(85 days)
No
The device description and performance studies focus on the mechanical properties and equivalence to predicate devices, with no mention of AI/ML capabilities or data-driven performance metrics.
No.
The device is described as a system of plates and screws for stabilizing and fixating fractures and performing fusions and reconstructions in the foot, which are surgical interventions rather than therapeutic treatments.
No
The device is described as a system of bone plates and screws used for fixation, fusion, and reconstruction in the foot, which are therapeutic interventions rather than diagnostic processes.
No
The device description explicitly states it consists of "a variety of bone 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 INTEGRA® Total Foot System consists of bone plates and screws. These are implanted inside the body to fix fractures, osteotomies, and fusions.
- Intended Use: The intended use is for the stabilization and fixation of bones in the foot, which is a surgical procedure performed on the body.
The device is a surgical implant, not a diagnostic tool that analyzes samples.
N/A
Intended Use / Indications for Use
INTEGRA® Total Foot System is indicated for skeletally mature patients for the following:
- Stabilization and fixation of fresh fractures
- Intra and extra articular fractures, joint depression, and multi-fragmentary fractures
- Revision procedures, joint fusion, and reconstruction of small bones of the feet.
Product codes
HRS, HWC
Device Description
The INTEGRA "Total Foot System consists of a variety of bone plates and screws intended to be used in fixating fractures, osteotomies, and fusions in the adult foot. The various plate designs are divided into forefoot, midfoot, and rearfoot applications. Plate designs include MPJ fusion, Opening Wedge, Calcaneus, Dwyer, Interpositioning, Lapidus, Reconstruction, 2-10 Hole Tarsalis, fibula, and fibula tubular plates. Screws include both locking and non-locking designs. All plates and screws are manufactured from ASTM F136 Ti-6Al-4V ELI alloy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot
Indicated Patient Age Range
skeletally mature patients
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 INTEGRA® Total Foot System and Ascension Total Foot System (K100502) are both systems comprised of titanium plates and screws with identical indications for use. Additional predicate devices have been included to justify the inclusion of new components to the system. All new or redesigned components to this system were examined, and results of the verification activities demonstrated that the tests were acceptable and the components substantially equivalent to the predicate devices identified.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K100502, K091614, K094037, K102282, K063049
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
K123000(pg 1/2)
Integra LifeSciences Corporation Traditional 510(k) Premarket Notification INTEGRA® Total Foot System
510(K) SUMMARY
INTEGRA® Total Foot System
Submitter's name and address:
Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536 USA
Contact person and telephone number:
Facsimile: 609.275.9445
Stephen Beier Senior Specialist, Regulatory Affairs Telephone: 609.936.5436
Date Summary was prepared:
September 26, 2012
Name of the device:
Proprietary Name: INTEGRA Total Foot System Common Name: Plate, Fixation, Bone Product Code: HRS Subsequent Product Code: HWC (Screw, Fixation, Bone) Classification Panel: Orthopedic
Substantial Equivalence:
INTEGRA Total Foot System is substantially equivalent in function and intended use to the predicate device detailed in the following table.
| 510(k) Number | Product Code | Trade Name | Manufacturer |
|---|---|---|---|
| K100502 | HRS; HWC | Ascension Total Plate | |
| System | Integra LifeSciences | ||
| Corporation, formally | |||
| Ascension Orthopedics, | |||
| Inc. | |||
| K091614 | HRS; HWC | Osetomed Foot Plating | |
| System | Osteomed, L.P. | ||
| K094037 | KTT | TC Plating System | Orthopro, LLC |
| K102282 | HRS | VariAx Locked Plating | |
| System | Howmedica Osteonics | ||
| Corp | |||
| K063049 | HRS | Synthes (USA) Modular | |
| Mini Fragment LCP | |||
| System | Synthes (USA) |
Device Description:
The INTEGRA "Total Foot System consists of a variety of bone plates and screws intended to be used in fixating fractures, osteotomies, and fusions in the adult foot. The various plate designs are divided into forefoot, midfoot, and rearfoot applications. Plate designs include MPJ fusion, Opening Wedge, Calcaneus, Dwyer, Interpositioning, Lapidus, Reconstruction, 2-10 Hole Tarsalis,
DEC 2 1 2012
1
Integra LifeSciences Corporation Traditional 510(k) Premarket Notification INTEGRA® Total Foot System
fibula, and fibula tubular plates. Screws include both locking and non-locking designs. All plates and screws are manufactured from ASTM F136 Ti-6Al-4V ELI alloy.
Intended Use:
INTEGRA Total Foot System is indicated for skeletally mature patients for the following:
- Stabilization and fixation of fresh fractures
- Intra and extra articular fractures, joint depression, and multi-fragmentary fractures
- Revision procedures, joint fusion, and reconstruction of small bones of the feet.
Substantial Equivalence Comparison:
Components of the INTEGRA Total Foot System are similar in design and materials to the predicate devices: (K100502, K091614, K094037, K102282, and K063049).
Testing and Test Results:
The INTEGRA® Total Foot System and Ascension `Total Foot System (K100502) are both systems comprised of titanium plates and screws with identical indications for use. Additional predicate devices have been included to justify the inclusion of new components to the system.
All new or redesigned components to this system were examined, and results of the verification activities demonstrated that the tests were acceptable and the components substantially equivalent to the predicate devices identified.
Conclusion:
The INTEGRA Total Foot System is substantially equivalent to the commercially marketed devices, Ascension Total Foot System (K100502). Additional predicate devices to this system include Osteomed Foot Plating System (K091614), OrthoPro TC Plating System (K094037), Stryker VariAx Locked Plating System (K102282), and the Synthes Modular Mini Fragment LCP System (K063049).
The designs and design modifications expressed in this 510(k) Premarket Notification do not change the intended use or fundamental scientific technology of the predicate devices, nor do they raise any new issues of safety or 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 stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Integra LifeSciences Corporation % Mr. Stephen H. Beier Senior Specialist, Regulatory Affairs 311 Enterprise Drive Plainsboro, New Jersey 08536
December 21, 2012
Re: K123000
Trade/Device Name: INTEGRA® Total Foot System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: September 26, 2012
Received: September 27, 2012
Dear Mr. Beier:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Mr. Stephen H. Beier
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Peter D. Rumm -S
Mark N. Melkerson Director . Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
INTEGRA® Total Foot System Device Name:
Indications For Use: INTEGRA® Total Foot System is indicated for skeletally mature patients for the following:
- Stabilization and fixation of fresh fractures
- Intra and extra articular fractures, joint depression, and multi-fragmentary fractures
- Revision procedures, joint fusion, and reconstruction of small bones of the feet.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Krishna Asundi
Division of Orthopedic Devices
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