(213 days)
Not Found
No
The device description focuses on the material and mechanical design of a screw for bone fusion, with no mention of software, algorithms, or any AI/ML related terms.
Yes
The device is used for arthrodesis (fusion of a joint) in the PIP and DIP joints, which is a therapeutic intervention to treat conditions affecting these joints.
No
Explanation: The device, the ReUnite™ Fusion Screw, is indicated for joint arthrodesis (fusion of bones), which is a surgical treatment rather than a diagnostic process. It is a physical implant used for treatment, not for identifying the presence or nature of a disease or condition.
No
The device description clearly states it is a physical screw made of LactoSorb®, which is a hardware component.
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 for diagnosis, monitoring, or screening.
- Device Description: The ReUnite™ Fusion Screw is a physical implantable device made of LactoSorb® designed to fuse bones in finger joints. It is used in the body, not to test specimens from the body.
- Intended Use: The intended use is for surgical procedures (arthrodesis) to fuse joints, which is a treatment, not a diagnostic test.
The information provided clearly describes a surgical implant, not a device used for laboratory testing of biological samples.
N/A
Intended Use / Indications for Use
The ReUnite™ Fusion Screw is indicated for proximal interphalangeal (PIP) joint arthrodesis and distal interphalangeal (DIP) joint arthrodesis in the presence of appropriate protection or immobilization.
Product codes (comma separated list FDA assigned to the subject device)
87HWC, HTY
Device Description
The ReUnite™ Fusion Screw is made out of LactoSorb® and has an elongated, tapered head at the proximal end, a smooth shaft in the middle, and a threaded portion at the distal end. A three-pronged driver is used to insert the threeshotted screw head. During insertion, as the threads gain purchase in the distal bone fragment, the tapered head is completely countersunk within the bone. After insertion, the driving head breaks off.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal interphalangeal (PIP) joint, distal interphalangeal (DIP) joint
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)
Not Found
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.
K953194, K990291, K992301, K901456, K850631
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
DEC 1 0 2001 SUMMMARY OF SAFETY AND EFFECTIVENESS
| Applicant or Sponsor: | Biomet, Inc.
P.O. Box 587
Warsaw, IN 46581-0587 |
|-----------------------|-----------------------------------------------------------------------------------------------------------------|
| Contact Person: | Sara Bailey Shultz
Regulatory Specialist |
| Proprietary Name: | ReUnite™ Fusion Screw |
| Common or Usual Name: | Arthrodesis screw |
| Classification Name: | Screw, Fixation, Bone, Non-spinal, Non-metallic
(888.3040)
Pin, Fixation, Smooth, Non-metallic (888.3040) |
| Device Product Code: | 87HWC and HTY |
Substantially Equivalent Devices: LactoSorb® Bone Pin (K953194 and K990291), ReUnite™ Screw (K992301), OrthoSorb® Absorbable Pin (K901456), Kirschner Orthopedic Wire (K850631)
Indications for Use: The ReUnite™ Fusion Screw is indicated for proximal interphalangeal (PIP) joint arthrodesis and distal interphalangeal (DIP) joint arthrodesis in the presence of appropriate protection or immobilization.
Device Description: The ReUnite™ Fusion Screw is made out of LactoSorb® and has an elongated, tapered head at the proximal end, a smooth shaft in the middle, and a threaded portion at the distal end. A three-pronged driver is used to insert the threeshotted screw head. During insertion, as the threads gain purchase in the distal bone fragment, the tapered head is completely countersunk within the bone. After insertion, the driving head breaks off.
Basis of Substantial Equivalence: The ReUnite™ Fusion Screw has the same intended use and material, and similar design when compared to the following bone fixation devices:
-
- ReUnite™ Screw, Biomet Inc., K992301
-
- Kirschner Orthopedic Wire, Kirschner Medical Corporation, K850631
000080
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 0 2001
Ms. Sara Bailey Shultz Regulatory Specialist Biomet P.O. Box 587 Warsaw, Indiana 46581
Re: K011451
Trade/Device Name: ReUnite™ Fusion Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: September 26, 2001 Received: September 28, 2001
Dear Ms. Shultz:
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 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.
2
Page 2 - Ms. Sara Bailey Shultz
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Walker, MD
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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1191145 510(k) NUMBER (IF KNOWN):_
DEVICE NAME: ReUnite™ Fusion Screw
INDICATIONS FOR USE:
The ReUnite™ Fusion Screw is indicated for proximal interphalangeal (PIP) joint arthrodesis and distal interphalangeal (DIP) joint arthrodesis in the presence of appropriate protection or immobilization.
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
S Prescription Use (Per 21 CFR 801.109
OR
Over-The-Counter-Use
(Optional Format 1-2-96)
N
Susan weller (Division Sign-Off) Division of General, Restorative and Neurological Devices
000003
KO11451 510(k) Number _