(231 days)
Not Found
No
The device description focuses on the mechanical components of a fracture fixation system (plates, screws, instrumentation) and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are also marked as "Not Found".
Yes
The device is a titanium implant system designed for stabilizing bone fractures in long bones. Its purpose is to repair and fix fractures, which aligns with the definition of a therapeutic device aimed at treating a medical condition.
No
This device is a titanium implant fracture fixation system used for stabilizing fractures in long bones. It is a treatment device, not a diagnostic one.
No
The device description clearly outlines a system of titanium plates, screws, and instrumentation for fracture fixation, which are physical hardware components.
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, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The I.T.S. LRS Locking Reconstruction System is a surgical implant used to physically stabilize bone fractures. It is a mechanical device inserted into the body.
- Intended Use: The intended use is to fix fractures in long bones, not to analyze biological samples.
- Device Description: The description details plates, screws, and instrumentation for surgical implantation and fixation.
- Input Imaging Modality: The use of x-ray fluoroscopy is for guiding the surgical procedure and confirming the position of the implant, not for analyzing biological samples.
The device is a surgical implant/device used for orthopedic procedures.
N/A
Intended Use / Indications for Use
The I.T.S. LRS Locking Reconstruction System is a titanium implant fracture fixation system for stabilizing fractures in long bones of the distal femur and proximal lateral tibia of all pediatric patients (less than or equal to 21 years old) or adult patient.
Indications for Use include distal/proximal shaft fractures, supracondylar fractures, intra-articular fractures, metaphyseal fractures, osteotomies, nonunions and malunions of the distal femur and proximal tibia.
The system is not intended for spinal use.
Product codes (comma separated list FDA assigned to the subject device)
HWC, HRS
Device Description
The I.T.S. LRS (Locking Reconstruction System) consisting of the DFL (Distal Femur Locking) and PTL (Proximal Lateral Tibia Locking) are fracture fixation plating systems for repairing long bone factures located in the distal femur and proximal tibia in the human body. The DFL Plates consist of three plate lengths of 5, 9, & 13 hole pre-contoured shape in a left/right configuration to fit the distal femur and the PTL Plates consist of three plate lengths of 7, 12, & 17 hole precontoured shape in a left/right configuration to fit the proximal lateral tibia. Both plate systems are manufactured from Commercialy Pure (CP) Titanium material to allow for minor intra-operative forming/contouring by the surgeon. The plate design concept offers an extramedullary, internal fixation system, minimal bone contact, and a locked fixed-angle construct using angular stability locking screws into the plate. Both locking and non-locking high strength 6-4 Alloyed Titanium screws in a 5.9mm cancellous and 4.5mm cancellous/cortical sizes are offered. All screws are self-tapping for insertion into bone. The design intent of the aiming guide instrumentation allows the surgeon to prepare percutaneous targeting of screws through 'minimal invasive' stab incisions. This aiming guide instrument ensures that all targeted screws will be properly inserted and locked to the plate. The aiming guide instrumentation is radiolucent to allow offset (90 degree) fluroscopy evaluation in bone fragment reduction of the fracture site and confirmation of screw engagement into the plate. Small holes in the plate allow intermediate 'k-wire bone fracture segment positioning' for reducing and aligning the fracture bone segments while positioning the plate and the introduction of multiple sizes of locking/nonlocking screws as needed for stabilizing the fracture - when using x-ray fluroscopy.
All I.T.S. LRS - DFL & PTL plates and screws are processed with a TIODIZE II surface treatment. A full compliment of instrumentation is available for use with the system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray fluroscopy
Anatomical Site
distal femur and proximal tibia
Indicated Patient Age Range
all pediatric patents (less than or equal to 21 years old) or adult patient
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)
The Engineering Rationale is conclusive in showing greater size geometries, identical materials, and comparable 'Indications for Use' for the I.T.S. LRS - DFL & PTL plating systems in relation to the I.T.S. Straight Plate system (K060156).
The I.T.S. LRS Locking Reconstruction System is shown to be safe and effective for use in fracture fixation of long bones in the distal femur and proximal tibia.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K961413, K061012, K092015, K070906, K060156
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k) Summary of Safety and Effectiveness
SAFE MEDICAL DEVICES ACT OF 1990 510(k) Summary
| NAME OF FIRM: | I.T.S. 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:
Bone Plate System COMMON NAME:
Plate, Fixation, Bone & CLASSIFICATION:
Smooth or threaded metallic bone fixation appliances and accessories.
(see 21 CRF, Sec. 888.3030 & Sec. 888.3040).
I.T.S. LRS Locking Reconstruction System
DEVICE PRODUCT CODE:
HWC SUBSEQUENT PRODUCT CODE:
| SUBSTANTIALLY | Synthes LISS (ALPS) System (K961413) |
|---|---|
| EQUIVALENT DEVICES | Stryker AxSOS Locked Plating System (K061012) |
| Smith&Nephew PERI-LOC Periarticular Locked Plate (K092015) | |
| Zimmer Periarticular Locking Plates and Screws (K070906) | |
| I.T.S. GmbH Straight Plate with Angular Stability (K060156) |
HRS
The I.T.S. LRS (Locking Reconstruction System) consisting of the DEVICE DESCRIPTION: DFL (Distal Femur Locking) & PTL (Proximal Lateral Tibia Locking) are fracture fixation plating systems for repairing long bone factures located in the distal femur and proximal tibia in the human body. The DFL Plates consist of three plate lengths of 5, 9, & 13 hole pre-contoured shape in a left/right configuration to fit the distal femur and the PTL Plates consist of three plate lengths of 7, 12, & 17 hole precontoured shape in a left/right configuration to fit the proximal lateral tibia. Both plate systems are manufactured from Commercialy Pure (CP) Titanium material to allow for minor intra-operative forming/contouring by the surgeon. The plate design concept offers an extramedullary, internal fixation system, minimal bone contact, and a locked fixed-angle construct using angular stability locking screws into the plate. Both locking and non-locking high strength 6-4 Alloyed Titanium screws in a
Section XII
AUG - 5 2010
1
I.T.S. GmbH - K0093868 - 510(k) Summary:
5.9mm cancellous and 4.5mm cancellous/cortical sizes are offered. All screws are self-tapping for insertion into bone. The design intent of the aiming guide instrumentation allows the surgeon to prepare percutaneous targeting of screws through 'minimal invasive' stab incisions. This aiming guide instrument ensures that all targeted screws will be properly inserted and locked to the plate. The aiming guide instrumentation is radiolucent to allow offset (90 degree) fluroscopy evaluation in bone fragment reduction of the fracture site and confirmation of screw engagement into the plate. Small holes in the plate allow intermediate 'k-wire bone fracture segment positioning' for reducing and aligning the fracture bone segments while positioning the plate and the introduction of multiple sizes of locking/nonlocking screws as needed for stabilizing the fracture - when using x-ray fluroscopy.
All I.T.S. LRS - DFL & PTL plates and screws are processed with a TIODIZE II surface treatment. A full compliment of instrumentation is available for use with the system.
INTENDED USE:
The I.T.S. LRS Locking Reconstruction System is a titanium implant fracture fixation system for stabilizing fractures in long bones of the distal femur and proximal lateral tibia of all pediatric patents (less than or equal to 21 years old) or adult patient.
Indications for Use include distal/proximal shaft fractures, supracondylar fractures, intra-articular fractures, metaphyseal fractures, osteotomies, nonunions and malunions of the distal femur and proximal tibia.
The system(s) is not intended for spinal use.
EQUIVALENCE:
The I.T.S. LRS Locking Reconstruction System is substantially equivalent to the Synthes, Zimmer, Stryker, Smith & Nephew and I.T.S. GmbH bone plate systems. The Engineering Rationale is conclusive in showing greater size geometries, identical materials, and comparable 'Indications for Use' for the I.T.S. LRS - DFL & PTL plating systems in relation to the I.T.S. Straight Plate system (K060156).
SUMMARY OF SAFETY AND EFFECTIVENESS:
The I.T.S. LRS Locking Reconstruction System is shown to be safe and effective for use in fracture fixation of long bones in the distal femur and proximal tibia.
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Image /page/2/Picture/0 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of an eagle with its wings spread.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Implantat-Technologie-Systeme Gmbh % Engineering Consultant Services, Inc. Mr. Al Lippincott 3150 East 200th Street Prior Lake, Minnesota 55372
AUG - 5 2010
Re: K093868
Trade/Device Name: I.T.S. LRS Locking Reconstruction System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS, HWC Dated: July 2, 2010 Received: July 6, 2010
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
3
Page 2 - Mr. Al Lippincott
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Mark N. Melkerson · Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows a logo with the letters "I.T.S." to the right of a stylized letter "O". The letters "I.T.S." are in a simple, sans-serif font. Below the logo, there is some text that is too blurry to read. The logo appears to be for a company or organization with the initials "I.T.S."
Indications for Use
510(k) NUMBER: K0,93868
AUG-5 2010
DEVICE NAME: I.T.S. LRS Locking Reconstruction System
INDICATIONS FOR USE:
The I.T.S. LRS Locking Reconstruction System is a titanium implant fracture fixation system for stabilizing fractures in long bones of the distal femur and proximal lateral tibia of all pediatric patients (less than or equal to 21 years old) or adult patient.
Indications for Use include distal/proximal shaft fractures, supracondylar fractures, intra-articular fractures, metaphyseal fractures, osteotomies, nonunions and malunions of the distal femur and proximal tibia.
The system is not intended for spinal use.
Prescription Use AND/OR Over-The-Counter-Use (Per 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
IPLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
K093868 Mark Mullikin
(Division Sign-Oft) (Division Sign-Sign-Sical, Orthopedic, and Restorative Devices
510(k) Number K093868
ATU43757109
Concurrence of CDRH, Office of Device Evaluation (ODE)
p, lofl.
DVR 0934704
Tel .: +43 | 316 | 211 21 0