Hooks, Plate/Rods, Plates, Rods and Screws
When intended to provide stabilization as an adjunct to 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 skeletally mature patients using allograft and/or autograft 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 previous 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 and 4.0 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 (T4-T12), or lumbar spine.

Synthes OC Fusion System is intended to provide stabilization as an adjunct to fusion of the occipital-cervical junction. A complete occipital-cervical-thoracic construct can be created by using hooks (C1-T3) and screws (T1-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 skeletally mature patients using allograft and/or autograft 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.

Device Description

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.

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-thoracic 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) and screws (T1-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 occipital clamps are manufactured from both commercially pure Titanium, grade 4 and Titanium Aluminum Niobium (Ti-6Al-7Nb).

The plates are manufactured from commercially pure Titanium, grade 2. The two bodies in the plate that serve as rod connection points are manufactured from Titanium Aluminum Niobium (Ti-6Al-7Nb) as are the rods, and occipital screws.

AI/ML Overview

The provided 510(k) summary for the Synthes Synapse 4.0mm System and the Synthes OC Fusion 4.0mm System does not describe a study that involves acceptance criteria and device performance in the way typically associated with AI/ML-enabled medical devices or diagnostic tools.

Instead, this document details a submission for spinal implant systems, where the "acceptance criteria" for clearance are based on demonstrating substantial equivalence to previously cleared predicate devices through non-clinical performance data. Clinical data was explicitly stated as not needed for these devices.

Therefore, many of the requested points regarding sample size, data provenance, ground truth establishment, expert adjudication, MRMC studies, and standalone performance are not applicable to this type of medical device submission.

Here's the information that can be extracted or deduced from the provided text according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (for Substantial Equivalence)	Reported Device Performance
Intended Use Equivalence: The device's intended use should be equivalent to previously cleared predicate devices.	The Synthes Synapse 4.0mm System and Synthes OC Fusion 4.0mm System have indications for use that are equivalent to already cleared devices like Synthes CerviFix, Synthes Axon, and Synthes OC Fusion Systems. Their intended uses include providing stabilization as an adjunct to fusion for various cervical and occipitocervical conditions (e.g., DDD, spondylolisthesis, spinal stenosis, fracture/dislocation, tumor).
Material Equivalence: The device's materials of manufacture should be equivalent to previously cleared predicate devices.	The implants are manufactured from Titanium Aluminum Niobium (TAN) (Ti-6Al-7Nb) ASTM F1295, commercially pure Titanium Grade 4, and commercially pure Titanium Grade 2. These materials are stated to be the same or equivalent to the predicate devices.
Design Equivalence: The device's design should be equivalent to previously cleared predicate devices.	The 4.0mm components of both systems are a result of design modifications but are stated to be substantially equivalent to the predicates in design.
Function Equivalence: The device's function should be equivalent to previously cleared predicate devices.	The 4.0mm components of both systems are stated to be substantially equivalent to the predicates in function.
Anatomic Sites Equivalence: The device's anatomic sites of use should be equivalent to previously cleared predicate devices.	The devices are intended for use in the cervical and/or upper thoracic spine (C1-T3), with specific limitations on screw placement, which aligns with predicate devices.
Performance Equivalence: Non-clinical performance demonstrates equivalence.	`Non-Clinical Performance and Conclusions: Documentation was provided which demonstrated the [Device Name] System to be substantially equivalent to previously cleared devices. The substantial equivalence is based upon equivalence in intended use, indications, anatomic sites, performance, and material of manufacture.`
No Clinical Data Needed: Clearance did not require clinical studies to demonstrate safety and effectiveness.	`Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device.`

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

Not applicable. No test set in the context of AI/ML or diagnostic performance evaluation was used. The substantial equivalence was based on non-clinical performance documentation, generally referring to mechanical testing, material characterization, and design principle comparisons, rather than a "test set" of 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)

Not applicable. There was no "ground truth" establishment in the context of diagnostic assessment or expert consensus for a test set. The evaluation was primarily of engineering and material properties, compared against predicate devices.

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

Not applicable. No adjudication method was mentioned or required for this type of submission.

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 device is a spinal implant system, not an AI-assisted diagnostic tool.

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

Not applicable. This is a physical medical device.

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

Not applicable directly. The "ground truth" in this context is implicitly the established safety and effectiveness of the predicate devices based on their prior clearance, and the new devices' ability to meet comparable engineering and material standards. No clinical outcomes data or pathology was used or required for this 510(k) clearance itself.

8. The sample size for the training set

Not applicable. There was no "training set" as this is not an AI/ML device.

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

Not applicable. There was no "training set" or corresponding ground truth establishment described for this device.

Summary

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510(k) Summary 2

2.1 Synapse 4.0mm System 510K Summary

	510(k) Summary
Name of Firm:	Synthes Spine1302 Wrights Lane EastWest Chester, PA 19380
510(k) Contact:	Stacey BonnellRegulatory Affairs SpecialistTelephone: 610-719-5895 Facsimile: 610-719-5102Email: bonnell.stacey@synthes.com
Date Prepared:	June 8, 2009
Trade Name:	Synthes Synapse 4.0mm System
Common Name:	Posterior Cervical System
Classification:	21 CFR 888.3050 - Spinal Interlaminal Fixation Orthosis21 CFR 888.3070 - Pedicle Screw Spinal SystemClass II; Orthopaedic and Rehabilitation Devices PanelProduct Code(s): KWP, MNI & MNH
Predicate Device(s):	Synthes Synapse 4.0mm System is substantially equivalent to similarpreviously cleared devices.
Device Description:	The Synthes Synapse System consists of cancellous and cortex polyaxialscrews, hooks, rods, transverse bars, parallel connectors,transconnectors, and locking screws. These implants are designed forfixation of the cervical, and/or upper thoracic spine (C1 - T3). Acomplete occipital-cervical-thoracic construct can be created by usingcomponents that have been previously cleared within the SynthesCerviFix System, Synthes Axon System, and Synthes OC FusionSystem.The implants are manufactured from Titanium Aluminum NiobiumTAN (Ti-6Al-7Nb) ASTM F1295, the same as the predicate device.
Intended Use /Indications for Use:	Synthes Synapse System is indicated for the following:Hooks, Plate/Rods, Plates, Rods and ScrewsWhen intended to provide stabilization as an adjunct to fusion of thecervical spine and occipitocervical 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 indicated forskeletally mature patients using allograft and/or autograft for thefollowing:• 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 provide stabilizationto promote fusion following reduction of fracture/dislocation or traumain the cervical/upper thoracic (C1-T3) spine.
	Rods, Clamps, Screws, Nuts, Variable Axis Screws, Locking Screws,and Transverse BarsThe rods, clamps, screws, nuts, variable axis screws, locking screws,and transverse bars are intended to promote fusion following reductionof 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, and3.5 mm and 4.2 mm cortex) is limited to placement in T1-T3 in treatingthoracic conditions only. They are not intended to be placed in or treatconditions involving the cervical spine.
	The Synthes CerviFix, Axon, and Synapse Systems can also be linkedto the Synthes Universal Spinal System using the 3.5 mm/6.0 mm and4.0 mm/6.0 mm parallel connectors from that system and via theCerviFix tapered rods using lamina hooks, transverse process hooks,pedicle hooks, 4.2 mm screws and the 5.0 mm/6.0 mm parallelconnector.
	Warning: This device is not intended for screw attachment or fixationto the posterior elements (pedicles) of the cervical, thoracic (T4-T12),or lumbar spine.
Comparison of thetechnologicalcharacteristics of thedevice to thepredicate device:	Synthes Synapse System 4.0mm components are a result of designmodifications to the predicate devices. The 4.0mm components aresubstantially equivalent to the predicates in design, function, materialand intended use.
Performance Data(Nonclinical and/orClinical)	Non-Clinical Performance and Conclusions:Documentation was provided which demonstrated the Synapse 4.0mmSystem to be substantially equivalent to previously cleared devices. Thesubstantial equivalence is based upon equivalence in intended use,indications, anatomic sites, performance, and material of manufacture.
	Clinical Performance and Conclusions:Clinical data and conclusions were not needed for this device.

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page 2 of 4

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. - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Name of Firm:	Synthes Spine1302 Wrights Lane EastWest Chester, PA 19380
510(k) Contact:	Stacey BonnellRegulatory Affairs SpecialistTelephone: 610-719-5895 Facsimile: 610-719-5102Email: bonnell.stacey@synthes.com
Date Prepared:	June 8, 2009
Trade Name:	Synthes OC Fusion 4.0mm System
Common Name:	Posterior, Cervical, Non-pedicle System
Classification:	21 CFR 888.3050 Spinal Interlaminal Fixation OrthosisClass II; Orthopaedic and Rehabilitation Devices PanelProduct Code KWP
Predicate Device(s):	Synthes OC Fusion 4.0mm System is substantially equivalent to similar previously cleared devices.
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-thoracic 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) and screws (T1-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 occipital clamps are manufactured from both commercially pure Titanium, grade 4 and Titanium Aluminum Niobium (Ti-6Al-7Nb).The plates are manufactured from commercially pure Titanium, grade 2. The two bodies in the plate that serve as rod connection points are manufactured from Titanium Aluminum Niobium (Ti-6Al-7Nb) as are the rods, and occipital screws.
Intended Use /Indications for Use:	Synthes OC Fusion System is intended to provide stabilization as an adjunct to fusion of the occipital-cervical junction. A complete occipital-cervical-thoracic construct can be created by using hooks (C1-T3) and screws (T1-T3) that have been previously cleared within the Synthes CerviFix System, Synthes Axon System, and Synthes Synapse System.
	510(k) Summary
	using allograft and/or autograft 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.
Comparison of thetechnologicalcharacteristics of thedevice to predicatedevice(s):	The Synthes OC Fusion System 4.0mm components are a result ofdesign modifications to the predicate devices. These 4.0mmcomponents are substantially equivalent to the predicates in design,function, material and intended use.
Performance Data(Nonclinical and/orClinical):	Non-Clinical Performance and Conclusions:Documentation was provided which demonstrated the OC Fusion4.0mm System to be substantially equivalent to previously cleareddevices. The substantial equivalence is based upon equivalence inintended use, indications, anatomic sites, performance, and material ofmanufacture.
	Clinical Performance and Conclusions:Clinical data and conclusions were not needed for this device.

OC Fusion 4.0mm System 510K Summary 2.2

: 上一篇: 大中小上一一一一一一一一一一一 5 10 (k) Summary | 上 |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.

Public Health Service

Synthes (USA) . % Ms. Stacey Bonnell Regulatory Affairs Specialist 1302 Wrights Lane East West Chester, Pennsylvania 19380

Re: K091689

Trade/Device Name: Synthes Synapse 4.0mm System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: KWP, MNI, MNH Dated: June 8, 2009 Received: June 10, 2009

Dear Ms. Bonnell:

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.

JUL 1 0 2009

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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Page 2 - Ms. Stacey Bonnell

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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark A. Millman

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

Enclosure

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Page 1 of 3

Indications for Use Statement 1

Synapse 4.0 Indications for Use 1.1

510(k) Number: K091689 (if known)

Device Name: Synthes Synapse 4.0mm System

Hooks, Plate/Rods, Plates, Rods and Screws

When intended to provide stabilization as an adjunct to 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 skeletally mature patients using allograft and/or autograft 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 previous cervical spine surgery
Tumor

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

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)

=_"(EXT for UKM)

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

K091689 - Synthes Synapse 4.0 & OC Fusion 4.0 Systems

510(k) Number K091689

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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).

Warning: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic (T4-T12), 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)

E- ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------(EXT forman)

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

510(k) Number_ K091689

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Page 3 of 3

K091689

OC Fusion 4.0 Indications for Use 1.2

K091689 510(k) Number: (if known)

Device Name: OC Fusion 4.0mm System

Indications for Use:

The Synthes OC Fusion System is intended to provide stabilization as an adjunct to fusion of the occipital-cervical junction. A complete occipital-cervical-thoracic construct can be created by using hooks (C1-T3) and screws (T1-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 skeletally mature patients using allograft and/or autograft 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.

Prescription Use X (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)

E_ (EXIT for MKU)

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

510(k) Number.

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.