(30 days)
Not Found
Not Found
No
The description focuses on mechanical and ultrasonic fixation methods and does not mention any AI or ML components.
Yes
The device is described as an "Anchor System" used for "fixation of tissue, ligament, tendon, and bone," indicating its purpose is to repair or restore function to damaged biological structures, which aligns with the definition of a therapeutic device.
No
Explanation: The device is described as an "absorbable implant" and a "fastener" for "fixation of tissue, ligament, tendon, and bone." Its purpose is to physically secure body parts rather than to identify or analyze a condition.
No
The device description clearly outlines hardware components including absorbable implants, an electrical generator, a handpiece, and an end effector, indicating it is not a software-only device.
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 "fixation of tissue, ligament, tendon, and bone" and "general soft tissue approximation/ligation." This describes a surgical or procedural use, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a system that uses absorbable implants and ultrasonic energy to physically secure tissues. This is a mechanical process for repair, not a method for analyzing biological samples to diagnose a condition.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
In summary, the Unity Beta Anchor System is a surgical device used for tissue fixation, not a diagnostic device used to test samples.
N/A
Intended Use / Indications for Use
The Unity Beta Anchor System consists of single patient use absorbable (PLLA) implants intended for use as fasteners (anchors) in the fixation of tissue, ligament, tendon, and bone. The system is indicated in general soft tissue approximation/ligation.
Product codes
HWC
Device Description
The Unity Beta Anchor System is designed for the fixation of tissue, ligament, tendon, and bone. Absorbable poly-L-lactic acid (PLLA) implant materials are ultrasonically joined to secure tissue, ligament, tendon, and bone at a repair site. An electrical generator provides ultrasonic energy to the end effector of a handpiece to weld the two pieces of implant material together and secure tissue, ligament, tendon, and/or bone. The system provides a means of sutureless fixation that facilitates overall, suture management.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tissue, ligament, tendon, and bone
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)
Design verification testing identified and conducted as part of the risk analysis assessment compared the mechanical strengths and failure modes of the Unity Beta Anchor System to predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found - The text states "Unity Beta Anchor System is similar in design and intended use to existing Bonutti Research, Inc., fixation products and various other suture anchors determined to be substantially equivalent and that are commonly used in tissue and bone fixation." but does not list specific K/DEN numbers.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows the logo for Bonutti Technologies. The word "BONUTTI" is in large, bold, sans-serif font on the top line. Below that, in a smaller font, is the word "TECHNOLOGIES". The logo is simple and professional.
ham. IL 62401
Phone: 217.342.3412 217 342 3460
K082906 p. 1/2
Bonutti Research, Inc. Unity Beta Anchor System 510(k) Premarket Notification
OCT 3 0 2008
510(k) SUMMARY
The following information is submitted in accordance with the requirements of 21 CFR 807.92:
| Contact Person: | Patrick Balsmann, MBA, MS, RAC |
|---|---|
| Director, Regulatory/Clinical Affairs & QA | |
| Bonutti Research, Inc., | |
| P.O. Box 1367 | |
| Effingham, Illinois 62401 | |
| Phone: (217) 342-3412, ext. 321 | |
| Fax: (217) 342-1043 |
Date Prepared: September 29, 2008
Proprietary Name: Unity Beta Anchor System
Common Name: Fixation Device
Classification Name: Fastener, Fixation, Biodegradable, Soft Tissue.
Device Description: The Unity Beta Anchor System is designed for the fixation of tissue, ligament, tendon, and bone. Absorbable poly-L-lactic acid (PLLA) implant materials are ultrasonically joined to secure tissue, ligament, tendon, and bone at a repair site. An electrical generator provides ultrasonic energy to the end effector of a handpiece to weld the two pieces of implant material together and secure tissue, ligament, tendon, and/or bone. The system provides a means of sutureless fixation that facilitates overall, suture management.
1
p. 2/2
Bonutti Research, Inc. - Unity Beta Anchor System 510(k) Summary -- September 29, 2008 Page 2
Indications for Use: The Unity Beta Anchor System consists of single patient use absorbable (PLLA) implants intended for use as fasteners (anchors) in the fixation of tissue, ligament, tendon, and bone. The system is indicated in general soft tissue approximation/ligation.
Predicate Device(s): Unity Beta Anchor System is similar in design and intended use to existing Bonutti Research, Inc., fixation products and various other suture anchors determined to be substantially equivalent and that are commonly used in tissue and bone fixation.
Predicate Comparison: Design verification testing identified and conducted as part of the risk analysis assessment compared the mechanical strengths and failure modes of the Unity Beta Anchor System to predicate devices.
Submitted by:
Walter Bailey
Patrick Balsmann, MBA, MS, RAC Director, Regulatory/Clinical Affairs & QA
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Public Health Service
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Bonutti Research, Inc., % Mr. Patrick Balsmann, MBA, MS, RAC Director, Regulatory/Clinical Affairs & QA P.O. Box 1367 Effingham, Ilinois 62401
OCT 3 0 2008
K082906 Re
Trade/Device Name: Unity Beta Anchor System Regulation Number: 21 CFR 888.3040 Regulation Namc: Smooth or threaded metallic bone fixation fastencr Regulatory Class: Class II Product Code: HWC Dated: September 29, 2008 Received: September 30, 2008
Dear Mr. Balsmann:
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
3
Page 2 - Mr. Patrick Balsmann, MBA, MS, RAC
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Wilkerson
Mark N. Melkerson Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure .
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Image /page/4/Picture/0 description: The image shows the words "BONUTTI TECHNOLOGIES" stacked on top of each other. The word "BONUTTI" is in a bold, sans-serif font and appears to be textured. The word "TECHNOLOGIES" is in a thinner, sans-serif font and is not textured. The words are centered horizontally.
PO Box 1367 Effingham, IL 62401 Phone: 217.342.3412 Fax: 217.342.3460 http://www.bonuttitec.com
Indications for Use
510(k) Number: K082906
Device Name: Unity Beta Anchor System
Indications For Use: The Unity Beta Anchor System consists of single patient use absorbable (PLLA) implants intended for use as fasteners (anchors) in the fixation of tissue, ligament, tendon, and bone. The system is indicated in general soft tissue approximation/ligation.
Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use_ U6 (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of _ 1 _
Mark A. Milkersen
(Division Sign-O Division of General, Restorative, and Neurological
510(k) Number K08290