(57 days)
No
The description focuses on a mechanical suture anchor and its intended surgical uses, with no mention of AI or ML capabilities.
Yes.
The device is intended for soft tissue to bone suture fixation for various repairs and reconstructions across multiple anatomical sites (Shoulder, Foot and Ankle, Elbow, Knee, Hand/Wrist), which are all therapeutic interventions.
No
The device is a surgical anchor and suture system used for repairing soft tissue to bone, not for diagnosing conditions. Its intended use is for fixation in various orthopedic procedures.
No
The device description clearly describes a physical anchor and suture system, which are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for surgical fixation of soft tissue to bone. This is a mechanical function performed in vivo (within the body).
- Device Description: The description details a physical anchor and sutures used for surgical repair.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests outside the body on biological samples. This device is used inside the body during surgery.
N/A
Intended Use / Indications for Use
The devices are intended for soft tissue to bone suture fixation for the following indications:
Shoulder
- Bankart lesion repairs
- S.L.A.P. lesion repairs
- Acromio-clavicular Repairs
- Capsular Shift/Capsulolabral Reconstruction
- Deltoid Repair
- Rotator cuff tear repairs
- Biceps tenodesis
Foot and Ankle
- Medial/lateral repairs, reconstructions
- Achilles tendon repairs
- Midfoot and forefoot repairs
- Hallux Valgus reconstruction
Elbow
- Ulnar or radial collateral ligament reconstructions
- Tennis elbow repair
- Biceps tendon reattachment
Knee
- Extra-capsular repairs: -Medial collateral ligament Lateral collateral ligament Posterior oblique ligament
- Iliotibial band tenodesis
- Patellar tendon repair
- -VMO advancement
- Joint capsule closure
Hand/Wrist
- Collateral ligament repair (Gamekeeper's Thumb)
- Scapholunate ligament reconstruction
- Tendon transfers in phalanx
- Volar plate reconstruction
Product codes
MBI
Device Description
The anchor is cylindrical in shape and is preassembled threaded with USP size 2-0 I he anchor is cynnurear in shape and if production Device holds the anchor and through 2 braided poryester suture. The mass of the sutures can then be used to secure the soft tissue to the bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Foot and Ankle, Elbow, Knee, Hand/Wrist
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)
The Multitak Suture System was compared in pullout testing to the predicate I he Marinak Sutare System was vellipared sequal to or better than the predicate device(s).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
I RESEARCH, INC
OCT - 9 1997
1303 evergreen avenue, effingham, illinois 62401 tel. (217) 342-3412 fax (217) 342-6416
Summary of Safety and Effectiveness Multitak Suture System™
Submitted by
Bonutti Research, Inc. 1303 Evergreen Ave. Effingham, IL 62401
Prepared by .
Lynnette Whitaker Director Regulatory Affairs/Quality Assurance
Date .
August 8, 1997
Trade Name .
Multitak Suture System
Common Name .
Soft Tissue Anchor
Classification Name .
21 CFR 888.3040, Smooth or Threaded Metallic Bone Fixation Fastener
Predicate Devices .
- Multitak SS Suture System, manufactured by Bonutti Research, K934183. .
- Multitak SS Suture System, manufactured by Bonutti Research, K964532. ●
- Statak Soft Tissue Attachment Device, manufactured by Zimmer, Inc., . Statur 84, cleared November 16, 1993 and K962397, cleared August 27, 1996.
1
BONUTTI RESEARCH, INC
1303 evergreen avenue, effingham, illinois 62401 tel. (217) 342-3412 fax (217) 342-5416
Device Description
.
The anchor is cylindrical in shape and is preassembled threaded with USP size 2-0 I he anchor is cynnurear in shape and if production Device holds the anchor and through 2 braided poryester suture. The mass of the sutures can then be used to secure the soft tissue to the bone.
Intended Use
The devices are intended for soft tissue to bone suture fixation for the following indications:
Shoulder
- Bankart lesion repairs -
- S.L.A.P. lesion repairs -
- Acromio-clavicular Repairs -
- Capsular Shift/Capsulolabral Reconstruction -
- Deltoid Repair -
- Rotator cuff tear repairs -
- Biceps tenodesis -
Foot and Ankle
- Medial/lateral repairs, reconstructions 1
- Achilles tendon repairs -
- Midfoot and forefoot repairs -
- Hallux Valgus reconstruction -
Elbow
- Ulnar or radial collateral ligament reconstructions -
- Tennis elbow repair -
- Biceps tendon reattachment -
Knee
- Extra-capsular repairs: -Medial collateral ligament Lateral collateral ligament Posterior oblique ligament
- Iliotibial band tenodesis -
- Patellar tendon repair -
- -VMO advancement
- Joint capsule closure -
Hand/Wrist
- Collateral ligament repair (Gamekeeper's Thumb) -
- -Scapholunate ligament reconstruction
- Tendon transfers in phalanx -
- Volar plate reconstruction -
2
NUTTI RESEARCH, INC
1303 evergreen avenue, effingham, illinois 62401 tel. (217) 342-3412 fax (217) 342-6416
Performance Data
.
The Multitak Suture System was compared in pullout testing to the predicate I he Marinak Sutare System was vellipared sequal to or better than the predicate device(s).
3
Image /page/3/Picture/1 description: The image is a black and white 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 eagle is composed of three thick, curved lines that form the body and wings, and the overall design is simple and clean.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 9 1997
Lynnette Whitaker, RAC Director, Regulatory Affairs and Quality Assurance Bonutti Research 1303 Evergreen Avenue Effingham, Illinois 62401
Re: K973015 Multitak SS Suture System™ Trade Name: Requlatory Class: II Product Code: MBI Dated: August 8, 1997 Received: August 13, 1997
Dear Ms. Whitaker:
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 Administration (FDA) will verify such assumptions. Failure to 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 - Lynnette Whitaker, 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,
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
Page 1 of 1
510(k) Number (if known): K973015
Device Name: MULTITAK SUTURE SySTEM
Indications For Use:
The Multitak Suture System is intended for soft tissue to bone suture fixation for the following indications: Knee Shoulder Extra-capsular repairs: Bankart lesion repairs Medial collateral ligament S.L.A.P. lesion repairs Lateral collateral ligament Acromio-clavicular repairs Posterior oblique ligament Capsular shift/capsulolabral reconstruction Iliotibial band tenodesis Deltoid repair Patellar tendon repair Rotator cuff tear repairs VMO advancement Biceps tenodesis
Foot and Ankle Medial/lateral repairs, reconstructions Achilles tendon repairs (Gamekeeper's Thumb) Midfoot and forefoot repairs Hallux valgus reconstruction
Elbow
Ulnar or radial collateral ligament reconstructions Tennis elbow repair Biceps tendon reattachment
Joint capsule closure
Hand/Wrist Collateral ligament repair Scapholunate ligament reconstruction Tendon transfers in phalanx Volar plate reconstruction
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) t ﺔ، ﻓ Division of General Restorative Devices 73015 510(k) Number Prescription Use OR Over-The-Counter Use_ (Per 21 CFR 801.109)
(Optional Format 1-2-96)