(29 days)
The Mini MaxLock Extreme® Plating System is intended to stabilize and aid in the repair of fractures, fusions, and osteotomies for small bones and bone fragments.
The submission is a modification to the Mini MaxLock Extreme® Plating System to add additional plate styles. No modifications were made to the existing plates or screws
The provided text describes a 510(k) submission for a medical device (Mini MaxLock Extreme® Plating System), which is a premarket notification to demonstrate that the device is at least as safe and effective as a legally marketed predicate device.
For this type of device (bone fixation appliances), the FDA review primarily focuses on establishing substantial equivalence to a predicate device, rather than defining specific acceptance criteria for a new, standalone performance study in the way one might for a diagnostic AI algorithm. The 510(k) summary explicitly states:
"Calculations and finite element analysis comparing the strength of the subject and predicate devices were performed and the results support substantial equivalence. Due to similarities in indications, design, and materials, no other testing was required. No new issues of safety and effectiveness have been raised."
This means that a direct "acceptance criteria" and "device performance" in terms of clinical outcomes or diagnostic accuracy were not established or tested in this submission. Instead, the acceptance criteria were implicitly met by demonstrating mechanical equivalence to an already approved device.
Therefore, many of the requested points regarding acceptance criteria, study details, and ground truth establishment are not applicable to this specific 510(k) submission.
Here's an breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Implicit Acceptance Criteria: Substantial equivalence in terms of strength, indications, design, and materials to the predicate device (OrthoHelix Mini MaxLock Extreme® Plating System K120157). | Performed calculations and finite element analysis (FEA) comparing the strength of the subject and predicate devices. Results support substantial equivalence. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not Applicable. No human or animal test set data was used. The study relied on computational analysis (calculations and Finite Element Analysis).
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. No expert-established ground truth was required for this type of substantial equivalence demonstration. The "ground truth" was derived from engineering principles and comparison to the predicate device's established properties.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. No human adjudication was involved as no patient data or expert review was part of this submission.
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 is a hardware device (bone plating system), not an AI diagnostic tool. MRMC studies are irrelevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a hardware device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable / Engineering Equivalent. The "ground truth" for showing substantial equivalence was the known mechanical properties and performance of the predicate device, as assessed through engineering calculations and finite element analysis.
8. The sample size for the training set
- Not Applicable. No machine learning or AI models were involved; therefore, no training set was used.
9. How the ground truth for the training set was established
- Not Applicable. No training set was used.
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K121437 (Vi
Submitter Information
Submitter's Name: Address:
Telephone Number: Fax Number: Prepared By: Contact Person: Date Prepared:
Device Information
Trade Name:
Common Name:
Classification Name:
Device Classification:
Material Composition:
Device Description:
Intended Use:
Substantial Equivalence:
510(k) SUMMARY
JUN 1 3 2012
OrthoHelix Surgical Designs, Inc. 1065 Medina Rd, Suite S00 Medina, Ohio 44256 330-869-9562 330-247-1598 Brian Hockett, Liz Altenau Derek Lewis 5/7/12
Mini MaxLock Extreme® Plating System
Fixation Plates and Screws
Plate, Fixation, Bone
Single/multiple component metallic bone fixation appliances (Class II per 21 CFR 888.3030) Panel: Orthopedic, Product Code: HRS Smooth or threaded metallic bone fixation fastener (Class II per 21 CFR 888.3040) Panel: Orthopedic, Product Code: HWC
Titanium Alloy, PEEK
The submission is a modification to the Mini MaxLock Extreme® Plating System to add additional plate styles. No modifications were made to the existing plates or screws
The Mini MaxLock Extreme® Plating System is intended to stabilize and aid in the repair of fractures, fusions, and osteotomies for small bones and bone fragments.
The new Mini MaxLock Extreme® Plating System is substantially equivalent to the existing OrthoHelix Mini MaxLock Extreme® Plating System (K120157). Calculations and finite element analysis comparing the strength of the subject and predicate devices were performed and the results support substantial equivalence. Due to similarities in indications, design, and materials, no other testing was required. No new issues of safety and effectiveness have been raised.
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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 - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an 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 Vice President of Research and Development 1065 Medina Road, Suite 500 Medina. Ohio 44256
JUN 1 3 2012
Re: K121437
Trade/Device Name: Mini MaxLock Extreme® 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: May 9, 2012 Received: May 15, 2012
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.
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 or my 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 Or ic rated adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. Derek Lewis
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,
Erine Keith
For 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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K12143
Indications for Use
KIZI437 510(k) Number (if known):
Device Name: Mini MaxLock Extreme® Plating System
Indications for Use:
The Mini MaxLock Extreme® Plating System is intended to stabilize and aid in the repair of fractures, fusions, and osteotomies for small bones and bone fragments.
× Prescription Use __
AND/OR
Over-The-Counter-Use
(21 CFR 801 Subpart C)
(Part 21 CFR 801 Subpart D)
(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
A.Shtf
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(Division Sign-Off) Division of Surgical. Orthopedic, and Restorative Devices
510(k) Number K121437
§ 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.