TRIMED RADIAL BULLET

K030877 · Tri-Med, Inc. · HRS · Feb 5, 2004 · Orthopedic

Device Facts

• Record ID: K030877
• Device Name: TRIMED RADIAL BULLET
• Applicant: Tri-Med, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Feb 5, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TriMed Radial Bullet is intended for use as an aid to fracture healing. The implants are inserted across a fracture site and aid in stabilization of the bone fragments until bone healing occurs. The implant design includes a tip that is placed up against the subchondral bone of the tip of the radial styloid to prevent loss of radial length during fracture healing. The TriMed Radial Bullet may be used with bone screws, washers, locking bone screws and/or locking fixation pegs of the same material. The principal site of application is along the radial column in the context of distal radius fixation for treatment of fractures or osteotomies. Other sites of application may be reserved for future use.

Device Story

TriMed Radial Bullet is a metallic bone fixation implant; used as an aid to fracture healing by stabilizing bone fragments. Implant features a tip placed against subchondral bone of radial styloid to prevent loss of radial length. Used in conjunction with bone screws, washers, locking screws, or locking fixation pegs. Principal application is distal radius fixation for fractures or osteotomies. Operated by surgeons in clinical settings. Provides mechanical stabilization to facilitate bone healing.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and design similarities to legally marketed predicate devices.

Technological Characteristics

Materials: medical grade 316 stainless steel or titanium-vanadium-aluminum alloy. Form factor: bone fixation implant with specialized tip for radial styloid subchondral bone. Mechanical fixation device; no energy source or software components.

Indications for Use

Indicated for fixation of fractures or non-unions of the distal radius and osteotomies of the distal radius to correct malunion.

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

• TriMed small fragment clamp and buttress pin (K951303)
• Distal radius plate (Hand Innovations)
• Forte distal radius fixation plate (Zimmer)
• TriMed Radial Pin Plate (TriMed)
• Dorsal Nail Plate (Hand Innovations)
• Flexible Intramedullary Nail System for metacarpal fractures (Hand Innovations)

Submission Summary (Full Text)

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FEB - 5 2004

Page 1 of 2 510(k) summary

December 29, 2003

## 510(k) SUMMARY, revised.

K030877 510(k) number:

TriMed, Inc. Submitted by: 25768 Parada Drive Valencia, California 91355 800-633-7221

| Prepared by: | Robert J. Medoff, MD |
|----------------------|--------------------------------------------------------|
| Contact person: | Robert J. Medoff, MD ([e-mail]) |
| Date prepared: | December 29, 2003 |
| Proprietary Name: | TriMed Radial Bullet |
| Classification Name: | Bone fixation plate |
| Common/Usual Name: | TriMed Radial Bullet |
| | (other names reserved for future sites of application) |

Sample Predicate Devices:

TriMed small fragment clamp and buttress pin (510(k) K951303) Distal radius plate (Hand Innovations) Forte distal radius fixation plate (Zimmer) TriMed Radial Pin Plate (TriMed) Dorsal Nail Plate (Hand Innovations) Flexible Intramedullary Nail System for metacarpal fractures (Hand Innovations)

(PLATE, FIXATION, BONE) Class: II, Sec. 888.3030

Classification Panel: These devices are reviewed by an orthopaedic panel (888)

Product Code: HRS

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Page 2 of 2 510(k) summary

December 29, 2003

Description of the device:

The TriMed Radial Bullet is a bone fixation implant that is used as an aid to fracture fixation. All components of the implant are manufactured either from medical grade 316 stainless steel or medical grade titanium-vanadium-aluminum alloy. Dimensional characteristics of the devices have been provided in enclosure 1 of the 510(k) submission as well as attachment A of the first 510(k) supplement.

Intended use of the Device:

The TriMed Radial Bullet is intended for use as an aid to fracture healing. The implants are inserted across a fracture site and aid in stabilization of the bone fragments until bone healing occurs. The implant design includes a tip that is placed up against the subchondral bone of the tip of the radial styloid to prevent loss of radial length during fracture healing. The TriMed Radial Bullet may be used with bone screws, washers, locking bone screws and/or locking fixation pegs of the same material. The principal site of application is along the radial column in the context of distal radius fixation for treatment of fractures or osteotomies. Other sites of application may be reserved for future use.

Technological characteristics:

The TriMed Radial Bullet has identical technical characteristics to existing bone fixation plates that are in common use. Sample existing implant literature is supplied with enclosure 5 of the 510(k) application, and material specification sheets are supplied with enclosure 6 of the initial 510(k) application as well as attachment C of the first 510(k) supplement.

Indications for use:

The TriMed Radial Bullet is indicated for:

- 1. Fixation of fractures or non-unions of the distal radius
- 2. Osteotomies of the distal radius to correct malunion

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Image /page/2/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" around the perimeter. Inside the circle is a stylized symbol of three horizontal lines that resemble a person.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 5 2004

TriMed, Inc. C/o Robert J. Medoff, M.D. 159 Ku'ukama Street Kailua, Hawaii 96734

Rc: K030877

Trade/Device Name: TriMed Radial Bullet Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: December 29, 2003 Received: January 7, 2004

Dear Dr. Medoff:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 107 use stated in the enatiment date of the Medical Device Amendments, or 10 devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, de rices mat have been require approval of a premarket approval application (PMA). and cosmetre rearly for, 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 Codc 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 - Robert J. Medoff, M.D.

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,

Mark N Milliman

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: K030877 Supplement 2 - Attachment 2A

Indications for Use

The TriMed Radial Bullet is indicated for:

- 1. Fixation of fractures or non-unions of the distal radius
- 2. Osteotomies of the distal radius to correct malunion

Prescription Use (Part 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)

f Mark A. Mulkinson

Restorative
Devices

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