(30 days)
When labeled for pedicle screw fixation, the Pediatric Rod System is intended for use in grade 3 or 4 spondylolisthesis at the fifth lumbar - first sacral vertebral joint (LS-S1) utilizing autologous bone graft and intended to be removed after solid fusion is attained. The Pediatric Rod System is intended for pediatric patients with a body weight of 50lbs or less.
Synthes Pediatric Rod System consists of rods, clamps, nut and screws. The screws are composed of commercially pure grade 4 Titanium (ASTM F67). The clamps and rods are composed of the titanium alloy TAN (ASTM F1295). The Starlock clamps, Starlock screws and nut are composed of the titanium alloy TAN (ASTM F1295).
The 3.5mm rod is provided in four lengths, 80, 120, 240 and 300mm. The clamps are designed to connect the 3.5mm rods and screws utilized for this system. The screws are provided in the following configurations: 3.5mm cancellous screw, a 4.0mm cancellous screw, 4.0mm or 4.35mm expansion screw with 1.8mm locking screw, 3.5mm and 4.0mm cancellous and 3.5 cortical StarLock screws, medial, lateral, and upgoing, and offset StarLock clamps. Manual surgical instruments are included to implant components of this system.
The device functions as follows: The end of the rod, cut to an appropriate length, is inserted into the rod opening of the clamps and loosely tightened into position with the set screws included in the clamps. The awl is used to open the cortex. The K-wire is used to manually extend the hole. The length of screw is determined with the depth gauge, then the hole is tapped. The screw is inserted through the clamp at the desired level. The set screws are then locked down to the rod.
When the StarLock components are used with the 3.5 mm rod, the following assembly steps are followed after the screw hole is prepared and proper screw length determined: A StarLock screw is inserted at the desired level. A StarLock clamp is placed onto the screw and a StarLock nut is loosely threaded onto the head of the screw. The remaining screws, clamps and nuts are inserted in the same manner. A 3.5mm rod, cut to an appropriate length, is inserted into the rod opening of the clamps and loosely tightened into position with the set screws included with the clamps. After final adjustment of the construct, the set screws are locked down to the rod and the nuts are fully tightened.
This system is provided non-sterile; moist heat sterilization is recommended.
The provided text describes a 510(k) premarket notification for the Synthes Pediatric Rod System, a medical device for spinal fixation. It focuses on the device's components, function, and intended use as a pedicle screw fixation system for grade 3 or 4 spondylolisthesis in pediatric patients.
Notably, this document is a regulatory submission for premarket notification (510(k)) and not a scientific study or clinical trial report. The purpose of a 510(k) submission is to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. This typically involves showing that the device has the same intended use and either the same technological characteristics or different technological characteristics that do not raise new questions of safety and effectiveness.
Therefore, the input does not contain information regarding:
- Acceptance criteria and reported device performance metrics from a study.
- Sample sizes, data provenance, or details of a test set.
- Number and qualifications of experts for ground truth.
- Adjudication methods.
- Multi Reader Multi Case (MRMC) comparative effectiveness studies or effect sizes.
- Stand-alone (algorithm only) performance studies.
- Types of ground truth used in a study.
- Sample size for a training set.
- How ground truth for a training set was established.
The document confirms substantial equivalence to a predicate device (K980761) based on comparison of intended use and technological characteristics, not through a performance study against specific acceptance criteria.
If this were a document about a software algorithm or an AI/ML device, the requested information would be expected. However, for this type of mechanical spinal implant, performance is typically assessed through design specifications, material testing, mechanical testing (e.g., fatigue, static strength), and comparison to predicate device specifications, rather than the types of studies outlined in your request.
In summary, based solely on the provided text, I cannot complete the requested tables and information because the document does not describe a study involving acceptance criteria, performance metrics, ground truth, expert adjudication, or MRMC/standalone evaluations.
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Synthes Pediatric Rod System Special 510(k) Premarket Notification - Device Line Extension
K991552
1 of 1
Summary of Safety and Effectiveness Information [510(k) Summary]
SYNTHES (U.S.A.) 1690 Russell Road Paoli, PA 19301
(610) 647-9700 Contact: Jon Gilbert 4/30/99
Device: Synthes Pediatric Rod System consists of rods, clamps, nut and screws. The screws are composed of commercially pure grade 4 Titanium (ASTM F67). The clamps and rods are composed of the titanium alloy TAN (ASTM F1295). The Starlock clamps, Starlock screws and nut are composed of the titanium alloy TAN (ASTM F1295).
The 3.5mm rod is provided in four lengths, 80, 120, 240 and 300mm. The clamps are designed to connect the 3.5mm rods and screws utilized for this system. The screws are provided in the following configurations: 3.5mm cancellous screw, a 4.0mm cancellous screw, 4.0mm or 4.35mm expansion screw with 1.8mm locking screw, 3.5mm and 4.0mm cancellous and 3.5 cortical StarLock screws, medial, lateral, and upgoing, and offset StarLock clamps. Manual surgical instruments are included to implant components of this system.
The device functions as follows: The end of the rod, cut to an appropriate length, is inserted into the rod opening of the clamps and loosely tightened into position with the set screws included in the clamps. The awl is used to open the cortex. The K-wire is used to manually extend the hole. The length of screw is determined with the depth gauge, then the hole is tapped. The screw is inserted through the clamp at the desired level. The set screws are then locked down to the rod.
When the StarLock components are used with the 3.5 mm rod, the following assembly steps are followed after the screw hole is prepared and proper screw length determined: A StarLock screw is inserted at the desired level. A StarLock clamp is placed onto the screw and a StarLock nut is loosely threaded onto the head of the screw. The remaining screws, clamps and nuts are inserted in the same manner. A 3.5mm rod, cut to an appropriate length, is inserted into the rod opening of the clamps and loosely tightened into position with the set screws included with the clamps. After final adjustment of the construct, the set screws are locked down to the rod and the nuts are fully tightened.
The Synthes Pediatric Rod System is a pedicle screw fixation system for use in grade 3 or 4 spondylolisthesis at the fifth lumbar - first sacral vertebral joint (1.5-S1) utilizing autologous bone graft and intended after solid fusion is attained. The Synthes Pediatric Rod System is intended for pediatric patients with a body weight of 501bs or less.
This system is provided non-sterile; moist heat sterilization is recommended.
Based on the above, the Synthes Pediatric Rod System is substantially equivalent to K980761.
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Public Health Service
Image /page/1/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
2 1999 JUN ...
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jonathan Gilbert Senior Regulatory Affairs Associate SYNTHES SPINE P.O. Box 0548 1690 Russell Road Paoli, Pennsylvania 19301
K991552 Re: Synthes Pediatric Rod System Trade Name: Regulatory Class: II Product Code: MNH Dated: April 30, 1999 Received: May 3, 1999
Dear Mr. Gilbert:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Jonathan Gilbert
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
fo
collf
Celia M. Witten, Ph.D., M.D.
Director
Division of Coporal and
Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): NA> K991552
Device Name: Synthes Pediatric Rod System
Indications for Use:
When labeled for pedicle screw fixation, the Pediatric Rod System is intended for use in grade 3 or 4 spondylolisthesis at the fifth lumbar - first sacral vertebral joint (LS-S1) utilizing autologous bone graft and intended to be removed after solid fusion is attained. The Pediatric Rod System is intended for pediatric patients with a body weight of 50lbs or less.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use × (Per 21 CFR 801.109)
OR
Over-the-Counter Use ___
coello
N/A