SYNTHES LCP DYNAMIC HELICAL HIP SYSTEM, ADDITIONAL HELIX BLADES

K042895 · Synthes (Usa) · KTT · Nov 16, 2004 · Orthopedic

Device Facts

• Record ID: K042895
• Device Name: SYNTHES LCP DYNAMIC HELICAL HIP SYSTEM, ADDITIONAL HELIX BLADES
• Applicant: Synthes (Usa)
• Product Code: KTT · Orthopedic
• Decision Date: Nov 16, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Synthes LCP® Dynamic Helical Hip System is intended to treat stable and unstable intertrochanteric, subtrochanteric and basilar neck fractures in which a stable medial buttress can be reconstructed.

Device Story

The Synthes LCP Dynamic Helical Hip System is a metallic bone fixation device consisting of a straight plate with an angled barrel that accepts a helical blade. This submission adds helical blades ranging from 135 mm to 150 mm to the existing system. The device is used by surgeons in a clinical/OR setting to stabilize hip fractures. The helical blade is inserted into the bone to provide fixation, facilitating fracture healing. The system is designed for use in cases where a stable medial buttress can be reconstructed.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and technological similarities to the predicate device.

Technological Characteristics

Metallic bone fixation system composed of stainless steel. Consists of a straight plate with an angled barrel and helical blades. Dimensions for added blades range from 135 mm to 150 mm. Mechanical fixation device.

Indications for Use

Indicated for patients with stable and 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 LCP® Dynamic Helical Hip System

Submission Summary (Full Text)

{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 with a design inside. A horizontal line is present beneath the word, adding emphasis to the brand name.

Image /page/0/Picture/1 description: The image shows the text "K042895 Page 1 of 3". The text appears to be handwritten in black ink. There is a horizontal line below the text "Page 1 of 3".

NOV 1 6 2004

- 3. 510(k) Summary:

| Sponsor: | Synthes (USA)<br>1690 Russell Road<br>Paoli, PA 19301<br>[phone] |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Sheri L. Musgnung |
| Device Name: | Synthes LCP® Dynamic Helical Hip System, Additional Helix<br>Blades |
| Device Classification: | 21 CFR 888.3030 -- "Single/multiple component metallic bone<br>fixation appliances and accessories" |
| Predicate Device: | Synthes LCP® Dynamic Helical Hip System |
| Description of Device: | Synthes LCP Dynamic Helical Hip System is a plate and screw system<br>that consists of a straight plate with an angled barrel that accepts a<br>helical blade. Synthes Helical blades, ranging in lengths from 135<br>mm to 150 mm are to be added to this system |
| Indications: | Synthes LCP® Dynamic Helical Hip System is intended to treat stable<br>and unstable intertrochanteric, subtrochanteric and basilar neck<br>fractures in which a stable medial buttress can be reconstructed. |
| Material: | Stainless Steel |
| Substantial Equivalence: | Documentation is provided which demonstrates that the Synthes LCP<br>Dynamic Helical Hip System, additional Helix Blades is substantially<br>equivalent to other legally marketed Synthes devices. |

.

000005

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 6 2004

Ms. Sheri L. Musgnung Regulatory Affairs Specialist Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, Pennsylvania 19301-0800

Re: K042895

K042895
Device Name: Synthes (USA) LCP® Dynamic Helical Hip System (LCP DHHS), Additional Helix Blades Regulation Number: 21 CFR 888.3030 Regulation Number. 21 CFK 886.5050
Regulation Name: Single, multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: October 29, 2004 Received: November 1, 2004

Dear Ms. Musgnung:

We have reviewed your Section 510(k) premarket notification of intent to market the device indication we have reviewed your Section 910(x) premained in substantially equivalent (for the indications relerenced above and nave determined in marketed predicate devices marketed in interstate for use stated in the encrosuly manactment date of the Medical Device Americal Forley of Food Drus commerce provi to May 20, 1776, the enaounce with the provisions of the Federal Food, Drug, devices that have been reclassince in accera was a proval approval application (PMA). and Cosment Act (Act) that do not require approvise to the general controls provisions of the Act. The You may, therefore, market the act include requirements for annual registration, listing of general controls provisions of the Fiel libeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it IT your device is classified (600 a0010) als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation FRA may be subject to such additional controller Life 21, Parts 800 to 898. In addition, FDA may be found in the Code of I saeral singerning your device in the Federal Register.

{2}------------------------------------------------

## Page 2 – Ms. Sheri L. Musgnung

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised fillat IDA s Issualled of a succements with other requirements of the Act that FDA has made a decemination that Jour at 100 received agencies. You must or any rederal statutes and regulations and limited to: registration and listing (21 comply with an the Act 3 requirements, moreans, and manufacturing practice requirements as set CFK Part 807); labeling (21 CFR Part 801); good maker 820); and if applicable, the electronic form in the quality systems (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) This letter will anow you to begin manus of substantial equivalence of your device to a legally premarket notification: "The PDA mailing of bation 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 specific as Compliance at [phone]. Also, please note the regulation entitled, Conder the Office of Company of Commarket notification" (21CFR Part 807.97). You may obtain Misoranumig by reference to premaintentibilities under the Act from the Division of Small other general informational on your respender Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Sincerely yours,

Mark McMullan

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 design inside. A horizontal line is underneath the word. The logo and word are likely part of a company or brand identity.

2. Indications for Use

Page __ 1__ of________________________________________________________________________________________________________________________________________________________________

:

| 510(k) Number (if known): | K042895 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Synthes (USA) LCP® Dynamic Helical Hip System<br>(LCP DHHS), Additional Helix Blades |
| Indications for Use: | To treat stable and unstable intertrochanteric,<br>subtrochanteric and basilar neck fractures in which a<br>stable medial buttress can be reconstructed. |

Prescription Use X (Per 21 CFR 801.109) OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of GDRH, Office of Device Evaluation (ODE)

f
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

000004

Number K04 2875