(71 days)
It looks like the predicate devices are not listed for this particular product. Please provide the correct input or let me know if there's anything else I can help you with!
Not Found
No
The provided text describes a spinal implant system and its components, materials, and intended use. There is no mention of any software, algorithms, or data processing capabilities that would suggest the use of AI or ML. The focus is entirely on the physical device and its surgical application.
Yes
The device description states its purpose is to "stabilize the lumbar and sacral spine areas to promote fusion," which indicates a therapeutic intent to treat conditions like degenerative disc disease and spondylolisthesis.
No
The "Intended Use / Indications for Use" section describes the device for use in patients with degenerative conditions (e.g., discogenic back pain with disc disruption), spondylolisthesis, and spinal stenosis, and specifically mentions its use in promoting fusion. It also states that the device is intended to be removed after fusion occurs. These indicate that the device is a therapeutic implant for spinal stabilization and fusion, not a diagnostic device.
No
The device description explicitly lists hardware components such as implants, rods, screws, plates, hooks, and instruments made of titanium and stainless steel.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical implant system used to stabilize the spine and promote fusion in patients with various spinal conditions. This is a therapeutic intervention, not a diagnostic test performed on samples from the body.
- Device Description: The device is described as implants (screws, rods, plates, hooks) made of surgical implant materials. This aligns with a surgical device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition based on in vitro analysis.
Therefore, this device falls under the category of a surgical implant or spinal fixation system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
When wed as a non cervical hook and sarel services in indicated for we in prisents with degenerative discover (discosenic back pain with deserentian of the discomplies to racked studies), spondegical sociosis, spinel starts spinel starts with winnely falled back suppens, and frances. Villem wed as credicte screens (a) lawing sever sports (a) lawing sever sport 4) at the L.S.S) joint, , who are receiving fusion using anto cone watt only, (c) who are having the device for attacked to the lumber and (d) who are lasing the clerine "tenoved after development of a stid fision mess The simple, is intended for ossein five levels 17 through S. The Searl Pares are interned for posterior sacral fixation at S1 and S2. Levels of pedicle screw fivation are posterior from levels L3 to through S1 only.
Product codes
MNH, KWP
Device Description
The J.S.Spine System @ inplans are station of the stablic the hunter and torners were to promote insion. The System is to be removed aller fision occurs. The JBS. Spine Systems, sazal plates, pedicle screws, reds, pedicle and laminer hooks and linking plates. J.B.S. has both firm rod systems. The inqlant are composed of surgical implant timinon, T.6ALAVELL, accoming to ASTM-136-92. Instruments to implat the IB.S. Spine System are made of ZOC'l stainless steel source to ATM grace 400 staries see) with a polyna handle, ar surgical implant titanium, Ti 6Al 4V EI I .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal, hook and sarel services, L.S.S) joint, lumber, posterior sacral fixation at S1 and S2, L3 to through S1
Indicated Patient Age Range
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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
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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
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
Regulatory Authority:
Company:
Safe Medical Devices Act of 1990, 21 CFR 807.92
J.B.S. (USA), Inc. Parc dactivities Savipol 10300 Ste. Savine, Troyes Tel: 011-33-2571-2500 Fax: 011-33-2571-2506
SEP 2 5 1996
Medical Device Establishment Registration #: 9681258
| FDA Owner/Operator #: | 9021265 |
|---|---|
| Contact: | Ms. Liza Burns, Regulatory Consultant |
| Trade Name: | J.B.S. SPINE SYSTEM® WITH PEDICLE SCREWS |
| Common Name: | Spinal Fixation Device |
| Classification Name: | Spinal Pedicle Screw, Fixation, Appliance System |
| Classification Code: | 87 MNH, KWP |
Device Description: The J.S.Spine System @ inplans are station of the stablic the hunter and torners were to promote insion. The System is to be removed aller fision occurs. The JBS. Spine Systems, sazal plates, pedicle screws, reds, pedicle and laminer hooks and linking plates. J.B.S. has both firm rod systems. The inqlant are composed of surgical implant timinon, T.6ALAVELL, accoming to ASTM-136-92. Instruments to implat the IB.S. Spine System are made of ZOC'l stainless steel source to ATM grace 400 staries see) with a polyna handle, ar surgical implant titanium, Ti 6Al 4V EI I .
Indications for Use: When wed as a non cervical hook and sarel services in indicated for we in prisents with degenerative discover (discosenic back pain with deserentian of the discomplies to racked studies), spondegical sociosis, spinel starts spinel starts with winnely falled back suppens, and frances. Villem wed as credicte screens (a) lawing sever sports (a) lawing sever sport 4) at the L.S.S) joint, , who are receiving fusion using anto cone watt only, (c) who are having the device for attacked to the lumber and (d) who are lasing the clerine "tenoved after development of a stid fision mess The simple, is intended for ossein five levels 17 through S. The Searl Pares are interned for posterior sacral fixation at S1 and S2. Levels of pedicle screw fivation are posterior from levels L3 to through S1 only.
Contraindications: The IBS. Spiens system in paired in paired on systems who ace pregrant, or patients who are a dease of ofter medical condition which internation (such as osterprosis, lidher; clicker) didness and pedice frances in additional contransis include these paints receiving fissem using all grad, institute spiral lists and milliate spiral fusion dove the 1.5-S1 interverted pion, first fraction of the posicle screens to the or vical, thoracic, or lumbar spine, except for in cases of severe spondy knistins as described above, and/or in patients with stable spines.
Warnings, Precautions and Potential Adverse Effects: The spiral instration with spiral instrumentation and the we of this system. All implans and instruments are pakeged and supplied non-sealing land in the sterlined according to the directions provided in this inset. The inset. The inset The singles in single paired we cally and must never be reased. An explanted implanted. Dissimizar netals in contact with each other can other an occessed the occrosion process due to galvance consion effects. Therefore, connects from the manufacturers whan using the IBS. Spine System included in attend or antervised frontine When wed as a police scent the IBS. Spire System is intended any for Craces 3 of 4 Space is in 1 fill humber instal (1-51) vetetal joint. The screws of the LBS. Spines System are not intensed for memor und fision above the LSS interenterial part. The IBS. Some System is not approved for seeve attactor to the posterial collinary of the cervical, formain, a lumber spine, encessf. or severe spacity in above. The bearfts of spine fission using of peach system from here not been sufficients established in patients with states with states with states with station included wit the use of the LB.S. Spines System, witch nagery induste (out are not limited to) : weeksal frashre, firstares of the centre of the composess, nearcharded anneg, vacular and/or visean injay, loss of firstian, sex tissue formation, leakage of carbrasinal finid, and demage to the surrounding off tisse. Also included are tisks associated with the use of general anethesia. Rich spinal instrumentation include neve not or spinal one inpringences resulting from pody positioned screws or from bone fragments, and bone resorption and/or loosening of the implant.
Substantially Equivalent Devices: 1. TSRH System by Sofanor Danek 2. PLSA System by Advanced Spine Fixation Systems 3. Rogozinsky System by Richards 4. Harrington System by Zimmer 5. C-D System by Stuart (Danek).
Distributed by:
Aesculap Inc. 10 Gateway Blvd. San Francisco, CA 94080 US Patented Manufactured by: J.B.S., SA France