VOLAR RADIUS PLATE WITH ANGULAR STABILITY

K033756 · I.T.S. Implantat-Technologie-Systeme GmbH · HRS · Feb 6, 2004 · Orthopedic

Device Facts

• Record ID: K033756
• Device Name: VOLAR RADIUS PLATE WITH ANGULAR STABILITY
• Applicant: I.T.S. Implantat-Technologie-Systeme GmbH
• Product Code: HRS · Orthopedic
• Decision Date: Feb 6, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The I.T.S. Volar Radius Plate is used to stabilize distal radius fractures in the wrist with an accurate retention of articular fracture elements.

Device Story

Metallic bone fixation system for distal radius fractures; consists of titanium plates (4, 6, 8, 10, 12 hole configurations) and stabilization/cortical screws. Used by orthopedic surgeons in clinical/OR settings to stabilize fractures and retain articular elements. Provides immediate mechanical stability to facilitate rapid recovery and wrist functionality. Device is implanted surgically; no electronic or software components.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Plates: CP Titanium (ASTM F 67-00). Screws: 6-4 Alloyed Titanium (ASTM F 136-98). Angular stability design. Mechanical fixation system. No energy source, connectivity, or software.

Indications for Use

Indicated for patients with comminuted extra and intra-articular distal radius fractures, failed original fracture fixation, osteotomy and repair of a distal radius malunion, and comminuted volar shearing fractures.

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

• Avanta SCS/V Distal Radius Plate - Volar
• Hand Innovations DVR Plate
• Synthes Locking Distal Radius System 2.4

Submission Summary (Full Text)

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## 510(k) Summary of Safety and Effectiveness Section XII:

| FEB - 6 2004 | SAFE MEDICAL DEVICES ACT OF 1990<br>510(k) Summary |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| NAME OF FIRM: | I.T.S. Implantat-Technologie-Systeme GmbH.<br>Autal 28.<br>Lassnitzhoche A-8301<br>AUSTRIA |
| 510(k) FIRM CONTACT: | Al Lippincott<br>Engineering Consulting Services, Inc.<br>3150 E. 200th St.<br>Prior Lake, MN 55372 |
| TRADE NAME: | Volar Radius Plate with Angular Stability |
| COMMON NAME: | Fracture Fixation Plating system for fracture fixation of the end of<br>long bones |
| CLASSIFICATION: | Single/multiple component metallic bone fixation appliances and<br>accessories (see 21 CRF, Sec. 888.3030). |
| DEVICE PRODUCT CODE: HRS | |
| SUBSTANTIALLY<br>EQUIVALENT DEVICES: | Avanta SCS/V Distal Radius Plate - Volar<br>Hand Innovations DVR Plate<br>Synthes Locking Distal Radius System 2.4 |
| DEVICE DESCRIPTION: | The I.T.S. Volar Radius Plate with Angular Stability provides<br>various width 4 and 6 hole standard plates, various width 8, 10,<br>and 12 hole long plates, various length stabilization screws, and<br>various length cortical fixation screws. The volar radius plates are<br>made from CP Titanium according to ASTM F 67-00 and the<br>screws are made from 6-4 Alloyed Titanium according to ASTM F<br>136-98. |
| INTENDED USE: | The I.T.S. Volar Radius Plate is used to stabilize distal radius<br>fractures in the wrist with an accurate retention of articular fracture<br>elements. |
| BASIS OF SUBSTANTIAL<br>EQUIVALENCY: | The I.T.S. Volar Radius Plate is substantially equivalent to the<br>Avanta, Hand Innovations, and Synthes fracture plating systems |
| SUMMARY OF SAFETY<br>AND EFFECTIVENESS: | The I.T.S. Volar Radius Plate system is shown to be safe and<br>effective for use in fracture fixation of the distal radius in the wrist. |

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FEB - 6 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

I.T.S. Implantat-Technologie-Systeme GMBH Al Lippincott c/o Engineering Consulting Services, Inc. 3150 East 2000 Street Prior Lake, Minnesota 55372

Re: K033756

Trade/Device Name: Volar Radius Plate with Angular Stability Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: November 24, 2003 Received: December 1, 2003

Dear Mr. Lippincott:

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 docs 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. Al Lippincott

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 you

Mark A. Mulkeen

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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## Spectromed

Geschäftsführer: Herbert Seinsteiner & Dr Eva Rapter Mer

8301 Laßnitzhohe/Grat, Austria Antal 28

Spectromed GmbH lef=043 Ho241 21 0 - 1ax=43 316 211 21 30 l mail verkant-spectromed net IN 34940 h. DVR 0747473

1.T.S. Implantat · Technologie-Systeme GmbH lel .: . 43 316 211 21 0 Tax: [phone] www.ts implant.com - [ mail:its@its amplant.com I N 16396ab - DVR 0934704

510(k) NUMBER: k033756
DEVICE NAME: Volar Radius Plate
INDICATIONS FOR USE:

The I.T.S. Volar Radius Plate with Angular Stability is a titanium implant fracture fixation system for distal radius fractures of the wrist.

Indications for Use include comminuted extra and intra-articular distal radius fractures, failed original fracture fixation, osteotomy and repair of a distal radius malunion, and comminuted volar shearing fractures

The I.T.S. Volar Radius Plate system provides immediate stability, rapid recovery, and prompt wrist functionality.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

001 FUB B

OR

Over-The-Counter-Use

(Optional Format)

for Mark A. Melber