J.B.S. T.T.A SCREW

K955710 · J.B.S. (Usa), Inc. · HWC · Mar 4, 1996 · Orthopedic

Device Facts

• Record ID: K955710
• Device Name: J.B.S. T.T.A SCREW
• Applicant: J.B.S. (Usa), Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Mar 4, 1996
• Decision: SN
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Transposition of Anterior Tibial Tuberosity. Possibility of compression without adding any washer.

Device Story

Single-use, permanent internal bone fixation screw; flat-headed, partially threaded design; used without washer for tibial tuberosity transposition; provides compression; available in 40-60 mm lengths; implanted by orthopedic surgeons in clinical/OR settings; stabilizes bone segments to facilitate fusion.

Clinical Evidence

No clinical data provided; device relies on established material properties and mechanical design equivalence to predicate devices.

Technological Characteristics

Material: Titanium alloy Ti6Al4V ELI per ASTM F136-92 or ISO 5832-3-90. Form factor: Flat-headed, partially threaded screw. Sizes: 40, 45, 50, 55, 60 mm. Energy source: None (mechanical). Sterilization: Not specified.

Indications for Use

Indicated for patients requiring transposition of the anterior tibial tuberosity. Contraindicated in patients with active localized or systemic infection, pregnancy, or conditions inhibiting bony fusion (e.g., osteoporosis, kidney disease).

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Partially threaded bone screw (Howmedica, Inc.)
• Partially threaded bone screw (Synthes)

Submission Summary (Full Text)

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X955710

# SUMMARY OF SAFETY AND EFFECTIVENESS

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

Company:
J.B.S
Parc d'activités Savipol
10000 Ste Savine, Troyes
Tel: [phone]
Fax: [phone]
MAR - 4 1996

Medical Device Establishment Registration #: 9681258

FDA Owner/Operator #: 9021265

Contact: Mrs Liza Burns, Regulatory consultant.

Trade name: J.B.S T.T.A screw.

Common name: T.T.A screw.

Classification: Bone, fixation, screw.

Classification Code: 87 KWC.

Device description:
This is a single-use, permanent internal device.
This is a Flat-headed, partially threaded screw, designed to be used without any washer.
This screw is available in six sizes: (40, 45, 50, 55 and 60 mm).
This screw is made of surgical implant Titanium, Ti6Al4EVELI, according to ASTM-136-92 or to ISO 5832-3-90.

Indications or use:
Transposition of Anterior Tibial Tuberosity. Possibility of compression without adding any washer.

Contraindications:
The J.B.S T.T.A is not to be used for patients with active localized or systemic infection, patients who are pregnant or patients who have disease or other medical condition which inhibits the potential of bony fusion. (i.e., osteoporosis, kidney analysis, etc.).

Substantially equivalent devices:
1. The partially threaded bone screw manufactured by Howmedica, Inc.
2. The partially threaded bone screw manufactured by Synthes.

Distributed by J.B.S USA
204E Blithedale Avenue
Mill Valley
CA 94941

Made in France by
J.B.S
Parc d'activités Savipol
10300 Ste Savine, Troyes.