(65 days)
Not Found
No
The device description focuses on the physical components and materials of a pelvic reconstruction system, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is a fracture fixation system designed to stabilize pelvic bone fractures, not to provide therapy itself.
No
Explanation: The I.T.S. Pelvic Reconstruction System (PRS) is described as a system for stabilizing bone fractures and for fracture fixation and reconstruction, which indicates it is a therapeutic or surgical device, not a diagnostic one.
No
The device description clearly details physical hardware components made of titanium, such as plates, screws, rods, and washers, intended for surgical implantation. There is no mention of any software component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the I.T.S. Pelvic Reconstruction System is a system of implants (plates, rods, screws) designed to stabilize bone fractures in the pelvic area. This is a surgical device used in vivo (within the body) for structural support and fixation.
- Lack of Diagnostic Activity: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information about a patient's health status.
Therefore, the I.T.S. Pelvic Reconstruction System is a surgical implant device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the I.T.S. Pelvic Reconstruction System (PRS) is to stabilize one or more pelvic bone fractures in the 'pelvic ring' area of the pelvis of an adult or pediatric patient which include the use of the following pelvic fracture fixation systems.
Indications for use of the I.T.S. PRS Low Profile - Multiple Type - Pelvic Plating System include:
- Fracture reconstruction of the acetabulum, sacrum, illium, and entire pelvic ring,
- Revision surgery of pseoduarthroses, non-unions and mal-unions,
- Ilio-Iliac distance osteosynthesis,
- Osteotomies,
- Arthrodesis,
- Sacroiliac joint dislocations, and
- Symphysis pubis disruptures
Indications for use of the I.T.S. PRS Sacral Rod System include:
- Fixation of fractures of the posterior pelvis,
- Fixation of fractures of the posterior iliac spine,
- Fixation of fractures of the posterior inferior illac spine,
- Dorsal stabilization of the posterior pelvic ring for unstable pelvic ring injuries,
- Fixation of sacral fractures, and
- Fracture dislocations of the sacro-iliac joint
Indications for use of the I.T.S. PRS 7.3mm Cannulated SIJ Traction Screw & Washer include fracture fixation of pelvic bone fractures where indicated and for periacetabular osteotomies.
The system(s) has not been studied in spinal use, and is not intended for use in vertebral column fracture or fusion procedures.
Product codes
HRS, JDW, HWC, HTN
Device Description
The I.T.S. Pelvic Reconstruction System (PRS) encompasses a number of fracture fixation subsystems (multiple pelvic plate designs, sacral threaded rod, and cannulated screw & washer) for facture fixation and reconstruction of pelvic ring fractures in the pelvis.
The I.T.S. PRS Low Profile - Multiple Type - Pelvic Plating System consists of the following plate types: 1) A Straight Plate at a 2.5mm thickness with 10 to 14 hole length sizes, 2) A Curved Plate with a 108mm radius at a 2.5mm thickness with 4 to 16 hole length sizes, 3) A Curved Plate with a 88mm radius at a 2.5mm thickness also with 4 to 16 hole length sizes, 4) A Symphysis Plate at a 4.0mm thickness in both a 4 & 6 hole size, 5) A SacroIlliac-Joint (SIJ) L-Shaped Plate at a 2.5mm thickness in a left and right 5 hole size, and 6) A SIJ Closed Plate at a 2.5mm thickness in a 4 hole size.
All plate designs are low profile in thickness and made from CP of Cancellous (5.9mm std.compression & 5.9mm Locking screws) and Cortical (4.5mm std.compression screw) screw types and length sizes. All bone screws are pre-drilling and self-tapping in design and manufactured from high strength 6-4 Alloyed Titanium. All components (plates & screws) have a TIODIZE II surface treatment preparation. The I.T.S. PRS Sacral Rod System consists of a threaded pin, wedgeshaped washers, and nut/locknut design with one end of the threaded pin having a trocar point. The assembled unit is used to stabilize ilio-iliac posterior pelvic ring disruption injuries. All components are manufactured from high strength 6-4 Alloyed Titanium material and have the TIODIZE II surface preparation. The I.T.S. PRS 7.3mm Cannulated SIJ Traction Screw & Washer is a pre-drilling, self-tapping, and back-tapping screw design for guided reduction of pelvic bone fractures. Washers (flat & curved) are available for use with the screw. All 7.3mm Cannulated Screws & washers are manufactured from high strength 6-4 Alloyed Titanium and have the TIODIZE II surface preparation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvic ring area of the pelvis, acetabulum, sacrum, illium, posterior pelvis, posterior iliac spine, posterior inferior iliac spine, sacro-iliac joint, symphysis pubis
Indicated Patient Age Range
adult or pediatric 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K031573, K001614, K001720, K051642, K013044, K060156
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
K063/66
510(k) Summary of Safety and Effectivenes Section XII:
SAFE MEDICAL DEVICES ACT OF 1990
510(k) Summary
| NAME OF FIRM: | I.T.S. Implantat-Technologie-Systeme GmbH.
Autal 28.
Lassnitzhoehe A - 8301
AUSTRIA | DEC 22 2006 |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| 510(k) FIRM CONTACT: | Al Lippincott
Engineering Consulting Services, Inc.
3150 E. 200th St.
Prior Lake, MN 55372 | |
| TRADE NAME: | Pelvic Reconstruction System (PRS) | |
| COMMON NAME: | Pelvic Bone Fixation Set | |
| CLASSIFICATION: | Plate, Fixation, Bone (see 21 CRF, Sec. 888.3030),
Pin, Fixation, Threaded (see 21 CRF, Sec. 888.3040)
Screw, Fixation, Bone (see 21 CFR, Sec. 888.3040),
Washer, Bolt, Nut (see 21 CFR, Sec. 888.3030) | |
| DEVICE PRODUCT CODE: | HRS | |
| SUBSEQUENT PRODUCT CODE: | JDW, HWC, HTN | |
| SUBSTANTIALLY
EQUIVALENT DEVICES | Synthes 3.5mm Low Profile Pelvic Reconstruction (K031573)
Stryker Trauma Pelvic Set (K001614)
Zimmer Pelvic Reconstruction Set
Synthes Sacral Bar System (K001720)
I.T.S. GmbH FR.O.H. Calcaneus Repair System (K051642)
Synthes 3.9mm Pelvic Screw (K013044)
I.T.S. Straight Plate with Angular Stability & Screw System (K060156) | |
| DEVICE DESCRIPTION: | The I.T.S. Pelvic Reconstruction System (PRS) encompasses a number
of fracture fixation subsystems (multiple pelvic plate designs, sacral
threaded rod, and cannulated screw & washer) for facture fixation and
reconstruction of pelvic ring fractures in the pelvis.
The I.T.S. PRS Low Profile - Multiple Type - Pelvic Plating System
consists of the following plate types: 1) A Straight Plate at a 2.5mm
thickness with 10 to 14 hole length sizes, 2) A Curved Plate with a
108mm radius at a 2.5mm thickness with 4 to 16 hole length sizes, 3) A
Curved Plate with a 88mm radius at a 2.5mm thickness also with 4 to 16
hole length sizes, 4) A Symphysis Plate at a 4.0mm thickness in both a
4 & 6 hole size, 5) A SacroIlliac-Joint (SIJ) L-Shaped Plate at a 2.5mm
thickness in a left and right 5 hole size, and 6) A SIJ Closed Plate at a
2.5mm thickness in a 4 hole size.
All plate designs are low profile in thickness and made from CP | |
1
of Cancellous (5.9mm std.compression & 5.9mm Locking screws) and Cortical (4.5mm std.compression screw) screw types and length sizes. All bone screws are pre-drilling and self-tapping in design and manufactured from high strength 6-4 Alloyed Titanium. All components (plates & screws) have a TIODIZE II surface treatment preparation. The I.T.S. PRS Sacral Rod System consists of a threaded pin, wedgeshaped washers, and nut/locknut design with one end of the threaded pin having a trocar point. The assembled unit is used to stabilize ilio-iliac posterior pelvic ring disruption injuries. All components are manufactured from high strength 6-4 Alloyed Titanium material and have the TIODIZE II surface preparation. The I.T.S. PRS 7.3mm Cannulated SIJ Traction Screw & Washer_is a pre-drilling, self-tapping, and back-tapping screw design for guided reduction of pelvic bone fractures. Washers (flat & curved) are available for use with the screw. All 7.3mm Cannulated Screws & washers are manufactured from high strength 6-4 Alloyed Titanium and have the TIODIZE II surface preparation. The intended use of the I.T.S. Pelvic Reconstruction System (PRS) is to INTENDED USE: stabilize one or more pelvic bone fractures in the pelvic ring area of the pelvis of an adult or pediatric patient which include the use of the following pelvic fracture fixation systems. Indications for use of the I.T.S. PRS Low Profile - Multiple Type_ Pelvic Plating System include: 1) Fracture reconstruction of the acetabulum, sacrum, illium, and entire pelvic ring. 2) Revision surgery of pseoduarthroses, non-unions and mal-unions, 3) Ilio-Iliac distance osteosynthesis, 4) Osteotomies, 5) Arthrodesis. 6) Sacroiliac joint dislocations, and 7) Symphysis pubis disruptures Indications for use of the I.T.S. PRS Sacral Rod System include: 1) Fixation of fractures of the posterior pelvis, 2) Fixation of fractures of the posterior iliac spine, 3} Fixation of fractures of the posterior inferior iliac spine, 4) Dorsal stabilization of the posterior pelvic ring for unstable pelvic ring injuries, 5) Fixation of sacral fractures, and 6) Fracture dislocations of the sacro-iliac joint Indications for use of the I.T.S. PRS 7.3mm Cannulated SIJ Traction Screw & Washer include fracture fixation of pelvic bone fractures where indicated and for periacetabular osteotomies. The system(s) has not been studied in spinal use, and is not intended for use in vertebral column fracture or fusion procedures. The I.T.S. Pelvic Reconstruction System (PRS) is substantially BASIS OF SUBSTANTIAL equivalent to the Synthes, Zimmer, and Stryker pelvic reconstruction EQIVLAENCE: systems and the I.T.S. GmbH stabilizing bone plating systems. The I.T.S. Pelvic Reconstruction System (PRS) is shown to be safe and SUMMARY OF SAFETY effective for use in 'pelvic ring' bone fracture fixation of the pelvis. AND EFFECTIVENESS:
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
I.T.S Implantat-Technologie-Systeme GmbH % Mr. Al Lippincott Engineering Consulting Services, Inc. 3150 E. 200th Street Prior Lake, Minnesota 55372
DEC 2 2 2006
Re: K063166
Trade/Device Name: Pelvic Reconstruction System (PRS) Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, JDW, HWC Dated: October 13, 2006 Received: October 18, 2006
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.
3
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 Office of Compliance at (240) 276-0210 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbag Buchnd
to
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/1 description: The image shows a logo with the letters "U.T.S." in a bold, sans-serif font, with a right-pointing arrow extending from the right side of the "S". The letters are arranged horizontally, and the arrow is stylized with a gradient effect. Below the logo, there is a textured or patterned background that appears to be composed of small dots or pixels, creating a visually noisy effect.
Indications for Use
510(k) NUMBER: K063166
DEVICE NAME: PELVIC RECONSTRUCTION SYSTEM (PRS)
The intended use of the I.T.S. Pelvic Reconstruction System (PRS) is to stabilize one or more pelvic bone fractures in the 'pelvic ring' area of the pelvis of an adult or pediatric patient which include the use of the following pelvic fracture fixation systems.
Indications for use of the I.T.S. PRS Low Profile - Multiple Type - Pelvic Plating System include:
-
- Fracture reconstruction of the acetabulum, sacrum, illium, and entire pelvic ring,
-
- Revision surgery of pseoduarthroses, non-unions and mal-unions,
-
- Ilio-Iliac distance osteosynthesis,
-
- Osteotomies,
-
- Arthrodesis,
-
- Sacroiliac joint dislocations, and
-
- Symphysis pubis disruptures
Indications for use of the I.T.S. PRS Sacral Rod System include:
-
- Fixation of fractures of the posterior pelvis,
-
- Fixation of fractures of the posterior iliac spine,
-
- Fixation of fractures of the posterior inferior illac spine,
-
- Dorsal stabilization of the posterior pelvic ring for unstable pelvic ring injuries,
-
- Fixation of sacral fractures, and
-
- Fracture dislocations of the sacro-iliac joint
Indications for use of the I.T.S. PRS 7.3mm Cannulated SIJ Traction Screw & Washer include fracture fixation of pelvic bone fractures where indicated and for periacetabular osteotomies.
The system(s) has not been studied in spinal use, and is not intended for use in vertebral column fracture or fusion procedures.
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)
Barbara Buchen
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of General. Restorative.
510(k) Number K063166