(73 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and fixation strength of a physical implant (suture anchor) and do not mention any software, algorithms, or data processing that would involve AI/ML.
Yes.
The device is intended for the fixation of soft tissue to bone, used in various applications like rotator cuff repair, ligament repair, and tendon reattachment, which are therapeutic interventions aimed at treating injuries or conditions.
No
This device is a surgical implant designed for fixation of soft tissue to bone, not for diagnosing medical conditions.
No
The device description clearly states it is a bone implant device made of PEEK-OPTIMA® or Titanium, which are hardware materials, and it is pre-loaded onto an insertion device.
Based on the provided text, 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 soft tissue to bone" in various anatomical locations. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as a "bone implant device" and a "fully threaded anchor" made of materials like PEEK-OPTIMA® and Titanium. These are physical implants used in surgery.
- 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, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The Tornier Insite™ FT Suture Anchors are intended for fixation of soft tissue to bone.
The Tornier Insite™ FT 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 5. and Radial collateral ligament reconstruction.
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The Tornier Insite™ FT Suture Anchor consists of a bone implant device intended for the fixation of soft tissue to bone. This device is a fully threaded anchor that is available in three sizes (4.5mm, 5.5mm, and 6.5mm) and two materials (PEEK-OPTIMA® and Titanium) for use in a range of fixation applications. The device is assembled pre-loaded onto the insertion device with attached USP size #2 UHMWPE braided sutures.
The Tornier Insite™ FT Suture Anchor is individually packaged and sterilized through ethylene oxide (EO) using appropriate standards and guidelines.
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 was performed to verify the fixation strength of the Tornier Insite™ FT Suture Anchors in mechanical insertion and pullout testing as compared to the predicate devices for specific indications for use. The efficacy of the Tornier Insite™ FT Suture Anchors were compared to the above cited predicates device. The test results indicate that the Tornier Insite™ FT Suture Anchors provide equivalent fixation strength to the above cited predicate devices and would be functional 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
K110773 (113)
SECTION 5
JUN - 2 2011
510(k) SUMMARY
Summary of Safety and Effectiveness information
Tornier Insite™ FT Suture Anchors
Regulatory authority: Safe Medical Devices Act of 1990, 21 CRF 807.92
fixation fastener.
-
- Device name
Device name: Common name: Classification name: Classification number:
- Device name
Fastener, fixation, non-degradable, soft tissue Smooth or threaded metallic bone fixation fastener 888.3040 - Smooth or threaded metallic bone
Tornier Insite™ FT Suture Anchors
Product code: MBI
-
- Submitter
Tornier Inc. 7701 France Avenue South; Suite 600 Edina, MN 55435 Registration Number: 9100540
- Submitter
3) Company contact
Brahim Hadri
Sr. Regulatory affairs Specialist 100 Cummings Center, Suite 444C, Beverly, MA 01915, U.S.A Phone: 1 978 232-9997 ext: 617 1 978-232-9998 Fax: bhadri@tornier.com
4) Classification
| Device class: | Class II |
|---|---|
| Classification panel: | Orthopedic |
| Product code: | MBI |
510(k) Submission Tornier Insite™ FT Suture Anchors Tornier Inc.
Page 12 of 63
1
5) Legally Marketed Device to which Equivalence is Claimed:
The Tornier Insite™ FT Suture Anchor is substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed devices in commercial distribution:
- TORNIER, INC., INSITE SUTURE ANCHORS K083268 .
- TORNIER, PITON FIXATION IMPLANT SYSTEM K091870 .
- SMITH & NEPHEW INC., ENDOSCOPY DIVISION BIORAPTOR 2.3 PK SUTURE . ANCHOR K071586
6) Device Description
The Tornier Insite™ FT Suture Anchor consists of a bone implant device intended for the fixation of soft tissue to bone. This device is a fully threaded anchor that is available in three sizes (4.5mm, 5.5mm, and 6.5mm) and two materials (PEEK-OPTIMA® and Titanium) for use in a range of fixation applications. The device is assembled pre-loaded onto the insertion device with attached USP size #2 UHMWPE braided sutures.
The Tornier Insite™ FT Suture Anchor is individually packaged and sterilized through ethylene oxide (EO) using appropriate standards and guidelines.
-
- Materials
.
- Materials
The Tornier Insite™ FT Suture Anchor is available in two materials: PEEK-OPTIMA® (ASTM F-2026) and Titanium (ASTM F-136) with attached USP size #2 UHMWPE braided sutures.
2
8) Indications for Use
The Tornier Insite™ FT Suture Anchors are intended for fixation of soft tissue to bone.
The Tornier Insite™ FT 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 2. 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.
9) Summary of Technologies
The technological characteristics (material, design, sizing, indications, sterilization, and fixation strength) of the Tornier Insite™ FT Suture Anchors are similar or identical to the cited predicate devices.
10) Nonclinical Testing
Non-clinical laboratory testing was performed to verify the fixation strength of the Tornier Insite™ FT Suture Anchors in mechanical insertion and pullout testing as compared to the predicate devices for specific indications for use. The efficacy of the Tornier Insite™ FT Suture Anchors were compared to the above cited predicates device. The test results indicate that the Tornier Insite™ FT Suture Anchors provide equivalent fixation strength to the above cited predicate devices and would be functional within their intended use.
510(k) Submission Tornier Insite™ FT Suture Anchors Tornier Inc.
Page 14 of 63
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Tornier, Inc. % Mr. Brahim Hadri Senior Regulatory Affairs Specialist 100 Cummings Center, Suite 444C Beverly, Massachusetts 01915
Re: K110773
Trade/Device Name: Tornier Insite™ FT Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: April 26, 2011 Received: April 27, 2011
I
Dear Mr. Hadri:
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 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
JUN - 2 2011
4
Page 2 -- Mr. Brahim Hadri
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportaProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Eric S. Keith.
130
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
KII0773 (111)
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: Tornier Insite™ FT Suture Anchor
Indications for Use
The Tornier Insite™ FT Suture Anchors are intended for fixation of soft tissue to bone.
The Tornier Insite™ FT 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 5. and Radial collateral ligament reconstruction.
AND/OR
Prescription Use _____________________________________________________________________________________________________________________________________________________________ .
Over-The-Counter Use_
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY) Concurrence of CDRH, Office of Device Evaluation (ODE)
Eric L. Keith
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Submission: Tornier Insite™ FT Suture AndHotek) Number Tornier Inc.
K110773
Page 11 of 63