(41 days)
DePuy Ace Calcaneal Peri-articular Plate
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No
The description focuses on the mechanical components (plates, screws, instruments) and their material properties for fracture fixation. There is no mention of software, algorithms, or data processing that would suggest AI/ML.
No
The description states its intended use is to stabilize fractures, which is a structural/mechanical function for repair after injury, not for therapy or treatment of a disease.
No
Explanation: The device is a surgical implant system (plates, screws, and instruments) used for fracture stabilization, not for diagnosing medical conditions. Its purpose is to repair, not to detect or identify.
No
The device description explicitly states it is a set of metallic, implantable bone fixation plates and screws, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The provided description clearly states that the Calcaneal Trauma System is a set of implantable bone fixation plates and screws. These are surgically implanted into the body to stabilize fractures.
- Intended Use: The intended use is for the repair of intra and extra articular fractures of the calcaneus. This is a surgical procedure, not a diagnostic test performed on a specimen outside the body.
The device is a surgical implant used for internal fixation of bone fractures, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
To stabilize fractures of the calcaneus when internal fixation of either intra-articular or extra-articular fractures is required.
The Calcaneal Trauma System is indicated for the repair of intra and extra articular fractures of the calcaneus
Product codes
HRS, HWC
Device Description
The OrthoHelix Calcaneal Trauma System is a set of metallic (titanium alloy), implantable, bone fixation plates and screws. Its' intended function use is to stabilize fractures of the calcaneus when internal fixation of either intra-articular or extra-articular fractures is required.
The System includes four (4) fixation plates and forty five (45) screws. It also includes various surgical instruments such as drill guides, drill bits and drivers. All screws and plates are made from implant grade titanium, Ti 6Al type 4V ELI per ASTM F 136.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
calcaneus
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
FEA's and hand calculations confirm that the Calcaneal Trauma 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.)
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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.
DePuy Ace Calcaneal Peri-articular Plate
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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
510(k) Premarket Notification
Calcaneal Trauma System
510(k) SUMMARY
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared.
OrthoHelix Surgical Designs, Inc. 1815 West Market St. Suite #205 Akron, Ohio 44313 Phone: (330) 869-9563 Fax: (330) 869-9583
Contact Person:
Lee A. Strad Director of Operations & Development OrthoHelix Surgical Designs, Inc.
Date Prepared:
May 4, 2006
Name of Device
Calcaneal Trauma System
Common or Usual Name
Fixation Plates and Screws
Classification Name
Single/Multiple Component Metallic Fixation Appliances and Accessories
Predicate Devices
DePuy Ace Calcaneal Peri-articular Plate
Intended Use
To stabilize fractures of the calcaneus when internal fixation of either intra-articular or extra-articular fractures is required.
Device Description
The OrthoHelix Calcaneal Trauma System is a set of metallic (titanium alloy), implantable, bone fixation plates and screws. Its' intended function use is to stabilize
JUN 2 9 2006
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KC0614000
Pg 2 of 2
510(k) Premarket Notification
Calcaneal Trauma System
fractures of the calcaneus when internal fixation of either intra-articular or extra-articular fractures is required.
The System includes four (4) fixation plates and forty five (45) screws. It also includes various surgical instruments such as drill guides, drill bits and drivers. All screws and plates are made from implant grade titanium, Ti 6Al type 4V ELI per ASTM F 136.
Performance Data
FEA's and hand calculations confirm that the Calcaneal Trauma System is substantially equivalent to its' predicate devices, and that it meets specified requirements for its' intended use.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 9 2006
Orthohelix Surgical Designs, Inc. c/o Lee A. Strnad Director of Operations & Development 1815 West Market Street, Suite 205 Akron, Ohio 44313
Re: K061400
Trade/Device Name: Calcaneal Trauma System Regulation Number: 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories. Regulatory Class: II Product Code: HRS, HWC Dated: May 15. 2006 Received: May 25, 2006
Dear Mr. Strnad:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such 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); good manufacturing practice requirements as set forth in the quality
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Page 2 - Mr. Strnad
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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Office of Compliance at (240) 276-0120 . Also, please note the regulation ent thed, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Bartare Bruckum
Mark Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): TBD
Device Name: Calcancal Trauma System
Indications for Use:
The Calcaneal Trauma System is indicated for the repair of intra and extra articular fractures of the calcaneus
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
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Martina Buchwald for Men
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K061406