Synthes OC Fusion System is intended to provide stabilization to promote fusion of the occipital-cervical junction. A complete occipital-cervical-thoracic construct can be created by using hooks (C1-T3) that have been previously cleared within the Synthes CerviFix System, Synthes Axon System, and Synthes Synapse System.

Synthes OC Fusion System is indicated for the following: DDD of the cervical vertebrae (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies), spondylolisthesis, spinal stenosis, atlanto/axial fracture with instability, occipital-cervical dislocation, revision of previous cervical spine surgery, and tumors (primary and metastatic)

The use of screws is limited to placement in the occiput. Screws are not intended to be placed in the cervical spine.

Synthes Synapse System is indicated for the following: Hooks, Plate/Rods, Plates, Rods and Screws

When intended to promote fusion of the cervical spine and occipitocervical junction (occiput-T3), the plate/rod, plates, rod, hook and screw (3.2 mm cortex) components of the Synthes Cervifix, Axon, OC Fusion and Synapse Systems are indicated for the following:

Degenerative Disc Disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
Spondylolisthesis
Spinal Stenosis
Fracture/dislocation
Atlantoaxial fracture with instability
Occipitocervical dislocation
Revision of pervious cervical spine surgery
Tumor

When used to treat these cervical and occipitocervical conditions, screws are limited to occipital fixation only.

Hooks and Rods
The rod and hook components are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Rods, Clamps, Screws, Nuts, Variable Axis Screws, Locking Screws, and Transverse Bars
The rods, clamps, screws, nuts, variable axis screws, locking screws, and transverse bars are intended to promote fusion following reduction of fracture/dislocation or trauma in the upper thoracic spine (T1-T3).

The use of these screws (3.5 mm, 4.0 mm and 4.5 mm cancellous, and 3.5 mm and 4.2 mm cortex) is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine.

The Synthes CerviFix, Axon, and Synapse Systems can also be linked to the Synthes Universal Spinal System using the 3.5 mm/6.0 mm parallel connectors from that system and via the CerviFix tapered rods using lamina hooks, transverse process hooks, pedicle hooks, 4.2 mm screws and the 5.0 mm/6.0 mm parallel connector.

Warning: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Device Description

The Synthes OC Fusion System consists of occipital plates, occipital screws, occipital clamps, and rods intended to provide stabilization to promote fusion of the occipital-cervical junction. This system allows an occipital-cervical construct of either the occipital plate and rods or occipital clamps and rods. Rods are connected to the occipital plate or occipital clamps using a locking screw. A complete occipital-cervical-thoracic construct can be created by using hooks (C1-T3) that have been previously cleared within the Synthes CerviFix System, Synthes Axon System, and Synthes Synapse System.

The occipital bone screws are available in 4.5mm and 5.0mm diameters in lengths from 4mm to 18mm. Variable angle screw insertion is possible.

The occipital clamps are available in either a one-hole or two-hole configuration. The occipital plate is available in two sizes in either a medial or lateral configuration for a total of four available plates.

The plates are manufactured from commercially pure Titanium, grade 4. The rod connection points (rod clamps) in the plate are manufactured from Titanium Aluminum Niobium (Ti-6Al-7Nb) as are the occipital clamps, rods, and occipital screws.

The Synthes Synapse System consists of cancellous and cortex polyaxial screws, hooks, rods, transverse bars, parallel connectors, transconnectors, and locking screws. These implants are designed for fixation of the cervical, and/or upper thoracic spine (C1 - T3). A complete occipital-cervical-thoracic construct can be created by using components that have been previously cleared within the Synthes CerviFix System, Synthes Axon System, and Synthes OC Fusion System.

The implants are manufactured from Titanium Aluminum Niobium TAN (Ti-6Al-7Nb) ASTM F1295, the same as the predicate device.

AI/ML Overview

The provided 510(k) summaries (K072434) for the Synthes OC Fusion System and Synthes Synapse System do not contain detailed acceptance criteria or a study proving the device meets specific performance metrics in the way that would typically be described for a diagnostic AI device.

Instead, these submissions are for spinal implant systems which demonstrate substantial equivalence to predicate devices through bench testing (non-clinical performance data) and explicitly state that clinical data and conclusions were not needed for these devices due to their nature (they are modifications of existing, already cleared devices).

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions about sample sizes, ground truth establishment, expert adjudication, or comparative effectiveness studies, as these types of studies were not required or performed for these specific 510(k) clearances.

Here's what can be extracted from the provided text based on the request's categories, tailored to the context of these spinal implant devices:

Acceptance Criteria and Device Performance (Not Applicable in the traditional sense for Software/AI, but for Physical Device Equivalence)

The "acceptance criteria" and "reported device performance" in this context refer to the demonstration of substantial equivalence to predicate devices through non-clinical bench testing. The criteria are likely related to mechanical properties, material integrity, and functional performance matching or exceeding the predicate.

Acceptance Criteria (Implied by Substantial Equivalence Claim)	Reported Device Performance
Device design, function, material, and intended use are substantially equivalent to predicate devices.	"Bench testing results demonstrate that the Synthes OC Fusion System is substantially equivalent to the predicate devices." (For OC Fusion System)
	"Bench testing results demonstrate that the Synthes Synapse System is substantially equivalent to the predicate device." (For Synapse System)

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

As explained above, the "acceptance criteria" here is that the device is substantially equivalent to its predicate. The "reported device performance" is the statement that bench testing confirmed this substantial equivalence. Specific quantitative metrics such as sensitivity, specificity, accuracy, or specific mechanical thresholds are not detailed in these summaries.

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

Sample Size: Not applicable. These are physical devices evaluated through bench testing, not data-driven software. The "test set" would refer to the physical samples of the device undergoing mechanical testing. The specific number of samples tested for each mechanical assessment (e.g., fatigue, static strength) is not provided in the 510(k) summary.
Data Provenance: Not applicable in the context of country of origin or retrospective/prospective data as these relate to clinical or AI data studies. These are non-clinical biomechanical bench tests typically performed in a laboratory setting.

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

Number of Experts: Not applicable. For physical device bench testing, "ground truth" is established by engineering specifications, material science standards, and comparison to predicate device performance. It doesn't rely on expert human consensus in the way an AI diagnostic device would.
Qualifications of Experts: Not applicable. The validation is based on objective measurements against engineering standards and predicate device data, not expert clinical judgment.

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

Adjudication Method: Not applicable. This concept is relevant for reconciling discrepancies in human expert opinions for ground truth establishment in studies involving subjective interpretation (like medical image analysis). For physical device bench testing, results are objective measurements.

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:

MRMC Study: No, an MRMC comparative effectiveness study was not done. These devices are spinal implants, not AI-powered diagnostic tools intended to assist human readers.
Effect Size: Not applicable.

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

Standalone Performance: No, a standalone algorithm performance study was not done. These are physical medical devices, not algorithms.

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

Type of Ground Truth: For the "study" (bench testing), the "ground truth" is the established mechanical performance and material properties of the predicate device(s) and relevant engineering standards. The goal is to demonstrate that the modified device performs equivalently or better.

8. The sample size for the training set:

Training Set Sample Size: Not applicable. These are physical devices; there is no "training set" in the context of machine learning or AI.

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

Training Set Ground Truth Establishment: Not applicable. Since there's no training set, there's no ground truth established for it.

Summary

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K072434

510(k) Summary – OC Fusion System Sa

JAN 10 0 2008

510(k) Summary
Name of Firm:	Synthes Spine1302 Wrights Lane EastWest Chester, PA 19380
510(k) Contact:	Susan LewandowskiManager, Spine Regulatory AffairsTelephone: 610-719-5712Facsimile: 610-719-5102Email: Lewandowski.susan@synthes.com
Date Prepared:	November 2007
Trade Name:	Synthes OC Fusion System
Common Name:	Posterior, Cervical, Non-pedicle System
Classification:	21 CFR 888.3050 Spinal Interlaminal Fixation OrthosisClass IIOrthopaedic and Rehabilitation Devices PanelProduct Code KWP
Predicate Device(s):	K053418 Synthes OC Fusion System
Device Description:	The Synthes OC Fusion System consists of occipital plates, occipital screws, occipital clamps, and rods intended to provide stabilization to promote fusion of the occipital-cervical junction. This system allows an occipital-cervical construct of either the occipital plate and rods or occipital clamps and rods. Rods are connected to the occipital plate or occipital clamps using a locking screw. A complete occipital-cervical-thoracic construct can be created by using hooks (C1-T3) that have been previously cleared within the Synthes CerviFix System, Synthes Axon System, and Synthes Synapse System.The occipital bone screws are available in 4.5mm and 5.0mm diameters in lengths from 4mm to 18mm. Variable angle screw insertion is possible.The occipital clamps are available in either a one-hole or two-hole configuration. The occipital plate is available in two sizes in either a medial or lateral configuration for a total of four available plates.
510(k) Summary
	The plates are manufactured from commercially pure Titanium,grade 4. The rod connection points (rod clamps) in the plate aremanufactured from Titanium Aluminum Niobium (Ti-6Al-7Nb)as are the occipital clamps, rods, and occipital screws.
Intended Use /Indications for Use:	Synthes OC Fusion System is intended to provide stabilization topromote fusion of the occipital-cervical junction. A completeoccipital-cervical-thoracic construct can be created by usinghooks (C1-T3) that have been previously cleared within theSynthes CerviFix System, Synthes Axon System, and SynthesSynapse System.
	Synthes OC Fusion System is indicated for the following: DDDof the cervical vertebrae (neck pain of discogenic origin withdegeneration of the disc as confirmed by patient history andradiographic studies), spondylolisthesis, spinal stenosis,atlanto/axial fracture with instability, occipital-cervicaldislocation, revision of previous cervical spine surgery, andtumors (primary and metastatic)
	The use of screws is limited to placement in the occiput. Screwsare not intended to be placed in the cervical spine.
Comparison of thetechnologicalcharacteristics of thedevice to predicatedevice(s):	The Synthes OC Fusion System is a result of designmodifications to the predicate devices. It is substantiallyequivalent to the predicates in design, function, material andintended use.
Performance Data(Nonclinical and/orClinical):	Non-Clinical Performance and Conclusions:Bench testing results demonstrate that the Synthes OC FusionSystem is substantially equivalent to the predicate devices.Clinical Performance and Conclusions:
	Clinical data and conclusions were not needed for this device.

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510(k) Summary – Synapse System 5b

Name of Firm:	Synthes Spine1302 Wrights Lane EastWest Chester, PA 19380
510(k) Contact:	Susan LewandowskiManager, Spine Regulatory AffairsTelephone: 610-719-5712Facsimile: 610-719-5102Email: lewandowski.susan@synthes.com
Date Prepared:	November 2007
Trade Name:	Synthes Synapse System
Common Name:	Posterior Cervical System
Classification:	21 CFR 888.3050 - Spinal Interlaminal Fixation OrthosisClass IIOrthopaedic and Rehabilitation Devices PanelProduct Code KWP21 CFR 888.3070 -- Pedicle Screw Spinal SystemClass IIOrthopaedic and Rehabilitation Devices PanelProduct Codes MNH, MNI
Predicate Device:	K070573 Synthes Synapse System
Device Description:	The Synthes Synapse System consists of cancellous and cortexpolyaxial screws, hooks, rods, transverse bars, parallelconnectors, transconnectors, and locking screws. These implantsare designed for fixation of the cervical, and/or upper thoracicspine (C1 - T3). A complete occipital-cervical-thoracic constructcan be created by using components that have been previouslycleared within the Synthes CerviFix System, Synthes AxonSystem, and Synthes OC Fusion System.The implants are manufactured from Titanium AluminumNiobium TAN (Ti-6Al-7Nb) ASTM F1295, the same as thepredicate device.
Intended Use /Indications for Use:	Synthes Synapse System is indicated for the following:Hooks, Plate/Rods, Plates, Rods and Screws
	When intended to promote fusion of the cervical spine andoccipitocervical junction (occiput-T3), the plate/rod, plates, rod,hook and screw (3.2 mm cortex) components of the SynthesCervifix, Axon, OC Fusion and Synapse Systems are indicatedfor the following:
•	Degenerative Disc Disease (DDD) (defined as neck pain ofdiscogenic origin with degeneration of the disc as confirmed bypatient history and radiographic studies)
•	Spondylolisthesis
•	Spinal Stenosis
•	Fracture/dislocation
•	Atlantoaxial fracture with instability
•	Occipitocervical dislocation
•	Revision of previous cervical spine surgery
•	Tumor
	When used to treat these cervical and occipitocervical conditions,screws are limited to occipital fixation only.
	Hooks and RodsThe rod and hook components are also intended to providestabilization to promote fusion following reduction offracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
	Rods, Clamps, Screws, Nuts, Variable Axis Screws, LockingScrews, and Transverse BarsThe rods, clamps, screws, nuts, variable axis screws, lockingscrews, and transverse bars are intended to promote fusionfollowing reduction of fracture/dislocation or trauma in the upperthoracic spine (T1-T3).
	The use of these screws (3.5 mm, 4.0 mm and 4.5 mmcancellous, and 3.5 mm and 4.2 mm cortex) is limited toplacement in T1-T3 in treating thoracic conditions only. Theyare not intended to be placed in or treat conditions involving thecervical spine.
	The Synthes CerviFix, Axon, and Synapse Systems can also belinked to the Synthes Universal Spinal System using the 3.5mm/6.0 mm parallel connectors from that system and via theCerviFix tapered rods using lamina hooks, transverse processhooks, pedicle hooks, 4.2 mm screws and the 5.0 mm/6.0 mmparallel connector.
	Warning: This device is not intended for screw attachment orfixation to the posterior elements (pedicles) of the cervical,thoracic, or lumbar spine.
Comparison of thetechnologicalcharacteristics of thedevice to thepredicate device:	The Synthes Synapse System is a result of design modificationsto the predicate device. It is substantially equivalent to thepredicate in design, function, material and intended use.
Performance Data(Nonclinical and/orClinical)	Non-Clinical Performance and Conclusions:
	Bench testing results demonstrate that the Synthes SynapseSystem is substantially equivalent to the predicate device.
	Clinical Performance and Conclusions:
	Clinical data and conclusions were not needed for this device.

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and the control control of the control of the control of

{5}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail feathers. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Public Health Service

JAN 1 0 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Synthes Spine % Ms. Susan Lewandowski Manager, Spine Regulatory Affairs 1302 Wrights Lane East West Chester, PA 19380

Re: K072434

Trade/Device Name: Synthes OC Fusion and Synapse Systems Regulation Number: 21 CFR 888.3070 Regulation Names: Pedicle screw spinal system Regulatory Class: II Product Code: MNI, MNH, KWP Dated: November 30, 2007 Received: December 3, 2007

Dear Ms. Lewandowski:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 - Ms. Susan Lewandowski

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark M Millman

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

Enclosure

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4a Indications for Use Statement - OC Fusion System

510(k) Number: K (if known)

Device Name:

Synthes OC Fusion System

The Synthes OC Fusion System is intended to provide stabilization to Indications for Use: promote fusion of the occipital-cervical junction. A complete occipitalcervical-thoracic construct can be created by using hooks (C1-T3) that have been previously cleared within the Synthes CerviFix System, Synthes Axon System, and Synthes Synapse System.

Synthes OC Fusion System is indicated for the following:

Degenerative disc disease of the cervical vertebrae (neck pain of . discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
. Spondylolisthesis
Spinal Stenosis .
. Fracture/Dislocation
. Atlanto/axial fracture with instability
. Occipital-cervical dislocation
. Revision of previous cervical spinal surgery
. Tumors (primary and metastatic)

The use of screws is limited to placement in the occiput. Screws are not intended to be placed in the cervical spine.

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

Over-the-Counter Use (21 CFR 801 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 General, Restorative. and Neurological Devices

510(k) Number K072434

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Indications for Use Statement - Synapse System

510(k) Number:	K072434
(if known)

Device Name: Synthes Synapse System

Synthes Synapse System is indicated for the following: Indications for Use:

Hooks, Plate/Rods, Plates, Rods and Screws

· Degenerative Disc Disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
· Spondylolisthesis
· Spinal Stenosis
· Fracture/dislocation
Atlantoaxial fracture with instability
· Occipitocervical dislocation
· Revision of pervious cervical spine surgery
· Tumor

When used to treat these cervical and occipitocervical conditions, screws are limited to occipital fixation only.

Hooks and Rods

The rod and hook components are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

(Continued on next page)

X Prescription Use (21 CFR 801 Subpart D)

510(k) Number.

AND / OR

Over-the-Counter Use (21 CFR 801 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 General, Restorative,
and Neurological Devices

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

Rods, Clamps, Screws, Nuts, Variable Axis Screws, Locking Screws, and Transverse Bars The rods, clamps, screws, nuts, variable axis screws, locking screws, and transverse bars are intended to promote fusion following reduction of fracture/dislocation or trauma in the upper thoracic spine (T1-T3).

Warning: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

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

Over-the-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Darbone Buelin
(Division Sign Off)

Division of General, Restorative, and Neurological Devices

510(k) Number K072434

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.