SYNTHES LCP PROXIMAL HUMERUS PLATES

K011815 · Synthes (Usa) · KTW · Sep 6, 2001 · Orthopedic

Device Facts

• Record ID: K011815
• Device Name: SYNTHES LCP PROXIMAL HUMERUS PLATES
• Applicant: Synthes (Usa)
• Product Code: KTW · Orthopedic
• Decision Date: Sep 6, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Synthes LCP Proximal Humerus Plate is a metallic bone fixation device designed to match proximal humerus anatomy. It features threaded proximal holes for 3.5 mm or 2.7 mm screws and distal combination holes for 3.5 mm locking/cortex screws or 4.0 mm cancellous screws. Used by surgeons in clinical settings to stabilize fractures, fracture dislocations, osteotomies, and non-unions, particularly in osteopenic bone. The device provides mechanical fixation to support bone healing. It is an addition to the existing Synthes Small Fragment LCP System.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Metallic bone fixation plate available in stainless steel or titanium. Features threaded proximal holes and distal combination holes for locking/cortex/cancellous screws. Designed for anatomical fit of the proximal humerus.

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 Small Fragment Dynamic Compression Locking (DCL) System
• De Puy Ace Symmetry Proximal Humerus Plate

Submission Summary (Full Text)

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SEP - 6 2001

## Summary of Safety and Effectiveness Information [510(k) Summary] 3.

| Sponsor | Synthes (USA)<br>1690 Russell Road<br>Paoli, PA 19301 |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact | Matthew M. Hull<br>[phone] ext. 7191 |
| Name of the Device | Synthes LCP Proximal Humerus Plate |
| Regulation & Classification | Class II, §888.3030 - Plate, Fixation, Bone, Non-spinal, Metallic<br>Product code: NDF |
| Predicate Device(s) | - Synthes Small Fragment Dynamic Compression Locking (DCL)<br>System<br>- De Puy Ace Symmetry Proximal Humerus Plate |
| Device Description | The Synthes LCP Proximal Humerus Plates are designed to match the<br>anatomy of the proximal humerus. These plates can be applied to<br>either the right or left humerus. The proximal portion of each plate has<br>threaded holes that accept 3.5 mm or 2.7 mm screws. The distal<br>portion of the plate has combination holes that allow the option of<br>using 3.5 mm locking or cortex screws, or 4.0 mm cancellous screws<br>to accomplish plate fixation. These plates will be offered as an<br>addition to the Synthes Small Fragment LCP (formerly DCL) System. |
| Intended Use | Synthes LCP Proximal Humerus Plate is indicated for fractures,<br>fracture dislocations, osteotomies, and non-unions of the proximal<br>humerus, particularly in osteopenic bone. |
| Material(s) | The LCP Proximal Humerus Plates will be available in either<br>Stainless Steel or Titanium versions as are the other plates in the<br>Synthes Small Fragment LCP System. |

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three wavy lines representing its wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 6 2001

Mr. Matthew M. Hull, RAC Senior Regulatory Specialist Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, Pennsylvania 19301

Re: K011815

Trade/Device Name: Synthes LCP Proximal Humerus Plate Regulation Number: 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTW

Dated: June 8. 2001 Received: June 11, 2001

Dear Mr. Hull:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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## Page 2 - Norman F. Estrin, Ph.D., RAC

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nouticate 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at additionally 6071 v 1011 onally, for questions on the promotion and advertising of your device, (2017) 594-1639. I readiness at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mormation on your respond and Consumer Assistance at its toll-free number [phone] or Manufactor Internations met address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Sis WC MD

For 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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## Indications for Use Statement 2.

Page 1 of 1

510(k) Number (if known):

Device Name:

Indications/ Contraindications:

Synthes LCP Proximal Humerus Plate

Koll 815

Synthes LCP Proximal Humerus Plate is indicated for ByIthes EOF Fracture dislocations, osteotomies, and fractures and the proximal humerus, particularly in osteopenic bone.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use_

SL

Division of Oil

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

510(k) Number k011815

CONFIDENTIAL Synthes(USA) Synthes LCP Proximal Humerus Plates 510(k)

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