(120 days)
Not Found
No
The summary describes a mechanical implant (plate and screws) for fracture fixation and does not mention any software, algorithms, or data processing capabilities that would indicate AI/ML.
No
The device is a fracture plate system used for fixation of calcaneal fractures, which is a structural support device rather than a device that produces a therapeutic effect such as treating or curing a disease.
No
The device is a fracture plate system used for fixation, not for diagnosing medical conditions.
No
The device description clearly states it is a physical plate made of 316L Stainless Steel with specific dimensions and screw holes, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The Tornier Calcaneal Fracture Plate System is a surgical implant designed to fix broken bones in the heel (calcaneus). It is a physical device used in the body during surgery, not a test performed on a sample outside the body.
- Intended Use: The intended use clearly states it's for fixing fractures and osteotomies of the calcaneus, which is a surgical procedure.
The information provided describes a surgical implant, not a diagnostic test.
N/A
Intended Use / Indications for Use
The Tornier Calcaneal Fracture Plate System is indicated for fractures and osteotomies of the calcaneus, including, but not limited to extra-articular, intra-articular, joint depression, tongue-type and severely comminuted fractures.
The Tornier Calcaneal Fracture Plate System is indicated for fractures and osteotomies of the calcaneus, including, but not limited to extra-articular, intra-articular, joint depression, tongue-type and severely comminuted fractures.
Product codes (comma separated list FDA assigned to the subject device)
LXT, HRS
Device Description
The Tornier Calcaneal Fracture Plate System is a low profile, anatomical plate designed for the fixation of Calcaneal fractures. The plate has 7 screw holes, which accept 4mm diameter screws. The plates are 2.0 to 3mm thick, comes in 3 sizes (Large, Medium and Small) for optimal anatomic fit and are available for right and left placements. The Tornier Calcaneal Fracture Plate System is made out of 316L Stainless Steel material per ASTM F138.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
calcaneus
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): 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.
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
SECTION 7
JUL - 2 2009
510 (k) SUMMARY
The following information summarizes the safety and effectiveness information upon which the substantial equivalence determination for the Calcaneal Fracture Plate System is based.
| Prepared: | Monday, February 23, 2009 |
|---|---|
| Applicant: | Tornier, Inc. |
| 3601 West 76th Street | |
| Suite 200 | |
| Edina, MN 55435 | |
| Registration Number: 9100540 | |
| Telephone: | 978-232-9997 |
| Fax: | 978-232-9998 |
| Contact: | Brahim Hadri (Sr. Regulatory Affairs Specialist (RAC US) |
| Device Name: | Calcaneal Fracture Plate System |
| Device Trade Name: | (tbd) |
| Device Classification: | Class II |
| Reviewing Panel: | Orthopedic |
| Regulation Number | 888.3030, Single/multiple component metallic bone fixation |
| appliances and accessories | |
| Product Code: | LXT |
| Description: | The Tornier Calcaneal Fracture Plate System is a low profile, |
| anatomical plate designed for the fixation of Calcaneal | |
| fractures. The plate has 7 screw holes, which accept 4mm | |
| diameter screws. The plates are 2.0 to 3mm thick, comes in 3 | |
| sizes (Large, Medium and Small) for optimal anatomic fit and | |
| are available for right and left placements. The Tornier | |
| Calcaneal Fracture Plate System is made out of 316L Stainless | |
| Steel material per ASTM F138. | |
| Predicate Devices: | The Synthes Locking Calcaneal Plates, K991407. |
| The Newdeal CalcaneaTM Plate, K041786 |
1
SECTION 7
510 (k) SUMMARY (continued)
Indications for Use
The Tornier Calcaneal Fracture Plate System is indicated for fractures and osteotomies of the calcaneus, including, but not limited to extra-articular, intra-articular, joint depression, tongue-type and severely comminuted fractures.
Comparison of Technological Characteristics:
The Tornier Calcaneal Fracture Plate System, Synthes Locking Calcaneal Plates, and the Newdeal Calcanea™ Plate, K041786 have equivalent Intended Use and are indicated for fixation of fractures and osteotomies of the calcaneus
Like the predicate; the Tornier Calcaneal Fracture Plate System is offered in 316L Stainless Steel material per ASTM F138..
Conclusion:
The Tornier Calcaneal Fracture Plate System is substantially equivalent to commercially marketed devices, the Synthes Locking Calcaneal Plates, K991407 and the Newdeal Calcanea™ Plate, K041786
The Tornier Calcaneal Fracture Plate System does not raise any new issues of scientific technology, safety or effectiveness.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features an eagle with its wings spread, symbolizing the federal government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Tornier, Inc. % Mr. Brahim Hadri Senior Regulatory Affairs Specialist 3601 West 76th Street, Suite 200 Edina, Minnesota 55435
JUL - 2 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Re: K090582
Trade/Device Name: Calcaneal Fracture Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: June 19, 2009 Received: June 30, 2009
Dear Mr. Hadri:
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 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 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.
3
Page 2 – Mr. Brahim Hadri
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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Валавићтетт
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SECTION 6 Indications for Use Statement
Indications for Use 510(k) Number (if known): N/A
Device Name: Calcaneal Fracture Plate System
Indications for Use: ·
The Tornier Calcaneal Fracture Plate System is indicated for fractures and osteotomies of the calcaneus, including, but not limited to extra-articular, intra-articular, joint depression, tongue-type and severely comminuted fractures.
Prescription Use Over-The-Counter Use X AND/OR (21 CFR 801 Subpart C), (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEÈDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Texte
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices :
510(k) Number K090582