(316 days)
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No
The document describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is a spinal fixation system intended to provide immobilization and stabilization of spinal segments, which is a clear therapeutic intervention for various spinal conditions.
No
Explanation: The device is described as a "posterior pedicle screw fixation system" and is intended to provide "immobilization and stabilization of spinal segments," which indicates a therapeutic rather than a diagnostic function. While "radiographic studies" are mentioned in the context of confirming disc degeneration, this refers to an external diagnostic tool, not an inherent diagnostic capability of the device itself.
No
The device description explicitly states it consists of "a variety of rods, hooks, station is also, avgileble The Synthes Sthair Stature OOO Consisted of a variety of Feat, Normentation is also available to facilitate implantation of the device components," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system designed to provide immobilization and stabilization of spinal segments. This is a therapeutic device used in vivo (within the body) during surgery.
- Device Description: The device is described as consisting of rods, hooks, and instrumentation for implantation. These are physical components used in a surgical procedure.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens (like blood, urine, or tissue) from the human body to provide information for diagnosis, monitoring, or screening. The description of the Synthes Small Stature USS does not involve any of these activities.
The mention of "radiographic studies" as an input imaging modality is for assessing the patient's condition and the outcome of the surgical procedure, not for performing an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
When used as a posterior pedicle screw fixation system, the Synthes Small Stature USS Is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients (including small stature) as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the theracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scallosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
In addition, the Synthes Small Stature USS is intended for treatment of severe spondylofisthesis (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 is intended for scollotic, lordotic, or kyphotic deformities (such as 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 when used in skeletally mature patients (Including small stature) and pediatric patients are intended for anterclateral 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 78-L5),
In addition, when used with 3.5/5.0mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix System. When used with 5.0/6.0mm parallel connectors, the Synthes Small Stature USS can be linked to the Universal Spinal System
Product codes
MNI, MNH, KWP
Device Description
The Synthes Small Stature USS consists of a variety of rods, hooks, station is also, avgileble The Synthes Sthair Stature OOO Consisted of a variety of Feat, Normentation is also available to facilitate implantation of the device components.
Certain implant components from the Synthes Small Stature USS can be used to connect the se Geltain Implant components from the Synthes Synthes posterior spinal systems (USS or CerviFix).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal segments in thoracic, lumbar, and sacral spine; L5-S1 vertebra; posterior thoracolumbar spine; thoracolumbar spine (levels 78-L5).
Indicated Patient Age Range
Skeletally mature patients (including small stature) and pediatric patients.
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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
K994121
OCT 1 7 2000
Synthes Small Stature USS Summary of Safety and Effectiveness 12/2/99
SYNTHES (U.S.A.) 1690 Russell Road Paoli, PA 19301 (610) 647-9700
Device
Synthes Small Stature USS
Product Description
Product Description
The Synthes Small Stature USS consists of a variety of rods, hooks, station is also, avgileble The Synthes Sthair Stature OOO Consisted of a variety of Feat, Normentation is also available to facilitate implantation of the device components.
Certain implant components from the Synthes Small Stature USS can be used to connect the se Geltain Implant components from the Synthes Synthes posterior spinal systems (USS or CerviFix).
Indications
When used as a posterior pedicle screw fixation system, the Synthes Small Stature USS is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients (including small stature) as an adjunct to fusion in the freatment of the following acute patients (including Small Stature) as an adjunct to factor in the sacral spine. degenerative and Chrome Instablities of delomition of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
In addition, the Synthes Small Stature USS is intended for treatment of severe spondyclishesis In addition, the Synthes Onlar Octore Occasion in the patients (including small status) and (Grade 3 and 4) of the Lo-of Veltebran by autogenous bone graft having implants attached to the pealating patients receiving fusion by autogue to 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 pediatic patients, the Synthes Small Stature USS intended for scoliotic, lordotic, or kyphotic deformities (such as scoliosis, Schuerman's disease), degenerative disc disease (back pain of discogenic origin with degeneration of the disc confirmed degencrative und radiographic studies), and fractures of the posterior thoracolumbar spine.
The anterior components of the Synthes Small Stature USS when used in skeletally mature patients (including small stature) and pediatic patients are intended for antercoping lumber patientis (including onlial other of anterolateral lordotic deformities for the spine, humbar andror stable fixation for the ocerceden of the thoracolumbar spine (levels T8-L5).
In addition, when used with 3.5/5.0mm parallel connectors, the Synthes Small Stature USS can in addition, when used with b.org. only parallel connectors, the Synthes Small Stature USS can be linked to the Universal Spinal System
3
1
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle's head and neck, with three stylized lines representing the eagle's feathers.
OCT 1 7 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jonathan M. Gilbert Senior Regulatory Affairs Associate SYNTHES (USA) 1690 Russell Road Post Office Box 1766 Paoli, Pennsylvania 19301
Re: K994121
Trade Name: Small Statue USS Regulatory Class: II Product Code: MNI, MNH and KWP Dated: July 19, 2000 Received: July 20, 2000
!
Dear Mr. Gilbert:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have 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 stated in the oneround) to ceet Device Amendments, or to devices that have been reclassified in enceditions with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general control provisions of the Act. The general thereof 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations (1 remance ripproval), in the Code of Federal Regulations, 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 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 nspotions, and 1 000 and 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.
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.
2
Page 2 - Mr. Jonathan Gilbert
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 additionally 809.10 for m Yriro diagnostions on the promotion and advertising of your device, (301) 394-4659. Additionally, for questions on the presses note the regulation please contact the Office or Comphanee at (301) 0 - 1 (30 ) - 1 (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small information on your responsionnes ander and rise no rio not (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Mark M. Milken
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
3
Indications For Use Statement
Page 1 of 1
510(k) Number (if Known): NA K99412)
Device Name: Synthes Small Stature USS
Indications for Use:
When used as a posterior pedicle screw fixation system, the Synthes Small Stature USS Is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients (including small stature) as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the theracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scallosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
In addition, the Synthes Small Stature USS is intended for treatment of severe spondylofisthesis (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 is intended for scollotic, lordotic, or kyphotic deformities (such as 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 when used in skeletally mature patients (Including small stature) and pediatric patients are intended for anterclateral 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 78-L5),
In addition, when used with 3.5/5.0mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix System. When used with 5.0/6.0mm parallel connectors, the Synthes Small Stature USS can be linked to the Universal Spinal System
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (OBE)
Prescription Use (Per 21 CFR 801.109) OR
Over-the-Counter Use
Mark n Milkman
(Division Sign-C (Division Sign oral Restorative 510(k) Number.