FR.O.H. CALCANEUS REPAIR SYSTEM

K051642 · I.T.S. Implantat-Technologie-Systeme GmbH · NDF · Aug 22, 2005 · Orthopedic

Device Facts

• Record ID: K051642
• Device Name: FR.O.H. CALCANEUS REPAIR SYSTEM
• Applicant: I.T.S. Implantat-Technologie-Systeme GmbH
• Product Code: NDF · Orthopedic
• Decision Date: Aug 22, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The I.T.S. FR.O.H. Calcaneus Repair System is used to stabilize a inta-articular and/or extra-articular fracture(s) and/or osteotomy of the calcaneus heel bone in the foot.

Device Story

FR.O.H. Calcaneus Repair System provides fracture reduction, alignment, and fixation for calcaneal heel bone fractures. System components include 15-hole calcaneus plates (CP titanium, ASTM F 67-00) and cannulated cancellous bone screws (6-4 alloyed titanium, ASTM F 136-02). Plates and screws feature TIODIZE Type II surface conditioning. Surgeons use the system in clinical settings to stabilize fractures via plate and/or screw fixation. By providing rigid internal fixation, the system facilitates bone healing and structural reconstruction of the calcaneus, potentially improving patient mobility and reducing pain associated with calcaneal fractures.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and intended use comparisons to legally marketed predicate devices.

Technological Characteristics

Materials: CP titanium (ASTM F 67-00) for plates; 6-4 alloyed titanium (ASTM F 136-02) for screws. Surface treatment: TIODIZE Type II. Components: 15-hole calcaneus plates, 3.5mm/4.2mm self-tapping cancellous screws, 7.3mm fully threaded cannulated cancellous screws. Mechanical fixation principle.

Indications for Use

Indicated for adult and pediatric patients with intra-articular, extra-articular, comminuted, multifragmentary, non-displaced, or tongue-type calcaneal fractures; corrective osteotomy; joint depression; joint fusion; revision procedures; and open or closed calcaneal fractures. 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

• Synthes Locking Calcaneal Plates (K991407)
• DePuy/Ace Calcaneal Peri-articular Plate (K993465)
• Ace/DePuy Cannulated Cancellous Bone Screw (K903810)

Submission Summary (Full Text)

{0}------------------------------------------------

K051642

:

AUG 2 2 2005

## 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: | FR.O.H. Calcaneus Repair System |
| COMMON NAME: | Bone Plate & Cannulated Cancellous Bone Screw System |
| CLASSIFICATION: | Plate, Fixation, Bone (see 21 CRF, Sec. 888.3030)<br><br>Smooth or threaded metallic bone fixation fastener<br>(see 21 CFR, Sec. 888.3040) |
| DEVICE PRODUCT CODE: | HRS & HWC |
| SUBSTANTIALLY<br>EQUIVALENT DEVICES | Synthes Locking Calcaneal Plates (K991407)<br>DePuy/Ace Calcaneal Peri-articular Plate (K993465)<br>Ace/DePuy Cannulated Cancellous Bone Screw (K903810) |
| DEVICE DESCRIPTION: | The I.T.S. FR.O.H. Calcaneus Repair System is a combination of<br>fracture reduction and alignment instrumentation with either<br>calcaneus plate and/or cannulated cancellous screw fixation across<br>calcaneal heel bone fracture site(s). The 15-hole Calcaneus Plate<br>(universal left and right in 2 sizes) is made from CP titanium<br>according to ASTM F 67-00 and corresponding plate locking and<br>self-tapping 3.5 & 4.2mm Cancellous Screws from 6-4 alloyed<br>titanium according to ASTM F 136-02. The fully threaded 7.3mm<br>Cannulated Cancelous Screw is in various lengths from 50 to<br>90mm in 5mm increment sizes and is also made from 6-4 alloyed<br>titanium according to ASTM F 136-02. All titanium plates and<br>screws are surface conditioned with a TIODIZE, Type II<br>preparation |
| INTENDED USE: | The I.T.S. FR.O.H. Calcaneus Repair System is used to stabilize a<br>inta-articular and/or extra-articular fracture(s) and/or osteotomy of<br>the calcaneus heel bone in the foot. |
| BASIS OF SUBSTANTIAL<br>EQIVLAENCE: | The I.T.S. FR.O.H. Calcaneus Repair System Calcaneal Plate is<br>substantially equivalent to the Synthes (K991407) and, DePuy/Ace<br>(K993465) plating systems.<br>The I.T.S. FR.O.H. Calcaneus Repair System Cannulated<br>Cancellous Screw is substantially equivalent to the DePuy/Ace<br>(K903810) cannulated screw system. |
| SUMMARY OF SAFETY<br>AND EFFECTIVENESS: | The I.T.S. FR.O.H. Calcaneus Repair System is shown to be safe<br>and effective for use in fracture fixation of the calcaneus heel bone<br>in the foot. |

{1}------------------------------------------------

# 510(k) Summary of Safety and Effectiveness Continued:

:

.

·

-

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three stripes forming its body and two curved lines representing its legs. The eagle is encircled by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 2 2005

I.T.S. Implantat-Technologie-Systeme GmbH Mr. Albert Lippincott, III U.S. Agent and official Correspondent for I.T.S. Implantat-Technologie-Systeme GmbH Engineering Consulting Services, Inc. 3150 E. 200th Street Prior Lake, Minnesota 55372

Re: K051642

Trade/Device Name: FR.O.H. Calcaneus Repair System Regulation Number: 21 CFR 888.3030, 21 CRF 888.3040 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories, Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: NDF, NDJ Dated: June 10, 2005 Received: June 20, 2005

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 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.

{3}------------------------------------------------

### Page 2 – Mr. Albert Lippincott III

This letter will allow you to begin marketing your device as described in your Section 510(k) I ins letter will anow you to oegin mainening of substantial equivalence of your device to a legally premarket hourication. The PDA mising of cassification 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 If you desire specific advisor at [phone]. Also, please note the regulation entitled, Contact the Office of Come to premarket notification" (21CFR Part 807.97). You may obtain Misoranding by reference to prenessponsibilities under the Act from the Division of Small other general information on your respenser 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,

Barbato Bocchino
tor

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

FN 163060 F

hnology-Systems GmbH

Geschaftsfuhrende Geseilschafterin: Dr. Eva Ruprechter

Tel ++43 (0)316 211 21 0 Fax ++43 (0)316 211 21 20 [e-mail]

# Indications for Use

510(k) NUMBER: DEVICE NAME: FR.O.H. Calcaneus Repair System INDICATIONS FOR USE:

The I.T.S. FR.O.H. Calcaneus Repair System is a titanium implant fracture fixation system for repairing fractures located in the calcaneus heel bone of the foot.

Indications for Use include: Intra and extra-articular fracture(s) of the calcaneus, corrective osteotomy, joint depression, non-displaced and tonque type, severely comminuted fractures, multifragmentary fractures, revision procedures, joint fusion, stabilization and fixation of fresh fractures, reconstruction of the calcaneus bones, and open and closed fractures of the calcaneus. The system can be used in both adult and pediatric patients.

This system is not intended for spinal use.

Prescription Use (Per 21 CFR 801 Subpart D)

AND/OR Over-The-Counter-Use

(21 CFR 801 Subpart C)

ILEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)