(57 days)
Not Found
No
The 510(k) summary describes a mechanical plating system for bone fixation and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is used for fixation of fractures and non-unions of the tibia, which is a therapeutic intervention to treat bone injuries.
No
The device is a plating system designed for the fixation of bone fractures, not for diagnosing medical conditions.
No
The device description explicitly states it consists of implants (plates and screws) and instruments, which are physical hardware components used for internal bone alignment and fixation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description and Intended Use: The Emerge Medical Small Fragment Locked Plating System is described as implants and instruments used for internal bone alignment and fixation of fractures. Its intended use is to fix fractures of the tibia, ankle, and fibula. This involves surgical implantation directly into the body.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens taken from the body.
Therefore, this device falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Emerge Medical Locking Medial Distal Tibia Plate Set is indicated for the fixation of fractures of the distal tibia including, but not limited to, ankle fractures, periarticular, intraarticular and distal tibia fractures with a shaft extension, malleolar and distal fibular fractures.
The Emerge Medical Locking Proximal Tibia Plate Set is intended for treatment of non-unions, malunions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft fractures.
Product codes
HRS, HWC
Device Description
The Emerge Medical Small Fragment Locked Plating System Line Extension consists of implants and instruments designed to be used for internal bone alignment and fixation of fractures of the tibia. The system features a single plate design, bone screws for fixation, and a set of instruments to facilitate installation and removal of the implants. The plates have screw holes, which allow for attachment to the bones or bone fragments. The plates are fabricated from medical grade stainless steel (ASTM F139-12), and offered in various widths, lengths, and thicknesses. Plates and screws are provided non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tibia, ankle
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Static and Dynamic Bending of the Emerge Medical Small Fragment Locked Plating System Line were evaluated via finite element analysis (FEA) demonstrating the predicate device was the worst case scenario. The results of this non-clinical testing show that the strength of the Emerge Medical Small Fragment Locked Plating System Line Extension is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K983787, K002361, K011978, K001945
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
5.510(K) SUMMARY
Table 5-1 Summary Table
| Submitter: | Emerge Medical |
|---|---|
| Submitter's Name: | Michelle Potvin, Vice President of Quality Assurance |
| michelle.potvin@emergemedical.com | |
| Submitter's Address: | 720 S. Colorado Blvd. |
| Suite 550-S | |
| Denver, CO 80246 | |
| Submitter's Telephone: | 720.459.6392 |
| Submitter's Fax: | 800.698.1440 |
| Contact Person: | Meredith L. May MS, RAC |
| 719.337.7579 | |
| MMay@EmpiricalTesting.com | |
| Date Summary was Prepared: | 15 January 2014 |
| Trade or Proprietary Name: | Emerge Medical Small Fragment Locked Plating System |
| Common or Usual Name: | Single/multiple component metallic bone fixation appliances and |
| accessories (§888.3030), Smooth or threaded metallic bone | |
| fixation fastener (§888.3040) | |
| Classification: | Class II per 21 CFR §888.3030 and §888.3040 |
| Product Code: | HRS and HWC |
| Classification Panel: | Division of Orthopedic Devices |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION
The Emerge Medical Small Fragment Locked Plating System Line Extension consists of implants and instruments designed to be used for internal bone alignment and fixation of fractures of the tibia. The system features a single plate design, bone screws for fixation, and a set of instruments to facilitate installation and removal of the implants. The plates have screw holes, which allow for attachment to the bones or bone fragments. The plates are fabricated from medical grade stainless steel (ASTM F139-12), and offered in various widths, lengths, and thicknesses. Plates and screws are provided non-sterile.
TECHNOLOGICAL CHARACTERISTICS
The Emerge Medical Small Fragment Locked Plating System Line Extension has the same or similar design, sizes, indications for use, and materials as the predicate systems. The sizes differ slightly, but present no new risks.
INDICATIONS FOR USE
The indications for the Emerge Medical Small Fragment Locked Plating System are as follows for the two subsystems:
The Emerge Medical Locking Medial Distal Tibia Plate Set is indicated for the fixation of fractures of the distal tibia including, but not limited to, ankle fractures, periarticular, intraarticular and distal tibia fractures with a shaft extension, malleolar and distal fibular fractures.
Emerge Medical Small Fragment Locked Plating System Line Extension
1
The Emerge Medical Locking Proximal Tibia Plate Set is intended for treatment of non-unions, malunions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft fractures.
The Emerge Medical Small Fragment Locked Plating System Line Extension is not intended for use with active or latent infection, osteoporosis, insufficient quantity of bone/soft tissue, material sensitivity (if suspected tests should be performed prior to implantation), sepsis, and patients who are unwilling or incapable of following postoperative care instructions. This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
The indication for use for the Emerge Medical Small Fragment Locked Plating System Line Extension is similar to that of the predicate devices listed in Table 5-2.
| 510k | Trade or Proprietary or Model | Manufacturer |
|---|---|---|
| Number | Name | |
| K983787 | Proximal Tibia Plating System | Synthes |
| K002361 | Locking Proximal Tibia Plating(L- | |
| PTP) System | Synthes | |
| K011978 | LCP Proximal Tibia Plate | Synthes |
| K001945 | Medial Distal Tibia Plates | Synthes |
Table 5-2 Predicate Devices
PERFORMANCE DATA
Static and Dynamic Bending of the Emerge Medical Small Fragment Locked Plating System Line were evaluated via finite element analysis (FEA) demonstrating the predicate device was the worst case scenario. The results of this non-clinical testing show that the strength of the Emerge Medical Small Fragment Locked Plating System Line Extension is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
CONCLUSION
The overall technology characteristics and mechanical performance analysis lead to the conclusion that the Emerge Medical Small Fragment Locked Plating System Line Extension is substantially equivalent to the predicate device.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002
March 12, 2014
Emerge Medical % Ms. Meredith May MS. RAC Senior Manager Empirical Testing Corporation 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K140098
Trade/Device Name: Emerge Medical Small Fragment Locked 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, HWC Dated: January 15, 2014 Received: January 14, 2014
Dear Ms. May:
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 10 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
3
Page 2 - Ms. Meredith May MS, RAC
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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Lori A. Wigqins
- for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K140098 page 1 of 1
4. INDICATIONS FOR USE STATEMENT
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: December 31, 2013
See PRA Statement on last page. |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| Indications for Use | |
| 510(k) Number (if known) | K140098 |
| Device Name | Emerge Medical Small Fragment Locked Plating System |
| Indications for Use (Describe) | |
| The indications for the Emerge Medical Small Fragment Locked Plating System are as follows for the two subsystems: | |
| The Emerge Medical Locking Medial Distal Tibia Plate Set is indicated for the fixation of fractures of the distal tibia including, but not limited to, ankle fractures, periarticular, intraarticular and distal tibia fractures with a shaft extension, malleolar and distal fibular fractures. | |
| The Emerge Medical Locking Proximal Tibia Plate Set is intended for treatment of non-unions, malunions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft fractures. | |
| Type of Use (Select one or both, as applicable) | |
| Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
| PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| FOR FDA USE ONLY | |
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | |
| Elizabeth Frank -S | |
| Division of Orthopedic Devices | |
| FORM FDA 3881 (9/13) | PSC Publishing Services (301) 443-6740 EF |
Emerge Medical Small Fragment Locked Plating System Line Extension
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