(61 days)
The OrthoHelix Edgelock Plate System is indicated for fixation of fractures, fusions and osteotomies of the small bones in the hand, wrist, foot and ankle in pediatric and adult patients.
The OrthoHelix Edgelock Plate System is a set of metallic, implantable, bone fixation plates. All plates are made from implant grade titanium alloy.
This is a 510(k) summary for a medical device (Edgelock Plate System) and does not contain information about an AI/ML powered device or a study involving human readers or ground truth in the context of diagnostic performance. Therefore, most of the requested fields cannot be filled.
Here's what can be extracted:
Device Name: Edgelock Plate System
Device Description: The OrthoHelix Edgelock Plate System is a set of metallic, implantable, bone fixation plates, made from implant grade titanium alloy.
Intended Use/Indications for Use: The Edgelock Plate System is indicated for fixation of fractures, fusions and osteotomies of small bones in the hand, wrist, foot and ankle in pediatric and adult patients.
Study Type: Substantial Equivalence Study
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices (Edgelock Plate System) for intended use. | Finite Element Analysis and mechanical testing confirm that the implants within the Edgelock Plate System are substantially equivalent to its predicate devices. The device meets the specified requirements for its intended use. |
| No new issues of safety or efficacy raised. | No new issues of safety or efficacy have been raised. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. The study was a non-clinical evaluation (Finite Element Analysis and mechanical testing) comparing the device to its predicates.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The study involved engineering analysis and mechanical testing, not ground truth established by medical experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This was a non-clinical study.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a bone fixation plate, not an AI-powered diagnostic tool, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" equivalent here would be engineering standards and performance characteristics for bone fixation plates, established through Finite Element Analysis and mechanical testing, and comparison to predicate devices, rather than medical ground truth.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device, not an AI/ML algorithm.
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Kog3900 (112)
FEB 1 7 2010
510(k) SUMMARY
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared.
OrthoHelix Surgical Designs, Inc. 1065 Medina Rd., Suite 500 Medina, Ohio 44256 Phone: (330) 869-9582 Fax: (330) 247-1598
Derek Lewis Contact Person: Vice President of Research and Development
Date Prepared: November 18, 2009
Name of Device
Edgelock Plate System
Common or Usual Name
Fixation Plates
Classification Name
Plate, Fixation, Bone
Predicate Devices
The Edgelock Plate System is substantially equivalent to currently marketed devices.
Intended Use
The Edgelock Plate System is indicated for fractures, fusions and osteotomies of small bones in the hand, wrist, foot and ankle in pediatric and adult patients.
Device Description
The OrthoHelix Edgelock Plate System is a set of metallic, implantable, bone fixation plates. All plates are made from implant grade titanium alloy.
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Substantial Equivalence
Finite Element Analysis and mechanical testing confirm that the implants within the Edgelock Plate System are substantially equivalent to its predicate devices, and that it meets the specified requirements for its intended use. No new issues of safety or efficacy have been raised.
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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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is an emblem featuring a stylized depiction of an eagle or bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
OrthoHelix Surgical Designs, Inc. % Mr. Derek Lewis Vice President of Research and Development 1065 Medina Road, Suite 500 Medina, Ohio 44256
FEB 1 7 2010
Re: K093900
Trade/Device Name: Edgelock 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: December 15, 2009 Received: December 18, 2009
Dear Mr. Lewis:
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 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.
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Page 2 - Mr. Derek Lewis
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,
Mark N. Melke Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): JBD K0939 OO
Device Name: Edgelock Plate System
Indications for Use:
The OrthoHelix Edgelock Plate System is indicated for fixation of fractures, fusions and osteotomies of the small bones in the hand, wrist, foot and ankle in pediatric and adult patients.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page of of
Smita for mxn
(Bivision Sign Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093900
§ 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.