(138 days)
Not Found
No
The device description and intended use are for a mechanical implant system (plates and screws) used in surgical procedures. There is no mention of software, image processing, or any terms related to AI/ML.
No.
The device is an orthopedic implant used for surgical fixation of humerus fractures, not for therapeutic treatment.
No
The device is a system of plates and screws used for surgical repair of proximal humerus fractures, not for diagnosing them.
No
The device description explicitly lists physical components made of 316L Stainless Steel, such as plates, screws, and blades, which are hardware intended for surgical implantation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "Open Reduction Internal Fixation (ORIF) procedures of the proximal humerus" to treat fractures, dislocations, osteotomies, and non-unions. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device consists of plates, screws, and blades made of stainless steel, designed for internal fixation of bone. These are implantable surgical devices.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with bodily specimens in this way.
The device described is a surgical implant used for orthopedic procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Equinoxe® Shoulder Proximal Humerus Fracture Plate System is indicated for Open Reduction Internal Fixation (ORIF) procedures of the proximal humerus. Clinical indications are as follows: Fractures, fracture dislocations, osteotomies, and non-unions of the proximal humerus.
Product codes (comma separated list FDA assigned to the subject device)
KTW, HRS
Device Description
The Equinoxe Proximal Humerus Fracture Plate System is for use in the repair of proximal humerus fractures. The system consists of the following components. With the exception of blade locking screws, all components are provided in various sizes. Proximal Humerus Fracture Plates Locking Screws, Cancellous and Cortical Humeral Blades Blade Locking Screws Compression Screws, Cortical
Made of 316L Stainless Steel (per ASTM F138-08), all components are supplied nonsterile and must be sterilized in a provided re-usable sterilization container, prior to implantation. Cleaning and Sterilization instructions are provided in the package insert for the Equinoxe® Proximal Humerus Fracture Plate System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal humerus
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)
Results from mechanical tests and simulated-use studies provided within this 510(k) premarket notification demonstrate that Exactech® Equinoxe® Proximal Humerus Fracture Plate System is substantially equivalent to the identified predicate devices.
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.
K011815, K041860, K042059, K051728, K060290
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.
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MAY 1 1 2010
Exactech® Equinoxe® Proximal Humerus Fracture Plate System Traditional 510(k)
510(k) Summary
| Company: | Exactech®, Inc |
|---|---|
| Date: | December 22, 2009 |
| Contact Person: | Shing Jen Tai, PhD |
| Regulatory Affairs Specialist | |
| Proprietary Name: | Exactech® Equinoxe® Proximal Humerus Fracture Plate |
| System | |
| Common Name: | Proximal Humerus Fracture Plate |
| Classification Name: | Single/Multiple Component Metallic Bone Fixation |
| Appliances and Accessories (21 CFR 888.3030, Class II, | |
| Product Code KTW) |
Legally Marketed Devices to Which Substantial Equivalence Is Claimed
- Synthes LCP® Proximal Humerus Plate (#K011815) �
- . Synthes (USA) LCP® Proximal Humerus Plates, Long (#K041860)
- Hand Innovations Modified Shoulder Fixation Systems (#K042059, #K051728, . #K060290)
Device Description
The Equinoxe Proximal Humerus Fracture Plate System is for use in the repair of proximal humerus fractures. The system consists of the following components. With the exception of blade locking screws, all components are provided in various sizes.
- . Proximal Humerus Fracture Plates
- Locking Screws, Cancellous and Cortical ●
- . Humeral Blades
- Blade Locking Screws .
- � Compression Screws, Cortical
Made of 316L Stainless Steel (per ASTM F138-08), all components are supplied nonsterile and must be sterilized in a provided re-usable sterilization container, prior to
1
K093978 Exactech® Equinoxe® Proximal Humerus Fracture Plate System Traditional 510(k)
implantation. Cleaning and Sterilization instructions are provided in the package insert for the Equinoxe® Proximal Humerus Fracture Plate System.
Indications for Use
The Equinoxe® Shoulder Proximal Humerus Fracture Plate System is indicated for Open Reduction Internal Fixation (ORIF) procedures of the proximal humerus. Clinical indications are as follows:
- Fractures, fracture dislocations, osteotomies, and non-unions of the proximal . humerus.
Summary of Technological Characteristics
The rationale for substantial equivalence is based on consideration of the following characteristics:
- Intended Use. Similar to the intended uses for its predicate devices. the Equinoxe® . Proximal Humerus Fracture Plate System is intended to be used for internal fixation of fractures, fracture dislocations, osteotomies, and non-unions of the proximal humerus. Equinoxe® Proximal Humerus Fracture Plate System and predicate devices also have similar indications for use statements.
- Materials. Equinoxe® Proximal Humerus Fracture Plate System and predicate . devices are composed of equivalent materials conforming to recognized industry standards for orthopedic and trauma implants.
- . Dimensions. Equinoxe® Proximal Humerus Fracture Plate System and predicate device components are available in equivalent size ranges.
- Sterilization processes. Equinoxe® Proximal Humerus Fracture Plate System and . predicate devices are provided non-sterilized prior to implantation, using equivalent sterilization processes conforming to recognized industry standards.
- . Performance specifications. Equinoxe® Proximal Humerus Fracture Plate System and predicate devices withstand clinically relevant biomechanical loads that are exerted on the humerus during post-operative rehabilitation and fracture healing.
Substantial Equivalence Conclusion
Results from mechanical tests and simulated-use studies provided within this 510(k) premarket notification demonstrate that Exactech® Equinoxe® Proximal Humerus Fracture Plate System is substantially equivalent to the identified predicate devices.
.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY 1 1 2010
2320 N.W. 66th Court Gainesville, Florida 32653
% Ms. Shing Jen Tai
Re: K093978
Exactech, Inc.
Trade/Device Name: Exactech Equinoxe Proximal Humerus Fracture Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: April 16, 2010 Received: April 22, 2010
Dear Ms. Tai:
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 - Ms. Shing Jen Tai
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/McdicalDcvices/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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Cboulare BrehmD
Mark N. Me Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Exactech® Equinoxe® Proximal Humerus Fracture Plate System Traditional 510(k)
Indications for Use Statement
K093978 510(k) Number:
Device Name: Exactech® Equinoxe® Proximal Humerus Fracture Plate System
INDICATIONS FOR USE:
The Equinoxe® Shoulder Proximal Humerus Fracture Plate System is indicated for Open Reduction Internal Fixation (ORIF) procedures of the proximal humerus. Clinical indications are as follows:
- . Fractures, fracture dislocations, osteotomies, and non-unions of the proximal humerus.
| Prescription Use X | and/or |
|---|---|
| (Part 21 CFR 801 Subpart D) |
Over-The-Counter Use (21 CFR 807 Subpart C)
Please do not write below this line - use another page if needed.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Onette for Mxm
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093978
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