EPIPHYSIS SCREW

K043410 · I.T.S. Implantat-Technologie-Systeme GmbH · HWC · Feb 24, 2005 · Orthopedic

Device Facts

• Record ID: K043410
• Device Name: EPIPHYSIS SCREW
• Applicant: I.T.S. Implantat-Technologie-Systeme GmbH
• Product Code: HWC · Orthopedic
• Decision Date: Feb 24, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The I.T.S. Epiphysis Screw is used to stabilize a slipped capital femoral epiphysis and fracture fixation in the pelvis of large bones and large bone fragments. The system is not intended for spinal use.

Device Story

Cannulated bone screw system for orthopedic fracture fixation. Device features self-tapping, self-drilling design; guided placement via guidewire pin. Used by surgeons in clinical/OR settings for stabilization of large bone fragments and slipped capital femoral epiphysis. Provides mechanical fixation to facilitate bone healing. System includes associated instrumentation for placement.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and design characteristics.

Technological Characteristics

Material: 6-4 ELI Titanium alloy with Tiodize Type II surface. Design: Cannulated, self-tapping, self-drilling screw. Lengths: 50mm to 120mm in 5mm increments. Energy source: None (manual surgical instrumentation).

Indications for Use

Indicated for fracture fixation of large bone fragments including femoral neck fractures, slipped capital femoral epiphysis, tibial plateau fractures, pediatric femoral neck fractures, intercondylar femur fractures, and subtalar arthrodeses. Not for spinal use.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Synthes 6.5mm Cannulated Screw (K021932)
• Howmedica Osteonics ASNIS III Cannulated Screw (K000080)
• Orthomet/Wright Medical Cannulated Screw (K862157)
• Ace/Depuy Cannulated Self Tapping Cancellous Bone Screw (K903810)
• Zimmer MAGNA-Fx Cannulated Screw Fixation system
• Richards/Smith Nephew Universal Cannulated Screw
• DePuyAce ACE SCFE Screw

Submission Summary (Full Text)

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FEB * 4 2005

K043410

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

### SAFE MEDICAL DEVICES ACT OF 1990 510(k) Summary

| NAME OF FIRM: | I.T.S. Implantat-Technologie-Systeme GmbH.<br>Autal 28.<br>Lassnitzhoehe 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: | Epiphysis Screw |
| COMMON NAME: | Cannulated Bone Screw |
| CLASSIFICATION: | Smooth or threaded metallic bone fixation fastener<br>(see 21 CRF, Sec. 888.3040). |
| DEVICE PRODUCT CODE: | HWC |
| SUBSTANTIALLY<br>EQUIVALENT DEVICES: | Synthes 6.5mm Cannulated Screw (K021932)<br>Howmedica Osteonics ASNIS III Cannulated Screw (K000080)<br>Orthomet/Wright Medical Cannulated Screw (K862157)<br>Ace/Depuy Cannulated Self Tapping Cancellous Bone Screw<br>(K903810)<br>Zimmer MAGNA-Fx Cannulated Screw Fixation system<br>Richards/Smith Nephew Universal Cannulated Screw<br>DePuyAce ACE SCFE Screw |
| DEVICE DESCRIPTION: | The I.T.S. Epiphysis Screw is a self-tapping and self-drilling screw<br>with a cancellous thread that can be guided into a position via a<br>guidewire pin. Screws are available partially threaded in lengths<br>from 50mm to 120mm in 5mm increments. A full complement of<br>instrumentation is available to assist in placement. The screws are<br>manufactured from 6-4 ELI Titanium alloy with a Tiodize, Type II<br>surface. |
| INTENDED USE: | The I.T.S. Epiphysis Screw is used to stabilize a slipped capital<br>femoral epiphysis and fracture fixation in the pelvis of large bones<br>and large bone fragments. The system is not intended for spinal<br>use |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Public Health Service

FEB 2 4 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

I.T.S. Implant-Technologie-SystemeGMBH Al Lippincott Engineering Consulting Services, Inc. 3150 E. 200th Street Prior Lake, Minnesota 55372

Re: K043410

Trade/Device Name: Epiphysis Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: December 10, 2004 Received: December 10, 2004

Dear Mr. Al 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. Iisting 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. 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/industry/support/index.html.

Sincerely yours,

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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I.T.S. Implant-Technology-Systems GmbH

chäftsführende Gesellschafterin: Dr

1081 69 4 11 1 STORE CONSTITUTION

## Indications for Use

# 510(k) NUMBER: DEVICE NAME: EPIPHYSIS SCREW INDICATIONS FOR USE:

The I.T.S. Epiphysis Screw is a titanium implant fracture fixation screw system for a slipped femoral capital epiphysis and alternative cancellous bone screw fixation where accurate screw placement is required such as in the pelvis, ankle, knee, etc.,

Indications for Use include fracture fixation of large bone fragments, such as femoral neck fractures; slipped capital femoral epiphysis; tibial plateau fractures; pediatric femoral neck fractures; intercondylar femur fractures; and subtalar arthrodeses.

The system is not intended for spinal use.

Prescription Use

AND/OR Over-The-Counter-Use

(Per 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

Section X

EN ISO 1349

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

(Division Sign-Off)

Comeral, Regenciality of CDRH, Office of Device Evaluation (ODE) Division and Neurological Dev