(62 days)
The MaxLock Extreme® Distal Radius Plates and Screws are indicated for fractures and osteotomies of the distal radius in adult patients.
The MaxLock Extreme® System Distal Radius Plates and Screws are a modification to the previously cleared Modular Foot System to include site-specific plates and screws for distal radius fixation. The plates are offered in different lengths and sizes. The screws are offered in different diameters and lengths. All implantable components are manufactured from implant grade titanium alloy. The MaxLock Extreme® System Distal Radius Plates and Screws have the same technological characteristics as the predicate devices.
The provided text describes a medical device submission (K102156) for the "MaxLock Extreme® System Distal Radius Plates and Screws." This is a Class II medical device, and the submission is a 510(k) premarket notification, which means the manufacturer is claiming substantial equivalence to an already legally marketed device (predicate device).
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Equivalence to Predicate Device | The OrthoHelix plate performed better than the clinically successful legally marketed predicate device. |
| Screws meet specified requirements for intended use | A screw bending moment study verified that the screws are equivalent to the predicate and meet specified requirements. |
2. Sample Size Used for the Test Set and Data Provenance
The text explicitly states: "Mechanical testing was conducted to confirm that the MaxLock Extreme® System Distal Radius Plates and Screws are equivalent to the predicate and meet the specified requirements for their intended use."
- Test Set Sample Size: Not specified. The document refers to "mechanical testing" and "a screw bending moment study" but does not provide details on the number of devices or components tested.
- Data Provenance: Not specified. The testing was conducted by the submitter (OrthoHelix Surgical Designs, Inc.). The location (e.g., country of origin) of the testing is not mentioned, nor is whether the data is retrospective or prospective. Given it's a device premarket notification, it's generally prospective testing specifically performed for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable for this type of submission. Mechanical testing of a medical device (like a bone plate and screws) does not typically involve human experts establishing a "ground truth" in the way clinical studies or diagnostic AI algorithms do. Instead, the "ground truth" or standard for acceptance is based on established engineering principles, regulatory standards, and performance of the predicate device.
- Qualifications of Experts: N/A.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. As discussed above, mechanical testing doesn't involve subjective human assessment requiring adjudication. The comparison is against objective, measurable mechanical properties of a predicate device and industry-accepted benchmarks.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices or AI algorithms where human interpretation of images or data is involved. This submission concerns mechanical fixation devices.
- Effect Size of Human Readers Improvement with AI: N/A, as no such study was performed or is relevant here.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance: No, a standalone "algorithm only" study was not done. This device is a physical implant, not a software algorithm.
7. The Type of Ground Truth Used
- Ground Truth Type: For mechanical testing, the "ground truth" or benchmark is the performance of the legally marketed predicate devices and generally accepted mechanical performance standards for bone fixation devices. The tests are designed to show that the new device performs at least as well as, or better than, the predicate. The text states: "Mechanical testing was conducted to confirm that the MaxLock Extreme® System Distal Radius Plates and Screws are equivalent to the predicate and meet the specified requirements for their intended use."
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device is a physical implant, not a machine learning model or algorithm that requires a "training set" in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment for Training Set: Not applicable, as there is no training set for this type of device.
In summary:
This 510(k) submission primarily relies on mechanical testing to demonstrate substantial equivalence of a bone fixation device. The acceptance criteria are that the new device's mechanical properties (like strength and bending moment) are at least equivalent to, or superior to, those of the predicate devices already on the market and meet "specified requirements for their intended use." The study conducted was mechanical testing and a screw bending moment study. No clinical studies involving patients, human readers, or AI algorithms were part of this specific submission to demonstrate substantial equivalence.
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K102156 *'1/d
510{k} SUMMARY Submitter Information Submitter's Name: OrthoHelix Surgical Designs, Inc. Address: 1065 Medina Rd, Suite 500 Medina, Ohio 44256 SEP 3 0 2010 Contact Person: Derek Lewis Telephone Number: 330-869-9562 Fax Number: 330-247-1598 Prepared By: Rebecca DiLiberto and Amanda Martin Date Prepared: 8/27/2010 Device Information MaxLock Extreme® System Distal Radius Plates and Screws Trade Name: Fixation Plate Common Name: Classification Name: Plate, Fixation, Bone Device Classification: Single/multiple component metallic bone fixation appliances (Class II per 21 CFR 888.3030) Panel: Orthopedic, Product Code: HRS The MaxLock Extreme® System Distal Radius Plates and Screws is Predicate Device: equivalent to current legally marketed devices. Material Composition: Titanium Alloy Device Description: The MaxLock Extreme® System Distal Radius Plates and Screws are a modification to the previously cleared Modular Foot System to include site-specific plates and screws for distal radius fixation. The plates are offered in different lengths and sizes. The screws are offered in different diameters and lengths. All implantable components are manufactured from implant grade titanium alloy. The MaxLock Extreme® System Distal Radius Plates and Screws have the same technological characteristics as the predicate devices. The MaxLock Extreme® System Distal Radius Plates and Screws are Intended Use: intended for fractures and osteotomies of the distal radius in adult patients. The MaxLock Extreme® System Distal Radius Plates and Screws are Substantial Equivalence: equivalent to the OrthoHelix Modular Foot System (K073624) and its subsequent Special 510(k) submission (K100618). In addition, the plates are equivalent to the Hand Innovations Distal Volar Radius Fracture Repair System (K002775) and the screws are equivalent to the Synthes Modular Mini Fragment LCP System (K063049). No new issues of safety and effectiveness have been raised.
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K102156 #d/d
Mechanical testing was conducted to confirm that the MaxLock Extreme® System Distal Radius Plates and Screws are equivalent to the predicate and meet the specified requirements for their intended use. The OrthoHelix plate performed better than the clinically successful legally marketed predicate device. A screw bending moment study was performed to verify that the screws are equivalent to the predicate and meet the specified requirements for their intended use. It is concluded from the static mechanical testing and the screw maximum bending moment study that the devices are substantially equivalent to the legally marketed predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with its wings spread, and three wavy lines below it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Orthohelix Surgical Designs, Inc. % Mr. Derek Lewis 1065 Medina Road, Suite 500 Medina, Ohio 44256
SEP 30 2010
Re: K102156
Trade/Device Name: Distal Radius Plating for the MaxLock Extreme® Extremity Plating 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 Dated: August 27, 2010 Received: August 31, 2010
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
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Page 2 - Mr. Derek Lewis
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.
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
erely yours,
For
N. Melkerson
Mark N. Melkerson 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
102156
SEP 3 0 2010
510(k) Number (if known): IBB
Device Name: Distal Radius Plating for the MaxLock Extreme® Extremity Plating System
Indications for Use:
The MaxLock Extreme® Distal Radius Plates and Screws are indicated for fractures and osteotomies of the distal radius in 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
sion of Surgical thopedic. and Restorative Devices
510(k) Number K102156
§ 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.