(105 days)
K0022775, K030310
Not Found
No
The device description and performance studies focus on mechanical properties and equivalence to predicate devices, with no mention of AI/ML or related concepts.
Yes
The device is described as aiding in the fusion of fractures and osteotomies and is an implantable bone fixation system, indicating it provides a therapeutic effect for the patient.
No
The device is described as an implantable system of plates, pegs, and screws intended to stabilize and aid in the fusion of fractures and osteotomies, which is a therapeutic function, not diagnostic.
No
The device description explicitly states that the DRLock System is a series of metallic, implantable bone fixation plates, pegs, and screws, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "stabilize and aid in the fusion of fractures and osteotomies of the distal radius." This is a surgical implant used directly on the patient's bone.
- Device Description: The device is described as "metallic (stainless steel), implantable, bone fixation plates, pegs and screws." These are physical implants for surgical procedures.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
This device is clearly a surgical implant used for orthopedic procedures, not for testing biological samples.
N/A
Intended Use / Indications for Use
The DRLock ™ Distal Radius Volar System is used to stabilize and aid in the fusion of fractures and osteotomies of the distal radius.
The DRLock Distal Radius Volar System is indicated for the fixation of unstable distal radius fractures and osteotomies.
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
The DRLock ™ Distal Radius Volar System (DRLock) is a series of metallic (stainless steel), implantable, bone fixation plates, pegs and screws. Its' intended use is to stabilize and aid in the fusion of fractures and osteotomies involving the distal radius.
The System includes four (4) fixation plates, twenty-five (25) screws and eleven (11) pegs. All screws and plates are made from type 316L Stainless Steel in conformance with ASTM F 138 Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal radius
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)
Finite Element Analysis in conjunction with mechanical testing confirms that the DRLock System is substantially equivalent to its' predicate devices, and that it meets specified requirements for its' intended use.
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.
K0022775, K030310
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
§ 888.3030 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
FEB 2 7 2006
510(k) Premarket Notification
DRLock™ Distal Radius Volar System
510(k) SUMMARY
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared.
OrthoHelix Surgical Designs, Inc. 1815 West Market Street Suite 205 Akron, Ohio 44313 Phone: (866) 904-3549 Fax: (352) 371-3932
Contact Person: Edward A. Kroll Representative Consultant for OrthoHelix Surgical Designs, Inc.
January 23, 2006 Date Prepared:
Name of Device
DRLock ™ Distal Radius Volar System
Common or Usual Name
Fixation Plates and Screws
Classification Name
Single/Multiple Component Metallic Fixation Appliances and Accessories
Predicate Devices
Hand Innovations Distal Volar Radius Fracture Repair System (K0022775) Synthes (USA) Stainless Steel Modular Hand System (K030310)
Intended Use
The system is used to stabilize and aid in the fusion of fractures and osteotomies of the distal radius.
1
510(k) Premarket Notification
DRLock™ Distal Radius Volar System
Device Description
The DRLock ™ Distal Radius Volar System (DRLock) is a series of metallic (stainless steel), implantable, bone fixation plates, pegs and screws. Its' intended use is to stabilize and aid in the fusion of fractures and osteotomies involving the distal radius.
The System includes four (4) fixation plates, twenty-five (25) screws and eleven (11) pegs. All screws and plates are made from type 316L Stainless Steel in conformance with ASTM F 138 Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants.
Performance Data
Finite Element Analysis in conjunction with mechanical testing confirms that the DRLock System is substantially equivalent to its' predicate devices, and that it meets specified requirements for its' intended use.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the staff and a snake winding around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 7 2006
Mr. Lee A. Strnad Senior Development Manager OrthoHelix Surgical Designs, Inc. 1815 West Market Street, Suite 205 Akron, Ohio 44313
K053182 Re:
K055162
Trade/Device Name: DRLock Distal Radius Volar System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Codes: HRS Dated: January 25, 2006 Received: January 26, 2006
Dear Mr. Strnad:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 9 rQxy press. In substantially equivalent (for the indications felerenced above and nave determined ly marketed predicate devices marketed in interstate for use stated in the encrosure) to regions and ment date of the Medical Device Amendments, or to commerce provision way 20, 1976, the eccordance with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I bu may, incretore, market the device, books requirements for annual registration, listing of general controls provisions of the ling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (600 world). Existing major regulations affecting your device can may be subject to suen additions, Title 21, Parts 800 to 898. In addition, FDA may oc found in the Couvencements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please oe advised that I DTT 3 issualled of a babbailer.
that FDA has made a determination that your device complies with other requirements of the Act that I DA has made a deceminations administered by other Federal agencies. You must or any I catal suttates and regulations, including, but not limited to: registration and listing (21
3
Page 2 - Mr. Lee A. Strnad
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set a CFR Part 807), labeling (21 CFR Part 800); good in and 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Sections over device as described in your Section 510(k) I his letter will anow you to ocgin manketing your arrivalence of your device to a legally premarket nothleation: "The PDF mailing of castination for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please IT you desire specific arrice ior J ow (240) 276-0120. Also, please note the regulation entitled, Colliact the Office of Compilance as (E++ Part 807.97). You may obtain Misolallang by relected to promantonionshibilities under the Act from the Division of Small other general information on your response Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Vicker Leen 40
for
Mark N. Melkerson, M.S. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K053182
Device Name: DRLock™ Distal Radius Volar System
Indications for Use:
The DRLock Distal Radius Volar System is indicated for the fixation of unstable distal radius fractures and osteotomies.
Prescription Use 区 (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)
Page | of |
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
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