(96 days)
No
The description focuses on the mechanical properties, materials, and anatomical design of the plating system, with no mention of AI or ML.
No
This device is a fixation system for fractures and non-unions of the humerus, particularly in osteopenic bone, which is a structural implant and not a device that treats or cures a disease or condition.
No
Explanation: The device description indicates that the "Biomet Proximal Humerus Plating System" is used for fixation of fractures and other bone issues, and includes plates, screws, and instrumentation to aid alignment and stabilization. This is an orthopedic implant system, designed for treatment (fixation), not for diagnosing medical conditions.
No
The device description clearly states that the system includes plates, screws, and instrumentation, all of which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the fixation of fractures, dislocations, fusions, osteotomies, and non-unions of the humerus. This is a surgical implant used directly on the patient's bone.
- Device Description: The description details plates and screws made of titanium alloy and cobalt chromium, designed to be implanted into the body.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests.
This device is a surgical implant, specifically a bone plating system.
N/A
Intended Use / Indications for Use
The Biomet Proximal Humerus Plating System is indicated for fixation of fracture dislocations, fusions, osteotomies and non-unions of the humerus, particularly in osteopenic bone.
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
The Biomet Proximal Humeral Plating System offers two plating families (Low and High) with both left and right configurations in various lengths. Both plating families in the Biomet Proximal Humerus Plating System incorporate the same spatial subchondral support as the Biomet S3 proximal humerus plates (K060290) in the head of the plates. The plates and screws will be manufactured from Titanium Alloy (ASTM F136) and are either type II or color anodized. The system will also include multidirectional screws that are manufactured from Cobalt Chromium (ASTM F1537). The plates are anatomically designed to match the anatomy of the proximal humerus. The system will also include instrumentation to aid the user in alignment and stabilization of fractures to the skeletal system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
humerus
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)
Non-clinical performance testing included axial load construct testing, engineering evaluations and galvanic corrosion assessment to determine substantial equivalence of the Biomet Proximal Humerus Plating System. Results indicate that the subject plating system is substantially equivalent to legally marketed devices offering a reasonable assurance of safety and effectiveness.
No clinical tests are provided for basis of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/1 description: The image contains the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of an eagle or bird with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 30, 2015
Biomet Manufacturing Ms. Julie Largent Regulatory Affairs Specialist P.O. Box 587 56 East Bell Drive Warsaw, Indiana 46582
Re: K143697
Trade/Device Name: Biomet Proximal Humerus 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: February 18, 2015 Received: February 19, 2015
Dear Ms. Largent:
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
1
Page 2 - Ms. Julie Largent
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K143697 (paqe 1/1)
Device Name
Biomet Proximal Humerus Plating System
Indications for Use (Describe)
The Biomet Proximal Humerus Plating System is indicated for fixation of fracture dislocations, fusions, osteotomies and non-unions of the humerus, particularly in osteopenic bone.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the word "BIOMET" in a bold, sans-serif font. The letters are all capitalized and appear to be a dark gray or black color. A thin, horizontal line runs underneath the word, emphasizing the text.
510(k) Summary
In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the Biomet Proximal Humerus Plating System 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.
| Sponsor: | Biomet Inc.
56 East Bell Drive
PO Box 587
Warsaw, IN 46581
Establishment Registration Number: 1825034 |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Julie Largent
Regulatory Affairs Specialist
305-269-6391 |
| Date: | March 12, 2015 |
| Subject Device: | Trade Name: Biomet Proximal Humerus Plating System
Common Name: Plate, Fixation, Bone
Classification Name:
• HRS - Single/multiple component metallic bone fixation |
- appliances and accessories (21 CFR 888.3030)
Legally marketed devices to which substantial equivalence is claimed:
- ACE Proximal Humerus Plates K955472 ●
- S Shoulder Plating System K060290
- Anatomic Locked Plating System Long Plate Line Extension K101421
Device Description
The Biomet Proximal Humeral Plating System offers two plating families (Low and High) with both left and right configurations in various lengths. Both plating families in the Biomet Proximal Humerus Plating System incorporate the same spatial subchondral support as the Biomet S3 proximal humerus plates (K060290) in the head of the plates. The plates and screws will be manufactured from Titanium Alloy (ASTM F136) and are either type II or color anodized. The system will also include multidirectional screws that are manufactured from Cobalt Chromium (ASTM F1537). The plates are anatomically designed to match the anatomy of the proximal humerus. The system will also include instrumentation to aid the user in alignment and stabilization of fractures to the skeletal system.
4
Intended Use and Indications for Use
The Intended Use of the Biomet Proximal Humerus Plating System is for internal fixation of humeral fractures. The indications for the Proximal Humerus Plating System are as follows: The Biomet Proximal Humerus Plating System is indicated for fixation of fractures and fracture dislocations, fusions, osteotomies and non-unions of the humerus, particularly in osteopenic bone.
Summary of Technological Characteristics
The rationale for substantial equivalence is based on consideration of the following characteristics:
- Intended Use: The Intended Use of the Biomet Proximal Humerus Plating System is the same as to the intended uses cleared in K955472 and K060290 and similar to K101421.
- Indications for Use: The indications for the Biomet Proximal Humerus Plating System is similar to and based on the Indications for Use cleared in K955472, K060290, and K101421.
- Materials: The Biomet Proximal Humerus Plating System plates are manufactured from Type II anodized Titanium Alloy (Ti-6Al-4V ELI). The locking and non-locking screws included in the system are also manufactured from Titanium Alloy (Ti-6Al-4V ELI ASTM F-136) and are either type II anodized or color anodized. The system also contains multi-directional screws that are manufactured from Cobalt Chromium (ASTM F1537). Titanium alloys as well as implant grade cobalt chromium are commonly used materials in orthopedic implants and are used in predicate devices cleared via K955472 and K101421. The patient contact instrumentation is comprised of stainless steel that meets ASTM F-899.
- . Design Features: The design features for the Biomet Proximal Humerus Plating System are similar to currently marketed devices K955472, K060290 and K101421. The design differences have not identified any issues that would impact the safety and effectiveness of the devices.
- . Sterilization: The implants are offered to the user either in the sterile or non-sterile configuration. The non-sterile devices will be required to be steam sterilized by the user prior to use while the sterile implants will be terminally sterilized by gamma irradiation. These sterilization configurations are the same as the predicate devices currently marketed and cleared via K060290 and K101421.
Summary of Performance Data (Nonclinical and/or Clinical)
- . Non-Clinical Tests
- Non-clinical performance testing included axial load construct testing, o engineering evaluations and galvanic corrosion assessment to determine substantial equivalence of the Biomet Proximal Humerus Plating System. Results indicate that the subject plating system is substantially equivalent to legally marketed devices offering a reasonable assurance of safety and effectiveness.
- Clinical Tests
- o No clinical tests are provided for basis of substantial equivalence.
5
Image /page/5/Picture/0 description: The image contains the word "BIOMET" in all capital letters. The letters are bold and gray. The font is sans-serif and the letters are evenly spaced.
Substantial Equivalence Conclusion
The Biomet Proximal Humerus Plating System has shown to be substantially equivalent to the predicate devices. Results of non-clinical tests/engineering justification and the similarities with legally marketed predicated devices indicate the device will perform within the intended uses and no new issues of safety and effectiveness have been raised.