I.T.S. Hand Locking Plates System - HLS

K142418 · I.T.S. GmbH · HRS · Sep 26, 2014 · Orthopedic

Device Facts

• Record ID: K142418
• Device Name: I.T.S. Hand Locking Plates System - HLS
• Applicant: I.T.S. GmbH
• Product Code: HRS · Orthopedic
• Decision Date: Sep 26, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the I.T.S. Hand Locking Plates System - HLS is to draw two or more aligned bone fragments together to facilitate healing in an adult patient. The I.T.S. Hand Locking Plates System - HLS is indicated for use in fracture fixation of: the phalanges, the metacarpal bones, the carpal bones, for arthrodesis, for corrective osteotomies, and for subcapital radial head fractures. The I.T.S. Hand Locking Plates System is not for spinal use.

Device Story

System consists of metallic bone plates and screws for small bone trauma; plates available in various configurations (straight, T, Y, L, extended, square) with 1.0mm or 1.5mm thickness; utilizes locking and non-locking self-tapping screws (1.5mm, 1.8mm, 2.3mm) and 2.0mm headless compression screws. Used by surgeons in clinical settings to stabilize bone fragments; plates allow intra-operative contouring to fit anatomy. Low-profile design minimizes soft-tissue irritation. System includes associated manual instrumentation (drills, guides, reamers). Provides mechanical fixation to facilitate bone healing.

Clinical Evidence

No clinical data provided; substantial equivalence determined via comparison of technological characteristics and intended use to predicate devices.

Technological Characteristics

Plates: Commercially Pure (CP) Titanium (ASTM F67). Screws: 6-4 Alloyed Titanium (ASTM F136). Surface treatment: Anodized DOTIZE. Manual instrumentation included. Non-sterile. No software or electronic components.

Indications for Use

Indicated for adult patients requiring fracture fixation of phalanges, metacarpal bones, carpal bones, arthrodesis, corrective osteotomies, and subcapital radial head 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

• Stryker - Hand Plating System (K961497 & K060613)
• Synthes - LCP Compact Hand 1.5 (K092247)
• Biomet/DePuy - ALPS Small Bone Locked Plating System (K101240, K061748 & K041081)
• I.T.S. GmbH - Extremity Fixation Systems (K131722)

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized image of three human profiles facing right, layered on top of each other to create a sense of depth.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 26, 2014

I.T.S. GmbH % Mr. Al Lippincott Engineering Consulting Services, Inc. 3150 East 200th Street Prior Lake, Minnesota 55372

Re: K142418 Trade/Device Name: I.T.S. Hand Locking Plates System- HLS Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories Regulatory Class: Class II Product Code: HRS, KTT, HWC Dated: August 20, 2014 Received: August 28, 2014

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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

Page 2 - Mr. Al 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

## Lori A. Wiggins -S

for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

# INDICATIONS FOR USE

K142418 page 1 of 1

#### K142418 510(k) NUMBER:

#### DEVICE NAME: I.T.S. Hand Locking Plates System - HLS

The intended use of the I.T.S. Hand Locking Plates System - HLS is to draw two or more aligned bone fragments together to facilitate healing in an adult patient .

The I.T.S. Hand Locking Plates System - HLS is indicated for use in fracture fixation of:

- the phalanges, 트
- the metacarpal bones. ■
- 트 the carpal bones,
- . for arthrodesis,
- . for corrective osteotomies, and
- . for subcapital radial head fractures.

The I.T.S. Hand Locking Plates System is not for spinal use.

XXXXX AND/OR Over-The-Counter-Use Prescription Use

(21 CFR 801 Subpart C) (Per 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

1 | Page

-

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

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

#### SAFE MEDICAL DEVICES ACT OF 1990

510(k) Summary

| NAME OF FIRM: | I.T.S. GmbH<br>Autal 28<br>Lassnitzhöehe A-8301<br>AUSTRIA<br>www.its-implant.com |
|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) FIRM CONTACT: | Al Lippincott<br>Engineering Consulting Services, Inc.<br>3150 E. 200th St.<br>Prior Lake, MN 55372<br>Tel. No. 952-492-5858<br>e-mail: [e-mail] |
| DATE: | August 20, 2014 |
| TRADE NAME: | I.T.S. Hand Locking Plates System - HLS |
| COMMON NAME: | Small Bone Plating System, Compression Screw |
| CLASSIFICATION: | Plate, Fixation, Bone & Screw, Fixation, Bone |
| | Smooth or threaded metallic bone fixation appliances and<br>accessories (per 21 CRF, Sec. 888.3040). |
| | Single/Multiple Component Metallic Bone Fixation Appliances<br>and Accessories (per 21 CRF, Sec. 888.3030). |
| DEVICE PRODUCT CODE: | HRS |
| SUBSEQUENT PRODUCT CODE: | KTT, HWC |
| SUBSTANTIALLY<br>EQUIVALENT DEVICES | Stryker - Hand Plating System (K961497 & K060613)<br>Synthes - LCP Compact Hand 1.5 (K092247)<br>Biomet/DePuy - ALPS Small Bone Locked Plating System<br>(K101240, K061748 & K041081)<br>I.T.S. GmbH - Extremity Fixation Systems (K131722) |
| DEVICE DESCRIPTION: | The I.T.S. Hand Locking Plates System -- HLS consists of Predicate<br>small bone trauma implant components commonly found with<br>large companies with orthopedic markets in the United States.<br>The I.T.S. HLS System consists of 1.0 and 1.5mm thick plates in<br>Straight, T-Shape, Y-Shape, L-Shape (Left & Right), Extended and<br>Square Plate configurations (with multiple hole sizing) that utilize<br>both Locking and Non-Locking self-tapping Screws in 1.5mm,<br>1.8mm and 2.3mm sizes in various lengths. A 2.0mm Headless<br>Compression Screw in various lengths is also available. |
| | All small plate components are manufactured from Commercialy<br>Pure (CP) Titanium material to ASTM F67 and allow for minor<br>intra-operative forming/contouring by the surgeon to fit the small<br>bone anatomy. All screws consist of a 6-4 Alloyed Titanium<br>material to ASTM F136. All I.T.S. small plates and screws are<br>processed with an anodize DOTIZE surface treatment. The low-<br>profile and contoured small plate design minimizes soft-tissue<br>irritation for the patient.<br>Associated instrumentation such as Plate Holder, Drills, Drill<br>Guides, Depth Guage, Countersink Reamers, Guide Wire and<br>ancillary instrumentation is available. All small plates and screws<br>are provided Non-Sterile. |
| INTENDED USE: | The intended use of the I.T.S. Hand Locking Plates System - HLS<br>is to draw two or more aligned bone fragments together to<br>facilitate healing in an adult patient. |
| | The I.T.S. Hand Locking Plates System - HLS is indicated for<br>use in fracture fixation of: |
| | the phalanges, the metacarpal bones, the carpal bones, for arthrodesis, for corrective osteotomies, and for subcapital radial head fractures. |
| | The I.T.S. Hand Locking Plates System is not for spinal use. |
| EQUIVALENCE: | The I.T.S. GmbH Hand Locking Plates System - HLS is<br>Substantially Equivalent (SE) to the Stryker, Synthes,<br>Biomet/DePuy and I.T.S. GmbH bone plate/screw systems. No<br>nonclinical testing was used in the determination of Substantial<br>Equivalence (SE). |
| SUMMARY OF TECH-<br>NOLOGICAL CHAR-<br>ACTERISTICS | The I.T.S. GmbH Hand Locking Plates System - HLS is Similar in<br>Material, Geometry Design/Markings, and Indications to Stryker,<br>Synthes and Biomet/DePuy predicate system(s) currently sold in<br>the U.S. market. |
| SUMMARY OF SAFETY<br>AND EFFECTIVENESS: | The I.T.S. GmbH Hand Locking Plates System - HLS is shown to<br>be safe and effective for use in fracture fixation of small bones in<br>the hand. |

Page 1 of 2

·

Section XII

் பட்டி போட்டிகள் விட

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

ﻤﺘﺮ

——————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————

Section XII

.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .