(61 days)
The I.T.S. Distal Humeral Plates with Angular Stability is a titanium implant fracture fixation system for stabilizing fractures of the distal humerus in the elbow of a pediatric or adult patient.
Indications for Use include intra-articular fractures, supracondylar fractures, osteotomies, and non-unions of the distal humerus.
The I.T.S. GmbH Distal Humeral Plates with Angular Stability is a fracture fixation plating system for repairing factures located in the distal area of the humerus in the elbow (in the area of medial and lateral epicondyles of the distal humerus). The Distal Humeral Plates consist of two plate designs as a medial (8 hole) and dorsolateral (5 hole) left and right plate configuration - anatomically pre-contoured to fit the distal humerus human anatomy and manufactured from Commercialy Pure (CP) Titanium material for minor intra-operative forming by the surgeon. The offset opposite location of the plates on the medial and lateral epicondyles provide a girder-like construct for difficult bone fracture reconstruction stability. The added benefit of locking screws within each plate and up to a +- 15° angle position allows a fixed-angle contruct of screw-to-plate and offers angle-flexibility in screw positioning for further optimal fracture stability. Small holes in the plate allow intermediate 'k-wire bone fracture segment positioning' for reducing and aligning the fracture bone segments while positioning the plates and introducing multiple sizes of locking/non-locking screws as needed for stabilizing the fracture(s) - when using optional x-ray fluroscopy. The system offers a 3.5mm locking and non-locking cortical screw and a 4.2mm locking cancellous screw in multiple lengths manufactured from High Strength 6-4 Alloyed Titanium material. All plates and screws are processed with a TIODIZE II surface treatment - which improves the material surface hardness and biocompatibility to adjacent tissues. The low-profile and contoured left and right plate design minimizes soft-tissue irritation for the patient. A full compliment of instrumentation is available for use with the system.
I am sorry but the provided text does not contain information about acceptance criteria, device performance results, or a clinical study. The document is a 510(k) summary for a medical device (Distal Humeral Plates with Angular Stability) seeking marketing clearance based on substantial equivalence to predicate devices, not on direct performance against acceptance criteria from a study. It outlines the device description, intended use, and substantial equivalence to legally marketed devices. Therefore, I cannot generate the requested table and answer the study-related questions based on this input.
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510(k) Summary of Safety and Effectiveness Section XII:
SAFE MEDICAL DEVICES ACT OF 1990
510(k) Summary
MAR 2 6 2008
| NAME OF FIRM: | I.T.S. Implantat-Technologie-Systeme GmbH.Autal 28.Lassnitzhoehe A-8301AUSTRIA |
|---|---|
| 510(k) FIRM CONTACT: | Al LippincottEngineering Consulting Services, Inc.3150 E. 200th St.Prior Lake, MN 55372 |
| TRADE NAME: | Distal Humeral Plates with Angular Stability |
| COMMON NAME: | Bone Plate System |
| CLASSIFICATION: | Plate, Fixation, Bone |
| (see 21 CRF, Sec. 888.3030). | |
| DEVICE PRODUCT CODE: | HRS |
| SUBSTANTIALLYEQUIVALENT DEVICES | Synthes 3.5mm LCP Distal Humerus System (K033995)Acumed Congruent Bone Plate System (K012655), (K063460),(K071715)Zimmer Periarticular Locking Plates and Screws (K040593) |
| DEVICE DESCRIPTION: | The I.T.S. GmbH Distal Humeral Plates with Angular Stability is afracture fixation plating system for repairing factures located in thedistal area of the humerus in the elbow (in the area of medial andlateral epicondyles of the distal humerus). The Distal HumeralPlates consist of two plate designs as a medial (8 hole) anddorsolateral (5 hole) left and right plate configuration -anatomically pre-contoured to fit the distal humerus humananatomy and manufactured from Commercialy Pure (CP) Titaniummaterial for minor intra-operative forming by the surgeon. Theoffset opposite location of the plates on the medial and lateralepicondyles provide a girder-like construct for difficult bonefracture reconstruction stability. The added benefit of lockingscrews within each plate and up to a +- 15° angle position allows afixed-angle contruct of screw-to-plate and offers angle-flexibilityin screw positioning for further optimal fracture stability. Smallholes in the plate allow intermediate 'k-wire bone fracture segmentpositioning' for reducing and aligning the fracture bone segmentswhile positioning the plates and introducing multiple sizes oflocking/non-locking screws as needed for stabilizing the fracture(s) |
| - when using optional x-ray fluroscopy. The system offers a3.5mm locking and non-locking cortical screw and a 4.2mmlocking cancellous screw in multiple lengths manufactured fromHigh Strength 6-4 Alloyed Titanium material. All plates andscrews are processed with a TIODIZE II surface treatment - whichimproves the material surface hardness and biocompatibility toadjacent tissues. The low-profile and contoured left and right platedesign minimizes soft-tissue irritation for the patient. A fullcompliment of instrumentation is available for use with the system. | |
| INTENDED USE: | The intended use of the I.T.S. Distal Humeral Plates with AngularStability is to stabilize fractures of the distal humerus in the elbowof a pediatric or adult patient. |
| Indications for use include intra-articular fractures, comminutedsupracondylar fractures, osteotomies, and non-unions of the distalhumerus. | |
| BASIS OF SUBSTANTIALEQUIVALENCE: | The I.T.S. Distal Humeral Plates with Angular Stability issubstantially equivalent to the Synthes and Acumed distal humeralbone plate systems. |
| SUMMARY OF SAFETYAND EFFECTIVENESS: | The I.T.S. Distal Humeral Plates with Angular Stability is shownto be safe and effective for use in fracture fixation of the distalhumerus in the elbow. |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular pattern around the symbol. The caduceus is depicted in black, and the text is also in black. The logo is simple and recognizable, representing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 6 2008
I.T.S. GmbH % Engineering Consulting Services, Inc. Mr. Al Lippincott Official Correspondent 3150 East 200th Street Prior Lake, MN 55372
Re: K080184 Trade/Device Name: Distal Humeral Plates with Angular Stability Regulation Number: 21 CFR 888.3030 Regulation Names: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: January 18, 2008 Received: January 25, 2008
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.
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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Millman
Mark N. Melkerson 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: DEVICE NAME: DISTAL HUMERAL PLATES WITH ANGULAR STABILITY INDICATIONS FOR USE:
The I.T.S. Distal Humeral Plates with Angular Stability is a titanium implant fracture fixation system for stabilizing fractures of the distal humerus in the elbow of a pediatric or adult patient.
Indications for Use include intra-articular fractures, supracondylar fractures, osteotomies, and non-unions of the distal humerus.
Prescription Use
Over-The-Counter-Use AND/OR
(Per 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
sion Sign-Off) Division of General, Restorative, and Neurological Devices
Section XI
510(k) Number K080184
I.T.S. Implantat-Technologie-Systeme GmbH part of the MED-HOLD GROUP Autal 28, 8301 Lassnitzhöhe, Austria
Tel.: +43 | 316 | 211 21 0 Fax: +43 | 316 | 211 21 20 office@its-implant.com www.its-implant.com
ATU43757109 FN 163966 b FBG LG Graz
DVR 0934704 ARA LN 5062 EN ISO 13485
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
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.(b)
Classification. Class II.