(56 days)
Not Found
No
The device description and performance studies focus on mechanical properties and fixation, with no mention of AI/ML or related concepts like image processing, training/test sets, or performance metrics typically associated with AI/ML devices.
Yes
The device is used for stabilization and/or correction of angular deviations within bones in the foot, which is a therapeutic purpose.
No
The device is described as a "Bone Locking Plate System" that is used for stabilization and correction of angular deviations. It is a surgical implant, not a diagnostic tool.
No
The device description explicitly states it consists of "plates and screws" and is a "Bone Locking Plate System," indicating it is a physical hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The OsteoWedge™ system is a surgical implant (plates and screws) used to stabilize and correct bone deformities in the foot. It is a physical device used in the body, not a test performed on samples from the body.
- Intended Use: The intended use is for surgical stabilization and correction of bone deviations, not for diagnosing a condition based on biological samples.
Therefore, based on the provided information, the OsteoWedge™ Opening Wedge Bone Locking Plate System is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The OsteoWedge™ Opening Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization and/or correction of angular deviations within an individual bone or in between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations.
Product codes
HRS
Device Description
The OsteoWedge™ Open Wedge Bone Locking Plate System consists of plates and screws and incorporates a screw-to-plate locking mechanism. The plate is attached to a prepared surface of the involved bone(s) of the foot using six (6) screws for fixation. The plates are available in six (6) wedge sizes. The fully threaded screws are available in 2 diameters, with numerous lengths.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot (within an individual bone or in between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations)
Indicated Patient Age Range
adult and transitional adolescent (18 to 21 years old)
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)
The following testing has been performed to support substantial equivalence:
- Bend Testing, including Static Four Point Bending & Dynamic Four Point Bending Bending Strength
- Torsion Testing, Self-Tapping Performance, Axial Pullout Testing, and Insertion and Removal Testing
- Cleaning and Sterilization Testing
Clinical trial or testing was not required for the OsteoWedge™ Opening Wedge Bone Locking Plate System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Graham Medical Technologies LLC (dba GraMedica) Traditional 510(k) Premarket Submission OsteoWedge™ Opening Wedge Bone Locking System
- 6 -2011 .. Jul
Section 5 - 510(k) Summary
Submission Correspondent
Emergo Group, Inc. www.emergogroup.com/
Address
611 West 5th Street, Third Floor Austin, TX 78701
Phone
(512) 327-9997
Fax
(512) 327-9998
Contact
Julie Powell jpowell@emergogroup.com
Submission Sponsor
Graham Medical Technologies, L.L.C. (d.b.a. GraMedica) 16137 Leone Drive Macomb, MI 48042 Tel: 586 677 9600 Fax: 586 677 9615 FDA Establishment Registration #: 3004993707
Date Prepared
June 30, 2011
Trade Name
OsteoWedge™ Opening Wedge Bone Locking System
Classification Name
Plate, Bone, Fixation
Regulation Number
888.3030
Product Code HRS
Classification Panel Orthopedic
1
Graham Medical Technologies LLC (dba GraMedica) Traditional 510(k) Premarket Submission OsteoWedge™ Opening Wedge Bone Locking System
Device Class
Class 2
Device Description
The OsteoWedge™ Open Wedge Bone Locking Plate System consists of plates and screws and incorporates a screw-to-plate locking mechanism. The plate is attached to a prepared surface of the involved bone(s) of the foot using six (6) screws for fixation. The plates are available in six (6) wedge sizes. The fully threaded screws are available in 2 diameters, with numerous lengths.
Intended Use
The OsteoWedge™ Opening Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization and/or correction of angular deviations within an individual bone or in between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations.
Predicate Device(s)
- Arthrex, Inc., Low Profile Plate and Screw System 1.
- Darco International, Inc., DACRO Locking Bone Plate System 2.
The following table identifies and compares OsteoWedge™ Opening Wedge Bone Locking Plate System to the predicate devices with respect to 510(k) number, product code, regulation number, regulation name and indications for use.
| Manufacturer | Graham Medical
Technologies LLC (dba
GraMedica) | Darco International,
Inc. | Arthrex, Inc. | OsteoWedge
Comparison to
Predicates |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | OsteoWedge™ Opening
Wedge Bone Locking
Plate System | DARCO Locking Bone
Plate System | Low Profile Plate and
Screw System | |
| 510(k) Number | TBD | K061808 | K052614 | NA |
| Product Code | HRS | HRS | HRS | Same |
| Regulation
Number | 880.3030 | 880.3030 | 880.3030 | Same |
| Regulation
Name | Single/multiple
component metallic
bone fixation
appliances and
accessories | Single/multiple
component metallic
bone fixation
appliances and
accessories | Single/multiple
component metallic
bone fixation
appliances and
accessories | Same |
| Indications for
use: | The OsteoWedge™
Opening Wedge Bone
Locking Plate System is
used for adult and
transitional adolescent
(18 to 21 years old)
patients for the
purpose of stabilization
and/or correction of
angular deviations
within an individual | The DARCO Locking
Bone Plate System is
intended for use in
stabilization of fresh
fractures, revision
procedures, joint
fusion and
reconstruction of
small bones of the
hand, feet, wrist,
ankles, fingers, and | The Arthrex Low Profile
Plate and Screw System
is intended to be used
for internal bone
fixation of bone
fractures, fusions, or
osteotomies in the
ankle, foot, hand, and
wrist, such as opening
wedge osteotomies of
Hallux Valgus. | Same patient
population.
Same use – for
fixation &
stabilization.
OsteoWedge is
indicated for
use only in
bones of foot
such as the first
metatarsal and |
Comparison Table
2
K111326 3/3
Graham Medical Technologies LLC (dba GraMedica) Traditional 510(k) Premarket Submission OsteoWedge™ Opening Wedge Bone Locking System
| Manufacturer | Graham Medical
Technologies LLC (dba
GraMedica) | Darco International,
Inc. | Arthrex, Inc. | OsteoWedge
Comparison to
Predicates |
|--------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|---------------------------------------|-------------------------------------------|
| Trade Name | OsteoWedge™ Opening
Wedge Bone Locking
Plate System | DARCO Locking Bone
Plate System | Low Profile Plate and
Screw System | |
| | bone or in between
two adjacent bones in
the foot, such as
opening wedge
osteotomy for first
metatarsal cuneiform
joint deviations. | toes. The system can
be used in both adult
and pediatric patients. | | first metatarsal
cuneiform
joints. |
Predicate Device Comparison
The OsteoWedge™ Opening Wedge Bone Locking Plate System has been compared with the Low Profile Plate and Screw System and the Locking Bone Plate System. All devices are made of the same materials, provided non sterile for cleaning and sterilization prior to use, have same indications for stabilization, and fixation, and are of similar size. The OsteoWedge™ Opening Wedge Bone Locking Plate System has slightly larger 'wedge size' and therefore has narrower 'indications for use' than that of the above predicate device, as described in above Comparison Table.
Summary of Non-Clinical Data Submitted
The following testing has been performed to support substantial equivalence:
- Bend Testing, including Static Four Point Bending & Dynamic Four Point Bending Bending Strength
- Torsion Testing, Self-Tapping Performance, Axial Pullout Testing, and Insertion and Removal Testing
- Cleaning and Sterilization Testing
Summary of Clinical Data Submitted
Clinical trial or testing was not required for the OsteoWedge™ Opening Wedge Bone Locking Plate System. Refer to the non-clinical testing listing above to support substantial equivalence.
Conclusion
By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device, or has the same intended use and different technological characteristics, and it can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise different questions regarding its safety and effectiveness as compared to the predicate device.
It has been shown in this 510(k) submission that the differences between the OsteoWedge™ Opening Wedge Bone Locking Plate System and the predicate devices do not raise any questions regarding its safety and effectiveness. The OsteoWedge™ Opening Wedge Bone Locking Plate System, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate devices.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 an eagle or bird-like figure with three curved lines representing its body and wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Graham Medical Technologies, LLC % Emergo Group, Inc. % Ms. Julie Powell 611 West 5th Street, 3rd Floor Austin, Texas 78701
JUL - 6 2011
Re: K111326
Trade/Device Name: OsteoWedge Opening Wedge Bone Locking System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS. HWC Dated: April 26, 2011 Received: May 11, 2011
Dear Ms. Powell:
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. Ilsting 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
4
Page 2 -- Ms. Julie Powell
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 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.
Eric Pratt
Image /page/4/Picture/7 description: The image contains a handwritten letter 'f' in a cursive style. The letter is small and slightly tilted to the right. The stroke of the letter is thin and consistent, suggesting it was written with a pen or pencil.
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
SECTION 4 - INDICATIONS FOR USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name
OsteoWedge™ Opening Wedge Bone Locking Plate System
Indications for Use
The OsteoWedge™ Opening Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization and/or correction of angular deviations within an individual bone or in between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations.
Prescription Use × (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 n. Melkerson
(Division Sign-Oft Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K111326
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