STRAIGHT PLATE WITH ANGULAR STABILITY & SCREW SYSTEM

K060156 · I.T.S. Implantat-Technologie-Systeme GmbH · HRS · Mar 20, 2006 · Orthopedic

Device Facts

• Record ID: K060156
• Device Name: STRAIGHT PLATE WITH ANGULAR STABILITY & SCREW SYSTEM
• Applicant: I.T.S. Implantat-Technologie-Systeme GmbH
• Product Code: HRS · Orthopedic
• Decision Date: Mar 20, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The intended use of the I.T.S. Straight Plate with Angular Stability is to stabilize an osteotomy or fracture of small bones, long bones, the pelvis and the calcaneus in an adult or pediatric patient. Indications for use include comminuted fractures, supercondylar fractures, intra-articular and extra-articular condylar fractures, fractures in osteopenic bone, nonunions, and malunions. And, as well, a fracture or osteotomy of the tibia, fibula, femoral condyle, acetabulum, humerus, ulna, middle hand and middle foot bones; treatment of the calcaneal; hip arthrodesis, and provisional hole fixation. The 3.5mm Cortical and Cancellous Angle Stable Screws used in conjunction with the Straight Plate may be used only on small bones. The intended use of the I.T.S. Screw System is for corrective osteotomy or internal fracture fixation of the patella, pelvis, ankle, and long bones in an adult or pediatric patient. For the 4.0mm Cannulated Cancellous Screw, indications for use are for radial and ulnar fractures, fractures of the proximal/distal humerus and of the patella, and for tendon fixation, maisonneuve injuries and disruption of the syndesmosis with bimalleolar or supermalleolar fractures and the instability of the talus centering. For the 6.5mm Cannulated Cancellous Screw, indications for use are for fractures of the femoral neck, tibiaplateau, of the sacrum and the articular cavity of the hip joint, and the metaphyseal fractures of the distal femur and distal tibia, fixation of the ileosacral joint, and fusion of the foot and ankle. For the 7.3mm Cannulated Cancellous Screw, indications for use are for fractures of the calcaneus, femoral neck, tibiaplateau, and of the sacrum and the articular cavity of the hip joint, fusion of the foot and ankle, fixation of the ileo-sacral joint, and metaphyseal fractures of the distal femur and distal tibia. The system(s) is not intended for spinal use.

Device Story

System comprises low-profile bone plates (4, 6, or 8 holes) and cannulated fracture fixation screws (4.0mm, 6.5mm, 7.3mm) with optional washers. Used by surgeons in clinical settings for internal fracture fixation or corrective osteotomy. Plates provide angular stability and compression. Screws are self-tapping. Device stabilizes bone segments to facilitate healing. No electronic or software components.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Plates: CP titanium (ASTM F 67-00). Screws/Washers: 6-4 Alloyed Titanium (ASTM F 136-02). Surface treatment: TIODIZE Type II. Mechanical fixation via locking/compression screws. Non-electronic, mechanical device.

Indications for Use

Indicated for adult and pediatric patients requiring stabilization of osteotomies or fractures of small bones, long bones, pelvis, and calcaneus. Includes comminuted, condylar, intra/extra-articular, and osteopenic bone fractures, nonunions, malunions, hip arthrodesis, and tendon/syndesmosis fixation. Not for spinal use.

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

• I.T.S. GmbH Claviculaplate with Angular Stability (K050852)
• Smith & Nephew Peri-Loc Locking Bone Plates and Locking Bone Screw System (K051735)
• Zimmer Periarticular Locking Plates and Screws (K051098)
• Synthes 4.5mm LCP Straight Reconstruction Plates (K051986)
• Acumed Congruent Plate System (K012655)
• I.T.S. GmbH FR.O.H. Calcaneus Repair System (K051642)
• Synthes Sterile 3.5mm and 4.0mm Cannulated Screw (K963192)
• Zimmer/Pioneer Cannulated Screw System (K003496)
• Synthes (USA) Spherical Washers (K052483)

Submission Summary (Full Text)

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MAR 2 0 2006

・・

### KOGOIS6 510(k) Summary of Safety and Effectiveness Section XII:

# 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: | Straight Plate with Angular Stability & Screw System |
| COMMON NAME: | Bone Plate & Screw System |
| CLASSIFICATION: | Plate, Fixation, Bone (see 21 CRF, Sec. 888.3030),<br>Screw, Fixation, Bone (see 21 CFR, Sec. 888.3040),<br>Washer, Bolt, Nut (see 21 CFR, Sec. 888.3030) |
| DEVICE PRODUCT CODE: | HRS |
| SUBSEQUENT PRODUCT CODE: | HWC, HTN |
| SUBSTANTIALLY | I.T.S. GmbH Claviculaplate with Angular Stability (K050852)<br>Smith & Nephew Peri-Loc Locking Bone Plates and Locking Bone<br>Screw System (K051735) |
| EQUIVALENT DEVICES | Zimmer Periarticular Locking Plates and Screws (K051098)<br>Synthes 4.5mm LCP Straight Reconstruction Plates (K051986)<br>Acumed Congruent Plate System (K012655)<br>I.T.S. GmbH FR.O.H. Calcaneus Repair System (K051642)<br>Synthes Sterile 3.5mm and 4.0mm Cannulated Screw (K963192)<br>Zimmer/Pioneer Cannulated Screw System (K003496)<br>Synthes (USA) Spherical Washers (K052483) |
| DEVICE DESCRIPTION: | The I.T.S. Straight Plate with Angular Stability is a low-profile 4,<br>6, or 8 hole plate with various length cortical and/or cancellous<br>self-tapping stabilization locking and/or compression screws. The<br>Straight Plate is made from CP titanium according to ASTM F 67-<br>00 and all screws are made from 6-4 Alloyed Titanium according<br>to ASTM F 136-02. The plate and screws are surface conditioned<br>with a TIODIZE, Type II preparation.<br><br>The I.T.S. Screw System is a group of cannulated fracture fixation<br>screws in various diameters of 4.0mm, 6.5mm, and 7.3mm and<br>lengths. A complement of flat and spherical Washers are available<br>with the system. All screws and washers are made from 6-4<br>Alloyed Titanium according to ASTM F 136-02 and are surface<br>conditioned with a TIODIZE, Type II preparation. |

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Section XII

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#### INTENDED USE:

The intended use of the I.T.S. Straight Plate with Angular Stability is to stabilize an osteotomy or fracture of small bones, long bones, the pelvis and the calcaneus in an adult or pediatric patient.

060156

Indications for use include comminuted fractures, supercondy ar fractures, intra-articular and extra-articular condylar fractures, fractures in osteopenic bone, nonumions, and malunions. And, as well, a fracture or osteotomy of the tibia, fibula, femoral condyle, acetabulum, humerus, ulna, middle hand and middle foot bones: treatment of the calcanest; hip arthrodesis, and provisional hole fixation. The 3.5mm Cortical and Cancellous Angle Stable Screws used in conjunction with the Straight Plate may be used only on small bones.

The intended use of the I.T.S. Screw System is for corrective osteotomy or internal fracture fixation of the patella, pelvis, ankle, and long bones in an adult or pediatric patient.

For the 4.0mm Cannulated Cancellous Screw, indications for use are for radial and ulmar fractures, fractures of the proximal/distal humerus and of the patella, and for tendon fixation, maisonneuve injuries and disruption of the syndesmosis with bimalleolar or supermalleolar fractures and the instability of the talus centering. For the 6.5mm Cannulated Cancellous Screw, indications for use are for fractures of the femoral neck, tibiaplateau, of the sacrum and the articular cavity of the hip joint, and the metaphyseal fractures of the distal fermur and distal tibia, fixation of the lleosacral joint, and fusion of the foot and ank

For the 7.3mm Canmiated Cancellous Screw, indications for use are for fractures of the calcaneus, femoral neck, tibiaplateau, and of the sacrum and the articular cavity of the hip joint, fusion of the foot and ankle, fixation of the lleo-sacral joint, and metaphyseal fractures of the distal femur and distal tibia.

The system (s) is not intended for spinal use.

#### BASIS OF SUBSTANTIAL EQIVLAENCE:

SUMMARY OF SAFETY AND EFFECTIVENESS:

The I.T.S. Straight Plate with Angular Stability is substantially equivalent to the Smith & Nephew. Zimmer. Synthes, Acumed. and I.T.S. GmbH stabilizing bone plate systems. The LT.S. Screw System is substantially equivalent to the I.T.S. GmbH, Zimmer, and Synthes cannulated screw and washer systems.

The I.J.S. Straight Plate with Angular Stability and Screw System is shown to be safe and effective for use in fracture fixation of small and long bones in the body.

Section XII

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings. The eagle is facing left. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 0 2006

I.T.S. Implantat-Technologie-Systeme GmbH c/o Engineering Consulting Services, Inc. Mr. Albert Lippincott Biomedical Engineer 3150 E. 200th Street Prior Lake, Minnesota 55372

Re: K060156

Trade/Device Name: Straight Plate with Angular Stability & Screw System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS, HWC, HTN Dated: March 7, 2006 Received: March 8, 2006

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 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

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Page 2 - Mr. Albert Lippincott

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.

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,

Herbert Lenner

Mark N. Melkerson Acting 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: _ KOGOI56

DEVICE NAME: STRAIGHT PLATE WITH ANGULAR STABILITY AND SCREW SYSTEM

The intended use of the I.T.S. Straight Plate with Angular Stablity is to stabilize an osteolomy or fracture of small bones, long bones, the pelvis and the calcaneus in an adult or pediatric patient.

Indications for use include comminuted fractures, supercondyter fractures, intraarticular and extre-articular condylar fractures in osteopenic bone, nonunions, and malunions. And, as well, a fracture or osteotomy of the tibia, fibula, femoral condyle, acetabulum, humerus, uina, middle hand and middle foot bones; treatment of the calcaneal; hip arthrodesis, and provisional hole fixation. The 3,5mm Cortical and Gencellous Angle Stable Screws used in conjunction with the Straight Plate may only be used on small bones.

The intended use of the LT.S. Screw System is for corrective asteotomy or internal fracture focation of the patella, pelvis, ankle, and long bones in an adult or pediatic palient.

For the 4.0mm Cannulated Cancellous Screw, indications for use are for radial and ulnar fractures, fractures of the proximal/distal humerus and of the patella, and for tendon fixation, maisonneuve injuries and disruption of the syndesmosis with bimalleolar or supermalleolar fractures and the instability of the talus centering.

For the 6.5mm Cannulated Cancellous Screw, Indications for use are for fractures of the fornoral neck, tibiaplateau, of the sacrum and the articular cavity of the hip joint, and the metaphyseal fractures of the distal femur and distal libia, fixation of the lleo-sacral joint, and fusion of the foot and ankle.

For the 7,3mm Cannulated Gancellous Screw, indications for use are for fractures of the calcaneus, femoral neck, tiblaplateau, and of the secrum and the articular cavity of the hip joint, fusion of the foot and ankle, fixation of the lleo-sacral joint, and metaphyseal fractures of the distal femur and distal tibia.

The system(s) Is not intended for spinal use.

Prescription Use

☑

Over-The Counter-Use

FR 801 Subpart D)

(21 CFR 801 Subpart C)

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

AND/OR

Division of General, Restorative, a corn. Offee of Device Evaluation (OOE) and Neurological Devices

**510(k) Number** K060156