(83 days)
Not Found
Not Found
No
The document describes a mechanical implant (a screw) and its intended uses in soft tissue reattachment. There is no mention of software, algorithms, or any technology that would typically incorporate AI or ML.
No.
The device is a tenodesis screw used for soft tissue reattachment, which is a surgical fixation device and not a therapeutic one that delivers a therapy.
No
Explanation: The provided text describes the G-FORCE™ Tenodesis Screw as a device for soft tissue reattachment procedures. Its features and intended uses relate to surgical repair and reconstruction, not to the diagnosis of medical conditions.
No
The device description clearly states it is a physical screw manufactured from PEEK-Optima, indicating it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the G-FORCE™ Tenodesis Screw is a surgical implant used for reattaching soft tissue in various parts of the body (shoulder, foot/ankle, knee, elbow, wrist/hand). It is a physical device implanted into the body, not a device used to analyze samples outside the body.
The information provided focuses on the surgical application and physical characteristics of the screw, which is consistent with a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
Indications for the G-FORCE™ Tenodesis Screw include use in soft tissue reattachment procedures in the shoulder, foot/ankle, knee, elbow and wrist/hand where the sizes offered are patient appropriate. Specific indications include the following:
Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsule Shift or Capsulolabral Reconstruction.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon Reconstruction and tendon transfers in the foot and ankle.
Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis.
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.
Wrist/Hand: Scapholunate Ligament Reconstruction, Ulnar/Radial Collateral Ligament Reconstruction, Carpometacarpal Joint Arthroplasty, Carpal Ligament Repair/Reconstruction and tendon transfers in the wrist and hand.
Product codes
MBI
Device Description
The design features of the G-FORCE™ Tenodesis Screw are described below.
- Generous thread radii to minimize soft tissue damage
- Manufactured from PEEK-Optima .
- Radiolucent
- Screws are available in five diameters and four lengths
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, foot/ankle, knee, elbow and wrist/hand.
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 safety and effectiveness of the G-Force™ Tenodesis Screw is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
K083150 #1
JAN 1 5 2009
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of the G-Force™ Tenodesis Screw.
Submitted By:
· Date:
Contact Person:
Proprietary Name:
Common Name:
Classification Name and Reference:
Device Product Code and Panel Code:
Wright Medical Technology, Inc.
October 6, 2008
Kellen Hills
Regulatory Affairs Specialist
G-FORCETM Tenodesis Screw
Interference Screw
21 CFR 888.3040 Fastener, Fixation, Nondegradable, Soft Tissue - Class II
Orthopedics/87/MBI
DEVICE INFORMATION
A. INTENDED USE
Indications for the G-FORCE™ Tenodesis Screw include use in soft tissue reattachment procedures in the shoulder, foot/ankle, knee, elbow and wrist/hand where the sizes offered are patient appropriate. Specific indications include the following:
Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsule Shift or Capsulolabral Reconstruction.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon Reconstruction and tendon transfers in the foot and ankle.
Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis.
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.
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Wrist/Hand: Scapholunate Ligament Reconstruction, Ulnar/Radial Collateral Ligament Reconstruction, Carpometacarpal Joint Arthroplasty, Carpal Ligament Repair/Reconstruction and tendon transfers in the wrist and hand.
B. DEVICE DESCRIPTION
The design features of the G-FORCE™ Tenodesis Screw are described below.
- Generous thread radii to minimize soft tissue damage ●
- Manufactured from PEEK-Optima .
- Radiolucent �
- Screws are available in five diameters and four lengths 0
The design features of the G-FORCE™ Tenodesis Screw are substantially equivalent to the design features of other devices previously cleared for market.
C. SUBSTANTIAL EQUIVALENCE INFORMATION
The design features, material, and indications for use of the G-Force™ Tenodesis Screw are substantially equivalent to previously cleared predicate devices. The safety and effectiveness of the G-Force™ Tenodesis Screw is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Wright Medical Technology, Inc. % Mr. Kellen Hills 5677 Airline Road . Arlington. Tennessee 38002
Re: K083150
Trade/Device Name: G-Force™ Tenodesis Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI Dated: October 23, 2008 Received: October 24, 2008
Dear Mr. Hills:
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.
JAN 1 5 2009
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 - Mr. Kellen Hills
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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N Milkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
1083150 510(k) Number (if known):
Device Name: G-FORCE™ Tenodesis Screw
Indications For Use:
Indications for the G-FORCE™ Tenodesis Screw include use in soft tissue reattachment procedures in the shoulder, foot/ankle, knee, elbow and wrist/hand where the sizes offered are patient appropriate. Specific indications include the following:
Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair. Capsule Shift or Capsulolabral Reconstruction.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon Reconstruction and tendon transfers in the foot and ankle.
Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair. Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis.
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.
Wrist/Hand: Scapholunate Ligament Reconstruction, Ulnar/Radial Collateral Ligament Reconstruction, Carpometacarpal Joint Arthroplasty, Carpal Ligament Repair/Reconstruction and tendon transfers in the wrist and hand.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General storative,
and Neurological Doces
510(k) Number. /L613150
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