T2 NAILING SYSTEM

K032523 · Howmedica Osteonics Corp. · HSB · Oct 22, 2003 · Orthopedic

Device Facts

• Record ID: K032523
• Device Name: T2 NAILING SYSTEM
• Applicant: Howmedica Osteonics Corp.
• Product Code: HSB · Orthopedic
• Decision Date: Oct 22, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The T2 Proximal Humeral Nail is intended to be used for various types of proximal and/or diaphyseal fractures of the humerus. The nails are inserted using an opened or closed technique and can be static, dynamic and compression locked. The T2 Proximal Humeral Nail is intended for single use only. Examples of specific indications according to AO classification include Type A-Fractures, dislocated, Type BFractures, dislocated, Type C-Fractures, with intact calotte, or Humeral Fractures according to Neer-Classification. The T2 Humeral Nail is intended to provide temporary stabilization of various types of fractures, malunions and nonunions of the humerus. The nails are inserted using an opened or closed technique and can be static, dynamic and compression locked. The subject and predicate devices are indicated for use in the humerus. Types of fractures include, but not limited to fractures of the humeral shaft, non-unions, malalignments, pathological humeral fractures, and impending pathological fractures.

Device Story

T2 Nailing System consists of intramedullary nails, end caps, and locking screws for humeral fracture fixation; provides temporary stabilization via static, dynamic, or compression locking; inserted using open or closed surgical techniques; used by orthopedic surgeons in clinical/hospital settings; design concepts and mechanical properties verified via Finite Element Analysis (FEA) to match predicate devices; intended for single use to facilitate bone healing in humeral fractures, nonunions, and malunions.

Clinical Evidence

Bench testing only; FEA analysis used to demonstrate comparable mechanical properties to predicate devices.

Technological Characteristics

Intramedullary fixation rod; metallic construction; includes nails, end caps, and locking screws; designed for static, dynamic, or compression locking; mechanical properties validated via FEA.

Indications for Use

Indicated for patients with proximal and/or diaphyseal humeral fractures, including AO Type A, B, and C fractures, Neer-classified fractures, humeral shaft fractures, non-unions, malalignments, pathological fractures, and impending pathological fractures.

Regulatory Classification

Identification

An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.

Predicate Devices

• Polarus Proximal Humeral Nail (Acumed, Inc.)
• Zimmer's M/DN Humeral Nail (Zimmer, Inc.)
• Polarus Plus Humeral Nail (Acumed, Inc.)
• T2 Humeral Nail System (Howmedica Osteonics Corp.)

Submission Summary (Full Text)

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510(k) Premarket Notification

# OCT 2 2 2003

### 510(k) Summary of Safety and Effectiveness: T2 Humeral Nail System Line Extension

### Submission Information

| Name and Address of the Sponsor<br>of the 510(k) Submission: | Howmedica Osteonics Corp<br>59 Route 17 |
|--------------------------------------------------------------|----------------------------------------------------------------------------------|
| | Allendale, NJ 07401-1677 |
| Contact Person: | Vivian Kelly |
| | Regulatory Affairs Consultant |
| Date of Summary Preparation: | August 14, 2003 |
| Device Identification | |
| Proprietary Name: | T2 Nailing System |
| Common Name: | Intramedullary Nail |
| | Classification Name and Reference: Intramedullary Fixation Rod, 21 CFR §888.3020 |

This 510(k) submission is a line extension to the T2 Nailing System to add a new Proximal Humeral Nail with accessories, additional sizes of the T2 Humeral Nail, additional End Caps for various T2 nails and additional lengths of T2 Locking Screws.

The T2 Proximal Humeral Nail is intended for the fixation of various types of proximal and/or diaphyseal fractures of the humerus. The T2 Humeral Nail is intended to provide temporary stabilization of various types of fractures, malunions and nonunions of the humerus.

The intended use of the subject devices is identical to the following predicate devices: Polarus Proximal Humeral Nail (Acumed, Inc.) and Zimmer's M/DN Humeral Nail for the T2 Proximal Humeral Nail and the Polarus Plus Humeral Nail (Acumed, Inc.), Zimmer's M/DN Humeral Nail, Zimmer Inc. and the previously cleared T2 Humeral Nail System by Howmedica Osteonics Corp. for the T2 Humeral Nail.

The T2 Nailing System also has the same basic design concepts as the predicate devices. FEA Analysis demonstrated comparable mechanical properties to the predicate device.

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized eagle or bird in flight, composed of curved lines.

Public Health Service

OCT 2 2 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Vivian Kelly Regulatory Affairs Consultant Howmedica Osteonics Corporation 59 Route 17 Allendale, NJ 07401-1677

Re: K032523

Trade/Device Name: T2 Nailing System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: August 14, 2003 Received: August 19, 2003

Dear Ms. Kelly:

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 - Ms. Vivian Kelly

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,

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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# 510(k) Number (if known): K. 0 305 d 3

Device Name: T2 Nailing System

Indications For Use:

T2 Proximal Humeral Nail

The T2 Proximal Humeral Nail is intended to be used for various types of proximal and/or diaphyseal fractures of the humerus. The nails are inserted using an opened or closed technique and can be static, dynamic and compression locked. The T2 Proximal Humeral Nail is intended for single use only. Examples of specific indications according to AO classification include Type A-Fractures, dislocated, Type BFractures, dislocated, Type C-Fractures, with intact calotte, or Humeral Fractures according to Neer-Classification.

#### T2 Humeral Nail

The T2 Humeral Nail is intended to provide temporary stabilization of various types of fractures, malunions and nonunions of the humerus. The nails are inserted using an opened or closed technique and can be static, dynamic and compression locked. The subject and predicate devices are indicated for use in the humerus. Types of fractures include, but not limited to fractures of the humeral shaft, non-unions, malalignments, pathological humeral fractures, and impending pathological fractures.

(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

(Optional Format 1-2-96)
Mark N Millican

neral, Restorative

K032523