(16 days)
No
The summary describes a mechanical implant for fracture fixation and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML.
No
This device is an implant for fracture fixation, which is a structural device, not a therapeutic device designed to cure, treat, mitigate, or prevent disease.
No
The device is described as an implantable fracture fixation system, specifically a titanium plate and screw system, used to stabilize fractures of the distal tibia. Its purpose is mechanical support and stabilization, not the diagnosis of medical conditions.
No
The device description clearly states it is a titanium implant fracture fixation system consisting of plates and screws, which are physical hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Description: The description clearly states that the I.T.S. Pilonplate with Angular Stability is a titanium implant fracture fixation system. It is a physical device designed to be surgically implanted inside the body to stabilize bone fractures.
- Intended Use: The intended use is to fix fractures of the distal tibia in the leg. This is a surgical procedure performed directly on the patient's bone.
The device is a surgical implant, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / Indications for Use
Indications for Use include fixation of complex intra- and extra- articular fractures, osteotomies, high medial malleollar fractures, and low boot top type rotational distal extra-articular shaft fractures of the distal tibia.
Product codes
HRS
Device Description
The I.T.S. Pilonplate with Angular Stability is a low-profile universal left and right titanium 4, 6, and 8 hole plate with various length 4.2mm Cancellous self-tapping and head locking stabilization screws. Additional 4.5mm Cortical screws of various lengths are self-tapping and secure the Pilonplate to the shaft of the tibia bone. The Pilonplate is made from CP titanium according to ASTM F 67-00 and the screws are made from 6-4 alloyed titanium according to ASTM F 136-02. The plate and screws are surface conditioned with a TIODIZE, Type II preparation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal tibia in the leg
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Synthes Pilon Plate (K020602), DePuy/Ace TIMAX Pilon Plate (K982347), Synthes LCP Distal Tibia Plates (K013248), Synthes (USA) Medial Distal Tibia Plates (K001945), Link Small Bone Plates (May Anatomical Plate) (K854825)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Koszoll
510(k) Summary of Safety and Effectiveness Section XII: SAFE MEDICAL DEVICES ACT OF 1990
510(k) Summary
AUG 1 0 2005
| NAME OF FIRM: | I.T.S. Implantat-Technologie-Systeme GmbH
Autal 28
Lassnitzhoehe A-8301
AUSTRIA |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) FIRM CONTACT: | Al Lippincott
Engineering Consulting Services, Inc.
3150 E. 200th St.
Prior Lake, MN 55372 |
| TRADE NAME: | Pilonplate with Angular Stability |
| COMMON NAME: | Bone Plate System |
| CLASSIFICATION: | Plate, Fixation, Bone (see 21 CRF, Sec. 888.3030). |
| DEVICE PRODUCT CODE: | HRS |
| SUBSTANTIALLY
EQUIVALENT DEVICES | Synthes Pilon Plate (K020602)
DePuy/Ace TIMAX Pilon Plate (K982347)
Synthes LCP Distal Tibia Plates (K013248)
Synthes (USA) Medial Distal Tibia Plates (K001945)
Link Small Bone Plates (May Anatomical Plate) (K854825)
Zimmer Periarticular Plating System |
| DEVICE DESCRIPTION: | The I.T.S. Pilonplate with Angular Stability is a low-profile universal left
and right titanium 4, 6, and 8 hole plate with various length 4.2mm
Cancellous self-tapping and head locking stabilization screws.
Additional 4.5mm Cortical screws of various lengths are self-tapping and
secure the Pilonplate to the shaft of the tibia bone. The Pilonplate is
made from CP titanium according to ASTM F 67-00 and the screws are
made from 6-4 alloyed titanium according to ASTM F 136-02. The plate
and screws are surface conditioned with a TIODIZE, Type II preparation. |
| INTENDED USE: | Indications for Use include fixation of complex intra- and extra- articular
fractures, osteotomies, high medial malleollar fractures, and low boot top
type rotational distal extra-articular shaft fractures of the distal tibia. |
| BASIS OF SUBSTANTIAL
EQUIVALENCE: | The I.T.S. Pilonplate with Angular Stability is
substantially equivalent to the Synthes, DePuy/ACE, Link America, and
Zimmer bone plate systems. |
| SUMMARY OF SAFETY
AND EFFECTIVENESS: | The I.T.S. Pilonplate with Angular Stability is shown to be safe and
effective for use in fracture fixation of the distal tibia in the leg. |
Section XII
1
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged around the circle's perimeter.
AUG 1 0 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
I.T.X. Implantat-Technologie-Systeme GmbH c/o 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: K052011
Trade/Device Name: Pilonplate 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: July 15, 2005 Received: July 25, 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.
2
Page 2 - Mr. Albert Lippincott III
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 (240) 276-0120. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Stept Rludn
Mark N. Melkerson
N. Melkers Acting Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Geschäftsführende Gesellschafterin: Dr. Eva Ruprechter
EN ISO 13485
EN ISO 9001
Indications for Use
KOSZOU 510(k) NUMBER: DEVICE NAME: PILONPLATE WITH ANGULAR STABILITY INDICATIONS FOR USE:
The I.T.S. Pilonplate with Angular Stability is a titanium implant fracture fixation system for stabilizing fractures of the distal tibia in the leg.
Indications for Use include fixation of complex intra- and extra-
articular fractures, osteotomies, high medial malleollar fractures, and low boot top type rotational distal extra-articular shaft fractures of the distal tibia.
Prescription Use X 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)
Stipt. Curde
Division Sign-Off
eneral, Restorative and Neurological Developments of CDRH, Office of Device Evaluation (ODE)
510(k) Number K052011