(236 days)
Not Found
No
The summary describes a mechanical implant system for bone fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended for internal bone fixation for fractures, fusions, or osteotomies, which are therapeutic interventions.
No
The device, TITAN 3-D™ Wedge System, is an implant used for internal bone fixation for fractures, fusions, or osteotomies in the foot and ankle, not for diagnosing conditions.
No
The device description explicitly states it contains "a series of titanium alloy implants," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "internal bone fixation for bone fractures, fusions or osteotomies in the foot and ankle." This describes a surgical implant used directly on the patient's body to treat a physical condition.
- Device Description: The description confirms it's a "series of titanium alloy implants used for the correction of small bones in the foot." This further reinforces its nature as a physical implant.
- Lack of IVD Characteristics: IVD devices are used in vitro (outside the body) to examine specimens (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. The provided information contains no mention of analyzing biological samples or providing diagnostic information based on such analysis.
Therefore, the TITAN 3-D™ Wedge System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The TITAN 3-DIM Wedge System implants are intended to be used for internal bone fixation for bone fractures, fusions or osteotomies in the foot and ankle. The TITAN 3-D™ Wedge System implants are use with ancillary fixation. The TITAN3-DTM Wedge System implants are not intended for use in the spine.
Product codes (comma separated list FDA assigned to the subject device)
PLF, HWC
Device Description
The TITAN 3-D™ Wedge System contains a series of titanium alloy implants used for the correction of small bones in the foot. It is offered in varying shapes and sizes to accommodate a variety of small bone applications. The implants are sold sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot and ankle
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Static and dynamic compression, and static compression-shear testing was performed following ASTM F2077. Expulsion testing was performed. Abrasion testing per ASTM F1978 was performed. LAL testing for bacterial endotoxins was performed.
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.
BIOFOAM® Bone Wedge (Wright Medical Technology, Inc. – K142724), 4Web Osteotomy Bone Wedge (4Web Inc. – K130185)
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.
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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 features a stylized depiction of an eagle or bird-like figure with three overlapping profiles facing to the right. The profiles are rendered in a simple, black silhouette. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 3, 2017
Paragon 28 Karen E. Warden, Ph.D. BackRoads Consulting Inc. P.O. Box 566 Chesterland, Ohio 44026
Re: K162241 Trade/Device Name: TITAN 3-DTM Wedge System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: PLF, HWC Dated: February 18, 2017 Received: February 21, 2017
Dear Dr. Warden:
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 Part 801); medical device reporting of medical devicerelated 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.
1
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" (21 CFR 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,
Ronald P. Jean -S for
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) K162241
Device Name TITAN 3-DTM Wedge System
Indications for Use (Describe)
The TITAN 3-DIM Wedge System implants are intended to be used for internal bone fixation for bone fractures, fusions or osteotomies in the foot and ankle. The TITAN 3-D™ Wedge System implants are use with ancillary fixation. The TITAN3-DTM Wedge System implants are not intended for use in the spine.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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| Date: | 8 August 2016 |
|---|---|
| Sponsor: | Paragon 28 |
| 4B Inverness Ct. E., STE 280 | |
| Englewood, Colorado 80112 | |
| Phone: (888) 728-1888 | |
| Facsimile: (888) 728-1220 | |
| Sponsor Contact: | Frank S. Bono, Chief Technology Officer |
| 510(k) Contact: | Karen E. Warden, PhD |
| BackRoads Consulting Inc. | |
| PO Box 566 | |
| Chesterland, OH 44026 | |
| Office: 440.729.8457 | |
| Trade Names: | TITAN 3-D™ Wedge System |
| Common Name: | Bone wedge |
| Regulatory Class: | Class II |
| Classification Name, | |
| Regulation, Product | Single/multiple component metallic bone fixation appliances and |
| accessories, 888.3030, PLF | |
| Code: | Smooth or threaded metallic bone fixation fastener, 888.3040, HWC |
| Device Description: | The TITAN 3-D™ Wedge System contains a series of titanium alloy |
| implants used for the correction of small bones in the foot. It is offered in | |
| varying shapes and sizes to accommodate a variety of small bone | |
| applications. The implants are sold sterile. | |
| Indications for Use: | The TITAN 3-D™ Wedge System implants are intended to be used for |
| internal bone fixation for bone fractures, fusions or osteotomies in the foot | |
| and ankle. The TITAN 3-D™ Wedge System implants are intended for | |
| use with ancillary fixation. The TITAN 3-D™ Wedge System implants are | |
| not intended for use in the spine. | |
| Materials: | The TITAN 3-D™ Wedge System implants are manufactured from |
| medical grade titanium alloy (per ASTM F2924). | |
| Primary Predicate: | BIOFOAM® Bone Wedge (Wright Medical Technology, Inc. – K142724) |
| Additional Predicate: | 4Web Osteotomy Bone Wedge (4Web Inc. – K130185) |
| Performance Data: | Static and dynamic compression, and static compression-shear testing |
| was performed following ASTM F2077. Expulsion testing was performed. | |
| Abrasion testing per ASTM F1978 was performed. LAL testing for | |
| bacterial endotoxins was performed. | |
| Technological | |
| Characteristics: | The TITAN 3-D™ Wedge System possesses the same technological |
| characteristics as one or more of the predicate devices. These include: | |
| • performance, | |
| • basic design, | |
| • material, manufacturing and | |
| • sizes (dimensions are comparable to those offered by the | |
| predicate systems). | |
| Therefore the fundamental scientific technology of the TITAN 3-D™ | |
| Wedge System is similar to previously cleared devices. |
510(k) Summary
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Conclusion:
The TITAN 3-D™ Wedge System possesses indications for use and
technological characteristics the same as the predicate devices. Therefore the TITAN 3-D™ Wedge System is substantially equivalent to the predicates.