(261 days)
Not Found
No
The summary describes a system of bone plates and screws for fracture fixation, which are physical implants. There is no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
No
The device is described as a system for internal fixation of bone fractures, not for therapeutic purposes such as treating a disease or illness.
No
Explanation: The device is described as a system of bone plates and screws for internal fixation of fractures, not for diagnosing conditions.
No
The device description explicitly states it consists of "stainless steel bone plate and bone screw implants," which are physical hardware components, not software.
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. They are used outside the body (in vitro).
- Device Description: The ORTHO SELECT Bone Plates and Screw System is described as stainless steel bone plate and bone screw implants intended for internal fixation of fractures. These are surgically implanted devices used inside the body.
- Intended Use: The intended use is for fixing bone fractures, which is a surgical procedure, not a diagnostic test performed on a sample.
The information provided clearly indicates this is a surgical implant, not a diagnostic device.
N/A
Intended Use / Indications for Use
The ORTHO SELECT Bone Plates and Screw System is used for adult or pediatric patients as indicated for pelvic, small, and long bone fracture fixation. Indications for use include fractures of the tibia, fibula, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, middle hand and middle foot bones; treatment of the calcaneal; and hip arthrodesis.
In pediatric patients, the ORTHO SELECT Bone Plates and Screw System is intended for use on mature bone only. It is not intended for placement across the growth plate.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The ORTHO SELECT Bone Plates and Screw System consists of stainless steel bone plate and bone screw implants intended for internal fixation of pelvic, small and long bone fractures according to the standard of the AO Foundation (AO Principles of Fracture Management). The bone plates and screws are provided non-sterile for steam sterilization by user and single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvic, small, and long bone fractures. Indications for use include fractures of the tibia, fibula, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, middle hand and middle foot bones; treatment of the calcaneal; and hip arthrodesis.
Indicated Patient Age Range
adult or pediatric 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)
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
Image /page/0/Picture/1 description: The image shows a handwritten string of characters. The string appears to be a combination of letters and numbers. The characters are 'K091493'.
510(k) summary of safety and effectiveness
| Date: | January 25, 2010 | |
|---|---|---|
| Submitter: | Name: | |
| Address: | ORTHO SELECT GmbH | |
| Eltrastrasse 2 | ||
| 78573 Wurmlingen | ||
| Germany | ||
| Contact Person: | ||
| Telephone: | ||
| Fax: | Thomas Maier | |
| +49.7461.9663230 | ||
| +49.7461.9663235 | ||
| Product: | Trade Name: | |
| Classification: | ORTHO SELECT BONE PLATES | |
| AND SCREW SYSTEM | ||
| HRS, HWC (Class II) | ||
| Common and | ||
| Classification Names: | Bone Fixation Plate and Screw | |
| Predicate | ||
| Device: | Smith & Nephew Bone Plate System (K993106) | |
| Synthes Bone Plates and Screws for Standard Osteosynthesis | ||
| (Preamendment) | ||
| Synthes Modular Foot System (K001941) | ||
| Device | ||
| Description: | The ORTHO SELECT Bone Plates and Screw System consists of | |
| stainless steel bone plate and bone screw implants intended | ||
| for internal fixation of pelvic, small and long bone fractures | ||
| according to the standard of the AO Foundation (AO | ||
| Principles of Fracture Management). The bone plates and | ||
| screws are provided non-sterile for steam sterilization by user | ||
| and single use only. | ||
| Intended | ||
| Use: | The ORTHO SELECT Bone Plates and Screw System is used for | |
| adult or pediatric patients as indicated for pelvic, small, and | ||
| long bone fracture fixation. Indications for use include fractures | ||
| of the tibia, fibula, femoral condyle, pelvis, acetabulum, | ||
| metacarpals, metatarsals, humerus, ulna, middle hand and | ||
| middle foot bones; treatment of the calcaneal; and hip | ||
| arthrodesis. | ||
| In pediatric patients, the ORTHO SELECT Bone Plates and Screw | ||
| System is intended for use on mature bone only. It is not | ||
| intended for placement across the growth plate. | ||
| Conclusion: | The basic features, design and intended uses of the ORTHO | |
| SELECT Bone Plates and Screw System are similar or identical to | ||
| those of the predicate devices. The minor differences in design | ||
| and dimensions have no effect on the performance, function | ||
| or intended use of the device and do not raise any new issues | ||
| of safety and effectiveness. In summary, the applicant | ||
| considers the ORTHO SELECT Bone Plates and Screw System to | ||
| be substantially equivalent to the predicate devices. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is simple and monochromatic.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
ORTHO SELECT GmbH % Ms. Angelika Scherp Amstel 320-1 Amsterdam NL 1017AP
FEB - 5 2010
Re: K091493
Trade/Device Name: ORTHO SELECT BONE PLATES 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: February 1, 2010 Received: February 4, 2010
Dear Ms. Scherp:
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
2
Page 2 - Ms. Angelika Scherp
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,
Aubare Buehr
for
Mark N. Melkerso Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE
510(k) Number (if known): K091493
Device Name: ORTHO SELECT BONE PLATES AND SCREW SYSTEM
Indications for Use: The ORTHO SELECT Bone Plates and Screw System is used for adult or pediatric patients as indicated for pelvic, small, and long bone fracture fixation. Indications for use include fractures of the tibia, fibula, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, middle hand and middle foot bones; treatment of the calcaneal; and hip arthrodesis.
In pediatric patients, the ORTHO SELECT Bone Plates and Screw System is intended for use on mature bone only. It is not intended for placement across the growth plate.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)
(Division Sign Off)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for mxr
Division of Surgical, Orthopedic,
and Restorative Devices
510(k) Number
Page 1 of ____________________________________________________________________________________________________________________________________________________________________