(172 days)
No
The device description mentions "IntelliFIT, a Biomet technology which uses contour analysis to map patterns in complex bone on cadaveric specimens to determine plate countouring." While this technology uses data analysis, the description explicitly states it was used to determine a set of pre-defined plate sizes and is not used to create individual, patient-matched plates. This suggests a static design process based on historical data analysis, not a dynamic AI/ML system operating on patient-specific data. There are no other mentions of AI, ML, or related terms.
Yes
The device is indicated for treating fractures, fracture dislocations, osteotomies, and non-unions, which are conditions requiring therapeutic intervention.
No
This device is a plating system (implants like plates, screws, and pegs) used for internal fixation of fractures and non-unions of the distal radius and ulna, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it is comprised of anatomic plates, screws, and pegs, which are physical hardware components. While software (IntelliFIT) was used in the design process, the final product is a hardware system.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Maestro® Wrist Plating System is for "fractures, fracture dislocations, osteotomies and non-unions of the distal radius and ulna." This describes a surgical implant used to stabilize bone, not a test performed on samples taken from the body to diagnose a condition.
- Device Description: The description details plates, screws, and pegs designed to be surgically implanted. This is consistent with a medical device used for treatment, not an IVD used for diagnosis.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
The Maestro® Wrist Plating System is a surgical implant used to treat bone fractures and related conditions.
N/A
Intended Use / Indications for Use
The Maestro® Wrist Plating System is indicated for fractures, fracture dislocations, osteotomies and non-unions of the distal radius and ulna.
Product codes
HRS, HWC
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.)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal radius and ulna.
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)
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE
Performance Test Summary-New Device:
- Characteristic: Plate Strength
- Standard/Test/FDA Guidance: Engineering Analysis
- Results Summary: Meet or exceed predicate
Comparative Performance Information Summary:
- Characteristic: Plate Strength
- Requirement: Meet or exceed predicate
- Predicate Device*: K093761
SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION
Clinical Performance Data/Information: None
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 not raise any new safety and efficacy issues and were found to be substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
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.
ﺮﺩ
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 Drive | |
| Warsaw, IN 46581-0857 | ||
| Phone number | (574) 267-6639 | |
| Fax number | (574) 371-1027 | |
| Establishment | ||
| Registration | ||
| Number | 1825034 | |
| Name of contact | ||
| person | Patricia Sandborn Beres | |
| Senior Regulatory Specialist | ||
| Date prepared | January 10, 2011 | |
| Name of device | ||
| Trade or | ||
| proprietary | ||
| name | Maestro® Wrist Plating System | |
| Common or usual | ||
| name | • 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 marketed | ||
| device(s) to which | ||
| equivalence is claimed | K093761 - OptiLock® VL Distal Plating System | |
| K040908 - 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 3.5mm | |
| Length: 10-30mm | K093761, K040908 | |
| PERFORMANCE DATA | ||
| SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF | ||
| SUBSTANTIAL 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 SUBSTANTIAL | ||
| EQUIVALENCE 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 not | ||
| raise 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
い
V 11027
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)] .
ਂ ਕ
2
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
3
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
4
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