DORSAL INTRAMEDULLARY PLATE

K042437 · Deo Volente Orthopaedics, LLC · HRS · Oct 8, 2004 · Orthopedic

Device Facts

• Record ID: K042437
• Device Name: DORSAL INTRAMEDULLARY PLATE
• Applicant: Deo Volente Orthopaedics, LLC
• Product Code: HRS · Orthopedic
• Decision Date: Oct 8, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The fixation of fractures and osteotomies involving the distal radius. This single use device is for cementless use only.

Device Story

Dorsal Intramedullary Plate system for distal radius fracture fixation. Device consists of anatomically contoured plate with distal head and proximal stem. Distal head features two rows of screw holes: distal row threaded for fixed-angle support; proximal row with spherical seat for variable angle. Proximal stem utilizes press-fit intramedullary fixation. System includes 2.7 mm screws (16mm-26mm length) and optional K-wires for stabilization. Used by orthopedic surgeons in clinical settings to stabilize bone fragments. Benefits include anatomical fit and secure fixation via combined intramedullary and screw-based approach.

Clinical Evidence

bench testing only

Technological Characteristics

Materials: Titanium (ASTM F-136) or stainless steel (ASTM F-138). Design: Anatomically contoured plate with distal head and proximal intramedullary stem. Fixation: Press-fit intramedullary stem and 2.7 mm threaded head screws. Sterilization: Not specified.

Indications for Use

Indicated for the fixation of fractures and osteotomies involving the distal radius. For single use, cementless application only.

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

• Hand Innovations, Distal Radius Fracture Repair System (K032705)
• Wright Medical Technology, Locon-T Distal Radial Plate System (K994061)

Submission Summary (Full Text)

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OCT 8 = 2004

C092437

## 510(k) Summary of Safety and Effectiveness

| SUMMARY PREPARED: | September 2, 2004 |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) SPONSOR/APPLICANT: | Deo Volente Orthopaedics, LLC<br>345 N. Buffalo St., Warsaw IN 46580 |
| 510(k) PREPARER and<br>CONTACT PERSON: | Dina L. Weissman, J.D.<br>P.O. Box 83, Warsaw IN 46581<br>Tel/Fax: [phone]<br>Email: [e-mail] |
| TRADE NAME:<br>COMMON NAME:<br>CLASSIFICATION: | Dorsal Intramedullary Plate<br>Plate, Fixation, Bone<br>Class II per 21 CFR § 888.3030<br>Single/multiple component metallic bone fixation<br>appliances and accessories. |
| DEVICE PRODUCT CODE: | 87 HRS |
| PREDICATE DEVICES:<br>· Hand Innovations, Distal Radius Fracture Repair System, K032705, cleared 1 Oct 2003<br>· Wright Medical Technology, Locon-T Distal Radial Plate System, K994061, cleared 30 Nov 1999 | |
| DEVICE DESCRIPTION: | This anatomically contoured plate system offers several<br>sizes and styles of distal heads in either titanium (ASTM<br>F-136) or stainless steel (ASTM F-138). |
| | The distal head of the plate contains two rows of two<br>screw holes each that accept 2.7 mm screws. The distal<br>row of screw holes are threaded allowing for fixed angle<br>support of the fracture fragments utilizing the threaded<br>head screws. The proximal row of screw holes has a<br>spherical seat allowing for variability in screw angle |

The threaded head screws vary in length from 16mm to 26mm and are fully threaded. K-wires may also be used for stabilization of bone fragments. The device utilizes a press fit intramedullary fixation for the proximal stem when inserted into the radial intramedullary canal while the distal head is secured to the fracture fragment using the above described bone screws.

fixation while still using the threaded head screws.

INTENDED USE: The fixation of fractures and osteotomies involving the distal radius. Single use device for cementless use only.

COMPARISON TO PREDICATES: The Deo Volente Orthopaedics Dorsal Intramedullary Plate is similar to the listed predicate devices in intended use, performance characteristics, materials of construction, manufacturing methods and design.

> 345 North Burfalo St Varsaw in 46580 977 777 9DVQ r 1x 574 268.1542 ANT 660 it case to

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a circular logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three parallel lines that curve and converge, resembling a stylized human figure.

Public Health Service

OCT 8 - 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Deo Volente Orthopaedics, LLC C/o Dina L. Weissman P.O. Box 83 Warsaw, Indiana 46581

Re: K042437

Trade/Device Name: Dorsal Intramedullary Plate Regulation Number: 21CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: September 2, 2004 Received: September 8, 2004

Dear Ms Weissman:

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 Dina L. Weissman

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 A. Milkean

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

510(k) Number (if known): k042437

Device Name: Dorsal Intramedullary Plate

Indications for Use:

The fixation of fractures and osteotomies involving the distal radius.

This single use device is for cementless use only.

Prescription Use XXXXX (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

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**510(k) Number** K042437