(89 days)
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No
The device description and intended use focus on a mechanical resorbable anchor system and do not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
No
The device is a resorbable anchor system used for attaching soft tissue to bone during surgical procedures, which is a structural component and not a therapeutic device designed to cure or prevent disease.
No
Explanation: The device is described as a surgical implant (suture anchor) used for fixing soft tissue to bone, not for diagnosing medical conditions.
No
The device description clearly describes a physical implant (resorbable anchor) and a disposable introduction device, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The Multitak Splinter 3.0 mm Resorbable Anchor System is a surgical implant used to physically attach soft tissue to bone during orthopedic procedures. It is a mechanical device used within the body, not for testing samples outside the body.
- Intended Use: The intended use clearly describes its function in surgical procedures for repairing ligaments, tendons, and other soft tissues. It does not mention any diagnostic testing or analysis of biological samples.
- Device Description: The description details the physical components of the anchor and how it is implanted, which is consistent with a surgical device, not an IVD.
Therefore, based on the provided information, the Multitak Splinter 3.0 mm Resorbable Anchor System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Multitak Splinter 3.0 mm Resorbable Anchor System consists of a single use bone soft tissue resorbable anchor implant and is intended for use as a load bearing or non-load bearing suture anchor in the attachment of soft tissue to bone in various arthroscopic and open orthopedic procedures.
The Multitak Splinter 3.0 mm Resorbable Anchors are indicated for use in the following orthopedic soft tissue to bone fixation applications:
- Shoulder: Bankart lesion repairs Acromio-clavicular repairs · Deltoid repairs Rotator cuff tear repairs Biceps tenodesis
- Elbow: Ulnar or radial collateral ligament reconstruction
- Knee: Extra-capsular repairs Medial collateral ligament repair Lateral collateral ligament repair Posterior oblique ligament repair Illiotibial band tenodesis Patellar tendon repair VMO advancement Joint capsule closure
- Foot/Ankle: Medial/Lateral repairs/reconstructions Achilles tendon repairs
Product codes (comma separated list FDA assigned to the subject device)
HWC, MAI
Device Description
The Multitak Splinter 3.0 mm Resorbable Anchors are cylindrical suture anchors with a conical tip on one end. The resorbable anchors are injection molded from a poly-L-lactic acid resin and have two transverse suture holes. The resorbable implant comes threaded with up to USP Size No. 2 polyester suture preloaded on the tip of a single use disposable introduction device. The resorbable implant and suture is delivered into a predrilled bone site. The suture ends are pulled to engage cancellous bone and to toggle and lock the anchor in bony tissue. A curved needle attached to the suture end is used to secure soft tissue to bone.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Shoulder, Elbow, Knee, Foot/Ankle
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing comparing the mechanical strengths and failure modes of the Multitak Splinter 3.0 mm Resorbable Anchors to predicate devices demonstrated that the anchors are statistically equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached 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 words "Multitak SS" in a bold, sans-serif font. The words "FROM BONUTTI RESEARCH" are written in a smaller, sans-serif font below the first line. There is a line separating the two lines of text. The text is black and the background is white.
K 0/2465
10Fd
OCT 2 9 2001
Bonutti Research, Inc. Multitak Splinter 3.0 mm Resorbable Anchor 510(k) Premarket Notification
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
The following information is submitted in accordance with the requirements of 21 CFR 807.92:
Patrick Balsmann, MS, RAC, Contact Person: Director, Regulatory/Clinical Affairs & QA Bonutti Research, Inc., P.O. Box 1367, Effingham, Illinois 62401 Phone: 217.342.3412, ext. 321
Date Prepared: July 31, 2001
Proprietary Name: Multitak Splinter 3.0 mm Resorbable Anchor
Common Name: Resorbable Soft Tissue Anchor
Classification Name: Fastener, Fixation, Biodegradable, Soft Tissue.
Device Description: The Multitak Splinter 3.0 mm Resorbable Anchors are cylindrical suture anchors with a conical tip on one end. The resorbable anchors are injection molded from a poly-L-lactic acid resin and have two transverse suture holes. The resorbable implant comes threaded with up to USP Size No. 2 polyester suture preloaded on the tip of a single use disposable introduction device. The resorbable implant and suture is delivered into a predrilled bone site. The suture ends are pulled to engage cancellous bone and to toggle and lock the anchor in bony tissue. A curved needle attached to the suture end is used to secure soft tissue to bone.
Intended Use: The Multitak Splinter 3.0 mm Resorbable Anchor System consists of a single use bone soft tissue resorbable anchor implant and is intended for use as a load bearing or non-load bearing suture anchor in the attachment of soft tissue to bone in various arthroscopic and open orthopedic procedures.
The Multitak Splinter 3.0 mm Resorbable Anchors are indicated for use in the following orthopedic soft tissue to bone fixation applications:
- Shoulder: Bankart lesion repairs Acromio-clavicular repairs · Deltoid repairs Rotator cuff tear repairs Biceps tenodesis
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K012465
2 OF 2
Bonutti Research, Inc. - Multitak Splinter 3.0 mm Resorbable Anchor 510(k) Summary of Safety and Effectiveness Page 2
Elbow: Ulnar or radial collateral ligament reconstruction
Knee: Extra-capsular repairs Medial collateral ligament repair Lateral collateral ligament repair Posterior oblique ligament repair Illiotibial band tenodesis Patellar tendon repair VMO advancement Joint capsule closure
Foot/Ankle: Medial/Lateral repairs/reconstructions Achilles tendon repairs
Predicate Device(s): The Multitak Splinter 3.0 mm Resorbable Anchors are similar in intended use and materials to current commercially available poly-L-lactic acid resorbable implants including the Mitek 3.5 mm Panalok Wedge Absorbable Suture System. The Multitak resorbable implants are similar in design and intended use to existing Multitak suture anchors determined to be substantially equivalent by FDA.
Predicate Comparison: Performance testing comparing the mechanical strengths and failure modes of the Multitak Splinter 3.0 mm Resorbable Anchors to predicate devices demonstrated that the anchors are statistically equivalent.
Submitted by:
Dicky Belamy
Patrick Balsmann Director, Regulatory/Clinical Affairs & QA
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the words "Public Health Service" in bold, black font. The words are stacked on top of each other, with "Public Health" on the top line and "Service" on the bottom line. The text appears to be extracted from a document or sign.
Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized emblem resembling three abstract shapes, possibly representing human figures or elements of health and well-being. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
OCT 2 9 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Patrick Balsmann Director, Regulatory/Clinical Affairs and Ouality Assurance Bonutti Research, Inc. P.O. Box 1367 Effingham, Illinois 62401
Re: K012465
Trade/Device Name: Multitak Splinter 3.0 mm Resorbable Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastner Regulatory Class: Class II Product Code: HWC, MAI Dated: July 31, 2001 Received: August 1, 2001
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 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.
3
Page 2 - Ms. Connie Ficklin
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,
e. Mark N. Millburn
Celia M. Witten, Ph.D., M.D. 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 "Multitak SS" in a bold, sans-serif font. The words are black and are set against a white background. A black line is underneath the words "Multitak SS". Below the line, the words "FROM BONUTTI RESEARCH" are written in a smaller, sans-serif font.
K01>465
Bonutti Research, Inc. - Multitak Splinter 3.0 mm Resorbable Anchor 510(k) Premarket Notification
INDICATIONS FOR USE
Device Name: Multitak Splinter 3.0 mm Resorbable Anchor.
Indications for Use: The Multitak Splinter 3.0 mm Resorbable Anchor System consists of a single use bone soft tissue resorbable anchor implant and is intended for use as a load bearing or non-load bearing suture anchor in the attachment of soft tissue to bone in various arthroscopic and open orthopedic procedures.
The Multitak Splinter 3.0 mm Resorbable Anchors are indicated for use in the following orthopedic soft tissue to bone fixation applications:
-
Bankart lesion repairs Shoulder: Acromio-clavicular repairs Deltoid repairs Rotator cuff tear repairs Biceps tenodesis
Ulnar or radial collateral ligament reconstruction Elbow: -
Extra-capsular repairs Knee: Medial collateral ligament repair Lateral collateral ligament repair Posterior oblique ligament repair Illiotibial band tenodesis Patellar tendon repair VMO advancement Joint capsule closure
Medial/Lateral repairs/reconstructions Foot/Ankle: Achilles tendon repairs
R. Mark N. Melleksen
Division Sign-O to rative Division of General and Neurological Decess
510(k) Number
Phone: (USA only) (800) 879-0117
Facsimile: (217) 347-33 www.BonuttiResearch.co