(80 days)
Not Found
Not Found
No
The document describes a mechanical implant (plate and screws) for spinal fusion and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
The device is used to treat various spinal instabilities and conditions, indicating a therapeutic purpose.
No
The Synthes Oracle Plate is an orthopedic implant for spine stabilization in patients with various spinal conditions, not for diagnosing them. Its purpose is to provide stability as an adjunct to fusion, as indicated by "adjunct to fusion" and "treatment of lumbar and lumbosacral (L1-S1) spine instability."
No
The device description explicitly states that the device consists of a plate and bone screws, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The provided information clearly describes a surgical implant (a plate and screws) used to stabilize the spine during fusion surgery. It is a physical device implanted in the body, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: The description does not mention any testing of biological samples, analysis of biomarkers, or diagnostic information derived from such tests.
Therefore, based on the provided information, the Synthes Oracle Plate is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Synthes Oracle Plate is indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels, or via the anterior surgical approach, below the bifurcation of the great vessels as an adjunct to fusion. This system is indicated in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudoarthrosis, spondylolysis, spondylolisthesis, scoliosis, lordotic deformities of the spine, spinal stenosis, or failed previous fusion.
Warning: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Product codes
KWQ
Device Description
The Synthes Oracle Plate is an addition to Synthes' existing anterior/anterolateral/lateral thoracolumbar spine systems. The Oracle Plate implant consists of a plate and 4 bone screws, all manufactured from Titanium Aluminum Niobium (Ti-6Al-7Nb) ASTM F1295, the same material as the predicates.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar and lumbosacral (L1-S1) spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Non-Clinical Performance and Conclusions: Bench testing results demonstrate that the Synthes Oracle Plate System is substantially equivalent to the predicate devices.
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
KO91159
JUL 1-0 2009
510(k) 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: | April 17, 2009 |
| Trade Name: | Synthes Oracle Plate System |
| Classification: | 21 CFR 888.3060 - Spinal Intervertebral Body Fixation Orthosis |
| Class II | |
| Orthopaedic and Rehabilitation Devices Panel | |
| Product Code: KWQ | |
| Predicates: | Synthes Oracle Plate System is substantially equivalent to similar previously cleared predicate devices. |
| Device Description: | The Synthes Oracle Plate is an addition to Synthes' existing anterior/anterolateral/lateral thoracolumbar spine systems. The Oracle Plate implant consists of a plate and 4 bone screws, all manufactured from Titanium Aluminum Niobium (Ti-6Al-7Nb) ASTM F1295, the same material as the predicates. |
| Intended Use/ Indications for Use: | The Synthes Oracle Plate is indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels, or via the anterior surgical approach, below the bifurcation of the great vessels as an adjunct to fusion. This system is indicated in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudoarthrosis, spondylolysis, spondylolisthesis, scoliosis, lordotic deformities of the spine, spinal stenosis, or failed previous fusion. |
| Warning: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. | |
| Comparison of the device to predicate device(s): | The Synthes Oracle Plate System is a result of design modifications to the predicate devices. It is substantially equivalent to the predicates in design, function, material, and intended use. |
| Performance Date (Non-Clinical and/or Clinical): | Non-Clinical Performance and Conclusions: |
| Bench testing results demonstrate that the Synthes Oracle Plate System 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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જિલ્લાના ગુજરાત lof l
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized eagle or bird in flight.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Synthes Spine % Ms. Stacey Bonnell Regulatory Affairs Specialist 1302 Wrights Lane East West Chester, Pennsylvania 19380
2009
Re: K091159
Trade/Device Name: Synthese Oracle Plate Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervetebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: April 17, 2009 Received: April 21, 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.
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 (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.
2
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,
Barbara Buellius
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
@ SYNTHES® Spine
Indications for Use Statement 4
510(k) Number: (if known)
K 691159
Device Name:
Synthes Oracle Plate
The Synthes Oracle Plate is indicated for use, via the lateral or anterolateral surgical approach above the bifurcation of the great vessels, or via the anterior surgical approach, below the bifurcation of the great vessels as an adjunct to fusion. This system is indicated in the treatment of lumbar and lumbosacral (LI-SI) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudoarthrosis, spondylolysis, spondylolisthesis, scoliosis, lordotic deformities of the spine, spinal stenosis, or failed previous fusion.
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)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
E Z (EXT. For MXM)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091159
Traditional 510(k) - Synthes Oracle Plate System