← Product Code [HSB](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB) · K032367 # ITST INTERTROCHANTERIC SUBTROCHANTERIC INTRAMEDULLARY FEMORAL NAIL (K032367) _Zimmer, Inc. · HSB · Aug 12, 2003 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB/K032367 ## Device Facts - **Applicant:** Zimmer, Inc. - **Product Code:** [HSB](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB.md) - **Decision Date:** Aug 12, 2003 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 888.3020 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The ITST Intramedullary Nail is indicated for use in a variety of femoral fractures, such as: • Subtrochanteric Fractures • Intertrochanteric Fractures • Comminuted Fractures • Segmental Fractures • Fractures with Bone Loss • Proximal and Distal Fractures • Nonunions ## Device Story ITST Intertrochanteric Subtrochanteric Intramedullary Femoral Nail provides reduction and internal fixation of femoral head and neck fractures. Device features curved, tapered intramedullary nail designed to match femoral canal anatomy. Modifications from predicate include features for easier insertion, accommodation of larger lag screw, and addition of sliding and locking nail caps. Used by surgeons in clinical settings for orthopedic fracture management. Benefits include anatomical fit and stable fixation for various femoral fracture types. ## Clinical Evidence No clinical data was required or provided for this device. Substantial equivalence was established through non-clinical performance testing as part of the design assurance procedure. ## Technological Characteristics Intramedullary fixation rod (21 CFR 888.3020). Features curved, tapered nail geometry. Includes sliding and locking nail caps and larger lag screw accommodation. Materials and sterilization processes are identical to the predicate device. ## 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 - M/DN Intramedullary Fixation System ([K965098](/device/K965098.md)) ## 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 contains the word "zımmer" in a bold, sans-serif font. To the left of the word is a circular logo with a stylized letter "Z" inside. The letter "Z" is also in a bold, sans-serif font and is black, while the circle is white with a black outline. ## Summary of Safety and Effectiveness 32367 page 1 of 2 | Submitter: | Zimmer, Inc.
P.O. Box 708
Warsaw, IN 46581-0708 | |---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Stephen H. McKelvey
Manager, Regulatory Affairs
Telephone: (574) 372-4944
Fax: (574) 372-4605 | | Date: | July 31, 2003 | | Trade Name: | ITST ™ Intertrochanteric Subtrochanteric
Intramedullary Femoral Nail | | Common Name: | Intramedullary Nail | | Classification Name
and Reference: | Intramedullary Fixation Rod
21 CFR § 888.3020 | | Predicate Device: | M/DN Intramedullary Fixation System,
manufactured by Zimmer, K965098, cleared
February 28, 1997. | | Device Description: | The ITST is used to provide reduction and internal
fracture fixation of the femoral head and neck and
has an intramedullary nail that is curved and tapered
anatomically to accommodate the curvature of the
intramedullary canal. | | Intended Use: | The ITST Intramedullary Nail is indicated for use in
a variety of femoral fractures, such as:
• Subtrochanteric Fractures
• Intertrochanteric Fractures
• Comminuted Fractures
• Segmental Fractures
• Fractures with Bone Loss
• Proximal and Distal Fractures
• Nonunions | · {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for Zimmer. The logo consists of a large, bold letter 'Z' inside of a circle, followed by the word 'zimmer' in a smaller, bold font. The logo is black and white. ## Comparison to Predicate Device: Except for modifications to facilitate easier insertion, accommodate a larger lag screw and the addition of sliding and locking nail caps, ITST components are identical to the predicate device. The modifications do not change the intended use or the fundamental scientific technology. The device is packaged and sterilized using the same materials and processes. Performance Data (Nonclinical and/or Clinical): Non-Clinical Performance and Conclusions: Performance testing completed as part of the design assurance procedure demonstrated that this device is safe and effective and substantially equivalent to the predicate device. Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three wavy lines or stripes, possibly representing a flag or a symbol of health and well-being. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG 1 2 2003 Mr. Stephen H. McKelvey Manager, Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708 Re: K032367 Trade/Device Name: ITST Intertrochanteric Subtrochanteric Intramedullary Femoral Nail Regulation Numbers: 21 CFR 888.3020 Regulation Names: Intramedullary fixation rod Regulatory Class: II Product Codes: HSB Dated: July 31, 2003 Received: August 1, 2003 Dear Mr. McKelvey: 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 {3}------------------------------------------------ ## Page 2 - Mr. Stephen H. McKelvey 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. 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, Ulan Witt 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 {4}------------------------------------------------ ## Indications for Use KO 32367 Page I of I 510(k) Number (if known): Device Name: ITST" Intertrochanteric Subtrochanteric Intramedullary Femoral Nail Indications for Use: The ITST Intramedullary Nail is indicated for use in a variety of femoral fractures, such as: - Subtrochanteric Fractures . - Intertrochanteric Fractures . - Comminuted Fractures ● - Segmental Fractures ● - Fractures with Bone Loss . - Proximal and Distal Fractures . - Nonunions ● (Please do not write below this line - Continue on another page if needed) Concurrence of CDRH, Office of Deyice Evaluation (ODE) (Division Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number_k032367 OR Prescription Use (Per 21 CFR 801.109) \$\checkmark\$ Over-The-Counter Use (Optional Format 1-2-96) --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB/K032367](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB/K032367) **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