(90 days)
Not Found
No
The device description and intended use focus on a mechanical implant for soft tissue fixation and do not mention any software, algorithms, or data processing capabilities that would indicate AI/ML.
Yes
The device is intended for fixation of soft tissue to bone to repair or reconstruct various anatomical structures, which are therapeutic medical procedures.
No
The device description clearly states its purpose is for "fixation of soft tissue to bone" and details its components as a "bone anchor and a disposable pre-loaded anchor Inserter" with "suture." This indicates a surgical implant and tool for repair, not a device designed to identify or diagnose medical conditions.
No
The device description clearly states it includes a bone anchor and an inserter, which are physical hardware components.
Based on the provided information, 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 description details a "bone anchor" and "suture," which are physical implants used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (in glass, or outside the body) to analyze biological samples. This device is used in vivo (in the body) for surgical repair.
N/A
Intended Use / Indications for Use
The Tornier PITON™ Fixation Implant is intended for fixation of soft tissue to bone.
The PITON™ Implant is intended for use in the following applications:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair. Illiotibial Band Tenodesis
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
Elbow: Biceps Tendon Reattachment, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency
Hip: Capsular Repair - Acetabular Labral Repair
Product codes
MBI
Device Description
The PITON™ Fixation Implant System includes a 2.8 mm diameter bone anchor and a disposable pre-loaded anchor Inserter. The PITON™ Fixation Implant is designed to secure soft tissue to bone using USP #2 high strength non-absorbable UHMWPE braided suture. The device is designed for inserting the implant directly into bone without a predrilled, punched, or tapped pilot hole.
The PITON™ Anchor configuration is comprised of a curved titanium base and a flared nitinol clip.
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, Pelvis, Hip
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
Not Found
Key Metrics
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
SEP 2 1 2009
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Per 21 CFR 807.92)
6691870
General Company Information
Name: Contact:
Tornier, Inc. Howard Schrayer Regulatory Affairs Consultant
Address:
100 Cummings Center Suite 444C Beverly, MA 01915
(978) 232 - 9997 Telephone: (978) 232 – 9998 Fax:
Date Prepared June 22, 2009
General Device Information
PITON™ Fixation Implant System Product Name:
"Non-degradable soft tissue fixation fastener" Classification: Product code: MBI - Class II
Predicate Device
| Tornier, Inc. | CINCH™ Fixation Implant System.
[510(k) Number K080335] |
|----------------------|-----------------------------------------------------------------------------------|
| Smith & Nephew, Inc. | TwinFix Ti 2.8mm, 3.5mm and BioRaptor 2.9mm
Suture Anchors
[510(k) K053344] |
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Description
The PITON™ Fixation Implant System includes a 2.8 mm diameter bone anchor and a disposable pre-loaded anchor Inserter. The PITON™ Fixation Implant is designed to secure soft tissue to bone using USP #2 high strength non-absorbable UHMWPE braided suture. The device is designed for inserting the implant directly into bone without a predrilled, punched, or tapped pilot hole.
The PITON™ Anchor configuration is comprised of a curved titanium base and a flared nitinol clip.
Intended Use (Indications)
The Tornier PITON™ Fixation Implant is intended for fixation of soft tissue to bone.
The PITON™ Implant is intended for use in the following applications:
- Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps . Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulabral Reconstruction
- Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair
- Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair. Illiotibial Band Tenodesis
- Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
- Elbow: Biceps Tendon Reattachment, Ulnar Collateral Ligament Reconstruction, . Radial Collateral Ligament Reconstruction
- Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral ◆ hypermobility or intrinsic sphincter deficiency
- Hip: Capsular Repair Acetabular Labral Repair ●
Substantial Equivalence
This submission supports the position that the Tornier PITON™ Fixation Implant System is substantially equivalent to previously cleared devices. including those listed above. A number of predicate devices list the same range of clinical uses.
Conclusions
Tornier. Inc. believes that the information provided establishes that similar legally marketed devices have been used for the same clinical applications as the Tornier PITON™ Fixation Implant System. The materials from which the Tornier device is fabricated have an established history of use, and the devices have been tested in accordance with applicable FDA guidelines.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem of an eagle with outstretched wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Tornier, Inc. % Mr. Howard Schrayer Regulatory Affairs Consultant 100 Cummings Center, Suite 444C Beverly, Massachusetts 01915
Re: K091870
Trade/Device Name: Tornier, PITON™ Fixation Implant System Regulation Number: 21 CFR 888.3040. Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI Dated: June 22, 2009 Received: June 23, 2009
Dear Mr. Schrayer:
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 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.
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Page 2 - Mr. Howard Schrayer
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/CDRH/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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourceforYou/Industry/default.htm.
Sincerely yours,
Mark M Millerson
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known):
Device Name: Tornier, PITON™ Fixation Implant System
Indications For Use:
The Tornier PITON™ Fixation Implant is intended for fixation of soft tissue to bone.
The PITON™ Implant is intended for use in the following applications:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valqus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar \ Tendon Repair, Posterior Oblique Ligament Repair. Illiotibial Band Tenodesis Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament
Reconstruction, Radial Collateral Ligament Reconstruction
Elbow: Biceps Tendon Reattachment, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency
Hip: Capsular Repair - Acetabular Labral Repair
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Quta for mxn
(Division Sign of)
Division of Surgic Orthopedic, and Restorative Devices
510(k) Number K091870
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