SYNAPSE SYSTEM 4.0MM, OC FUSION SYSTEM 4.0MM

K091689 · Synthes (Usa) · KWP · Jul 10, 2009 · Orthopedic

Device Facts

• Record ID: K091689
• Device Name: SYNAPSE SYSTEM 4.0MM, OC FUSION SYSTEM 4.0MM
• Applicant: Synthes (Usa)
• Product Code: KWP · Orthopedic
• Decision Date: Jul 10, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Synthes Synapse System is indicated for the following: 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.

Device Story

Posterior cervical/thoracic spinal fixation system; includes polyaxial screws, hooks, rods, transverse bars, and connectors. Used for stabilization as adjunct to fusion in occiput-T3 region. Implants manufactured from Titanium Aluminum Niobium (TAN). System components allow creation of occipital-cervical-thoracic constructs. Used by surgeons in clinical settings to treat degenerative disc disease, fractures, and tumors. Provides mechanical stabilization to promote bone fusion. Not for pedicle fixation.

Clinical Evidence

No clinical data provided; substantial equivalence established via non-clinical performance documentation and design comparison to predicate devices.

Technological Characteristics

Materials: Titanium Aluminum Niobium (Ti-6Al-7Nb) per ASTM F1295; commercially pure Titanium (Grade 2 and 4). Components: polyaxial screws, hooks, rods, transverse bars, parallel connectors. Mechanical fixation system. No software or energy source.

Indications for Use

Indicated for skeletally mature patients requiring stabilization as an adjunct to fusion of the cervical spine and occipitocervical junction (occiput-T3) or upper thoracic spine (T1-T3). Conditions include DDD, spondylolisthesis, spinal stenosis, fracture/dislocation, atlantoaxial fracture, occipitocervical dislocation, revision surgery, and tumors. Contraindicated for pedicle fixation in cervical, thoracic (T4-T12), or lumbar spine.

Regulatory Classification

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.

Predicate Devices

• Synthes Synapse 4.0mm System (K091689)
• Synthes OC Fusion 4.0mm System (K091689)

Reference Devices

• Synthes CerviFix System
• Synthes Axon System
• Synthes Universal Spinal System

Submission Summary (Full Text)

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#### 510(k) Summary 2

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#### 2.1 Synapse 4.0mm System 510K Summary

| | 510(k) Summary |
|----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of Firm: | Synthes Spine<br>1302 Wrights Lane East<br>West Chester, PA 19380 |
| 510(k) Contact: | Stacey Bonnell<br>Regulatory Affairs Specialist<br>Telephone: [phone] Facsimile: 610-719-5102<br>Email: [e-mail] |
| 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 Orthosis<br>21 CFR 888.3070 - Pedicle Screw Spinal System<br>Class II; Orthopaedic and Rehabilitation Devices Panel<br>Product Code(s): KWP, MNI & MNH |
| Predicate Device(s): | Synthes Synapse 4.0mm System is substantially equivalent to similar<br>previously cleared devices. |
| Device Description: | The Synthes Synapse System consists of cancellous and cortex polyaxial<br>screws, hooks, rods, transverse bars, parallel connectors,<br>transconnectors, and locking screws. These implants are designed for<br>fixation of the cervical, and/or upper thoracic spine (C1 - T3). A<br>complete occipital-cervical-thoracic construct can be created by using<br>components that have been previously cleared within the Synthes<br>CerviFix System, Synthes Axon System, and Synthes OC Fusion<br>System.<br><br>The implants are manufactured from Titanium Aluminum Niobium<br>TAN (Ti-6Al-7Nb) ASTM F1295, the same as the predicate device. |
| Intended Use /<br>Indications for Use: | Synthes Synapse System is indicated for the following:<br><br>Hooks, Plate/Rods, Plates, Rods and Screws<br>When intended to provide stabilization as an adjunct to fusion of the<br>cervical spine and occipitocervical junction (occiput-T3), the plate/rod,<br>plates, rod, hook and screw (3.2 mm cortex) components of the Synthes<br>Cervifix, Axon, OC Fusion and Synapse Systems are indicated for<br>skeletally mature patients using allograft and/or autograft for the<br>following:<br>• Degenerative Disc Disease (DDD) (defined as neck pain of<br>discogenic origin with degeneration of the disc as confirmed by<br>patient history and radiographic studies)<br>• Spondylolisthesis<br>• Spinal Stenosis<br>• Fracture/dislocation<br>• Atlantoaxial fracture with instability<br>• Occipitocervical dislocation |
| | • Revision of previous cervical spine surgery<br>• Tumor |
| | When used to treat these cervical and occipitocervical conditions,<br>screws are limited to occipital fixation only. |
| | Hooks and Rods<br>The rod and hook components are also intended to provide stabilization<br>to promote fusion following reduction of fracture/dislocation or trauma<br>in the cervical/upper thoracic (C1-T3) spine. |
| | Rods, Clamps, Screws, Nuts, Variable Axis Screws, Locking Screws,<br>and Transverse Bars<br>The rods, clamps, screws, nuts, variable axis screws, locking screws,<br>and transverse bars are intended to promote fusion following reduction<br>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<br>3.5 mm and 4.2 mm cortex) is limited to placement in T1-T3 in treating<br>thoracic conditions only. They are not intended to be placed in or treat<br>conditions involving the cervical spine. |
| | The Synthes CerviFix, Axon, and Synapse Systems can also be linked<br>to the Synthes Universal Spinal System using the 3.5 mm/6.0 mm and<br>4.0 mm/6.0 mm parallel connectors from that system and via the<br>CerviFix tapered rods using lamina hooks, transverse process hooks,<br>pedicle hooks, 4.2 mm screws and the 5.0 mm/6.0 mm parallel<br>connector. |
| | Warning: This device is not intended for screw attachment or fixation<br>to the posterior elements (pedicles) of the cervical, thoracic (T4-T12),<br>or lumbar spine. |
| Comparison of the<br>technological<br>characteristics of the<br>device to the<br>predicate device: | Synthes Synapse System 4.0mm components are a result of design<br>modifications to the predicate devices. The 4.0mm components are<br>substantially equivalent to the predicates in design, function, material<br>and intended use. |
| Performance Data<br>(Nonclinical and/or<br>Clinical) | Non-Clinical Performance and Conclusions:<br>Documentation was provided which demonstrated the Synapse 4.0mm<br>System to be substantially equivalent to previously cleared devices. The<br>substantial equivalence is based upon equivalence in intended use,<br>indications, anatomic sites, performance, and material of manufacture. |
| | Clinical Performance and Conclusions:<br>Clinical data and conclusions were not needed for this device. |

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| Name of Firm: | Synthes Spine<br>1302 Wrights Lane East<br>West Chester, PA 19380 |
|---------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Stacey Bonnell<br>Regulatory Affairs Specialist<br>Telephone: [phone] Facsimile: 610-719-5102<br>Email: [e-mail] |
| 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 Orthosis<br>Class II; Orthopaedic and Rehabilitation Devices Panel<br>Product 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.<br><br>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.<br><br>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).<br><br>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 /<br>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 the<br>technological<br>characteristics of the<br>device to predicate<br>device(s): | The Synthes OC Fusion System 4.0mm components are a result of<br>design modifications to the predicate devices. These 4.0mm<br>components are substantially equivalent to the predicates in design,<br>function, material and intended use. |
| Performance Data<br>(Nonclinical and/or<br>Clinical): | Non-Clinical Performance and Conclusions:<br>Documentation was provided which demonstrated the OC Fusion<br>4.0mm System to be substantially equivalent to previously cleared<br>devices. The substantial equivalence is based upon equivalence in<br>intended use, indications, anatomic sites, performance, and material of<br>manufacture. |
| | Clinical Performance and Conclusions:<br>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 [phone] or [phone] 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)

4

=_"(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).

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.

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.