(113 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and fixation strength of a physical implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as an implant used for the "fixation of soft tissue to bone" in various anatomical locations (e.g., shoulder, knee, ankle). It is intended for repairing tissues and supporting anatomical structures, which aligns with the definition of a therapeutic device.
No
The device is a PEEK knotless suture anchor intended for fixation of soft tissue to bone, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a "bone implant device" and a "fully threaded PEEK-OPTIMA® anchor," indicating it is a physical hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description: The Tornier Insite FT PEEK Knotless Suture Anchor is described as a "bone implant device intended for the fixation of soft tissue to bone." It is a physical implant used within the body during surgery.
- Intended Use: The intended use clearly states its purpose is for "fixation of soft tissue to bone" in various anatomical locations. This is a surgical procedure, not a diagnostic test performed on a sample.
The device is a surgical implant, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The Tornier Insite FT PEEK Knotless Suture Anchors are intended for fixation of soft tissue to bone.
The Tornier Insite FT PEEK Knotless Suture Anchors are intended for use in the following applications:
- Shoulder: Rotator Cuff, Bankart and SLAP lesion repair, Biceps tenodesis, Acromio-Clavicular separation and Deltoid repair, Capsular shift and Capsulolabral reconstruction.
- Foot/Ankle: Lateral and Medial stabilization, Achilles tendon and Metatarsal ligament repair, Hallux Valgus and Midfoot reconstruction.
- Knee: Medial collateral and Lateral collateral ligament repair, Patellar tendon and Posterior oblique ligament repair, Illiotibial band tenodesis.
- Hand/Wrist: Scapholunate ligament, Radial collateral ligament and Ulnar collateral ligament reconstruction.
- Elbow: Biceps tendon reattachment, Tennis elbow repair, Ulnar and Radial collateral ligament reconstruction.
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The Tornier Insite FT PEEK Knotless Suture Anchor is a bone implant device intended for the fixation of soft tissue to bone. This device is a fully threaded PEEK-OPTIMA® anchor that is available in three sizes (4.5mm, 5.5mm, and 6.5mm) for use in a range of fixation applications. The device is assembled pre-loaded onto the insertion device and may be used with specific USP Size #2 sutures.
The Tornier Insite FT PEEK Knotless Suture Anchor is individually packaged and sterilized through ethylene oxide (EO) using appropriate standards and quidelines.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Foot/Ankle, Knee, Hand/Wrist, Elbow
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)
Non-clinical laboratory testing and assessments were performed; these are: mechanical insertion and fixation strength, as compared to the predicate devices, for the specific indications for use. The results of these tests indicate that the Tornier Insite FT PEEK Knotless Suture Anchor is substantially equivalent in performance and efficacy to the above cited predicate devices within their intended use.
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.
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
APR 0 4 2014
SECTION 5: 510(K) PREMARKET NOTIFICATION
510(k) Summary of Safety and Effectiveness Information
Tornier, Inc. Insite FT PEEK Knotless Suture Anchor
Regulatory authority: Safe Medical Devices Act of 1990, 21 CRF 807.92
1. Device name
| Device name: | Tornier Insite™ FT PEEK Knotless Suture Anchor |
|---|---|
| Device: | Suture anchor |
| Classification name: | Smooth or threaded metallic bone fixation fastener |
| Classification number: | 21 CFR § 888.3030; 888.3040 |
| Product code: | MBI - Fastener, Fixation, Nondegradable, Soft Tissue |
2. Submitter
Tornier Inc. 10801 Nesbitt Avenue South Bloomington, MN 55437 Registration Number: 9100540
3. Company contact
Mireille Lemery Tornier Inc. 10801 Nesbitt Avenue South Bloomington, MN 55437 Phone: +33 4 76 61 38 98 Fax: +33 4 76 61 35 65 Email: mireille.lemery@tornier.com
4. Classification
Device class: Class II
Classification panel: Orthopedic
Product code: MBI
Legally Marketed Device to which Equivalence is Claimed: ട്.
The Tornier Insite FT PEEK Knotless Suture Anchor is substantially equivalent in intended use and fundamental scientific technology to the following legally marketed device in commercial distribution: Tornier, Inc. Insite FT Suture Anchor, K110773 and R6G Sports Medicine Knotless Anchor, K110230.
6. Device Description
The Tornier Insite FT PEEK Knotless Suture Anchor is a bone implant device intended for the fixation of soft tissue to bone. This device is a fully threaded PEEK-OPTIMA® anchor
1
that is available in three sizes (4.5mm, 5.5mm, and 6.5mm) for use in a range of fixation applications. The device is assembled pre-loaded onto the insertion device and may be used with specific USP Size #2 sutures.
The Tornier Insite FT PEEK Knotless Suture Anchor is individually packaged and sterilized through ethylene oxide (EO) using appropriate standards and quidelines.
7. . Materials
The Tornier Insite FT PEEK Knotless Suture Anchor is available in PEEK-OPTIMA® material.
8. Indications for Use
The Tornier Insite FT PEEK Knotless Suture Anchors are intended for fixation of soft tissue to bone.
The Tomier Insite FT PEEK Knotless Suture Anchors are intended for use in the following applications:
-
- Shoulder: Rotator Cuff, Bankart and SLAP lesion repair, Biceps tenodesis, Acromio-Clavicular separation and Deltoid repair, Capsular shift and Capsulolabral reconstruction.
- Foot/Ankle: Lateral and Medial stabilization, Achilles tendon and Metatarsal ligament 2. repair, Hallux Valgus and Midfoot reconstruction.
-
- Knee: Medial collateral and Lateral collateral ligament repair, Patellar tendon and Posterior oblique ligament repair, Illiotibial band tenodesis.
- বঁ Hand/Wrist: Scapholunate ligament, Radial collateral ligament and Ulnar collateral ligament reconstruction.
-
- Elbow: Biceps tendon reattachment, Tennis elbow repair, Ulnar and Radial collateral ligament reconstruction.
9. Summary of Technologies
The technological characteristics (material, design, sizing, indications, sterilization, and fixation strength) of the Tomier Insite FT PEEK Knotless Suture Anchors are similar or identical to the cited predicate devices.
10. Nonclinical Testing
Non-clinical laboratory testing and assessments were performed; these are: mechanical insertion and fixation strength, as compared to the predicate devices, for the specific indications for use. The results of these tests indicate that the Tornier Insite FT PEEK Knotless Suture Anchor is substantially equivalent in performance and efficacy to the above cited predicate devices within their intended use.
2
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 4, 2014
Tornier, Incorporated Ms. Mireille Lemery Director, Global Regulatory Affairs 10801 Nesbitt Avenue South Bloomington, Minnesota 55437
Re: K133777
Trade/Device Name: Insite™ FT PEEK Knotless Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metailic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: January 2, 2014 Received: January 7, 2014
Dear Ms. Lemery:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. Mircille Lemery
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also. please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Ronald P. Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K133777
Device Name Insite PT PEEK Knotless Suture Anchor
Indications for Use (Describe)
The Tornier Insite FT PEEK Knotless Suture Anchors are intended for lixation of soft tissue to bone.
The Tornier Insite FT PEEK Knotless Suture Anchors are in the following applications:
-
Shoulder: Rotator Cuff, Bankart and SLAP lesion repair, Biceps tenodesis, Acromio-Clavicular separation and Deltoid repair, Capsular shift and Capsulolabral reconstruction.
-
Foot/Ankle: Lateral and Medial stabilization, Achilles tendon and Metatarsal ligament repair, Hallux Valgus and Midfoot reconstruction.
-
Knee: Medial collateral and Lateral ligament repair, Patchar tendon and Posterior obligue ligament repair, Misothial band tenodesis.
-
Hand/Wrist: Scapholunate ligament Radial collateral ligament and Ultar collateral ligament reconstruction.
-
Elbow: Biceps tendon reattachment, Tennis elbow repair, Ulnar and Radial collateral ligament reconstruction.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
CHANGE ON THE FOR FOR FOR FOR FDA USE ONLY A DE ONLY A DE LONG BE ONLY BE ON Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices
page 1/1
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement on lest pege.
FORM FDA 3881 (1/14)