OLECRANONPLATE WITH ANGULAR STABILITY

K052368 · I.T.S. Implantat-Technologie-Systeme GmbH · HRS · Oct 17, 2005 · Orthopedic

Device Facts

• Record ID: K052368
• Device Name: OLECRANONPLATE WITH ANGULAR STABILITY
• Applicant: I.T.S. Implantat-Technologie-Systeme GmbH
• Product Code: HRS · Orthopedic
• Decision Date: Oct 17, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Indications for Use include fixation of complex intra- and extra- articular fractures, osteotomies, nonunions, malunions, Type 1, 2, 3, & 4 simple fractures, and Type 5a, 5b, 5c, & 6 complex fractures (comminuted) of the proximal ulna (olecranon). The I.T.S. Olecranonplate with Angular Stability is used to stabilize fracture(s) of the proximal ulna (olecranon) in the elbow.

Device Story

Titanium bone plate system for surgical fixation of proximal ulna (olecranon) fractures; includes 8, 10, and 12-hole plates with 4.2mm cancellous self-tapping/head-locking screws and 3.5mm cortical screws. Used by orthopedic surgeons in clinical/OR settings to stabilize fractures, osteotomies, nonunions, and malunions. Plate locks to dorsal shaft of ulna via screws; provides angular stability to bone fragments. Benefits patient by restoring structural integrity of proximal ulna, facilitating healing of complex fractures.

Clinical Evidence

Bench testing only.

Technological Characteristics

Low-profile universal left/right bone plate. Plate material: CP titanium (ASTM F 67-00). Screw material: 6-4 alloyed titanium (ASTM F 136-02). Surface treatment: TIODIZE Type II. Fixation: self-tapping cancellous and cortical screws with angular stability locking mechanism.

Indications for Use

Indicated for patients requiring fixation of proximal ulna (olecranon) fractures, including complex intra- and extra-articular fractures, osteotomies, nonunions, malunions, simple fractures (Types 1-4), and complex comminuted fractures (Types 5a-6).

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

• Acumed Olecranon Plate (K012655)
• Synthes Curved Reconstruction Plate (K011334)
• Zimmer (1974) Zuelzer Hook Plate

Submission Summary (Full Text)

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001 17 2005

## 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: | Olecranonplate with Angular Stability |
| COMMON NAME: | Bone Plate System |
| CLASSIFICATION: | Plate, Fixation, Bone (see 21 CRF, Sec. 888.3030). |
| DEVICE PRODUCT CODE: | HRS |
| SUBSTANTIALLY<br>EQUIVALENT DEVICES | Acumed Olecranon Plate (K012655)<br>Synthes Curved Reconstruction Plate (K011334)<br>Zimmer (1974) Zuelzer Hook Plate for fracture of the Olecranon |
| DEVICE DESCRIPTION: | The I.T.S. Olecranonplate with Angular Stability is a low-profile<br>universal left and right titanium 8, 10, and 12 hole plate with various<br>length 4.2mm Cancellous self-tapping and head locking stabilization<br>screws. Additional 3.5mm Cortical screws of various lengths are self-<br>tapping and are interchangeable in use to lock the plate to the dorsal shaft<br>of the ulna. The Olecranonplate is made from CP titanium according to<br>ASTM F 67-00 and the screws are made from 6-4 alloyed titanium<br>according to ASTM F 136-02. The plate and screws are surface<br>conditioned with a TIODIZE, Type II preparation. |
| INTENDED USE: | Indications for Use include fixation of complex intra- and extra- articular<br>fractures, osteotomies, nonunions, malunions, Type 1, 2, 3, & 4 simple<br>fractures, and Type 5a, 5b, 5c, & 6 complex fractures (comminuted) of<br>the proximal ulna (olecranon). The I.T.S. Olecranonplate with Angular<br>Stability is used to stabilize fracture(s) of the proximal ulna (olecranon) in<br>the elbow. |
| BASIS OF SUBSTANTIAL<br>EQUIVALENCE: | The I. T.S. Olecranonplate with Angular Stability is substantially<br>equivalent to the Acumed, Synthes, and Zimmer Olecranon plate systems. |
| SUMMARY OF SAFETY<br>AND EFFECTIVENESS: | The I.T.S. Olecranonplate with Angular Stability is shown to be safe and<br>effective for use in fracture fixation of the proximal ulna (olecranon) in<br>the elbow. |

KOS 2368

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a caduceus, a traditional symbol of medicine, with three branches instead of the usual two.

OCT 17 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

I.T.S. Implantat-Technologie-Systeme GmbH c/o Al Lippincott Engineering Consulting Services, Inc. 3150 E. 200" Street Prior Lake, Minnesota 55372

Re: K052368 Trade/Device Name: Olecranonplate 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: August 26, 2005 Received: August 29, 2005

Dear Mr. Lippincott:

We have reviewed your Scction 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 cither 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 - 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.hunl

Sincerely yours,

Mark N. Melkerson

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

Enclosure

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plant-Technology-Systems GmbH

Geschäftsführende Gesellschafterin: Dr. Eva Ruprechter

Autal 28, 8301 Lassnitzhone / Graz AUSTRIA ·

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

## Indications for Use

510(k) NUMBER:

DEVICE NAME: OLECRANONPLATE WITH

ANGULAR STABILITY

INDICATIONS FOR USE:

The I.T.S. Olecranonplate with Angular Stability is a titanium implant fracture fixation system for stabilizing fractures of the proximal ulna (olecranon) in the elbow.

Indications for Use include fixation of complex intra- and extra-

articular fractures, osteotomies, nonunions, malunions, Type 1, 2, 3, &

4 simple fractures, and Type 5a, 5b, 5c, & 6 complex fractures

(comminuted) of the proximal ulna (olecranon).

Prescription Use

AND/OR Over-The-Counter-Use

(Per 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

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

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

510(k) Number_10052368

Concurrence of CDRH, Office of Device Evaluation (ODE)