SYNTHES (USA) LCP PROXIMAL FEMUR HOOK PLATES

K032032 · Synthes (Usa) · HRS · Sep 4, 2003 · Orthopedic

Device Facts

• Record ID: K032032
• Device Name: SYNTHES (USA) LCP PROXIMAL FEMUR HOOK PLATES
• Applicant: Synthes (Usa)
• Product Code: HRS · Orthopedic
• Decision Date: Sep 4, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LCP Proximal Femur Hook Plates are 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

LCP Proximal Femur Hook Plates are metallic bone fixation implants; contoured to match proximal femur anatomy; low-profile design. Features dynamic compression holes and conical threaded screw holes; accepts 4.5 mm cortex/shaft screws, 4.0/5.0 mm locking screws, 5.0 mm cannulated screws, and 7.3 mm cannulated locking/conical screws. Used by surgeons in clinical settings for internal fixation of femoral fractures and osteotomies. Provides mechanical stabilization of bone fragments to facilitate healing.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Metallic bone fixation plate; low-profile, limited-contact design; contoured for proximal femur. Features dynamic compression and threaded locking screw holes. Compatible with various 4.0 mm to 7.3 mm diameter screws. Class II device per 21 CFR 888.3030.

Indications for Use

Indicated for patients with femoral fractures including trochanteric, cervicotrochanteric, trochanterodiaphyseal, pertrochanteric, intertrochanteric, transverse, or medial cortex fractures; 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 (USA) LCP Proximal Femur Plates

Submission Summary (Full Text)

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SEP - 4 2003

K032032
page 1 of 1

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

| 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 Hook Plates |
| CLASSIFICATION: | Class II § 21 CFR 888.3030: Plate , Fixation, Bone |
| PREDICATE DEVICE: | Synthes (USA) LCP Proximal Femur Plates |
| DEVICE DESCRIPTION: | The LCP Proximal Femur Hook Plates are contoured to match the anatomy<br>of the proximal femur with a limited contact low profile design. The plate<br>has dynamic compression holes combined with conical shaped threaded<br>screw holes, which accept 4.5 mm cortex, 4.5 mm shaft screws, 4.0 mm or<br>5.0 mm locking screws, 5.0mm cannulated screws, and 7.3 mm cannulated<br>locking & cannulated conical screws. The plates are available in a various<br>lengths. |
| INTENDED USE: | The LCP Proximal Femur Hook Plates are intended for fractures of the<br>femur 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.<br>The term "substantial equivalence" as used in this 510(k) notification is<br>limited to the definition of substantial equivalence found in the Federal<br>Food, Drug and Cosmetic Act, as amended and as applied under 21CFR<br>807, Subpart E under which a device can be marketed without pre-market<br>approval or reclassification. A determination of substantial equivalency<br>under this notification is not intended to have any bearing whatsoever on<br>the resolution of patent infringement suits or any other patent matters. No<br>statements related to, or in support of substantial equivalence herein shall<br>be construed as an admission against interest under the US Patent Laws or<br>their application by the courts. |

Confidential

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP = 4 2003

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

Re: K032032

Trade/Device Name: Synthes (USA) LCP Proximal Femur Hook Plates Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: June 30, 2003 Received: July 2, 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 10 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 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.

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Page 2 - Ms. Lisa M. Boyle

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 vours.

Mark N. Millman

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

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## 2.0 Indications for Use Statement

Page 1 of 1

| 510(k) Number (if known): | k032032 |
|---------------------------|----------------------------------------------|
| Device Name: | Synthes (USA) LCP Proximal Femur Hook Plates |

Indications: Synthes (USA) LCP Proximal Femur Hook 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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

*for*

(Division Sign-Off)

Division of General. Restorative

and Neurological Devices

| 510(k) Number | K032032 |
|---------------|---------|
|---------------|---------|

| Prescription Use | OR | Over-The-Counter Use |
|----------------------|----|----------------------|
| (Per 21 CFR 801.109) | | |

Confidential

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