(30 days)
No
The device description details a mechanical rod and screw system for spinal fixation and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
The device is described as a "Pediatric Rod System" intended for "pedicle screw fixation" in cases of "grade 3 or 4 spondylolisthesis at the fifth lumbar - first sacral vertebral joint (LS-S1)." This indicates a direct medical intervention to treat a specific condition, which aligns with the definition of a therapeutic device.
No
The device is described as an implantable rod system for spinal fusion, not a device used to diagnose medical conditions or diseases.
No
The device description explicitly details physical components made of titanium and titanium alloy (rods, clamps, nuts, screws) and manual surgical instruments, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. They are used outside the body.
- Device Description: The provided text describes a surgical implant system (rods, screws, clamps, etc.) used for spinal fixation within the body.
- Intended Use: The intended use is for surgical fixation of the spine in pediatric patients. This is a therapeutic intervention, not a diagnostic test performed on a specimen.
The device is a surgical implant, not an IVD.
N/A
Intended Use / 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.
Product codes
MNH
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fifth lumbar - first sacral vertebral joint (1.5-S1)
Indicated Patient Age Range
pediatric patients
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
0
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.
1
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.
2
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,
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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
3
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 ___
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