← Product Code [HTY](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY) · K960642 # NANCY NAIL (K960642) _Landos, Inc. · HTY · May 17, 1996 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY/K960642 ## Device Facts - **Applicant:** Landos, Inc. - **Product Code:** [HTY](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY.md) - **Decision Date:** May 17, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3040 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **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. ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} K960642 MAY 17 1997 # 8 - SUMMARY OF SAFETY & 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: (610) 644-4670 Fax: (610) 644-4429 | | 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: (301) 279-2899 Fax: (301) 294-0126 | | PROPRIETARY NAME | Nancy Nail™ | | COMMON NAME | Intramedullary Elastic Nail | 100 Lindenwood Drive . Malvern, PA 19355 Telephone: 610-644-4670 . fax: 610-644-4429 0 144 {1} 8 - SUMMARY OF SAFETY & 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 | 0 145 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY/K960642](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY/K960642) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com