(172 days)
The Maestro® Wrist Plating System is indicated for fractures, fracture dislocations, osteotomies and non-unions of the distal radius and ulna.
The Maestro® Wrist Plating System is comprised of anatomic plates in four styles: Volar, Dorsal, Radial Lateral and Ulnar. Both locking and non-locking screws in multiple lengths as well as pegs are designed for use with the plates. Plate sizing and contouring was developed through the use of IntelliFIT, a Biomet technology which uses contour analysis to map patterns in complex bone on cadaveric specimens to determine plate countouring. (Note, the software was used to determine a set of pre-defined plate sizes and is not used to create individual, patient matched plates.)
The provided document describes a 510(k) submission for the "Maestro® Wrist Plating System," a medical device for bone fixation. Here's an analysis of the acceptance criteria and supporting studies based on the provided text:
Important Note: This document primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory approval, rather than independent efficacy or performance studies involving human subjects in a clinical setting. For medical devices like bone fixation systems, regulatory approval often relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through mechanical testing and material characterization rather than clinical trials comparing outcomes.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Requirement) | Reported Device Performance (Results Summary) |
|---|---|---|
| Plate Strength | Meet or exceed predicate (K093761) | Meet or exceed predicate |
| Plate Design | Comparable to predicate (K093761, K040908) | Volar, Dorsal, Lateral, Ulnar |
| Plate Material | Comparable to predicate (K093761, K040908), Stainless Steel ASTM F-138, F-139 | Stainless Steel ASTM F-138, F-139 |
| Plate Lengths | Comparable to predicate (K093761, K040908), Length: 44-170mm | Length: 44-170mm |
| Screw Design | Comparable to predicate (K093761, K040908) | Locking, Non-Locking, Peg |
| Screw Material | Comparable to predicate (K093761, K040908), Stainless Steel ASTM F-138, F-139 | Stainless Steel ASTM F-138, F-139 |
| Screw Dimensions | Comparable to predicate (K093761, K040908), Diameter: 2.7 and 3.5mm, Length: 10-30mm | Diameter: 2.7 and 3.5mm, Length: 10-30mm |
| MR Safety | No known hazards in a specified MR environment (MR Conditional) per ASTM F-2503-08 | MR Conditional |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a "sample size" in the context of clinical trials. For the Plate Strength testing, an "Engineering Analysis" was performed. This typically involves mechanical testing of a representative number of plates and screws to assess their strength and fatigue properties. The document does not specify the number of devices tested.
- Data Provenance: Not applicable in the context of clinical or patient data. The engineering analysis and material testing are conducted in a laboratory setting. There is no mention of country of origin for such data. The study is not retrospective or prospective in the clinical sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- This information is not applicable to the type of studies conducted. The "ground truth" for this device's performance is based on established engineering standards, material specifications (e.g., ASTM F-138, F-139, F-2503-08), and comparison to the mechanical properties of predicate devices through engineering analysis. There is no expert consensus on clinical outcomes or diagnoses to establish "ground truth" in this submission.
4. Adjudication Method for the Test Set
- Not applicable. There were no human readers or diagnostic interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. An MRMC study was not conducted. This device is a bone fixation system, and its approval typically relies on mechanical and material equivalence rather than comparative effectiveness studies with human readers interpreting diagnostic images.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not applicable. This device is a physical implant, not an algorithm or AI software, so the concept of "standalone performance" for an algorithm does not apply.
7. Type of Ground Truth Used
- The "ground truth" for the device's technical performance is based on:
- Engineering Standards: Adherence to recognized ASTM standards for materials (F-138, F-139, F-2503-08) and performance evaluation.
- Predicate Device Performance: The primary "ground truth" is the established performance of the legally marketed predicate devices (K093761, K040908), which the new device aims to meet or exceed in terms of mechanical strength and functional characteristics.
8. Sample Size for the Training Set
- Not applicable. This device is a physical medical implant, not an AI/ML algorithm. Therefore, there is no "training set" in the computational sense. The design of the plates ("plate sizing and contouring") utilized "IntelliFIT, a Biomet technology which uses contour analysis to map patterns in complex bone on cadaveric specimens." However, this is described as a design methodology to determine pre-defined plate sizes, not a machine learning training process for the device's function in the clinical setting. The number of cadaveric specimens used is not specified.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As stated above, there is no "training set" for an AI/ML algorithm. The design process for the physical dimensions of the plates involved using "IntelliFIT" technology to analyze "patterns in complex bone on cadaveric specimens" to establish general contours and sizes for the plates. This informs the design of the product, but it is not a "training set" in the context of establishing ground truth for evaluating an algorithm's performance.
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K110271(#2)
Image /page/0/Picture/1 description: The image shows the logo for Biomet Manufacturing Corp. The word "BIOMET" is in a stylized font with a box around each letter. Below the logo, the words "MANUFACTURING CORP." are printed in a simple, sans-serif font.
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JUL 2 2 2 2011
510(k) SUMMARY
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92
| Submitter Information | ||
|---|---|---|
| Name | Biomet Manufacturing Corp. | |
| Address | 56 East Bell DriveWarsaw, IN 46581-0857 | |
| Phone number | (574) 267-6639 | |
| Fax number | (574) 371-1027 | |
| EstablishmentRegistrationNumber | 1825034 | |
| Name of contactperson | Patricia Sandborn BeresSenior Regulatory Specialist | |
| Date prepared | January 10, 2011 | |
| Name of device | ||
| Trade orproprietaryname | Maestro® Wrist Plating System | |
| Common or usualname | • plate, fixation, bone• screw, fixation, bone | |
| Classification name | • Single/multiple component metallic bone fixation appliances and accessories• Smooth or threaded metallic bone fixation fastener | |
| Classification panel | Orthopedics | |
| Regulation | • 21 CFR 888.3030• 21 CFR 888.3040 | |
| Product Code(s) | • HRS• HWC | |
| Legally marketeddevice(s) to whichequivalence is claimed | K093761 - OptiLock® VL Distal Plating SystemK040908 - EBI® Distal Radius Plating System | |
| Reason for 510(k)submission | New device | |
| Device description | The Maestro® Wrist Plating System is comprised of anatomic plates in four styles: Volar, Dorsal, Radial Lateral and Ulnar. Both locking and non-locking screws in multiple lengths as well as pegs are designed for use with the plates. Plate sizing and contouring was developed through the use of IntelliFIT, a Biomet technology which uses contour analysis to map patterns in complex bone on cadaveric specimens to determine plate countouring. (Note, the software was used to determine a set of pre-defined plate sizes and is not used to create individual, patient matched plates.) | |
| Intended use of the device | Bone fixation | |
| Indications for use | The Maestro® Wrist Plating System is indicated for fractures, fracture dislocations, osteotomies and non-unions of the distal radius and ulna. | |
| Summary of the technological characteristics of the device compared to the predicate | ||
| Characteristic | New Device | Predicate Device* |
| Plate Design | Volar, Dorsal, Lateral, Ulnar | K093761, K040908 |
| Plate Material | Stainless Steel ASTM F-138,F-139 | K093761, K040908 |
| Plate Lengths | Length:44-170mm | K093761, K040908 |
| Screw Design | Locking, Non-Locking, Peg | K093761, K040908 |
| Screw Material | Stainless Steel ASTM F-138, F-139 | K093761, K040908 |
| Screw Dimensions | Diameter: 2.7 and 3.5mmLength: 10-30mm | K093761, K040908 |
| PERFORMANCE DATA | ||
| SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OFSUBSTANTIAL EQUIVALENCE | ||
| Performance Test Summary-New Device | ||
| Characteristic | Standard/Test/FDA Guidance | Results Summary |
| Plate Strength | Engineering Analysis | Meet or exceed predicate |
| Comparative Performance Information Summary | ||
| Characteristic | Requirement | Predicate Device* |
| Plate Strength | Meet or exceed predicate | K093761 |
| SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIALEQUIVALENCE AND/OR OF CLINICAL INFORMATION | ||
| Clinical Performance Data/Information: None | ||
| MAGNETIC RESONANCE (MR) ENVIROMENT | ||
| Biomet® has performed non-clinical Magnetic Resonance Imaging (MRI) studies on Plating | ||
| Systems manufactured of 316L Stainless Steel per ASTM F-138. These Plating Systems are | ||
| determined to be MR Conditional in accordance to ASTM F-2503-08 Standard Practice for | ||
| Marking Devices and Other Items for Safety in the Magnetic Resonance Environment. MR | ||
| Conditional refers to an item that has been demonstrated to pose no known hazards in a | ||
| specified MR environment with specified conditions of use. | ||
| CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA | ||
| No mechanical or clinical testing was necessary for a determination of substantial equivalence. The | ||
| results of engineering analysis indicated the devices performed within the intended use, did notraise any new safety and efficacy issues and were found to be substantially equivalent to the | ||
| predicate devices. | ||
| *Any statement made in conjunction with this submission regarding and/or a determination of substantial equivalence to any other |
Mailing Address:
P.O. Box 587 Warsaw. IN 46581-0587 Toll Free: 800.348.9500
Office: 574.267.6639
Office: 574.267.6639
Main Fax: 574.267.8137 www.biomet.com
Shipping Address:
56 East Bell Drive Warsaw, IN 46582
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510(k) Summary ExploR® Radial Head Plating System Page 2 of 2
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product is intended only to relate the product can be lawfully market approval or recassifica
not intended to be interpreted as an admission or any other infringement litig Registration and Premarket Notification Procedures, Final Regulation, Preamble, August 23, 1977, 42 FR 42520 (Docket No. 76N-0355)] .
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is written around the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
Biomet Manufacturing Corporation % Ms. Patricia Sandborn Beres Senior Regulatory Specialist 56 East Bell Drive Warsaw, Indiana 46581
JUL 2 2 2911
Re: K110271
Trade/Device Name: Maestro® Wrist Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliance and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: June 22, 2011 Received: June 24, 2011
Dear Ms. Beres:
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 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
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Page 2 - Ms. Patricia Sandborn Beres
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.
K. Deffenbaugh
Mark N. Mel Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Kilo271 (11)
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Maestro® Wrist Plating System
Indications For Use:
The Maestro® Wrist Plating System is indicated for fractures, fracture dislocations, osteotomies and non-unions of the distal radius and ulna.
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ NO (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
fr M.M.ukerom
(Division Sign Oft) (Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of 1
510(k) Number
§ 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.