← Product Code [KTT](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KTT) · K033556 # SYNTHES (USA) LCP DYNAMIC HELICAL HIP SYSTEM (K033556) _Synthes (Usa) · KTT · Jan 13, 2004 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KTT/K033556 ## Device Facts - **Applicant:** Synthes (Usa) - **Product Code:** [KTT](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KTT.md) - **Decision Date:** Jan 13, 2004 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3030 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use Intended to treat stable and unstable intertrochanteric, subtrochanteric and basilar neck fractures in which a stable medial buttress can be reconstructed. ## Device Story Synthes LCP Dynamic Helical Hip System is a metallic bone fixation device; consists of a straight plate with an angled barrel accepting a helical blade. Plates feature grooved undersurface, combination locking, and dynamic compression holes. Sideplate holes accept 5.0 mm locking screws and 4.5 mm cortex screws. Used by orthopedic surgeons in clinical settings to stabilize hip fractures. Device provides mechanical fixation to support bone healing; surgeon selects appropriate plate length and barrel angle based on fracture anatomy. Benefits include stable fracture fixation and reconstruction of medial buttress. ## Clinical Evidence No clinical data provided; substantial equivalence is based on bench testing and design comparison. ## Technological Characteristics Material: Stainless steel. Components: Straight plate with angled barrel, helical blade, 5.0 mm locking screws, 4.5 mm cortex screws. Features: Grooved undersurface, combination locking and dynamic compression holes. Mechanical fixation device. ## Regulatory Identification Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system. ## Predicate Devices - Synthes Dynamic Helical Hip System ## 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}------------------------------------------------ . JAN 1 3 2004 page 10f1 K033556 - 3.0 510(k) Summary: | Sponsor | Synthes (USA)
1690 Russell Road
Paoli, PA 19301
(610) 647-9700 | |-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact | Bonnie Smith | | Device Name | Synthes (USA) LCP ® Dynamic Helical Hip System™ | | Device Classification | 21 CFR: 888.3030 - Single/multiple component metallic bone
fixation appliance and accessories. | | Predicate Device | Synthes Dynamic Helical Hip System | | Description of Device | Synthes LCP ® Dynamic Helical Hip System is a plate and screw
system that consists of a straight plate with an angled barrel that
accepts a helical blade. The plates have a grooved undersurface,
contain combination locking and dynamic compression holes and are
available in various barrel angles and plate lengths. The sideplate
combination holes accept 5.0 mm locking screws and 4.5 mm cortex
screws. | | Indications | Intended to treat stable and unstable intertrochanteric,
subtrochanteric and basilar neck fractures in which a stable medial
buttress can be reconstructed. | | Material | Stainless Steel | | Substantial Equivalence | Documentation is provided which demonstrates that the Synthes
LCP ® Dynamic Helical Hip System is substantially equivalent to
other legally marketed Synthes devices. | {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is a stylized image of an eagle. JAN 1 3 2004 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Bonnie J. Smith Scnior Regulatory Affairs Associate Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, Pennsylvania 19301 Rc: K033556 K035356 Trade/Device Name: Synthes (USA) LCP® Dynamic Helical Hip System™ Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: November 7, 2003 Received: November 12, 2003 Dear Ms. Smith: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to commerce processified 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). and consinete for (110) read the device, subject to the general controls provisions of the Act. The I va may, aterere, mains 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 If your device to such additional controls. Existing major regulations affecting your device can may be subject to Salen additions. 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 i least be advised that i Dr Provision that your device complies with other requirements of the Act that I Dr And Internations administered by other Federal agencies. You must or any I edetar states and equirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It in the quality systems (21 CFR Part 820); and if applicable, the electronic forth in the quarty systems (Sections 531-542 of the Act); 21 CFR 1000-1050. {2}------------------------------------------------ Page 2 - Ms. Bonnie J. Smith This letter will allow you to begin marketing your device as described in your Scction 510(k) I mis letter will and w you to organization of substantial equivalence of your device to a legally prematice hotification. The 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 If you desire speeme 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 other general 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. Marke McMullerson Celia 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}------------------------------------------------ ## 2. Indications for Use Page 1 of l 510(k) Number (if known): Device Name: Synthes (USA) LCP® Dynamic Helical Hip System™ Indications for Use: To treat stable and unstable intertrochanteric, subtrochanteric and basilar neck fractures in which a stable medial buttress can be reconstructed. for Mark N Melken K033556 ## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) 6033556 Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KTT/K033556](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KTT/K033556) **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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