(53 days)
No
The device description and intended use clearly define a mechanical implant system for fracture fixation, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
Yes
The device is an implantable fracture fixation system used for repairing bone fractures, which is a therapeutic intervention.
No
The device description indicates it is a titanium implant system for repairing bone fractures, which is a therapeutic function rather than a diagnostic one.
No
The device description clearly states it is a titanium implant fracture fixation system consisting of plates and screws, which are physical hardware components. There is no mention of software as the primary or sole component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The I.T.S. Fibula Plate PROlock with Angular Stability is a titanium implant designed for surgical fixation of bone fractures. It is physically implanted into the body to stabilize broken bones.
- Intended Use: The intended use clearly states it's for "repairing bone fractures" and "fracture fixation." This is a therapeutic intervention, not a diagnostic test performed on a specimen outside the body.
Therefore, this device falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The I.T.S. Fibula Plate PROlock with Angular Stability is a titanium implant fracture fixation system for repairing bone fractures located from the middle to the distal third of the fibula.
Indications for Use include metaphysial and diaphysial fracture fixation of acute fractures, malunions, and non-unions of the distal fibula. Other indications include corrective osteotomy and open and closed fractures.
The system is not intended for spinal use.
Product codes
HRS
Device Description
The I.T.S. Fibula Plate PROlock with Angular Stability is a low-profile left and right titanium plate in three lengths with various length cortical and/or cancellous locking self-tapping stabilization screws. The fibula plate 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
fibula, distal fibula
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)
The I.T.S. Fibula Plate PROlock with Angular Stability is shown to be safe and effective for use in fracture fixation of bone in the distal fibula.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K000684, K051986, K013248, K011335, K011334, K001945, K040593, K033639
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
| Section XII: 510(k) Summary of Safety and Effectiveness
| 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 | |||
| 510(k) FIRM CONTACT: | Al Lippincott | ||
| Engineering Consulting Services, Inc. | |||
| 3150 E. 200th St. | |||
| Prior Lake, MN 55372 | FEB - 2 2007 | ||
| TRADE NAME: | Fibula Plate PROlock 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 Semi-Tubular Plate (Pre – Amendment) | ||
| Synthes Small Fragment System (K000684) | |||
| Synthes 4.5mm LCP Straight Reconstruction Plates (K051986) | |||
| Synthes LCP Distal Tibia Plates (K013248) | |||
| Synthes One-Third Tubular DCL Plate (K011335) | |||
| Synthes Curved Reconstruction Plate (K011334) | |||
| Synthes Medial Distal Tibia Plates (K001945) | |||
| Zimmer Periarticular Plating System (K040593) | |||
| Acumed Lower Extremity Congruent Plate System (K033639) | |||
| DEVICE DESCRIPTION: | The I.T.S. Fibula Plate PROlock with Angular Stability is a low-profile | ||
| left and right titanium plate in three lengths with various length cortical | |||
| and/or cancellous locking self-tapping stabilization screws. The fibula | |||
| plate 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- |
- The plate and screws are surface conditioned with a TIODIZE, Type
II preparation. | | |
| INTENDED USE: | The I.T.S. Fibula Plate PROlock with Angular Stability is a titanium
implant fracture fixation system for repairing bone fractures located
from the middle to the distal third of the fibula. Indications for Use
include metaphysial and diaphysial fracture fixation of acute fractures,
malunions, and non-unions of the distal fibula. Other indications
include corrective osteotomy and open and closed fractures.
The system is not intended for spinal use. | | |
| BASIS OF SUBSTANTIAL
EQUIVLAENCE: | The I.T.S. Fibula Plate PROlock with Angular Stability is substantially
equivalent to the Pre-Amendment Synthes, current Synthes, Zimmer,
and Acumed bone plate systems. | | |
| SUMMARY OF SAFETY
AND EFFECTIVENESS: | The I.T.S. Fibula Plate PROlock with Angular Stability is shown to be
safe and effective for use in fracture fixation of bone in the distal fibula. | | |
| | Page 1 of 1 | | Section XII |
1
Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the eagle. The eagle is depicted in a simple, black and white design.
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
FEB - 2 2007
K063672 Re:
Trade/Device Name: Fibula Plate PROlock 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: January 24, 2007 Received: January 25, 2007
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 16 wor navaior 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.
2
Page 2 - Mr. Al Lippincott
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Buehrig
for
Mark N. Melkerson Director Division of General, Restorative . and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
S. Implant-Technology-Systems GmbH
Geschäftsführende Gesellschafterin: Dr. Eva Ruprechter
el ++43 (0)316 211 21 0 x ++43 (0)316 211 21 20 fice@its-implant.com
Indications for Use 510(k) NUMBER: __K063672 DEVICE NAME: FIBULA PLATE PROLOCK WITH ANGULAR STABILITY INDICATIONS FOR USE:
The I.T.S. Fibula Plate PROlock with Angular Stability is a titanium implant fracture fixation system for repairing bone fractures located from the middle to the distal third of the fibula.
Indications for Use include metaphysial and diaphysial fracture fixation of acute fractures, malunions, and non-unions of the distal fibula. Other indications include corrective osteotomy and open and closed fractures.
The system is not intended for spinal use.
Prescription Use
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
(Division Sign-Off) (Steffensen/McNutt/D.A. Mann)
Division of General, Restoff Restoff Reper of CDRH, Office of Device Evaluation (ODE) and Neurological Devices
11/17 Almo FN 163966 b DVR 0934704 ARA LN 5062 ATU 43757109 Section XI