← Product Code [HSB](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB) · K042135 # SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) SYSTEM (LINE EXTENSION) (K042135) _Synthes (Usa) · HSB · Oct 7, 2004 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB/K042135 ## Device Facts - **Applicant:** Synthes (Usa) - **Product Code:** [HSB](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB.md) - **Decision Date:** Oct 7, 2004 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3020 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic, Pediatric ## Intended Use The Synthes Elastic Intramedullary Nail (EIN) System is indicated for fixation of diaphyseal fractures where the canal is narrow or flexibility of the implant is paramount. This includes upper extremity fractures in all patients and lower extremity fractures in pediatric or small-stature patients. This system is also intended to treat metaphyseal and epiphyseal fractures, such as radial neck fractures and is intended for fixation of small long bones, such as carpal and tarsal bones. In pediatric applications, the flexibility of the EIN allows it to be inserted at a point which avoids disruption to the bone growth plate. ## Device Story Synthes Elastic Intramedullary Nail (EIN) system consists of flexible titanium alloy intramedullary fixation devices; varying diameters and lengths; cut to size intraoperatively; curved tapered tip facilitates insertion and manipulation. Used by surgeons in clinical settings for fracture fixation; flexibility allows insertion points avoiding pediatric bone growth plates. Provides mechanical stabilization of bone fractures; benefits include reduced trauma to growth plates and suitability for narrow canals. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Material: Titanium alloy. Design: Flexible intramedullary rod with curved tapered tip. Dimensions: Variable diameters and lengths, cut-to-size. Principle: Intramedullary fixation. Sterilization: Not specified. ## Regulatory Identification An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures. ## Predicate Devices - Synthes Elastic Intramedullary Nail (EIN) System - Depuy Ace Nancy 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}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo. A horizontal line is located underneath the word. K 042135 : ## 3.0 510(k) Summary Page __________ of ___________________________________________________________________________________________________________________________________________________________ | Sponsor: | Synthes (USA)
1690 Russell Road
Paoli, PA 19301
(610) 647-9700 | |-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name: | Synthes Elastic Intramedullary Nail (EIN) System (Line Extension) | | Classification: | 21 CFR 888.3020: Intramedullary fixation rod | | Predicate Devices: | Synthes Elastic Intramedullary Nail (EIN) System
Depuy Ace Nancy Nail | | Device Description: | The Synthes EIN system consists of flexible intramedullary
fixation devices that vary in diameters and lengths, which can be
cut to size intraoperatively. The EIN has a curved tapered tip to
facilitate insertion and manipulation. The EIN is manufactured
from Titanium Alloy. | | Intended Use: | The Synthes Elastic Intramedullary Nail (EIN) System is indicated
for fixation of diaphyseal fractures where the canal is narrow or
flexibility of the implant is paramount. This includes upper
extremity fractures in all patients and lower extremity fractures in
pediatric or small-stature patients. This system is also intended to
treat metaphyseal and epiphyseal fractures, such as radial neck
fractures and is intended for fixation of small long bones, such as
carpal and tarsal bones. In pediatric applications, the flexibility of
the EIN allows it to be inserted at a point which avoids disruption
to the bone growth plate. | | Substantial
Equivalence: | Comparative information presented supports substantial
equivalence. | | | The term "substantial equivalence" as used in this 510(k)
notification is limited to the definition of substantial equivalence
found in the Federal Food, Drug and Cosmetic Act, as amended
and as applied under 21CFR 807, Subpart E under which a device
can be marketed without premarket approval or reclassification. A
determination of substantial equivalency under this notification is
not intended to have any bearing whatsoever on the resolution of
patent infringement suits or any other patent matters. No
statements related to, or in support of substantial equivalence
herein shall be construed as an admission against interest under the
US Patent Laws or their application by the courts. | {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three curved shapes resembling a bird in flight or flowing water. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 OCT 7 - 2004 Lisa M. Boyle Regulatory Associate Synthes (USA) 1690 Russell Road Paoli, Pensylvania 19301 Re: K042135 Device Name: Synthes (USA) Elastic Intramedullary Nail (EIN) System (Line Extension) Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: August 6, 2004 Received: August 9, 2004 Dear Ms. Boyle: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {2}------------------------------------------------ Page 2 - Ms. Lisa M. Boyle This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Sincerely yours, Mark N Millenson Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a stylized figure inside. A horizontal line runs beneath the word "SYNTHES". The registered trademark symbol is located to the right of the word. Page 1 of l 2.0 Indications for Use 510(k) Number (if known): Device Name: Synthes (USA) Elastic Intramedullary Nail (EIN) System (Line Extension) Indications for Use: The Synthes Elastic Intramedullary Nail (EIN) System is indicated for fixation of diaphyseal fractures where the canal is narrow or flexibility of the implant is paramount. This includes upper extremity fractures in all patients and lower extremity fractures in pediatric or small-stature patients. This system is also intended to treat metaphyseal fractures, such as radial neck fractures and is intended for fixation of small long bones, such as carpal and tarsal bones. In pediatric applications, the flexibility of the EIN allows it to be inserted at a point which avoids disruption to the bone growth plate. Mark N Milkenson Division Sign-Off) Division of General, Restorative, and Neurological Devices 510(k) Number K042135 X Prescription Use (Per 21 CFR 801.109) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB/K042135](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB/K042135) **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. 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