(36 days)
Not Found
No
The device description focuses on the physical components (plates, screws, instrumentation) and materials used for fracture fixation. There is no mention of software, algorithms, or any capabilities that would suggest the use of AI or ML. The performance studies are based on mechanical testing of the screws.
Yes.
The device is indicated for fracture fixation, fusion, and osteotomies, which are treatments for medical conditions, thereby classifying it as a therapeutic device.
No
Explanation: The device is a rigid fixation and fusion system used for fracture fixation, fusion, and osteotomies. Its intended use is for surgical procedures, not for diagnosing conditions.
No
The device description explicitly states it consists of plates, screws, and instrumentation, which are physical hardware components.
Based on the provided information, the OsteoMed ExtremiLOCK Wrist Plating System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "fracture fixation, fusion and osteotomies of wrist and other bones appropriate for the size of the device." This describes a surgical implant used to physically stabilize and repair bone structures within the body.
- Device Description: The device consists of "plates and screws in various configurations along with the appropriate instrumentation to facilitate modification and implantation." These are physical components designed for surgical implantation.
- Anatomical Site: The device is used on "wrist and other bones." This refers to anatomical locations within the body.
- IVD Definition: An In Vitro Diagnostic (IVD) device is defined as a medical device intended for use in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
The OsteoMed ExtremiLOCK Wrist Plating System does not examine specimens from the human body in vitro. It is a surgical implant used directly within the body for structural support and repair.
N/A
Intended Use / Indications for Use
The OsteoMed ExtremiLOCK Wrist Plating System is indicated for fracture fixation, fusion and osteotomies of wrist and other bones appropriate for the size of the device. It is intended for use in trauma, general surgery and reconstructive procedures.
OsteoMed ExtremiLOCK Wrist Plating System implants are intended for single use only.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The OsteoMed ExtremiLOCK Wrist Plating System is a rigid fixation and fusion system consisting of plates and screws in various configurations along with the appropriate instrumentation to facilitate modification and implantation. Plates are anatomically pre-contoured in various shapes and sizes. Screws are provided with variable angle locking and non-locking heads and are either fully threaded or partially threaded in various lengths. These screws are either solid core or cannulated and can be used with or without plates. The system also contains K-wire implants.
The implants of the OsteoMed ExtremiLOCK Wrist Plating System are made from Titanium per ASTM F-67 (Plates), Titanium Alloy per ASTM F-136 (plates, screws and washer), and Stainless Steel per ASTM F-138( K-wires). The dimensional modifications to the screws include the addition of flutes (for screw lengths
§ 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.
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Image /page/0/Picture/1 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 image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 19, 2016
OsteoMed Ms. Kathryn Jayne Senior Specialist, Regulatory Affairs 3885 Arapaho Road Addison, Texas 75001
Re: K161041 Trade/Device Name: OsteoMed ExtremiLOCK Wrist 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: April 14, 2016 Received: April 15, 2016
Dear Ms. Jayne:
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 Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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/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 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
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Indications for Use
510(k) Number (if known): _K161041
Device Name: OsteoMed ExtremiLOCK Wrist Plating System
Indications for Use:
The OsteoMed ExtremiLOCK Wrist Plating System is indicated for fracture fixation, fusion and osteotomies of wrist and other bones appropriate for the size of the device. It is intended for use in trauma, general surgery and reconstructive procedures.
OsteoMed ExtremiLOCK Wrist Plating System implants are intended for single use only.
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)
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510(k) Summary
| Submitter Information | OsteoMed
3885 Arapaho Road
Addison, Texas 75001
Phone: (972) 677-4600
Fax: (972) 677-4601 |
|--------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Ms. Kathryn Jayne |
| Date Prepared | May 13, 2016 |
| Proprietary Name: | OSTEOMED EXTREMILOCK WRIST PLATING SYSTEM |
| Common Name: | Wrist Fixation System |
| Classification Names: | 21 CFR 888.3030: Single/multiple component metallic bone
fixation appliances and accessories
21 CFR 888.3040: Smooth or threaded metallic bone fixation
fastener |
| Product Codes: | HRS, HWC |
| Class: | II |
| Predicate: | OsteoMed ExtremiLOCK Wrist Plating System, K152145 |
| Classification Names: | 21 CFR 888.3030, Single/multiple component metallic bone
fixation appliances and accessories;
21 CFR 888.3040: Smooth or threaded metallic bone fixation
fastener |
| Product Code: | HRS, HWC |
| Class: | II |
| Device Description | The OsteoMed ExtremiLOCK Wrist Plating System is a rigid
fixation and fusion system consisting of plates and screws in
various configurations along with the appropriate instrumentation
to facilitate modification and implantation. Plates are anatomically
pre-contoured in various shapes and sizes. Screws are provided
with variable angle locking and non-locking heads and are either
fully threaded or partially threaded in various lengths.
These
screws are either solid core or cannulated and can be used with or
without plates. The system also contains K-wire implants. |
| | The implants of the OsteoMed ExtremiLOCK Wrist Plating
System are made from Titanium per ASTM F-67 (Plates),
Titanium Alloy per ASTM F-136 (plates, screws and washer), and
Stainless Steel per ASTM F-138( K-wires). The dimensional
modifications to the screws include the addition of flutes (for screw
lengths ≤ 16mm), tapered tip, decrease in thread pitch, and |
| | of the system has already been cleared through OsteoMed wrist
predicate 510(k) K152145. |
| Indications for use/
Intended Use | The OsteoMed ExtremiLOCK Wrist Plating System is indicated
for fracture fixation, fusion and osteotomies of wrist and other
bones appropriate for the size of the device. It is intended for use
in trauma, general surgery and reconstructive procedures. |
| | OsteoMed ExtremiLOCK Wrist Plating System implants are
intended for single use only. |
| Performance
Characteristics &
Testing & Clinical | Performance: Verification testing was conducted to assess the
performance of the screws (subject device). The verification
testing confirmed the screws met minimum requirements as
specified in ASTM F543 or performed equal or better compared to
the predicate devices. The screws met the mechanical strength
criteria for the intended use.
Performance equivalence was shown through the verification
comparison to the predicate devices. |
| | Clinical Testing is not required to support substantial equivalence. |
| Substantial Equivalence | The basis of substantial equivalence for this device, OsteoMed
ExtremiLOCK Wrist Plating System, is based on similarities in
indications for use, material, function, performance, design,
technology, shelf life, sterilization, and operational principles to the
OsteoMed predicate device. Performance comparisons were
performed which verified that the modified screws met required
mechanical strength criteria for their intended use compared to the
predicate devices listed in this summary. OsteoMed has shown
that the non-clinical tests demonstrate that the subject device is as
safe and effective as the predicate device. |
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