(63 days)
Not Found
No
The provided text describes a mechanical plating system for bone fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is described as a plating system intended for fixation of bone fragments, not for therapy or treatment of disease.
No
The device description indicates that it is a plating system used for the stabilization and fixation of bone fragments and the management of fractures, revisions, fusions, and reconstructive surgeries. This is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines physical components made of Titanium alloy and CoCr, including plates, screws, and instrumentation, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for the stabilization and fixation of bone fragments during surgical procedures. This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The description details plates, screws, and instrumentation used for bone fixation. These are surgical implants and tools, not reagents, instruments, or systems intended for the examination of specimens derived from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information about a patient's health status.
IVD devices are used to perform tests on samples like blood, urine, or tissue to diagnose diseases, monitor health, or screen for conditions. This device's function is entirely focused on the mechanical support and stabilization of bone.
N/A
Intended Use / Indications for Use
The system is intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions (osteotomies) of small bones of the hand, foot, radius, ulna, ankle, humerus, scapula and pelvis, particularly in osteopenic bone.
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
The Dorsal, Lateral and Ulna Plating System consists of Titanium alloy plates utilizing non-locking, locking and variable angle screws manufactured from Titanium alloy and CoCr for bone fixation and the management of fractures, revisions, fusions and reconstructive surgeries. They can be provided in a pre-packaged sterile kit with accompanying single use instrumentation, individually packaged sterile units or non-sterile for further steam sterilization prior to use. Offered in left and right configurations, with the exception of the Ulna plate that is bilateral, the plates are for use with existing 2.2mm pegs and 2.7mm locking and non-locking screws and multidirectional fasteners.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand, foot, radius, ulna, ankle, humerus, scapula and pelvis
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)
preclinical data including axial load construct testing, evaluation of galvanic corrosion potential and multidirectional screw capability.
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
Section 5 — 510(k) Summary
MAY 1 3 2014
| Submitted by: | Biomet Trauma
56 East Bell Drive
PO Box 587
Warsaw, IN 46581
Phone: (305) 269-6386
Fax:
(305) 269-6400 |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Suzana Otaño, Regulatory Affairs Manager |
| Date Prepared: | May 7, 2014 |
| Proprietary Name: | Dorsal, Lateral and Ulna Plating System |
| Common Name: | Plate, Fixation, Bone |
| Classification Name
/ Product Code: | Single/multiple component metallic bone fixation appliances and
accessories (21 CFR § 888.3030) / HRS |
| Predicate Devices: | The Dorsal, Lateral and Ulna Plating System is substantially
equivalent to the currently marketed Small Bone Locking Plating
System (K081546, K083364) and Distal Volar Radius Plating System
(K112345). |
| Device Description: | The Dorsal, Lateral and Ulna Plating System consists of Titanium
alloy plates utilizing non-locking, locking and variable angle screws
manufactured from Titanium alloy and CoCr for bone fixation and
the management of fractures, revisions, fusions and reconstructive
surgeries. They can be provided in a pre-packaged sterile kit with
accompanying single use instrumentation, individually packaged
sterile units or non-sterile for further steam sterilization prior to use.
Offered in left and right configurations, with the exception of the
Ulna plate that is bilateral, the plates are for use with existing
2.2mm pegs and 2.7mm locking and non-locking screws and
multidirectional fasteners. |
| Indications for Use: | The system is intended for stabilization and fixation of small bone
fragments in fresh fractures, revision procedures, joint fusion and
reconstructions (osteotomies) of small bones of the hand, foot,
radius, ulna, ankle, humerus, scapula and pelvis, particularly in
osteopenic bone. |
.
»
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Technological Characteristics:
Summary of Substantial Equivalence: The technological characteristics of the Dorsal, Lateral and Ulna Plating System are similar to the predicate devices including design, dimensions and material.
The Dorsal, Lateral and Ulna Plating System is substantially equivalent to currently marketed devices as demonstrated with preclinical data including axial load construct testing, evaluation of galvanic corrosion potential and multidirectional screw capability. No new issues of safety or efficacy have been raised.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing or supporting another, with flowing lines suggesting movement or support.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 13, 2014
Biomet Manufacturing Corporation Ms. Suzana Otaño Regulatory Affairs Manager 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581
. Re: K140622
Trade/Device Name: Dorsal, Lateral and Ulna 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: March 19, 2014 Received: March 20, 2014
Dear Ms. Otaño:
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
3
Page 2 - Ms. Suzana Otaño
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 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" (21 CFR 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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Ronald P. Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SECTION 4 - INDICATIONS FOR USE STATEMENT
K140622 510(k) Number:
Dorsal, Lateral and Ulna Plating System Device Name:
Indications For Use:
The system is intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions (osteotomies) of small bones of the hand, foot, radius, ulna, ankle, humerus, scapula and pelvis, particularly in osteopenic bone.
× Prescription Use (Per 21 CFR 801 Subpart D)
AND/OR
Over-the-Counter (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabet标垫蛋rank -S
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K140622
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