SYNTHES (USA) LCP DYNAMIC HELICAL HIP SYSTEM

K033556 · Synthes (Usa) · KTT · Jan 13, 2004 · Orthopedic

Device Facts

• Record ID: K033556
• Device Name: SYNTHES (USA) LCP DYNAMIC HELICAL HIP SYSTEM
• Applicant: Synthes (Usa)
• Product Code: KTT · Orthopedic
• Decision Date: Jan 13, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• 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.

Indications for Use

Indicated for patients with stable or unstable intertrochanteric, subtrochanteric, and basilar neck fractures where a stable medial buttress can be reconstructed.

Regulatory Classification

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)

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. JAN 1 3 2004

page 10f1
K033556

- 3.0 510(k) Summary:

| Sponsor | Synthes (USA)<br>1690 Russell Road<br>Paoli, PA 19301<br>[phone] |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Bonnie Smith |
| Device Name | Synthes (USA) LCP ^® Dynamic Helical Hip System™ |
| Device Classification | 21 CFR: 888.3030 - Single/multiple component metallic bone<br>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<br>system that consists of a straight plate with an angled barrel that<br>accepts a helical blade. The plates have a grooved undersurface,<br>contain combination locking and dynamic compression holes and are<br>available in various barrel angles and plate lengths. The sideplate<br>combination holes accept 5.0 mm locking screws and 4.5 mm cortex<br>screws. |
| Indications | Intended to treat stable and unstable intertrochanteric,<br>subtrochanteric and basilar neck fractures in which a stable medial<br>buttress can be reconstructed. |
| Material | Stainless Steel |
| Substantial Equivalence | Documentation is provided which demonstrates that the Synthes<br>LCP ^® Dynamic Helical Hip System is substantially equivalent to<br>other legally marketed Synthes devices. |

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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.

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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 [phone]. 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 [phone] or [phone] 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

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## 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

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6033556

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use