(28 days)
Not Found
No
The device description focuses on the mechanical components (plates and screws) and materials, with no mention of software, algorithms, or data processing that would indicate AI/ML. The performance studies are bench testing, not clinical studies involving data analysis.
Yes
The device is used in the treatment of various spinal instabilities, indicating a therapeutic purpose.
No
Explanation: The Synthes Antegra System is described as a surgical implant (plates and screws) used for stabilizing the spine in the treatment of various spinal conditions. It is a therapeutic device, not a device used to diagnose medical conditions.
No
The device description explicitly states that the system consists of lumbar and sacral plates and cancellous screws, which are physical hardware components. There is no mention of software being the primary or sole component of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The provided text describes a surgical implant system (plates and screws) used to stabilize the lumbar and lumbosacral spine. This is a physical device implanted during surgery.
- Intended Use: The intended use is for the surgical treatment of spine instability. This is a therapeutic intervention, not a diagnostic test.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, diagnostic testing, or any of the typical components or functions of an IVD device.
Therefore, based on the provided information, the Synthes Antegra System is a surgical implant device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Synthes Antegra System is intended 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.
Synthes Antegra System is indicated in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of the following: 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, and Failed previous spine surgery.
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 (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The Synthes Antegra System consists of lumbar and sacral plates (one-level and two-level) and cancellous screws with locking heads. The plate attaches to the anterior portion of the lumbar and lumbosacral spine (L1-S1). The screw heads and screw holes in the plates have matching conical profiles and are threaded. The screw head locks to the plate and is nominally flush with the plate surface when properly seated. The screws have a dual-core design.
The plates and screws are manufactured from Titanium Aluminum Niobium (Ti-6Al-7Nb) ASTM F1295, the same as the predicate device.
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 Antegra System is substantially equivalent to the predicate device.
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.
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
§ 888.3060 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
510(k) Summary
| 510(k) Summary | 11-14-06 |
|---|---|
| Name of Firm: | Synthes Spine |
| 1302 Wrights Lane East | |
| West Chester, PA 19380 | |
| 510(k) Contact: | Susan Lewandowski |
| Manager, Spine Regulatory Affairs | |
| Telephone: 610-719-5712 | |
| Facsimile: 610-719-5102 | |
| Email: lewandowski.susan@synthes.com | |
| Date Prepared: | November 2006 |
| Trade Name: | Synthes Antegra System |
| Common Name: | Lumbosacral Plate Fixation System |
| Classification: | 21 CFR 888.3060 - Spinal Intervertebral Body Fixation Orthosis |
| Class II | |
| Orthopaedic and Rehabilitation Devices Panel | |
| Product Code KWQ | |
| Predicate Device: | Synthes Anterior Tension Band (ATB) System - K022791 |
| Device Description: | The Synthes Antegra System consists of lumbar and sacral plates |
| (one-level and two-level) and cancellous screws with locking | |
| heads. The plate attaches to the anterior portion of the lumbar | |
| and lumbosacral spine (L1-S1). | |
| The screw heads and screw holes in the plates have matching | |
| conical profiles and are threaded. The screw head locks to the | |
| plate and is nominally flush with the plate surface when properly | |
| seated. The screws have a dual-core design. | |
| The plates and screws are manufactured from Titanium | |
| Aluminum Niobium (Ti-6Al-7Nb) ASTM F1295, the same as the | |
| predicate device. | |
| Intended Use / | |
| Indications for Use: | Synthes Antegra System is intended 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. | |
| Synthes Antegra System is indicated in the treatment of lumbar | |
| and lumbosacral (L1-S1) spine instability as a result of the | |
| following: | |
| 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, and Failed previous spine surgery. | |
| 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 | |
| technological | |
| characteristics of the | |
| device to the | |
| predicate device: | The Synthes Antegra System is a result of design modifications to |
| the predicate device. It is substantially equivalent to the predicate | |
| in design, function, material and intended use. | |
| Performance Data | |
| (Nonclinical and/or | |
| Clinical) | Non-Clinical Performance and Conclusions: |
Bench testing results demonstrate that the Synthes Antegra
System is substantially equivalent to the predicate device.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device. |
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:
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Synthes Spine % Ms. Susan Lewandowski Manager, Spine Regulatory Affairs 1302 Wrights Lane East West Chester, Pennsylvania 19380
NOV 1 4 2006
Re: K063158
Trade/Device Name: ANTEGRA System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: ClassII Product Code: KWQ Dated: October 16, 2006 Received: October 17, 2006
Dear Mrs. Lewandowski:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Susan Lewandowski
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276- 0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 vours.
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
Special 510(k) Device Modification
Indications for Use Statement
510(k) Number:
| Device Name: | Synthes Antegra System [modification to Synthes Anterior Tension Band (ATB) System] |
|---|---|
| Indications: | Synthes Antegra System is intended 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. |
| Synthes Antegra System is indicated in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of the following: Fracture (including dislocation and subluxation)TumorDegenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)PseudoarthrosisSpondylolysisSpondylolisthesisScoliosisLordotic deformities of the spineSpinal stenosisFailed previous spine surgery. | |
| Warning: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. |
| Prescription Use
(21 CFR 801 Subpart D) | X | AND/OR | Over-the-Counter Use
(21 CFR 801 Subpart C) |
| -------------------------------------------- | ---------- | -------- | ------------------------------------------------ |
|---|
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Con(Division Sign-Off) Office of Device Evaluation (ODE)
Division of General, Restorative,
and Neurological Devices
Synthes Antegra System Indications for Use Statement - Revised 110906.doc
| 510(k) Number | K663158 | CONFIDENTIAL |
|---|---|---|
| --------------- | --------- | -------------- |