J.B. S. C1-C2 CLAMP

K955864 · J.B.S., S.A. · KWP · Mar 15, 1996 · Orthopedic

Device Facts

• Record ID: K955864
• Device Name: J.B. S. C1-C2 CLAMP
• Applicant: J.B.S., S.A.
• Product Code: KWP · Orthopedic
• Decision Date: Mar 15, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Fixation of C1-C2 in case of fracture or multi-operated back.

Device Story

Single-use, temporary spinal fixation system for C1-C2 vertebrae; intended for removal post-fusion. Components include cervical hook, superior hook, linking screw, and locking screw. Implanted by surgeons in clinical/OR settings to stabilize vertebrae; facilitates bony fusion. Benefits include mechanical stabilization of C1-C2 segment.

Clinical Evidence

Bench testing only.

Technological Characteristics

Material: Surgical implant titanium (Ti-6AL-4V ELI) per ASTM-136-92 or ISO 5832-3-90. Components: Cervical hook, superior hook, linking screw, locking screw. Mechanical fixation device.

Indications for Use

Indicated for fixation of C1-C2 vertebrae in patients with fractures or history of multiple back surgeries. Contraindicated in patients with active localized or systemic infection, pregnancy, or conditions inhibiting bony fusion (e.g., osteoporosis, kidney dialysis).

Regulatory Classification

Identification

A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.

Predicate Devices

• APOFIX fixation device (K945022)
• HALIFAX clamp

Submission Summary (Full Text)

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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
K455864
EXHIBIT C

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

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

Medical Device Establishment Registration #: 9681258
MAR 15 1996

FDA Owner/Operator #: 9021265

Contact: Ms. Liza Burns, Regulatory Consultant

Trade Name: J.B.S. POSTERIOR C1-C2 CLAMP SYSTEM®

Common Name: Cervical Clamp System

Classification Name: Appliance, Fixation, Spinal Interlaminal

Classification Code: 87KWP

Device Description: The J.B.S. Posterior C1-C2 Clamp System is a single-use, temporary device used for fixation of the C1-C2 vertebrae. The System is to be removed after fusion occurs. It consists of a cervical hook, a superior hook, a linking screw and a locking screw. All these components are made of surgical implant titanium with the composition Ti-6AL-4V ELI according to ASTM-136-92 or ISO 5832-3-90.

Indications for use: Fixation of C1-C2 in case of fracture or multi-operated back.

Contraindications: The J.B.S. Posterior C1-C2 Clamp System is not to be used for 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 (i.e., osteoporosis, kidney dialysis, etc.).

Substantially Equivalent Devices:
1. The APOFIX fixation device by Sofamor Danek (K945022)
2. The HALIFAX clamp

Distributed by Aesculap
Aesculap Inc.
1000 Gateway Blvd.
So. San Francisco, CA 94080

Made in France by
J.B.S.