(140 days)
No
The 510(k) summary describes a mechanical plating and screw system for bone fixation. There is no mention of software, algorithms, image processing, or any other components typically associated with AI/ML. The modifications described relate to material and screw design.
Yes
The device is described as a "rigid fixation and fusion system consisting of plates and screws" used for "fracture fixation, fusion and osteotomies of wrist and other bones." Its function is to facilitate healing and provide stability to bones after injury or surgery, which aligns with the definition of a therapeutic device.
No
Explanation: The device is a surgical implant system (plates and screws) used for fracture fixation, fusion, and osteotomies. It is not designed to diagnose a condition, but rather to treat one.
No
The device description clearly outlines physical components made of titanium and stainless steel (plates, screws, pegs, K-wires) and instrumentation for implantation, indicating it is a hardware-based medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "fracture fixation, fusion and osteotomies of wrist and other bones." This describes a surgical procedure performed directly on the patient's 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 implants and surgical tools used in a surgical setting.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health status, diagnose, monitor, or screen for diseases.
IVD devices are used to perform tests on samples taken from the body, while this device is a surgical implant used to repair bones.
N/A
Intended Use / Indications for Use
OsteoMed ExtremiLOCK Wrist Plating System is indicated for fracture fixation, fusion and osteotomies of wrist and other bones appropriate for 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, KWC
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 smooth variable angle locking pegs and 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, pegs and washer), and Stainless Steel per ASTM F-138( K-wires). The modifications to the plates include the new material of CP Titanium per ASTM F-67 and the screw modifications include the new dual lead technology. The rest of the system has already been cleared through OsteoMed wrist predicate 510(k) K120015. The modification also introduced new sterile packaging configurations for the implants and disposable instruments. The system instruments included facilitate modification and insertion of the implants.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wrist and other bones appropriate for the size of the device
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)
Performance: Verification testing was conducted to ensure plates and screws performed equal or better compared to the predicate devices. The plates were tested against the Synthes Secondary Predicate Device to ensure the design features and new material met the required mechanical strength criteria for their intended use. The screws with the dual lead technology underwent verification evaluation to ensure the new design features met the mechanical strength criteria for the intended use. The screws were compared to their respective predicates.
Clinical Testing is not required to support substantial equivalence.
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.
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.
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Image /page/0/Picture/1 description: The image is the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The profiles are facing right and are stacked on top of each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
OsteoMed Ms. Piedad Peña Manager, Regulatory Affairs 3885 Arapaho Road Addison, Texas 75001
Re: K152145 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, KWC Dated: November 24, 2015 Received: November 25, 2015
Dear Ms. Peña:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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" (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): _ Device Name: OsteoMed ExtremiLOCK Wrist Plating System
Indications for Use:
OsteoMed ExtremiLOCK Wrist Plating System is indicated for fracture fixation, fusion and osteotomies of wrist and other bones appropriate for 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 Over-The-Counter Use __ AND/OR (Part 21 CFR 801 Subpart D) (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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Image /page/3/Picture/0 description: The image shows the logo for OsteoMed. The logo is in blue and gray, with the word "OSTEOMED" in bold, sans-serif letters. The logo is surrounded by a gray and blue swoosh design. The logo is simple and modern, and it is likely used to represent the company's brand.
510(k) Summary
| Submitter Information | OsteoMed
3885 Arapaho Road
Addison, Texas 75001
Phone: (972) 677-4600
Fax: (972) 677-4601 |
|-----------------------|-------------------------------------------------------------------------------------------------------|
| Contact Person | Mrs. Piedad Peña |
| Date Prepared | July 31, 2015 |
| Proprietary Name: | OSTEOMED EXTREMILOCK WRIST PLATING SYSTEM |
| Common Name: | Wrist Fixation System |
| Classification Name: | 21 CFR 888.3030, Single/multiple component metallic bone
fixation appliances and accessories |
| Product Code: | HRS, HWC |
Primary Predicate:
OsteoMed Wrist Plating System, K120015
Classification Name: 21 CFR 888.3030, Single/multiple component metallic bone fixation appliances and accessories; Product Code: HRS, HWC; Class: II
Secondary Predicate:
Synthes 2.4mm VA-LCP Two Column Volar Distal Radius Plate, K083694
Classification Name: 21CFR 888.3030 Single/multiple component metallic bone fixation appliances and accessories; Product Code: Product Code HRS, Class: II
3″d Reference Predicate:
OsteoMed Hand Plate and Screw Fixation System, K090522
Classification Name: 21 CFR 888.3030, Single/multiple component metallic bone fixation appliances and accessories; Product Code: HRS, HWC; Class: II
4th Reference Predicate:
OsteoMed Foot Plate and Screw Rigid Fixation System, K091614
Classification Name: 21 CFR 888.3030, Single/multiple component metallic bone fixation appliances and accessories; Product Code: HRS, HWC; Class: II
5th Reference Predicate:
OsteoMed Headless Cannulated Screw, K063298
Classification Name: 21 CFR 888.40, Smooth or threaded metallic bone fixation fastener; Product Code: HWC; Class: II
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| 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 smooth variable angle locking pegs and K-wire
implants. |
|--------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description | 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, pegs and washer), and Stainless Steel per ASTM
F-138( K-wires). The modifications to the plates include the new
material of CP Titanium per ASTM F-67 and the screw modifications
include the new dual lead technology. The rest of the system has
already been cleared through OsteoMed wrist predicate 510(k)
K120015. The modification also introduced new sterile packaging
configurations for the implants and disposable instruments.
The system instruments included facilitate modification and insertion
of the implants. |
| 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 ensure plates and
screws performed equal or better compared to the predicate devices.
The plates were tested against the Synthes Secondary Predicate
Device to ensure the design features and new material met the
required mechanical strength criteria for their intended use. The
screws with the dual lead technology underwent verification
evaluation to ensure the new design features met the mechanical
strength criteria for the intended use. The screws were compared to
their respective predicates. |
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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, intended use, material, function, performance, design, technology, sterilization, and operational principles to the OsteoMed predicates and Synthes predicate. Performance comparisons were performed which verified that the new plates and screws met required mechanical strength criteria for their intended use compared to the legally marketed predicate devices listed in this OsteoMed has shown that the non-clinical tests summary. demonstrate that the devices are as safe and effective as the predicate devices.