NANCY NAIL

K960642 · Landos, Inc. · HTY · May 17, 1996 · Orthopedic

Device Facts

• Record ID: K960642
• Device Name: NANCY NAIL
• Applicant: Landos, Inc.
• Product Code: HTY · Orthopedic
• Decision Date: May 17, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The intended use for the 450mm Nancy Nail™ is as a temporary implant to aid in the healing of long bone diaphysis fractures. It is intended for children above 4 years of age and below 65kg. The 100mm Nancy Nail™ is designed for small long bone fractures with a long diaphysis, such as carpal or tarsal bones.

Device Story

Nancy Nail™ is a titanium alloy intramedullary elastic nail used as a temporary implant for bone fracture fixation. Available in 450mm (five diameters: 2.0-4.0mm) and 100mm (1mm diameter) lengths. Implanted by orthopedic surgeons in clinical settings to stabilize long bone diaphysis fractures or small long bone fractures (carpal/tarsal). Provides mechanical support to facilitate bone healing; removed after fracture union.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Titanium alloy intramedullary elastic pin. Available in 450mm (2.0, 2.5, 3.0, 3.5, 4.0mm diameters) and 100mm (1.0mm diameter) lengths. Mechanical fixation device.

Indications for Use

Indicated for children >4 years old and <65kg with long bone diaphysis fractures (450mm nail) or small long bone fractures with long diaphysis, such as carpal or tarsal bones (100mm nail).

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

• Kirschner’s Wire
• Steinman Pin
• Howmedica’s Rush Nail

Submission Summary (Full Text)

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K960642
MAY 17 1997

# 8 - SUMMARY OF SAFETY &amp; EFFECTIVENESS

| MANUFACTURER IDENTIFICATION | Landanger-Landos
Z.I. La Vendue BP 88
52003 Chaumont Cedex France |
| --- | --- |
| ESTABLISHMENT REGISTRATION NUMBER | 9007981 |
| SPONSOR IDENTIFICATION | Jean-Paul Burtin, C.E.O.
Landos, Inc.
100 Lindenwood Drive
Malvern, PA 19355
Phone: [phone]
Fax: [phone] |
| SPONSOR ESTABLISHMENT REGISTRATION NUMBER | 2530066 |
| OFFICIAL CONTACT PERSON | Norman F. Estrin, Ph.D., RAC
President
Estrin Consulting Group, Inc.
9109 Copenhaver Drive
Potomac, MD 20854
Phone: [phone]
Fax: [phone] |
| PROPRIETARY NAME | Nancy Nail™ |
| COMMON NAME | Intramedullary Elastic Nail |

100 Lindenwood Drive . Malvern, PA 19355
Telephone: [phone] . fax: [phone]
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8 - SUMMARY OF SAFETY &amp; EFFECTIVENESS

| CLASSIFICATION NAME AND REFERENCE | FDA has classified smooth or threaded metallic bone fixation fastener in Class II 21 CFR Section 888.3040. The Nancy Nail™ is classified as a flexible, metallic bone fixation pin. |
| --- | --- |
| PRODUCT CLASSIFICATION CODE | 87 HTY |
| PROPOSED REGULATORY CLASS | Class II |
| PANEL CODE | 87 OR |
| INTENDED USE | The intended use for the 450mm Nancy Nail™ is as a temporary implant to aid in the healing of long bone diaphysis fractures. It is intended for children above 4 years of age and below 65kg. The 100mm Nancy Nail™ is designed for small long bone fractures with a long diaphysis, such as carpal or tarsal bones. |
| DESCRIPTION | The Nancy Nail™ is a titanium alloy pin, available in two lengths: 450mm and 100mm. The 450mm is available in five diameters: 2.0, 2.5, 3.0, 3.5, 4.0. The 100mm has a diameter of 1mm. |
| PREDICATE DEVICES | Kirschner’s Wire & Steinman Pin Howmedica’s Rush Nail |

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