(28 days)
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.
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.
The Synthes Antegra System, a lumbosacral plate fixation system, did not require a clinical study to prove its acceptance criteria. Its acceptance was based on a non-clinical bench testing comparison to a predicate device, the Synthes Anterior Tension Band (ATB) System (K022791).
Here's a breakdown of the information as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Substantial equivalence in mechanical properties to the predicate device, ensuring similar biomechanical stability and integrity. | Non-clinical bench testing demonstrated that the Synthes Antegra System is substantially equivalent to the predicate device in its mechanical performance characteristics. |
| Material Composition | Manufactured from Titanium Aluminum Niobium (Ti-6Al-7Nb) ASTM F1295. | The device is manufactured from Titanium Aluminum Niobium (Ti-6Al-7Nb) ASTM F1295, matching the predicate device. |
| Design and Function | Similar design and function to the predicate device, including plate and screw features for fixation of the lumbar and sacral spine. | The Synthes Antegra System is a result of design modifications to the predicate, and is substantially equivalent to the predicate in design and function. |
| Intended Use | Intended for use in the lumbar and lumbosacral (L1-S1) spine for various instability conditions. | The stated intended use for the Synthes Antegra System is consistent with the predicate device and indications for such fixation systems. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. The study was non-clinical bench testing.
- Data Provenance: Not applicable. The study involved laboratory bench testing of physical devices, not patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: Not applicable. Ground truth for non-clinical bench testing is typically established by engineering standards and validated testing protocols.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The evaluation was based on objective measurements and comparison to established engineering standards and the predicate device's performance.
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
- MRMC Study: No. This was a non-clinical evaluation of a surgical implant, not an AI-assisted diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Study: No. This was a non-clinical evaluation of a surgical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The ground truth was established through engineering and biomechanical testing standards and by comparison to the performance characteristics of the legally marketed predicate device (Synthes Anterior Tension Band System - K022791). This involved objective measurements of mechanical properties such as strength, stiffness, and fatigue resistance.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This was a non-clinical study comparing physical devices, not an AI model requiring a training set.
9. How the ground truth for the training set was established
- How Ground Truth for Training Set was Established: Not applicable.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The acceptance of the Synthes Antegra System was established through non-clinical bench testing. This testing successfully demonstrated that the Synthes Antegra System is substantially equivalent to its predicate device, the Synthes Anterior Tension Band (ATB) System (K022791), in terms of its design, function, materials, and mechanical performance. The FDA determined that clinical data and conclusions were not needed for this device due to this strong non-clinical equivalency. The device's materials (Titanium Aluminum Niobium (Ti-6Al-7Nb) ASTM F1295) are identical to the predicate device. The changes were identified as design modifications to the predicate, and the regulatory filing emphasized that these modifications did not raise new questions of safety or effectiveness.
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510(k) Summary
| 510(k) Summary | 11-14-06 |
|---|---|
| Name of Firm: | Synthes Spine1302 Wrights Lane EastWest Chester, PA 19380 |
| 510(k) Contact: | Susan LewandowskiManager, Spine Regulatory AffairsTelephone: 610-719-5712Facsimile: 610-719-5102Email: 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 OrthosisClass IIOrthopaedic and Rehabilitation Devices PanelProduct 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 lockingheads. The plate attaches to the anterior portion of the lumbarand lumbosacral spine (L1-S1).The screw heads and screw holes in the plates have matchingconical profiles and are threaded. The screw head locks to theplate and is nominally flush with the plate surface when properlyseated. The screws have a dual-core design. |
| The plates and screws are manufactured from TitaniumAluminum Niobium (Ti-6Al-7Nb) ASTM F1295, the same as thepredicate device. | |
| Intended Use /Indications for Use: | Synthes Antegra System is intended for use via the lateral oranterolateral surgical approach above the bifurcation of the greatvessels or via the anterior surgical approach, below thebifurcation of the great vessels. |
| Synthes Antegra System is indicated in the treatment of lumbarand 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 discogenicorigin with degeneration of the disc confirmed by patient historyand 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 orfixation to the posterior elements (pedicles) of the cervical,thoracic, or lumbar spine. | |
| Comparison of thetechnologicalcharacteristics of thedevice to thepredicate device: | The Synthes Antegra System is a result of design modifications tothe predicate device. It is substantially equivalent to the predicatein design, function, material and intended use. |
| Performance Data(Nonclinical and/orClinical) | Non-Clinical Performance and Conclusions:Bench testing results demonstrate that the Synthes AntegraSystem 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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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
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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 |
|---|---|---|
| --------------- | --------- | -------------- |
§ 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.