(259 days)
Not Found
No
The description focuses on the mechanical properties and surgical application of a fracture fixation system, with no mention of AI or ML capabilities.
Yes
The device is indicated for fracture fixation and provides an alternative to cancellous bone screws, which are therapeutic interventions.
No.
The device is a fracture fixation system, designed for surgical intervention and repair, not for diagnosing medical conditions.
No
The device description clearly outlines a physical implantable system (screw, washer, nut-and-bolt) made of titanium alloy, along with associated surgical instruments. This is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "fracture fixation" and "compression between separate bones." This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details a "fracture fixation screw, washer, nut-and-bolt system" made of titanium alloy. These are physical implants used in surgery.
- Anatomical Site: The anatomical sites listed (ankle, knee, etc.) are parts of the human body where surgical procedures are performed.
- Input Imaging Modality: The use of "fluoroscopic image x-ray" is for guiding the surgical placement of the device, not for analyzing biological samples.
- Performance Studies: The performance studies mentioned are related to the mechanical strength of the implant (pull-out and bending strength), not the analysis of biological samples.
In Vitro Diagnostics (IVDs) are medical devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of biological samples. It is a surgical implant used to physically stabilize bone fractures.
N/A
Intended Use / Indications for Use
The CompresSURE System is indicated for fracture fixation where fracture compression is desired, and where insertion of the nut-and-bolt system does not increase the risk of morbidity due to the need for surgical access to both sides of the compressed area. The device may also be used when compression between separate bones is desired (i.e.- the syndesmosis) as long as there is not increased morbidity associated with the insertion of a nut-and-bolt system, as discussed above. The system is not intended for spinal use.
Product codes (comma separated list FDA assigned to the subject device)
HWC, HTN
Device Description
The U.S. Implants CompresSURE Fracture Repair System is a fracture fixation screw, washer, nut-and-bolt system for cortical wall compression of a bone fracture across the fracture site and, as well, provides an alternative to a cancellous bone screw for fracture fixation in the ankle, knee - proximal tibia, distal femoral, patella, etc.. The screw/bolt and nut is cannulated for use over a 1.6mm guide pin allowing for accurate placement of the screw/nut assembly in conjuction with use of fluoroscopic image x-ray. A full range of sizes are available from 25mm to 67mm in 3mm increments. The screw/bolt, washers, and nut are manufactured from High Strength 6-4 ELI Titanium Alloy with an Anodized surface. Cannulated drills, countersinks, depth gauge, and driver instruments are available for use in insertion of the screw, washer, bolt-and-nut system. Removal (when necessary) of the device is carried out percutaneously. Pull-out and bending strength testing according to ASTM F543 & F1264 show over 2 times the strength to conventional standard 4.0mm cannulated cancellous screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopic image x-ray
Anatomical Site
ankle, knee - proximal tibia, distal femoral, patella, etc.
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)
Pull-out and bending strength testing according to ASTM F543 & F1264 show over 2 times the strength to conventional standard 4.0mm cannulated cancellous screws.
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.
Zimmer 878 Barr Bolt (Pre-amendment), Linvatec Corp. Washer, Bolt, Nut, Orthopedic (K954682), Biomet Cannulated Screw System (K024086), Osteonics Osteo 4.0 Cannulated Screw System (K983165), Synthes 4.5mm Cannulated Screw (K963172)
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
Section XII: 510(k) Summary of Safety and Effectiveness
SAFE MEDICAL DEVICES ACT OF 1990
510(k) Summary
MAR 1 2 2009
NAME OF FIRM: U.S. Implant Solutions, LLC 650 South Central Avenue, Suite 1000 Oviedo, FL 32765
510(k) FIRM CONTACT:
Scott Garrett President U.S. Implants
TRADE NAME:
CompresSURE Fracture Repair System
HTN
COMMON NAME:
CLASSIFICATION:
Smooth or threaded metallic bone fixation fastener (see 21CFR, Sec. 888.3040)
Cannulated Fixation Bone Screw with Washer, Bolt Nut
Single/multiple component metallic bone fixation appliances and accessories (see 21 CFR. Sec. 888.3030)
HWC DEVICE PRODUCT CODE:
SUBSEQUENT PRODUCT CODE:
SUBSTANTIALLY EQUIVALENT DEVICES: Zimmer 878 Barr Bolt (Pre-amendment) Linvatec Corp. Washer, Bolt, Nut, Orthopedic (K954682) Biomet Cannulated Screw System (K024086) Osteonics Osteo 4.0 Cannulated Screw System (K983165) Synthes 4.5mm Cannulated Screw (K963172)
DEVICE DESCRIPTION:
The U.S. Implants CompresSURE Fracture Repair System is a fracture fixation screw, washer, nut-and-bolt system for cortical wall compression of a bone fracture across the fracture site and, as well, provides an alternative to a cancellous bone screw for fracture fixation in the ankle, knee - proximal tibia, distal femoral, patella, etc.. The screw/bolt and nut is cannulated for use over a 1.6mm guide pin allowing for accurate placement of the screw/nut assembly in conjuction with use of fluoroscopic image x-ray. A full range of sizes are available from 25mm to 67mm in 3mm increments. The screw/bolt, washers, and nut are manufactured from High Strength 6-4 ELI Titanium Alloy with an Anodized surface. Cannulated drills, countersinks, depth gauge, and driver instruments are available for use in insertion of the screw, washer, bolt-and-nut system. Removal (when necessary) of the device is carried out percutaneously. Pull-out and bending strength testing according to ASTM F543 & F1264 show over 2 times the strength to conventional standard 4.0mm cannulated cancellous screws.
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510(k) Summary Continued:
INTENDED USE:
Indications for use is where the CompresSURE is indicated for fracture fixation where fracture compression is desired, and where insertion of the nut-and-bolt system does not increase the risk of morbidity due to the need for surgical access to both sides of the compressed area. The device may also be used when compression between separate bones is desired (i.e.- the syndesmosis) as long as there is not increased morbidity associated with the insertion of a nut-and-bolt system, as discussed above.
The system is not intended for spinal use.
BASIS OF SUBSTANTIAL EQUIVALENCY:
The U.S. Implants CompresSURE Fracture Repair System is substantially equivalent to a Pre-amendment device from Zimmer. Also SE to the Linvatec, Biomet, Synthes, and Osteonics (now Stryker) Cannulated Screw Systems.
SUMMARY OF SAFETY AND EFFECTIVENESS:
The U.S. Implants CompresSURE Fracture Repair System is shown to be safe and effective for use in fracture fixation in small and large bone and small and large bone fragments where precision placement is required.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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MAR I 2 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
US Implant Solutions, LLC % Mr. Scott Garrett 650 South Central Avenue, Suite 1000 Oviedo, FL 32765
Re: K081813
Trade/Device Name: CompresSURE Fracture Repair System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC, HTN Dated: March 2, 2009 Received: March 4, 2009
Dear Mr. Garrett:
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 – Mr. Scott Garrett
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,
for Ahmed. for.
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
510(k) NUMBER: DEVICE NAME: CompresSURE Fracture Repair System
INDICATIONS FOR USE:
The CompresSURE System is indicated for fracture fixation where fracture compression is desired, and where insertion of the nut-and-bolt system does not increase the risk of morbidity due to the need for surgical access to both sides of the compressed area. The device may also be used when compression between separate bones is desired (i.e.- the syndesmosis) as long as there is not increased morbidity associated with the insertion of a nut-and-bolt system, as discussed above.
The system is not intended for spinal use.
× Prescription Use AND/OR Over-The-Counter-Use (Per 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDF Office of Bevice Evaluation (ODE) (Division Sign-Of Division of General, Restorative, and Neurological Devices
510(k) Number
Corporate Office 650 South Central Avenue, Suite 1000 Oviedo, FL 32765 Tel: 407-971-8054 407-971-8056