(117 days)
Not Found
No
The document describes standard bone fixation screws and does not mention any AI or ML components or functionalities.
Yes.
The device's intended use is to provide bone fixation in the management of osteotomies, fusions, and fractures, which are medical treatments for diseases or injuries.
No
Explanation: The device is described as "Solid Bone Screws" intended for bone fixation in the management of osteotomies, fusions, and fractures. This indicates a therapeutic or surgical function, not a diagnostic one.
No
The device description explicitly states it consists of physical bone screws and washers, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the screws are for "bone fixation in the management of osteotomies, fusions, and fractures." This is a surgical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details physical screws and washers used for bone fixation.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used for structural support.
N/A
Intended Use / Indications for Use
"The Emerge Medical Solid Bone Screws are intended to provide bone fixation in the management of osteotomies, fusions, and fractures of metaphysis and diaphysis of both small and large bones and the pelvis. The screws may be used alone or with washers."
Product codes
HWC
Device Description
"The Emerge Medical Bone Fixation screws consist of cancellous, cortical and shaft screws with washers, as needed, in a variety of sizes to accommodate differing anatomic requirements. The screws are provided non-sterile."
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
metaphysis and diaphysis of both small and large bones and the 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
"Static tests performed according to ASTM 543 demonstrated that the device performs as well as or better than the predicate devices. Testing included screw variations in material, diameters, lengths, partial versus full threads, and drive types. Clinical data were not needed to demonstrate substantial equivalence for these devices."
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
K122489(1)
DEC 1 0 2012
:
| 510(k) Summary | |
|---|---|
| NAME OF FIRM: | Emerge Medical |
| 720 S. Colorado Blvd. | |
| Suite 550-S | |
| Denver, CO 80246 | |
| DATE PREPARED: | November 29, 2012 |
| 510(K) CONTACT: | Victoria Trafka |
| Vice President of Engineering & Quality | |
| Tel: (303) 225-7909 | |
| PROPOSED TRADE NAME: | Emerge Medical Solid Bone Screws |
| DEVICE CLASSIFICATION: | Class II; 21 CFR 888.3040 |
| CLASSIFICATION NAME: | Smooth or threaded metallic bone fixation fastener |
| PRODUCT CODE: | HWC |
| DEVICE DESCRIPTION: | The Emerge Medical Bone Fixation screws consist of cancellous, |
| cortical and shaft screws with washers, as needed, in a variety of | |
| sizes to accommodate differing anatomic requirements. | |
| The | |
| screws are provided non-sterile. | |
| INDICATIONS FOR USE: | The Emerge Medical Solid Bone Screws are intended to provide |
| bone fixation in the management of osteotomies, fusions, and | |
| fractures of metaphysis and diaphysis of both small and large | |
| bones and the pelvis. The screws may be used alone or with | |
| washers. | |
| MATERIALS: | Titanium alloy (ASTM F136) |
| Stainless steel (ASTM F138) | |
| PREDICATE DEVICES: | Synthes K112583 and K061621 |
| TECHNOLOGIC | |
| CHARACTERISTICS: | The fundamental scientific principles and technological |
| characteristics, including the intended use, material, general | |
| design, and sizes of the device are the equivalent the predicate | |
| devices. | |
| PERFORMANCE DATA: | Static tests performed according to ASTM 543 demonstrated that |
| the device performs as well as or better than the predicate | |
| devices. Testing included screw variations in material, diameters, | |
| lengths, partial versus full threads, and drive types. Clinical data | |
| were not needed to demonstrate substantial equivalence for these | |
| devices. |
Page 4 of 10-
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines forming the body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
· Letter dated: December 10, 2012
Emerge Medical % Ms. Victoria Trafka Vice President of Engineering & Quality 720 South Colorado Boulevard, Suite 550-S Denver, Colorado 80246
Re: K122489
Trade/Device Name: Emerge Medical Solid Bone Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: November 13, 2012 Received: November 14, 2012
Dear Ms. Trafka:
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 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
2
Page 2 - Ms. Victoria Trafka
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use Statement
510(k) Number (if known):
Device Name: Emerge Medical Solid Bone Screws
Indications for Use:
The Emerge Solid Bone Screws are intended to provide bone fixation in the management of rile Emerge Oolle Bone Golows and finetaphysis and diaphysis of both small and large bones and the pelvis. The screws may be used alone or with washers.
Over-The-Counter Use __ × Prescription Use OL (21 CFR 807 Subpart C) (21 CFR 801 Subpart D)
(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Krishna Asundi
for (Division Sign-Off) Division of Orthopedic Devices 2012.12.05 18:11:13 -05'00'