SYNTHES (USA) LCP PROXIMAL HUMERUS PLATES, LONG

K041860 · Synthes (Usa) · HRS · Sep 8, 2004 · Orthopedic

Device Facts

• Record ID: K041860
• Device Name: SYNTHES (USA) LCP PROXIMAL HUMERUS PLATES, LONG
• Applicant: Synthes (Usa)
• Product Code: HRS · Orthopedic
• Decision Date: Sep 8, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Synthes (USA) LCP Proximal Humerus Plate, long is indicated for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.

Device Story

Synthes LCP Proximal Humerus Plates, long are pre-contoured metallic bone fixation plates designed to match proximal humerus anatomy. Featuring a low-profile, limited-contact design, the plates include locking holes and combination locking/compression holes. They accept 2.7, 3.5, and 4.0 mm cortex screws, 3.5 mm locking screws, and 4.0 mm cancellous screws. Used by orthopedic surgeons in clinical settings to stabilize bone fractures, osteotomies, or non-unions, particularly in osteopenic bone. The system provides rigid fixation through locking screw technology, aiding in bone healing and patient recovery.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and technological characteristics.

Technological Characteristics

Metallic bone fixation plate; available in stainless steel and titanium; low-profile, limited-contact design; pre-contoured for proximal humerus; locking and combination locking/compression holes; accepts various screw diameters (2.7mm, 3.5mm, 4.0mm).

Indications for Use

Indicated for patients with fractures, fracture dislocations, osteotomies, and non-unions of the proximal humerus, including those with osteopenic bone.

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 Proximal Humerus Plates
• Synthes Small Fragment DCL System

Submission Summary (Full Text)

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## SEP - 8 2004

| 3.0 | 510(k) Summary | |
|-----|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Sponsor: | Synthes (USA)<br>1690 Russell Road<br>Paoli, PA 19301<br>[phone] |
| | Device Name: | Synthes (USA) LCP® Proximal Humerus Plates, Long |
| | Classification: | Class II, 21 CFR §888.3030<br>Single/multiple component metallic bone fixation appliances and<br>accessories |
| | Predicate Device: | Synthes LCP Proximal Humerus Plates<br>Synthes Small Fragment DCL System |
| | Device Description: | The Synthes LCP Proximal Humerus Plates, long are pre-contoured<br>to match the anatomy of the proximal humerus with a limited<br>contact low profile design. The plate features locking holes and<br>combination locking and compression holes which accept 2.7, 3.5,<br>& 4.0 mm cortex screws, 3.5 mm locking screws, and 4.0 mm<br>cancellous screws. The System will be available in Stainless Steel<br>and Titanium. These plates will be offered as an addition to the<br>Synthes Small Fragment LCP (formerly DCL) System. |
| | Intended Use: | Synthes (USA) LCP Proximal Humerus Plate, long is indicated for<br>fractures and fracture dislocations, osteotomies, and non-unions of<br>the proximal humerus, particularly in osteopenic bone. |
| | Substantial<br>Equivalence: | Documentation is provided which demonstrates that Synthes LCP<br>Proximal Humerus Plates, long is substantially equivalent to other<br>legally marketed Synthes devices. |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP = 8 2004

Sheri L. Musgnung Regulatory Affairs Specialist Synthes (USA) 1690 Russell Road Paoli, Pensylvania 19301

Re: K041860

Ro+1600
Device Name: Synthes (USA) LCP® Proximal Humerus Plates, long Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS, HWC Dated: July 8, 2004 Received: July 9, 2004

Dear Ms. Musgnung :

We have reviewed your Section 510(k) premarket notification of intent to market the device wf nave teviewed your beceren be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use suated in the encreations of the enactment date of the Medical Device Amendments, or to commerce pror to rias 2011-12-12 in accordance with the provisions of the Federal Food, Drug, de nees that have been rolat 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 r ou may, diorerors, mians of the Act include requirements for annual registration, listing of general controlo provision 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 is exassinou controls. Existing major regulations affecting your device can may or sations to outsil and 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 r toase of acrised that the rearmination that your device complies with other requirements of the Act that I DA has made a avoid regulations administered by other Federal agencies. You must or any I 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 OF R Part 877) facems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality of over is one of the Act); 21 CFR 1000-1050.

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Page 2 -- Sheri L. Musgnung

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin maneting of substantial equivalence of your device to a legally premits that notheadon. The PPA maing of casification 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 advice for your ac not one of one of the regulation entitled, the regulation entitled, the Colliact the Office of Compilation" (21CFR Part 807.97). You may obtain Milsblaining Uy tereforee to premientonsibilities 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.

Mark A. Milburn

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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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 located underneath the word "SYNTHES". The logo and word are likely part of a company or brand identity.

## Indications for Use

KO4180

510(k) Number (if known):

Device Name:

Synthes (USA) LCP® Proximal Humerus Plates, long

Indications:

Synthes (USA) LCP Proximal Humerus Plate, long is indicated for fractures and fracture dislocations, osteotomies, and nonunions of the proximal humerus, particularly in osteopenic bone.

X Prescription Use _ (Per 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use_ (21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Milburn

Jivision Sign-Division of General, Restorative, and Neurological Devices

**510(k) Number** K041860

000004