumors.
• 9. Spondylolisthesis.
• 10. Stenosis.
• 11. Pseudarthrosis.
• 12. Unsuccessful previous attempts at spinal fusion.

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For these indications, the SYNERGY™ screws and lateral connectors are intended for sacral/iliac attachment only. All of the SYNERGY™ hooks and transverse connectors are intended for posterior thoracic and/or lumbar use only. As a whole, the levels of use for the SYNERGY™ Posterior Spinal System are T1 to the Sacrum. The levels of screw fixation are L3 to ilium.

Note: The 4.75 mm diameter rod/hook constructs are intended only for patients weighing 70 pounds (32 kg) or less.

CONTRAINDICATIONS:

Contraindications include, but are not limited to:

• 1. History of recent infection; systemic, spinal or localized.
• 2. Morbid obesity.
• 3. Mental illness.
• 4. Alcoholism or drug abuse.
• 5. Fever or leukocytosis.
• 6. Pregnancy.
• 7. Metal sensitivity/allergies to the implant materials.
• 8. Severe osteopenia.
• 9. Presence of congenital abnormalities, vague spinal anatomy, tumors, or any other condition which prevents secure implant screw fixation and/or decreases the useful life of the device. Any condition where the device will interfere with anatomical structures or physiological performance, including inadequate tissue coverage over the operational site.
• 10. For pedicle screw cases, missing or congenitally deformed pedicles of the fifth lumbar (L5) vertebrae.
• 11. Patients unwilling or unable to follow post-operative care instructions.
• 12. Any circumstances not described under the heading INDICATIONS.

WARNINGS AND PRECAUTIONS:

Warnings:

• When used as a pedicle screw system, this device system is intended only . for Grade 3 or 4 spondylolisthesis at the fifth lumbar-first sacral (L5-S1) vertebral joint.
• The screws of this device system are not intended for insertion into the ● pedicles to facilitate spinal fusions above the L5-S1 vertebral joint.
• Benefit of spinal fusions utilizing any pedicle screw fixation system has . not been adequately established in patients with stable spines.
• Potential risks identified with the use of this device system, which may � require additional surgery, include:

device component fracture,

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loss of fixation, non-union, fracture of the vertebra, neurological injury, and vascular or visceral injury.

See Warnings and Precautions, and Potential Adverse Effects sections of the package insert for a complete list of potential risks.

In general, the SYNERGY™ Posterior Spinal System should only be implanted by surgeons fully experienced in the use of such implants and the required specialized surgery techniques. Even with the use of spinal implants, a successful result in terms of pain, function, or fusion is not always achieved in every surgical case.

CAUTION: Federal law (USA) restricts these devices to sale by or on the order of a physician.

This device system is not intended to be the sole means of spinal support. Its use without a bone graft or in cases that develop into a non-union will not be successful. No spinal implant can withstand the loads of the body without maturation of a solid fusion mass, and in this case, bending, loosening or fracture of the implant will eventually occur.

The proper selection and compliance of the patient will greatly affect the results. Patients who smoke have been shown to have an increased incidence of non-union. These patients should be advised of this fact and warned of the consequences. Other poor candidates for spine fusion include obese, malnourished, poor muscle and bone quality, and nerve paralysis patients.

Pre-Operative:

• 1. Only those patients who meet the criteria of one or more of the INDICATIONS and do not have any conditions included in the CONTRAINDICATIONS should be selected for implantation.
• 2. The implant components should be handled and stored carefully, protected from any damage, including corrosive environments.
• The surgeon must confirm that all necessary implants and instruments are 3. on hand for the planned surgical construct. Components from other manufacturers should not be combined with components of the SYNERGY™ Posterior Spinal System.
• 4. All implants and instruments must be unpacked, inspected for damage, cleaned and sterilized prior to use in the operative field.

Intra-Operative:

• 1. The Instrumentation Technique Manual should be carefully followed.

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• 2. Extreme caution should be used around the spinal cord and nerve roots, especially when inserting screws or hooks.
• 3. Breakage, slippage, misuse, or mishandling of the instruments or implant components, such as on sharp edges, may cause injury to the patient or operative personnel.
• 4. The implant must be handled and contoured carefully so as to avoid notching or scratching the surface.
• 5. Before closing the soft tissues, all of the nuts and set screws should be tightened firmly according to the operative technique. Recheck the tightness of all nuts and set screws after finishing to ensure that none loosened during tightening or manipulation of the other implants.
• 6. Explanted implants must never be reused.

Post-Operative

• 1. The surgeon must consider removing the implant after healing, as the implants can loosen, fracture or corrode even after fusion has occurred. The risks and benefits of a second surgery must be carefully evaluated.
• 2. The patient must be adequately instructed regarding the risks and limitations of the implant, as well as post-operative care and rehabilitation.
• 3. The patient should be instructed in the proper use of crutches, canes, external braces or any other weight bearing or assist devices that may be required, and limit those physical activities which would place excessive stresses on the implants or cause delay of the healing process. The patient should also be instructed in the proper methods to ambulate, climb stairs, get in and out of bed, and perform activities of daily living, while minimizing rotational and bending stresses.

POSSIBLE ADVERSE EFFECTS:

Pre-operatively, the patient should be made aware of the following possible adverse effects of spinal implant surgery. Additional surgery may be necessary to correct some of these effects.

• 1. Bending, loosening, or fracture of the implants or instruments.
• Metal sensitivity to a foreign body, including possible tumor formation, 2. auto-immune disease, metallosis and/or scarring.
• Skin or muscle sensitivity in patients with inadequate tissue coverage over 3. the operative site, which may result in skin breakdown and/or wound complications.
• 4. Nonunion or delayed union.
• 5. Infection.

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• Nerve or vascular damage due to surgical trauma, including loss of 6. neurological function, dural tears, radiculopathy, paralysis and cerebral spinal fluid leakage.
• 7. Gastrointestinal, urological, and/or reproductive system compromise, including sterility, impotency and/or loss of consortium.
• 8. Pain or discomfort.
• 9. Bone loss due to resorption or stress shielding, or bone fracture at, above or below the level of surgery.
• 10. Hemorrhage of blood vessels and/or hematomas.
• 11. Misalignment of anatomical structures, including loss of proper spinal curvature, correction, reduction and/or height.
• 12. Bursitis.
• 13. Bone graft donor site pain.
• 14. Inability to resume activities of normal daily living.
• 15. Death.

NOTE: The SYNERGY™ Posterior Spinal System Instrumentation Technique Manual should be carefully followed. It supplies important additional information on proper usage of the implants and instruments.

PACKAGING:

All packages containing implants or instruments should be sealed and intact upon receipt. The product should not be used and should be immediately returned to CROSS Medical Products, Inc., if the package or product is damaged.

Sterilization/Resterilization:

All instruments and implants are supplied Non-Sterile. instruments and implants are packaged in "clean only" condition. The labeling of the implants & instruments clearly indicates their sterility status. All packaging materials must be removed prior to sterilization. High temperature steam sterilization should be used, with the following cycle having been laboratory validated:

Method:	Steam
Cycle:	Gravity
Temperature:	250°F (121°C)
Exposure Time:	60 minutes

• Note: It is recommended to dry and/or cool the parts to prevent condensation after the steam cycle.

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Only sterile products should be used in the operative field. The recommended sterilization cycle is based on HIMA/AORN protocols. Other sterilization methods and cycles may also be suitable. However, individuals or hospitals not using the recommended method are advised to validate any alternative method using appropriate laboratory techniques.

INSTRUMENTATION:

Device specific instrumentation is necessary for the insertion and anchoring of the SYNERGY™ Posterior Spinal System. However, much of the surgical procedure is done with general orthopedic instrumentation of the appropriate size and type. SYNERGY™ Posterior Spinal System instruments are made from stainless steel meeting ASTM F899-84 and A276-91 standards.

PRODUCT COMPLAINTS:

Any dissatisfaction with the product quality, labeling or performance should be reported to CROSS® Medical Products, Inc. immediately by the customer or user. Furthermore, if any of the implants "malfunction" (i.e. do not meet any of their performance specifications or otherwise do not perform as intended) and may have caused or contributed to the death or serious injury of the patient, CROSS2 Medical Products, Inc. should be notified immediately by telephone, fax, or written correspondence.

When filing a complaint, the name, part number and lot number of the part should be provided along with the name and address of the person fling the complaint. In addition, the nature of the complaint should be clearly communicated along with a notification of whether a written report from CROSS® Medical Products, Inc. is requested.

COMPARISON WITH PREDICATE DEVICE(S):

The SYNERGY™ Posterior Spinal System has similar design concept, materials, features, intended use and surgical approach as existing legally marketed posterior spine system such as the TSRH®, Harrington, Dyna-Loks, and PWB Lumbosacral Systems. All of these systems are used to treat similar or the same conditions, and all have essentially the same cautions and contraindications for use.

CONCLUSION:

Based on the basic design concept, the use of well known materials, feature comparisons, mechanical testing, indications for use, surgical approach, preproduction quality assurance planning and engineering analysis CROSS® Medical Products, Inc. believes that sufficient evidence exists to reasonably conclude that this device is substantially equivalent to existing legally marketed posterior spine systems.

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.