(90 days)
The Synthes Antegra-T System 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 - Sl) 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 a 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-T System consists of one-level titanium lumbar and sacral plates and cancellous screws with locking heads. The plates attach to the anterior portion of the lumbar and lumbosacral spine (L1-S1). These one-level plates are available in lengths ranging from 37 mm to 53 mm in 2mm increments. The sacral plates have a step on the underside that allows for precise sacral placement. The Antegra-T System uses the bone-screws from the Synthes Antegra System (K063158).
The provided text describes a medical device, the Synthes Antegra-T System, and its 510(k) summary, but it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The document is a 510(k) summary for a spinal intervertebral body fixation orthosis. The key takeaway from the provided text regarding performance is:
- Non-Clinical Performance and Conclusions: "Bench testing results demonstrate that the Synthes Antegra-T System is substantially equivalent to the predicate devices."
- Clinical Performance and Conclusions: "Clinical data and conclusions were not needed for this device."
This means the device's substantial equivalence was established through bench testing only, comparing it to existing predicate devices. Since clinical data was not required, and no study is mentioned in the provided text, the specific information requested in the prompt (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, etc.) cannot be extracted.
Therefore, for each of the requested points, the answer is that the information is not available in the provided document.
{0}------------------------------------------------
Section 5 - 510(k) Summary
| 510(k) Summary | |
|---|---|
| Name of Firm: | Synthes Spine |
| 1302 Wrights Lane East | |
| West Chester, PA 19380 | |
| 510(k) Contact: | Susan Lewandowski |
| Manager, Spine Regulatory Affairs | |
| Telephone: 610-719-5712Facsimile: 610-719-5102 | |
| Email: lewandowski.susan@synthes.com | |
| Date Prepared: | June 3, 2008 |
| Trade Name: | Synthes Antegra-T System |
| Classification: | 21 CFR 888.3060 - Spinal Intervertebral Body Fixation Orthosis |
| Class II | |
| Orthopaedic and Rehabilitation Devices PanelProduct Code KWQ | |
| Predicates: | Synthes Anterior Tension Band (ATB) System (K022791) |
| Synthes Antegra System (K063158) | |
| Synthes VentroFix MIS System (K031100) | |
| Synthes Small Stature USS System (K994121) | |
| Device | |
| Description: | The Synthes Antegra-T System consists of one-level titanium lumbar and |
| sacral plates and cancellous screws with locking heads. The plates attach to | |
| the anterior portion of the lumbar and lumbosacral spine (L1-S1). These | |
| one-level plates are available in lengths ranging from 37 mm to 53 mm in | |
| 2mm increments. The sacral plates have a step on the underside that allows | |
| for precise sacral placement. The Antegra-T System uses the bone-screws | |
| from the Synthes Antegra System (K063158). | |
| Intended Use/ | The Synthes Antegra-T System is indicated for use via the lateral or |
| Indications for | anterolateral surgical approach above the bifurcation of the great vessels or |
| Use: | 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 a 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 | The Synthes Antegra-T System is a result of design modifications to the |
| device to predicate | predicate devices. It is substantially equivalent to the predicates in design, |
| device(s): | function, material, and intended use. |
| Performance Date | Non-Clinical Performance and Conclusions: |
| (Non-Clinical and/or | Bench testing results demonstrate that the Synthes Antegra-T System is |
| Clinical): | substantially equivalent to the predicate devices. |
| Clinical Performance and Conclusions: | |
| Clinical data and conclusions were not needed for this device. |
Traditional 510(k)
Synthes Antegra-T System
{1}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like bird with outstretched wings, positioned to the right of a circular arrangement of text. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular fashion around the bird. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Synthes Spine Company, LP % Ms. Susan Lewandowski Manager, Spine Regulatory Affairs 1302 Wrights Lane East West Chester, Pennsylvania 19380
SEP - 2 2008
Re: K081568
Trade/Device Name: Synthes Antegra-T System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWO Dated: June 3, 2008 Received: June 4, 2008
Dear Ms. 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.
{2}------------------------------------------------
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Presmarket, Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N. Millerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Section 4 - Indications for Use Statement
510(k) Number: (if known)
KO81568
Device Name: Synthes Antegra-T System
Indications for Use:
The Synthes Antegra-T System 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 - Sl) 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 a 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.
X Prescription Use (21 CFR 801 Subpart D) AND / OR
Over-the-Counter Use (21 CFR 801 Subpart C)
f
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Ev
Vaubare Bneam
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
Traditional 510(k) Synthes Antegra-T System
510(k) Number K081568
§ 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.