(52 days)
No
The device description and intended use describe a system of bone screws and associated instruments, with no mention of software, algorithms, or any technology that would incorporate AI or ML.
Yes
The device is described as being used for "fixation of bone fractures, osteotomies, non-unions and mal-unions in bone reconstruction," which are therapeutic interventions.
No
The device is described as screws intended for fixation of bone fractures, osteotomies, non-unions, and mal-unions, which are therapeutic interventions, not diagnostic procedures.
No
The device description clearly states it is comprised of physical screws and instruments made of titanium alloy, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The provided text describes surgical screws and associated instruments used for the fixation of bone fractures and other bone-related issues. These are physical implants and tools used directly on the patient's body during surgery.
- Intended Use: The intended use clearly states the screws are for "fixation of bone fractures, osteotomies, non-unions and mal-unions in bone reconstruction." This is a surgical procedure, not a diagnostic test performed on a sample.
The information provided aligns with a surgical device used for orthopedic procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Instratek 4.5mm, 5.5mm, and 6.5mm screws are indicated for fixation of bone fractures, osteotomies, non-unions and mal-unions in bone reconstruction. These devices are not intended for use in the spine.
The Instratek 4.5mm, 5.5mm, and 6.5mm screws are intended for the following surgical indications:
- Metatarsal fractures
- Fixation of malunions and nonunions
- Acute fractures
- Avulsion fractures
- Repetitive stress fractures
- Malleolar fractures
- Talus fractures
- Greater tuberosity fractures
- Small joint fusion
- Jones fractures
- Osteotomies and non-unions in the foot and ankle
Product codes
HWC
Device Description
The Instratek Jones-FX System is comprised of screws in diameters 4.5mm, 5.5mm and 6.5mm. The screws are available in cannulated and non-cannulated versions and are constructed of TI-6AL-4V anodized titanium alloy conforming to ASTM F136. The screws have Torx heads. Instruments provided in the set include: Tissue protector K-wire guides Drill guide inserts (3.1mm, 4.0mm and 4.9mm) Tap Guide inserts (4.5mm, 5.5mm and 6.5mm) K-wire (1.7mm x 230mm) Cannulated drill bits (3.1mm, 4.0mm and 4.9mm) Screw Taps, Cannulated (4.5mm, 5.5mm, 6.5mm) Depth gauge Driver blade Fixed and Rachet Quick Connect Drivers Countersink Tray with Caddy
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone, spine (not intended for use in), Metatarsal, Malleolar, Talus, Greater tuberosity, foot and ankle
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)
No testing was conducted for inclusion with this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
K131620 page 1 of 2
SECTION 5. 510(K) SUMMARY
| Submission Correspondent
and Owner: | Instratek, Inc.
4141 Directors Row, Suite H
Houston, TX 77092
USA
Phone: 281-890-8020
Fax: 281-890-8068
Email: jeff@instratek.com
Contact: Mr. Jeff Seavey
President | JUL 2 5 2013 |
|--------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Date summary prepared: | July 9, 2013 | |
| Device trade name: | Instratek Jones-FX System | |
| Device common name: | Bone Screw | |
| Device classification name: | Screw, Fixation, Bone.
HWC at 21 CFR Part 880.3040 | |
| Legally marketed device to
which the device is
substantially equivalent: | Arthrex, Low Profile Plate and Screw System, Cleared under
K123241
Wright - 5th Metatarsal Fracture Screw, Cleared under K053136 | |
| Description of the device: | The Instratek Jones-FX System is comprised of screws in diameters
4.5mm, 5.5mm and 6.5mm. The screws are available in cannulated
and non-cannulated versions and are constructed of TI-6AL-4V
anodized titanium alloy conforming to ASTM F136. The screws
have Torx heads. Instruments provided in the set include:
Tissue protector K-wire guides Drill guide inserts (3.1mm, 4.0mm and 4.9mm) Tap Guide inserts (4.5mm, 5.5mm and 6.5mm) K-wire (1.7mm x 230mm) Cannulated drill bits (3.1mm, 4.0mm and 4.9mm) Screw Taps, Cannulated (4.5mm, 5.5mm, 6.5mm) Depth gauge Driver blade Fixed and Rachet Quick Connect Drivers Countersink Tray with Caddy | |
| Intended use of the device: | The Instratek 4.5mm, 5.5mm and 6.5mm screws are indicated for fixation of bone fractures, osteotomies, non-unions and mal-unions in bone reconstruction. These devices are not intended for use in the spine.
The Instratek 4.5mm, 5.5mm, and 6.5mm screws are intended for the following surgical indications: Metatarsal fractures Fixation of malunions and nonunions Acute fractures Avulsion fractures Repetitive stress fractures Malleolar fractures Talus fractures Greater tuberosity fractures Small joint fusion Jones fractures Osteotomies and non-unions in the foot and ankle | |
| Technological
characteristics: | The proposed device has the same technological characteristics as the predicate devices. | |
| Testing: | No testing was conducted for inclusion with this submission. | |
| Conclusions: | The results of the comparison of design, materials, intended use and | |
·
1
K131620 page 2 of 2
.
.
technological characteristics demonstrate that the device is as safe and effective as the legally marketed predicate devices.
・
:
Instratek, Inc.
2
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 25, 2013
Instratek, Incorporated % Mr. Jeff Scavey President 4141 Directors Row, Suite H Houston, Texas 77092
Re: K131620
Trade/Device Name: Instratek Jones-FX System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone lixation fastener Regulatory Class: Class II Product Code: HWC Dated: June 20, 2013 Received: June 21, 2013
Dear Mr. Scavey:
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
3
Page 2 - Mr. Jeff Seavey
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 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/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Erin I. Keith
For
Mark N. Melkerson Director Division of Orthopedie Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SECTION 4. INDICATIONS FOR USE STATEMENT
510(k) Number:
K131620 (Page 1 of 1)
Device Name:
Instratek Jones-FX System
Indications for Use:
The Instratek 4.5mm, 5.5mm, and 6.5mm screws are indicated for fixation of bone fractures, osteotomies, non-unions and mal-unions in bone reconstruction. These devices are not intended for use in the spine.
The Instratek 4.5mm, 5.5mm, and 6.5mm screws are intended for the following surgical indications:
- Metatarsal fractures
- � Fixation of malunions and nonunions
- . Acute fractures
- . Avulsion fractures
- Repetitive stress fractures �
- Malleolar fractures .
- . Talus fractures
- Greater tuberosity fractures .
- Small joint fusion ●
- . Jones fractures
- Osteotomies and non-unions in . the foot and ankle
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Lori A. Wiggins
Division of Orthopedic Devices