(144 days)
Not Found
No
The 510(k) summary describes a simple bone fixation wire and makes no mention of AI or ML technology.
Yes
The device is intended for bone fracture fixation, osteotomy, arthrodesis, correction of deformity, revision procedures, and bone reconstruction, all of which fall under therapeutic interventions for medical conditions.
No
The device description and intended use indicate that K2M CoCr Wires are implants used for fixation and stabilization of bone, not for diagnosis.
No
The device description clearly states it is a physical implant made of Cobalt Chrome, intended for bone stabilization. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description and Intended Use: The K2M CoCr Wires are described as single-stranded implants intended for the stabilization of bony segments and used for procedures like bone fracture fixation, osteotomy, arthrodesis, etc. These are all procedures performed within the body (in vivo) and involve physically interacting with bone.
The device's function and intended use clearly fall under the category of a surgical implant or orthopedic device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
K2M CoCr Wires are intended for:
. Bone fracture fixation
. Osteotomy
. Arthrodesis
. Correction of deformity
. Revision procedures when other treatments or devices have been unsuccessful, and,.
Bone reconstruction procedures .
Product codes (comma separated list FDA assigned to the subject device)
JDQ
Device Description
K2M CoCr Wires are single stranded implants, with a diameter of 1.0mm (18 gauge).
Materials: The wires are manufactured from Cobalt Chrome per ASTM standards.
Function: K2M CoCr Wires are single use devices intended for the stabilization of bony segments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
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
§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.
0
K103797 (pg 1/1)
MAY 2 0 2011
510(k) Summary for the K2M CoCr Wire
This 510(k) summary for the K2M CoCr Wire is provided as required per Section 513(i)(3) of the Food, Drug and Cosmetic Act.
-
- Submitter :
K2M, Inc. 751 Miller Drive SE, Suite F1 Leesburg, VA 20175 Contact Person : Nancy Giezen K2M, Inc. Telephone: 703-777-3155
- Submitter :
Date Prepared: 12/23/10
- Tradename:
Common Name: Classification Name: Device Product Code: Regulatory Class:
K2M CoCr Wire Orthopedic Wire Bone Fixation Cerclage (21CFR 888.3010) 87 JDQ Class II
-
- Predicate or legally marketed devices which are substantially equivalent :
- Howmedica Orthopedic Wire (K031127) .
-
- Description of the device:
K2M CoCr Wires are single stranded implants, with a diameter of 1.0mm (18 gauge).
Materials: The wires are manufactured from Cobalt Chrome per ASTM standards.
Function: K2M CoCr Wires are single use devices intended for the stabilization of bony segments.
5. Intended Use:
K2M CoCr Wires are intended for:
- . Bone fracture fixation
- . Osteotomy
- Arthrodesis
- . Correction of deformity
- . Revision procedures when other treatments or devices have been unsuccessful, and.
- Bone reconstruction procedures .
-
- Comparison of the technological characteristics of the device to predicate and legally marketed devices : The K2M CoCr Wires are manufactured in compliance with ASTM F1091. There are no significant differences between the K2M wire and other wires currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use.
1
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 with three lines forming its body and wings. The eagle is enclosed within a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY 2 0 2011
K2M, Inc. % Nancy Giezen 751 Miller Dr. SE Leesburg, VA 20175
Re: K103797
Trade/Device Name: K2M CoCr Wire Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: Class II Product Code: JDQ Dated: May 11, 2011 Received: May 13, 2011
Dear-Ms-Giezen :-
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
2
Page - 2 - Ms. Nancy Giezen
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 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,
A.S. n
za nxn.
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K103797 (pq 1/17
Device Name: K2M CoCr Wire
Indications for Use:
K2M CoCr Wires are intended for:
- . Bone fracture fixation
- . Osteotomy
- Arthrodesis .
- Correction of deformity .
- Revision procedures when other treatments or devices have been unsuccessful, and, .
- Bone reconstruction procedures .
| Prescription Use | X |
|---|---|
| ------------------ | --- |
(Part-21-CFR-801-Subpart-D)
AND/OR
| Over-the-counter Use | |
|---|---|
| ---------------------- | -- |
(21-CFR-801-Subpart-C)(PLEASE DO NOT WRITE BELOW THIS-LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for M. Melkersen
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K103797