SYNTHES (USA) LCP PROXIMAL FEMUR PLATE AND SCREWS

K030858 · Synthes (Usa) · HRS · Apr 4, 2003 · Orthopedic

Device Facts

• Record ID: K030858
• Device Name: SYNTHES (USA) LCP PROXIMAL FEMUR PLATE AND SCREWS
• Applicant: Synthes (Usa)
• Product Code: HRS · Orthopedic
• Decision Date: Apr 4, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Synthes LCP Proximal Femur Plate is intended for fractures of the femur including: fractures of the trochanteric region, trochanteric simple, cervicotrochanteric, trochanterodiaphyseal, multifragmentary pertrochanteric, intertrochanteric, intertrochanteric reversed, or transverse or with additional fracture of medial cortex. Fractures of the proximal end of the femur combined with ispsilateral shaft fractures, metastatic fracture of the proximal femur and osteotomies of the proximal femur.

Device Story

Metallic bone fixation system consisting of contoured plates and screws for proximal femur stabilization. Plate features limited-contact, low-profile design with dynamic compression holes and threaded locking holes. Accepts 4.5mm cortex/shaft screws, 4.0mm/5.0mm locking screws, and 7.3mm cannulated locking/conical screws. Used by orthopedic surgeons in clinical/surgical settings to provide internal fixation for femoral fractures and osteotomies. Device stabilizes bone fragments to facilitate healing and restore structural integrity of the proximal femur.

Clinical Evidence

Bench testing only.

Technological Characteristics

Metallic bone fixation plate and screw system. Features dynamic compression and threaded locking holes. Compatible with various screw diameters (4.0mm, 4.5mm, 5.0mm, 7.3mm). Low-profile, anatomically contoured design.

Indications for Use

Indicated for patients with femoral fractures, including trochanteric, cervicotrochanteric, trochanterodiaphyseal, pertrochanteric, intertrochanteric, and transverse fractures; fractures with medial cortex involvement; proximal femoral fractures with ipsilateral shaft fractures; metastatic proximal femoral fractures; and proximal femoral osteotomies.

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 4.5mm Broad Locking Compression Plate (LCP)

Submission Summary (Full Text)

{0}------------------------------------------------

Ko30858P
page 1 of 1

#### 3.0 Summary of Safety and Effectiveness Information [510(k) Summary]

# APR 0 4 2003

| SPONSOR: | Synthes (USA)<br>1690 Russell Road<br>Paoli, PA 19301<br>[phone]<br>Contact: Lisa M. Boyle |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DEVICE NAME: | Synthes (USA) LCP Proximal Femur Plate and Screws |
| CLASSIFICATION: | Class II § 21 CFR 888.3030: Plate , Fixation, Bone<br>Class II § 21 CFR 888.3040: Smooth or Threaded Metallic Bone Fixation<br>Fastener. |
| PREDICATE DEVICE: | Synthes 4.5mm Broad Locking Compression Plate (LCP) |
| DEVICE DESCRIPTION: | The LCP Proximal Femur Plates are contoured to match the anatomy of the<br>proximal femur with a limited contact low profile design. The plate has<br>dynamic compression holes combined with conical shaped threaded screw<br>holes, which accept 4.5 mm cortex, 4.5 mm shaft screws, 4.0 mm or 5.0<br>mm locking screws, and 7.3 mm cannulated locking & cannulated conical<br>screws. The plates and screws are available in a various lengths. |
| INTENDED USE: | Synthes LCP Proximal Femur Plate is intended for fractures of the femur<br>including: fractures of the trochanteric region, trochanteric simple,<br>cervicotrochanteric, trochanterodiaphyseal, multifragmentary<br>pertrochanteric, intertrochanteric, intertrochanteric reversed, or transverse<br>or with additional fracture of medial cortex. Fractures of the proximal end<br>of the femur combined with ispsilateral shaft fractures, metastatic fracture<br>of the proximal femur and osteotomies of the proximal femur. |
| SUBSTANTIAL<br>EQUIVALENCE: | Comparative information presented supports substantial equivalence. |

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

Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three human profiles facing to the right. The profiles are connected and form a single, flowing shape. The text "DEPARTMENT OF HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## APR 0 4 2003

Ms. Lisa M. Boyle Regulatory Associate Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, PA 19301

Re: K030858

Trade/Device Name: Synthes (USA) LCP Proximal Femur Plate and Screws Regulation Number: 21 CFR 888.3030, 888.3040 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories, Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HRS, HWC Dated: March 12, 2003 Received: March 18, 2003

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 mav 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

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

#### Page 2 - Ms. Lisa M. Boyle

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 [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 Manufacturers, 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,

Mark N Milliken

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}------------------------------------------------

#### 2.0 Indications for Use Statement

Page 1 of 1

| 510(k) Number (if known): | K030858 |
|---------------------------|---------------------------------------------------|
| Device Name: | Synthes (USA) LCP Proximal Femur Plate and Screws |

Indications: Synthes LCP Proximal Femur Plate is intended for fractures of the femur including: fractures of the trochanteric region, trochanteric simple, cervicotrochanterodiaphyseal, multifragmentary pertrochanteric, intertrochanteric, intertrochanteric reversed, or transverse or with additional fracture of medial cortex. Fractures of the proximal end of the femur combined with ispsilateral shaft fractures, metastatic fracture of the proximal femur and osteotomies of the proximal femur.

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

| | Concurrence of CDRH, Office of Device Evaluation (ODE) |
|------------------------------------------|-----------------------------------------------------------|
| | (Division Sign-Off) |
| | Division of General, Restorative and Neurological Devices |
| | K Number K030858 |
| Prescription Use<br>(Per 21 CFR 801.109) | OR Over-The-Counter Use |