(49 days)
Not Found
No
The 510(k) summary describes a purely mechanical implant for bone fixation and makes no mention of AI or ML technology.
Yes
The device is an implant used for the fixation of osteotomies and reconstruction of lesser phalanges to correct deformities, which is a therapeutic purpose.
No
The provided text describes an implant (Metasurg DigiFuse implant) used for the fixation of osteotomies and reconstruction of lesser phalanges to correct deformities, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly states it is a physical implant made of titanium, which is a hardware component.
Based on the provided information, the Metasurg DigiFuse implant is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens from the human body. This includes things like blood, urine, tissue, etc., to provide information about a person's health.
- The Metasurg DigiFuse implant is a surgical implant. It is a physical device intended to be implanted directly into the bone of the lesser digits to fix osteotomies and reconstruct deformities.
The description clearly states its purpose is for surgical fixation within the body, not for testing or analyzing biological samples.
N/A
Intended Use / Indications for Use
The Metasurg DigiFuse implant is indicated for the fixation of osteotomies and reconstruction of the lesser phalanges during procedures to correct deformities of the toes and fingers.
- Hammer toe deformity
- Claw toe deformity
- Mallet toe deformity
- Other deformities of the feet and hands
The Metasurg DigiFuse implants are intended for single use only.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The Metasurg DigiFuse Implant is a one-piece threaded device made of titanium intended to be implanted into the medullary bone of the lesser digits. The implant is offered in 4 variations consisting of the combination of 2.0mm and 2.5mm threads and 0° and 10° blades.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lesser phalanges, toes and fingers, feet and hands
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)
A design and dimensional comparison was performed to establish Substantial Equivalence: substantial equivalence to the legally marketed predicate devices listed in this summary.
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.
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
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
K111536 1/2
.
510(k) Summary
JUL 2 1 2011
| Date Prepared: | May 19, 2011 |
|---|---|
| Sponsor: | Metasurg |
| 16350 Park Ten Place, Suite 101 | |
| Houston, TX 77084 | |
| Company Contact: | Joshua Scott |
| Phone: (281) 398-5656 | |
| Fax: (281) 398-5660 | |
| Device Trade Name: | Metasurg DigiFuse Implant |
| Classification Name: | Smooth & threaded metallic bone fixation fasteners (21 |
| CFR 888.3040, Product Code HWC, Class II) | |
| Common Name: | Intramedullary Bone Fastener |
| Predicate Devices: | OsteoMed Ext. 2.0/2.4 Cannulated Screw System (K062863) |
| Wright Medical Pro-Toe (K101165) | |
| NEWDEAL K-Wire (K022599) | |
| Device Description: | The Metasurg DigiFuse Implant is a one-piece threaded device |
| made of titanium intended to be implanted into the medullary | |
| bone of the lesser digits. The implant is offered in 4 variations | |
| consisting of the combination of 2.0mm and 2.5mm threads and | |
| 0° and 10° blades. | |
| Intended Usage: | The Metasurg DigiFuse implant is indicated for the fixation of |
| osteotomies and reconstruction of the lesser phalanges during | |
| procedures to correct deformities of the toes and fingers. | |
| · Hammer toe deformity | |
| · Claw toe deformity | |
| · Mallet toe deformity | |
| · Other deformities of the feet and hands | |
| The Metasurg DigiFuse implants are intended for single use only. | |
| Material: | Titanium Alloy (Ti 6Al-4V ELI) |
1
K1115 36$\frac{2}{2}$
- Technological Characteristics: The Metasurg DigiFuse implant and the other legally marketed predicate devices listed in this summary have similar indications, physical dimensions and are constructed of titanium and/or stainless steel.
- A design and dimensional comparison was performed to establish Substantial Equivalence: substantial equivalence to the legally marketed predicate devices listed in this summary.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Metasurg % Mr. Joshua Scott 16350 Park Ten Place Suite 101 Houston, Texas 77084
JUL 2 1 2011
Re: K111536
Trade/Device Name: Metasurg DigiFuse Implant Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: May 31, 2011 Received: June 2, 2011
Dear Mr. Scott:
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
3
Page 2 – Mr. Joshua Scott
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
E. Keith
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
KIII 234
510(k) Number: Pending
Device Name: Metasurg DigiFuse Implant
Indications for Use:
The Metasurg DigiFuse implant is indicated for the fixation of osteotomies and . reconstruction of the lesser phalanges during procedures to correct deformities of the toes and fingers.
- Hammer toe deformity �
- Claw toe deformity �
- Mallet toe deformity 0
- Other deformities of the feet and hands �
The Metasurg DigiFuse implants are intended for single use only.
Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WIRTE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for M. Melkern
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K111536
Section 4 - Page 1 of 1