(55 days)
K/DEN number:
Not Found
No
The summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
Explanation: The device is intended to provide immobilization and stabilization of spinal segments for various conditions, which are therapeutic interventions.
No
The device, Synthes Small Stature USS and Dual-Opening USS, is described as a "posterior pedicle screw fixation system" and a "posterior non-pedicle screw fixation system" intended for "immobilization and stabilization of spinal segments as an adjunct to fusion" in the treatment of various spinal conditions. This indicates it is a therapeutic device for surgical implantation, not a device used to diagnose medical conditions.
No
The device description explicitly lists hardware components (rods, plate/rods, clamps, screws, nuts, transconnectors) made of Titanium or Stainless Steel.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The description clearly states the device consists of "rods, plate/rods, clamps, screws, nuts and transconnectors" made of Titanium or Stainless Steel. These are physical implants used for spinal fixation.
- Intended Use: The intended use describes the device's function in providing "immobilization and stabilization of spinal segments" and "fixation" for various spinal conditions. This is a surgical intervention, not a diagnostic test performed on a sample.
The device is a surgical implant used to treat spinal conditions, not a tool for analyzing biological samples.
N/A
Intended Use / Indications for Use
When used as a posterior pedicle screw fixation system, the Synthes Small Stature USS and the Dual-Opening USS are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients (including small statue) as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
In addition, the Synthes Small Stature USS and the Dual-Opening USS are intended for treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients (including small stature) and pediatric patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine with removal of the implants after the attainment of a solid fusion. The levels of pedicle screw fixation for these patients are L3-S2.
When used as a posterior non-pedicle screw fixation system in skeletally mature patients (including small stature) and pediatric patients, the Synthes Small Stature USS and the Dual-Opening USS are intended for scoliosis, Schuermann's disease, degenerative disc disease (back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), and fractures of the posterior thoracolumbar spine.
The anterior components of the Synthes Small Stature USS and the Dual-Opening USS when used in skeletally mature patients (including small stature) and pediatric patients are intended for anterolateral screw and/or staple fixation for the correction of anterolateral lordotic deformities for the spine, lumbar scoliosis, pseudoarthrosis, and fracture or dislocation of the thoracolumbar spine (levels T8-L5).
Product codes
MNI, MNH, KWP
Device Description
Synthes Dual-Opening USS consists of rods, plate/rods, clamps, screws, nuts and transconnectors. The implants are composed of Titanium or Stainless Steel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar, sacral spine, L5-S1 vertebra, L3-S2, T8-L5
Indicated Patient Age Range
skeletally mature patients (including small statue), 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)
Not Found
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 Spine 510(k) Premarket Notification Synthes Dual-Opening USS Special 510K
K02051/
page 1 of 2
8.4 ATTACHMENT IV - 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
DEVICE
Synthes Dual-Opening USS consists of rods, plate/rods, clamps, screws, nuts and transconnectors. The implants are composed of Titanium or Stainless Steel.
INDICATIONS
When used as a posterior pedicle screw fixation system, the Synthes Small Stature USS and the Dual-Opening USS are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients (including small statue) as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
In addition, the Synthes Small Stature USS and the Dual-Opening USS are intended for treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients (including small stature) and pediatric patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine with removal of the implants after the attainment of a solid fusion. The levels of pedicle screw fixation for these patients are L3-S2.
When used as a posterior non-pedicle screw fixation system in skeletally mature patients (including small stature) and pediatric patients, the Synthes Small Stature USS and the Dual-Opening USS are intended for scoliosis, Schuermann's disease, degenerative disc disease (back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), and fractures of the posterior thoracolumbar spine.
1
The anterior components of the Synthes Small Stature USS and the Dual-Opening USS when used in skeletally mature patients (including small stature) and pediatric patients are intended for anterolateral screw and/or staple fixation for the correction of anterolateral lordotic deformities for the spine, lumbar scoliosis, pseudoarthrosis, and fracture or dislocation of the thoracolumbar spine (levels T8-L5).
In addition, when used with 3.5/5.0 mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix™ System. When used with 5.0/6.0 mm parallel connectors, the Synthes Small Stature USS can be linked to the Universal Spinal System and the Dual-Opening USS.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image. The logo is black and white.
Public Health Service
APR 1 5 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Vikki Hoffman Senior Regulatory Affairs Specialist Synthes Spine Post Office Box 0548 1690 Russell Road Paoli, Pennsylvania 19301
Re: K020517
Trade Name: Synthes Dual Opening USS Regulatory Number: 21 CFR 888.3070, 21 CFR 888.3050 Regulation Name: Pedicle Screw Spinal System, Spinal Interlaminal Fixation Orthosis Regulatory Class: II Product Code: MNI, MNH, KWP Dated: March 22, 2002 Received: March 25, 2002
Dear Ms. Hoffman:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have and we have determined the device is substantially equivalent (for the indications for use above and we nave acteriners marketed in interstate commerce prior to May 28, 1976, the stated in the of the Medical Device Amendments, or to devices that have been reclassified in enconnent unte of the Firstians of the Federal Food, Drug, and Cosmetic Act (Act). You may, accordance with the provincies of arts the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, controls provisions or use, labeling, and prohibitions against 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 ( Femanel 1 pp . 0 w/s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to inspotworld the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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.
3
Page 2 - Ms. Vikki Hoffman
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 regulation (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 at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
for Mark N. Milliken
Celia M. Witten, Ph.D., M.D.
Director Division of General Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
8.2 ATTACHMENT II – INDICATIONS FOR USE STATEMENT
510(k) Number (if known): KOQ OJ 7
Device Name: Synthes Dual-Opening USS
Indications for Use:
When used as a posterior pedicle screw fixation system, the Synthes Small Stature USS willing about as a points USS are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients (including small statue) as an adjunct to Spinal segments in sites of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
In addition, the Synthes Small Stature USS and the Dual-Opening USS are intended for in additions are of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients (including small stature) and pediatric patients receiving fusion by mature part having implants attached to the lumbar and sacral spine with removal of the implants after the attainment of a solid fusion. The levels of pedicle screw fixation for these patients are L3-S2.
When used as a posterior non-pedicle screw fixation system in skeletally mature patients (including small stature) and pediatric patients, the Synthes Small Stature USS and the Duel Opening USS are intended for scoliosis, Schuermann's disease, degenerative disc Disease (back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), and fractures of the posterior thoracolumbar spine.
The anterior components of the Synthes Small Stature USS and the Dual-Opening USS when used in skeletally mature patients (including small stature) and pediatric patients are intended for anterolateral screw and/or staple fixation for the correction of anterolateral lordotic deformities for the spine, lumbar scoliosis, pseudoarthrosis, and fracture or dislocation of the thoracolumbar spine (levels T8-L5).
Mark N. Milbersen
(Division Sign-Off) (Division of General, Restorative and Neurological Devices
510(k) Number -
CONFIDENTIAL
5
In addition, when used with 3.5/5.0 mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix™ System. When used with 5.0/6.0 mm parallel connectors, the Synthes Small Stature USS can be linked to the Universal Spinal System and the Dual-Opening USS.
(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
for Mark N Mulkerson
Division Sign Off
Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K020517