(30 days)
Not Found
Not Found
No
The document describes a system of mechanical implants for spinal fixation and does not mention any software, algorithms, or data processing capabilities that would suggest the use of AI or ML.
Yes
The device is described as providing stabilization as an adjunct to fusion for various spinal conditions, promoting fusion following reduction of fracture/dislocation or trauma, and facilitating a complete occipital-cervical-thoracic construct. These actions aim to treat or alleviate specific medical conditions related to the spine.
No
The device description and intended use indicate that the Synthes Synapse System is a surgical implant (hooks, plates, rods, screws) designed to provide stabilization and promote fusion in the cervical and upper thoracic spine, not to diagnose medical conditions.
No
The device description explicitly details various hardware components made of titanium alloys, such as screws, hooks, rods, plates, and clamps, intended for surgical implantation.
Based on the provided text, the Synthes Synapse System and Synthes OC Fusion System are not IVD (In Vitro Diagnostic) devices.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states that these systems consist of implants like screws, hooks, rods, and plates, which are surgically implanted into the spine.
- Intended Use: The intended use is to provide stabilization as an adjunct to fusion of the cervical and upper thoracic spine. This is a surgical intervention, not a diagnostic test performed on a specimen.
Therefore, these devices fall under the category of implantable medical devices used in surgery, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
- 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. 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."
- OC Fusion 4.0mm System: "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."
Product codes (comma separated list FDA assigned to the subject device)
KWP, MNI, MNH
Device Description
- Synthes Synapse 4.0mm System: "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."
- OC Fusion 4.0mm System: "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."
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical, occipitocervical junction (occiput-T3), upper thoracic spine (C1-T3, T1-T3), occipital-cervical junction.
Indicated Patient Age Range
Skeletally mature patients
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Synthes Synapse 4.0mm System: "Non-Clinical Performance and Conclusions: Documentation was provided which demonstrated the Synapse 4.0mm 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. Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device."
- OC Fusion 4.0mm System: "Non-Clinical Performance and Conclusions: Documentation was provided which demonstrated the OC Fusion 4.0mm 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. Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Synthes Synapse 4.0mm System is substantially equivalent to similar previously cleared devices.
Synthes OC Fusion 4.0mm System is substantially equivalent to similar previously cleared devices.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Page of 44
510(k) Summary 2
2.1 Synapse 4.0mm System 510K Summary
| 510(k) Summary | |
|---|---|
| Name of Firm: | Synthes Spine |
| 1302 Wrights Lane East | |
| West Chester, PA 19380 | |
| 510(k) Contact: | Stacey Bonnell |
| Regulatory Affairs Specialist | |
| Telephone: 610-719-5895 Facsimile: 610-719-5102 | |
| Email: 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 Orthosis |
| 21 CFR 888.3070 - Pedicle Screw Spinal System | |
| Class II; Orthopaedic and Rehabilitation Devices Panel | |
| Product Code(s): KWP, MNI & MNH | |
| Predicate Device(s): | Synthes Synapse 4.0mm System is substantially equivalent to similar |
| previously cleared devices. | |
| 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. |
| Intended Use /
Indications for 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. |
| Comparison of the
technological
characteristics of the
device to the
predicate device: | Synthes Synapse System 4.0mm components are a result of design
modifications to the predicate devices. The 4.0mm components are
substantially equivalent to the predicates in design, function, material
and intended use. |
| Performance Data
(Nonclinical and/or
Clinical) | Non-Clinical Performance and Conclusions:
Documentation was provided which demonstrated the Synapse 4.0mm
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. |
| | Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device. |
1
page 2 of 4
2
ﺍﻟﻌﻀﻠﺔ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻌﻠﻴﻘﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍ
. - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
| Name of Firm: | Synthes Spine
1302 Wrights Lane East
West Chester, PA 19380 |
|---------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Stacey Bonnell
Regulatory Affairs Specialist
Telephone: 610-719-5895 Facsimile: 610-719-5102
Email: 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 Orthosis
Class II; Orthopaedic and Rehabilitation Devices Panel
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.
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 the
technological
characteristics of the
device to predicate
device(s): | The Synthes OC Fusion System 4.0mm components are a result of
design modifications to the predicate devices. These 4.0mm
components are substantially equivalent to the predicates in design,
function, material and intended use. |
| Performance Data
(Nonclinical and/or
Clinical): | Non-Clinical Performance and Conclusions:
Documentation was provided which demonstrated the OC Fusion
4.0mm 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. |
| | 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 |
3
Page
4
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
5
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
6
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
7
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
8
Page 3 of 3
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.