J.B.S. SPINE SYSTEM WITH PEDICLE SCREWS - ADDITIONAL COMPONENTS - SCREWS, LINKING PLATES, HOOKS AND ROD CLAMP

K962757 · J.B.S., S.A. · MNH · Sep 25, 1996 · Orthopedic

Device Facts

• Record ID: K962757
• Device Name: J.B.S. SPINE SYSTEM WITH PEDICLE SCREWS - ADDITIONAL COMPONENTS - SCREWS, LINKING PLATES, HOOKS AND ROD CLAMP
• Applicant: J.B.S., S.A.
• Product Code: MNH · Orthopedic
• Decision Date: Sep 25, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

When used as a non-cervical hook and sacral screw system, the J.B.S. Spine System is indicated for use in patients with degenerative disc disease (discogenic back pain with degeneration of the disc confirmed by radiographic studies), spondylolisthesis, kyphosis, neurological scoliosis, spine tumors, spinal stenosis, patients with previously failed back surgeries, and fractures. When used as a pedicle screw system, it is intended for patients (a) having severe spondylolisthesis (grades 3 and 4) at the L5-S1 joint, who are receiving fusion using autogenous bone graft only, (c) who are having the device fixed or attached to the lumbar and sacral spine, and (d) who are having the device removed after development of a solid fusion mass. The J.B.S. Spine System, as a whole, is intended for posterior fixation from levels T1 through S1. The Sacral Plates are intended for posterior sacral fixation at S1 and S2. Levels of pedicle screw fixation are posterior fixation from levels L3 to through S1 only.

Device Story

Spinal fixation system for stabilization of lumbar and thoracic vertebrae to promote fusion; single-use temporary implants. Components include sacral screws, sacral plates, pedicle screws, rods, hooks, clamps, and linking plates. Used in posterior fixation (T1-S1); pedicle screw fixation limited to L3-S1. Surgeon-operated in clinical setting. Implants provide mechanical stabilization; removed after solid fusion mass development. Benefits include spinal stabilization; risks include vertebral fracture, neurological damage, vascular/visceral injury, loss of fixation, and infection. Not for anterior/anterolateral fixation.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Implants: Ti 6Al 4V ELI titanium (ASTM-136-92). Instruments: Z30C13 stainless steel (AFNOR/ASTM 420B) with polymer handles or Ti 6Al 4V ELI. System includes 5mm and 6mm rod options. Non-sterile; requires sterilization prior to use. Mechanical fixation principle.

Indications for Use

Indicated for patients with degenerative disc disease, spondylolisthesis, kyphosis, neurological scoliosis, spine tumors, spinal stenosis, failed back surgeries, and fractures. Pedicle screw use restricted to severe (grade 3-4) spondylolisthesis at L5-S1 with autogenous bone graft. Contraindicated in patients with active infection, pregnancy, or conditions inhibiting bony fusion (e.g., osteoporosis, dialysis).

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• TSRH System by Sofamor Danek
• PLSA System by Advanced Spine Fixation Systems
• Rogozinsky System by Richards
• Harrington System by Zimmer
• C-D System by Stuart (Danek)

Submission Summary (Full Text)

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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

EXHIBIT D

Regulatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92

Company: J.B.S. (USA), Inc.
Parc d'activites Savipol
10300 Ste. Savine, Troyes
Tel: [phone]
Fax: [phone]

SEP 25 1996
K962757

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.B.S. Spine System® implants are single-use temporary devices used to stabilize the lumbar and thoracic vertebrae, to promote fusion. The System is to be removed after fusion occurs. The J.B.S. Spine System® consists of sacral screws, sacral plates, pedicle screws, rods, pedicle and laminar hooks and clamps, and linking plates. J.B.S. has both 5mm and 6mm rod systems. The implants are composed of surgical implant titanium, Ti 6Al 4V ELI, according to ASTM-136-92. Instruments used to implant the J.B.S. Spine System are made of Z30C13 stainless steel according to AFNOR Standard (corresponding to ASTM grade 420B stainless steel) with a polymer handle, or surgical implant titanium, Ti 6Al 4V ELI.

Indications for Use: When used as a non-cervical hook and sacral screw system, the J.B.S. Spine System is indicated for use in patients with degenerative disc disease (discogenic back pain with degeneration of the disc confirmed by radiographic studies), spondylolisthesis, kyphosis, neurological scoliosis, spine tumors, spinal stenosis, patients with previously failed back surgeries, and fractures. When used as a pedicle screw system, it is intended for patients (a) having severe spondylolisthesis (grades 3 and 4) at the L5-S1 joint, who are receiving fusion using autogenous bone graft only, (c) who are having the device fixed or attached to the lumbar and sacral spine, and (d) who are having the device removed after development of a solid fusion mass. The J.B.S. Spine System, as a whole, is intended for posterior fixation from levels T1 through S1. The Sacral Plates are intended for posterior sacral fixation at S1 and S2. Levels of pedicle screw fixation are posterior fixation from levels L3 to through S1 only.

Contraindications: The J.B.S. Spine System is not to be used in patients with active localized or systemic infection, patients who are pregnant, or patients who have a disease or other medical condition which inhibits the potential of bony fusion (such as osteoporosis, kidney dialysis). When used as a pedicle fixation system additional contraindications include those patients receiving fusion using allograft, insertion of the screws into the pedicles to facilitate spinal fusion above the L5-S1 intervertebral joint, fixation of the pedicle screws to the cervical, thoracic, or lumbar spine, except for in cases of severe spondylolisthesis as described above, and/or in patients with stable spines.

Warnings, Precautions and Potential Adverse Effects: The surgeon should be thoroughly familiar with spinal instrumentation and the use of this system. All implants and instruments are packaged and supplied non-sterile. Prior to use, each implant must be sterilized according to the directions provided in this insert. The implant is designed for single patient use only and must never be reused. An explanted metal implant must never be reimplanted. Dissimilar metals in contact with each other can accelerate the corrosion process due to galvanic corrosion effects. Therefore, do not use components from other manufacturers when using the J.B.S. Spine System implants. This system is not to be used for anterior or anterolateral fixation. When used as a pedicle screw system, the J.B.S. Spine System is intended only for Grades 3 or 4 Spondylolisthesis at the fifth lumbar-first sacral (L5-S1) vertebral joint. The screws of the J.B.S. Spine System are not intended for insertion into the pedicles to facilitate spinal fusion above the L5-S1 intervertebral joint. The J.B.S. Spine System is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine, except for severe spondylolisthesis, as described above. The benefits of spine fusion using any brand of pedicle screw fixation system have not been sufficiently established in patients with stable spines. Possible risks identified with the use of the J.B.S. Spine System, which may require additional surgery include (but are not limited to): vertebral fracture, fracture of the device components, neurological damage, vascular and/or visceral injury, loss of fixation, bleeding, infection, scar tissue formation, leakage of cerebrospinal fluid, and damage to the surrounding soft tissue. Also included are risks associated with the use of general anesthesia. Risks specifically associated with spinal instrumentation include nerve root or spinal cord impingement resulting from poorly positioned screws or from bone fragments, and bone resorption and/or loosening of the implant.

Substantially Equivalent Devices: 1. TSRH System by Sofamor 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