SHOULDER NAIL PLATE

K052294 · Hand Innovations, LLC · HRS · Oct 21, 2005 · Orthopedic

Device Facts

• Record ID: K052294
• Device Name: SHOULDER NAIL PLATE
• Applicant: Hand Innovations, LLC
• Product Code: HRS · Orthopedic
• Decision Date: Oct 21, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Shoulder Nail Plate of the Shoulder Fixation System is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal Humerus.

Device Story

Shoulder Nail Plate is a metallic bone fixation device for proximal humerus fractures; consists of a plate segment for attachment to the humeral metaphysis and a nail segment for insertion into the humeral diaphysis; provides stabilization of fractures, fracture dislocations, osteotomies, and non-unions. Used by surgeons in clinical settings to fix bone segments; device design is bilaterally symmetric for use in either left or right humerus. Benefits include mechanical stabilization of bone to facilitate healing.

Clinical Evidence

Bench testing only.

Technological Characteristics

Metallic bone fixation appliance; fabricated from stainless steel meeting ASTM F 138-03 standards; bilaterally symmetric design; plate and nail segments.

Indications for Use

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

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

• Shoulder Fixation System (K051728)
• Dorsal Nail Plate of the Distal Radius Fracture Repair System (K023007)
• T2TM Proximal Humeral Nailing System (K043404)

Submission Summary (Full Text)

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K052294 v°/i

______________________________________________________________________________________________________________________________________________________________________________

# 0CT 2 1 2005

### 510(k) Summary of Safety and Effectiveness

| General<br>Provisions | The name of the device is: | | |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|--|
| | Proprietary Name | Common or Usual Name | |
| | Shoulder Nail Plate | Plate Fixation Bone | |
| Name of<br>Predicate<br>Devices | The Shoulder Nail Plate is substantially equivalent to the following predicate<br>devices:<br>• Shoulder Fixation System, 510(k) No. K051728 - June 20, 2005 - Hand<br>Innovations, LLC<br>• Dorsal Nail Plate of the Distal Radius Fracture Repair System, 510(k) No.<br>K023007 - December 5, 2002 - Hand Innovations, LLC<br>• T2TM Proximal Humeral Nailing System, 510(k) No. K043404 - December<br>27, 2004 - Stryker Corporation. | | |
| Classification | Class II. | | |
| Performance<br>Standards | Performance standards have not been established by the FDA under section 514 of<br>the Food, Drug and Cosmetic Act. | | |
| Indications for<br>Use | The Shoulder Nail Plate of the Shoulder Fixation System is intended for<br>fractures and fracture dislocations, osteotomies, and non-unions of the proximal<br>Humerus. | | |
| Device<br>Description | The bilaterally symmetric Shoulder Nail Plate is intended to treat fractures in both<br>left and right Humerus. The plate segment of the Shoulder Nail Plate is intended to<br>be attached to the metaphysis of the humerus. The nail segment of the Shoulder<br>Nail Plate is intended to be inserted into the humeral diaphysis for optimal<br>stabilization of the fracture. | | |
| Biocompati-<br>bility | The Shoulder Nail Plate do not require biocompatibility testing because the stainless<br>steel used in fabrications meets the requirements of ASTM F 138-03. | | |
| Summary of<br>Substantial<br>Equivalence | The Shoulder Nail Plate is substantially equivalent to the predicate Shoulder Side<br>Plate of the Shoulder Fixation System with regards to the intended use, materials,<br>biocompatibility, and overall performance characteristics. The equivalence was<br>confirmed through pre-clinical testing. | | |

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" written around the edge. Inside the circle is a stylized image of an eagle with three lines representing its wings.

#### Public Health Service

OCT 2 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Ernesto Hernandez Vice President, RA/QA Hand Innovations, LLC. 8905 SW 87th Avenue, Suite 220 Miami. Florida 33176

Re: K052294 Trade/Device Name: Shoulder Nail Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: August 19, 2005 Received: August 30, 2005

Dear Mr. Hernandez:

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 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 - Mr. Ernesto Hernandez

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter with and n your e FDA finding of substantial equivalence of your device to a legally promaticated predicated 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 n you don't 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 other general micromational 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. Mellon

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Shoulder Nail Plate

### Indications for Use Statement

The Shoulder Nail Plate of the Shoulder Fixation System is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal Humerus.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <div>✓</div> | OR | Over-The-Counter Use |
|------------------|--------------|----|----------------------|
|------------------|--------------|----|----------------------|

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

| 510(k) Number | K052294 |
|---------------|---------|
|---------------|---------|

Shoulder Nail Plate 510(k) Premarket Notification