(45 days)
No
The device description and intended use clearly define the device as a mechanical fixation device made of specific materials, with no mention of software, algorithms, or any form of computational processing. The "Mentions AI, DNN, or ML" field is also explicitly marked as "Not Found".
No.
The device is a fixation device that stabilizes bone fragments and distributes suture tension primarily to aid in the healing process, but it does not directly deliver therapy, substances, or energy to the patient for a therapeutic effect.
No
This device is described as a "fixation device" for orthopedic fracture and ligament/tendon repair, designed to stabilize bone fragments and distribute suture tension to facilitate healing. It does not perform any diagnostic function.
No
The device is described as physical fixation devices made of titanium, polypropylene, or polyethylene, intended for orthopedic fracture and ligament/tendon repair. There is no mention of any software component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Multitak SS Buttons are described as fixation devices used in the body during orthopedic fracture and ligament/tendon repair procedures. They are physically implanted or attached to bone and tissue to provide structural support and tension distribution.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens outside of the body. Its function is entirely mechanical and within the surgical context.
Therefore, the Multitak SS Buttons fall under the category of a surgical implant or fixation device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Multitak SS Buttons are new fixation devices indicated in orthopedic fracture and in ligament and tendon repair. The buttons allow for stabilization and linear fixation of bone fragments in fracture procedures. The buttons also serve as fixation posts for distributing suture tension over areas of ligament and tendon repair. The buttons are made of titanium, polypropylene, or polyethylene and are provided sterile with or without suture attached and are not intended for reuse. Maximum suture size to be used with each of the buttons are outlined in the following table:
| Multitak SS Button Size | Button Material | Maximum USP Suture Size |
|---|---|---|
| 3.0 mm x 10.0 mm | Ti-6Al-4V | Up to USP Size 2 |
| 3.0 mm x 10.0 mm | Polypropylene | Up to USP Size 2 |
| 3.0 mm x 10.0 mm | Ultra-high-molecular-weight polyethylene (UHMWPE) | Up to USP Size 2 |
| 2.5 mm x 8.3 mm | Ti-6Al-4V | Up to USP Size 2 |
| 2.5 mm x 8.3 mm | Polypropylene | Up to USP Size 1 |
| 2.5 mm x 8.3 mm | UHMWPE | Up to USP Size 1 |
| 1.8 mm x 6.0 mm | Ti-6Al-4V | Up to USP Size 2 |
| 1.2 mm x 4.0 mm | Ti-6Al-4V | Up to USP Size 2-0 |
Product codes (comma separated list FDA assigned to the subject device)
MBI, GAT
Device Description
The Multitak SS Buttons are fixation devices indicated in orthopedic fracture and in ligament and tendon repair They are intended to stabilize two or more bone hagments and distribute suture tension over the fracture site in order to facilitate healing. The buttons also serve as fixation posts for distributing surure tension over areas of ligament and renden repair The cyundneal buttons are made from titanium, polypropylene, or polyethylene and have an overali ratio of approximately 3 1, length to diameter. The buttons are available in the tollowing sizes ( ! ) ! 2 mm in diameter and 4 0 mm in length, (2) 1 8 mm in diameter and o 0 mm in length (3) 2 5 mm in diameter and 8 3 mm in length, and (4) 3 0 mm in diameter and I min in lengin The buttons are applied to the outer bone cortex over a prednilled hole across the manufe she Bone fragments are stabilized with suture running through the drill bone hole and off at the button The buttons provide linear fixation and compression of the bone trapments promoting healing at the fracture site Buttons can also be used as fixation posts and are praced outside the corucal bone in ligament and tendon repair. They provide a means of distributing suture tension over areas of repaired ligaments and tendons. The buttons are provided sterile with or without attached suture in packs of two and are not intended for reuse.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone, ligament, tendon
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)
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.
K961522, Class I
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.
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
3/5/99
Bonutti Research, Inc. - Multitak SS Buttons 510(k) Premarket Notification
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Inc following information is submitted in accordance with the requirements of 21 CFR 807.92
Contact Person: Patnek Balsmann, MS, RAC, Manager, QA/RA & Clinical Bonulli Research, Inc. P O Box 1367, Ettingham, Illinois 62401 Phone 217 342 3412 ext 321
Date Prepared: March i 1999
Proprietary Name: Multitak SS Buttons
Common Name: Fracture Fixation Device and Surgical Buttons.
Classification Name: 21 CFR 888 3040 Smooth Or Threaded Metallic Bone Fixation Fastener and 21 CFR 878 4930 Suture Retemion Device
Device Description: The Multitak SS Buttons are fixation devices indicated in orthopedic fracture and in ligament and tendon repair They are intended to stabilize two or more bone hagments and distribute suture tension over the fracture site in order to facilitate healing. The buttons also serve as fixation posts for distributing surure tension over areas of ligament and renden repair The cyundneal buttons are made from titanium, polypropylene, or polyethylene and have an overali ratio of approximately 3 1, length to diameter. The buttons are available in the tollowing sizes ( ! ) ! 2 mm in diameter and 4 0 mm in length, (2) 1 8 mm in diameter and o 0 mm in length (3) 2 5 mm in diameter and 8 3 mm in length, and (4) 3 0 mm in diameter and I min in lengin The buttons are applied to the outer bone cortex over a prednilled hole across the manufe she Bone fragments are stabilized with suture running through the drill bone hole and off at the button The buttons provide linear fixation and compression of the bone trapments promoting healing at the fracture site Buttons can also be used as fixation posts and are praced outside the corucal bone in ligament and tendon repair. They provide a means of distributing suture tension over areas of repaired ligaments and tendons. The buttons are provided sterile with or without attached suture in packs of two and are not intended for reuse.
intended Use: The Multiak SS Buttons are new fixation devices indicated in orthopedic fracture and in ligament and tendon repair The buttons allow for stabilization and linear fixation of bone fragments in fracture procedures The buttons also serve as fixation posts for arste buting subure tension over areas of ligament and tendon repair. The buttons are made of " manne polyerhylene or polyethylene and are provided sterile with or without suture attached and are not intended for reuse. Maximum surure size to be used with each of the buttons are out ned in the following table
1
Bonutti Research, Inc. -- Multitak SS Buttons S10(k) Summary of Safety and Effectiveness Page 2
| Multitak SS Button Size | Button Material | Maximum USP Suture Size |
|---|---|---|
| 3.0 mm x 10.0 mm | Ti-6Al-4V | Up to USP Size 2 |
| 3.0 mm x 10.0 mm | Polypropylene | Up to USP Size 2 |
| 3.0 mm x 10.0 mm | Ultra-high-molecular-weight | |
| polyethylene (UHMWPE) | Up to USP Size 2 | |
| 7.5 mm x 8.3 mm | Ti-6Al-4V | Up to USP Size 2 |
| 7.5 mm x 8.3 mm | Polypropylene | Up to USP Size 1 |
| 7.5 mm x 8.3 mm | UHMWPE | Up to USP Size 1 |
| 7.8 mm x 6.0 mm | Ti-6Al-4V | Up to USP Size 2 |
| 7.2 mm x 4.0 mm | Ti-6Al-4V | Up to USP Size 2-0 |
Predicate Device: The Multitak SS Buttons are similar in intended use to Kirschner Wires and Steinmann Pins manufactured by Synvasive Technology, Inc. (K961522) and to Ethicon, Inc., Polypropyiene Buttons regulated as Class I surgical buttons. The Multitak SS Buttons are similar in design and materials to the Multitak SSTM Suture System soft tissue suture anchor devices manufactured by Bonutt: Research, Inc (K973015 and K964532.)
Predicate Comparison: A chart comparing characteristics of the The Multitak SS Buttons to to as of the predicate devices is attached
Submitted by:
yielde more
Patrick Balsmann Manager, QARA & Clinical
2
Benner Kevneh, bie - Meltink SS Buttons 410gkt Promonten Natifustion JRHuxa v
| Device
Characteristic | Mulfitek SS
Buttons | Symante
Technology, Inc
Kirschmer Wires and
Steinmann Pins | Ethicon, Inc.
Polypropylene
Surgical Buttons | Mulfitek SS
Suture System -
Titanium Soft Tissue
Anchor | Mulfitek SS
Suture System -
UHMWPE Soft
Tissue Anchor |
|--------------------------|----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | Current Submission | K961522 | Class I | K973015 | K964532 |
| Intended Use | Stabilize two or more
bone fragments by
distributing suture
tension over fracture
site | Draw two or more
bone fragments
together to facilitate
healing | Aid wound healing by
distributing suture
tension over contact
surface area | Soft tissue to bone
suture fixation | Soft tissue to bone
suture fixation |
| Indications | Bone fracture repair
Ligament and tendon
repair | Bone fracture repair | Orthopedic tendon
repair | Shoulder, elbow,
knee, foot/ankle, and
hand/wrist soft tissue
to bone orthopedic
applications | Shoulder, elbow,
knee, and foot/ankle,
soft tissue to bone
orthopedic
applications |
| Design | Tubular buttons
approximate ratio of
3:1 length to
diameter | Sized K-wires and
pins | 14 mm diameter
round buttons. | Cylindrical anchors
approximate ratio of
2:1 length to
diameter. | Tubular anchors
approximate ratio of
2:1 length to
diameter. Single and
double anchor tube
constructs |
| Material | Titanium (Ti-6Al-4V)
alloy, polypropylene;
and polyethylene
(UHMWPE.) | Stainless steel. | Polypropylene. | Titanium (Ti-6Al-4V)
alloy and stainless
steel. | Polyethylene
(UHMWPE.) |
| Provided Sterile | Sterile. | Sterile and non-
sterile. | Sterile. | Sterile. | Sterile. |
.
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle are three stylized human profiles facing to the right, with flowing lines suggesting movement or connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 5 1999
Patrick G. Balsmann, M.S., RAC Manager, QA/RA and Clinical Affairs Bonutti Research, Inc. P.O. Box 1367 62401 Effingham, Illinois
Re: K990156 Multitak SS Button Regulatory Class: II Product Codes: MBI and GAT January 14, 1999 Dated: Received: January 19, 1999
Dear Mr. Balsmann:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Failure to Administration (FDA) will verify such assumptions. comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
4
Page 2 - Patrick G. Balsmann, M.S., RAC
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Russell Vayga
M. 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
5
Bonutti Research, Inc. -- Multitak SS Buttons 510(k) Premarket Notification
INDICATIONS FOR USE
Device Name: Multitak SS Buttons.
Indications for Use: The Multitak SS Buttons are new fixation devices indicated in orthopedic fracture and in ligament and tendon repair. The buttons allow for stabilization and linear fixation of bone fragments in fracture procedures. The buttons also serve as fixation posts for distributing suture tension over areas of ligament and tendon repair. The buttons are made of titanium, polypropylene, or polyethylene and are provided sterile with or without suture attached and are not intended for reuse. Maximum suture size to be used with each of the buttons are outlined in the following table:
| Multitak SS Button Size | Button Material | Maximum USP Suture Size |
|---|---|---|
| 3.0 mm x 10.0 mm | Ti-6Al-4V | Up to USP Size 2 |
| 3.0 mm x 10.0 mm | Polypropylene | Up to USP Size 2 |
| 3.0 mm x 10.0 mm | Ultra-high-molecular-weight | |
| polyethylene (UHMWPE) | Up to USP Size 2 | |
| 2.5 mm x 8.3 mm | Ti-6Al-4V | Up to USP Size 2 |
| 2.5 mm x 8.3 mm | Polypropylene | Up to USP Size 1 |
| 2.5 mm x 8.3 mm | UHMWPE | Up to USP Size 1 |
| 1.8 mm x 6.0 mm | Ti-6Al-4V | Up to USP Size 2 |
| 1.2 mm x 4.0 mm | Ti-6Al-4V | Up to USP Size 2-0 |
Prescription Use
(Per 21 CFR 801.109)
Aurell V. Hogan for me
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