(90 days)
Not Found
No
The 510(k) summary describes a set of bone screws and associated instruments. There is no mention of AI, ML, image processing, or any other technology that would suggest the incorporation of AI/ML. The description focuses solely on the physical characteristics of the screws and instruments and their intended surgical use.
Yes
Explanation: The device is indicated for use in the treatment of bone fractures, osteotomies, arthrodesis, osteochrondritis, and tendon reattachment, which are conditions that require therapeutic intervention.
No
The device is a set of bone screws and instruments used for the treatment of bone fractures, osteotomies, and other surgical indications, not for diagnosing conditions.
No
The device description clearly states it is comprised of physical screws and instruments, indicating it is a hardware medical device.
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 (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description: The provided text describes a set of surgical screws and instruments used for fixing bones during surgery. These are physical implants and tools used directly on the patient's body.
- Intended Use: The intended use clearly states the device is for the "treatment of bone fractures, osteotomies, arthrodesis, osteochrondritis, and tendon reattachment in small bones and interfragmentary indications." This is a surgical intervention, not a diagnostic test performed on a sample.
The device is a surgical implant/instrument, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The Instratek Cannulated Titanium (Ti6AL4V) Headed & Headless Mini 2.5mm, 3.0mm and 4.0mm bone screws are indicated for use in the treatment of bone fractures, osteotomies, arthrodesis, osteochrondritis, and tendon reattachment in small bones and interfragmentary indications including specific long bone indications. The device is intended for, but not limited to, Hand Surgery, Orthopedic Surgery, Plastic Surgery and Podiatric Surgery. These devices are not intended for use in the spine.
The Instratek Cannulated Titanium Headed & Headless Mini Screw Set is intended for the following surgical indications:
• Scaphoid Fractures
• Capitate
• Metacarpal Fractures
• Phalangeal Fractures
• Ulnar Styloid Fractures
• Small Joint Fusion
• Humeral head Fractures
• Intercarpal Fractures
• Tarsal Fusions
• Patellar Fractures
• Interfragmentary Ulnar Fractures
• Small Hand and Wrist Bone Fractures
• Forefoot Interfragmentary Fractures
• Lunate Fractures
• Trapezial Fractures
• Metatarsal Fractures
• Radial Head Fractures
• Osteo-Chondral
• Ostero-Chondral Fractures
• Glenoid Fractures
• Interphalangeal Fractures
• Malleolar Fractures
• Metaphyseal Fractures
• Interfragmentary Radius Fractures
• Distal Metatarsal Osteotomies
• Midfoot Interfragmentary Fractures
Product codes
HWC
Device Description
The Instratek Mini Cannulated Titanium Headed and Headless Screw Set is comprised of screws in diameters 2.5mm through 4.0mm. The screws are all cannulated and constructed of anodized titanium alloy. The screws have Torx heads. Instruments provided in the set include drivers (fixed and rotating) and blades, countersink/depth gauge, screw pickup, drill bits, threaded and unthreaded kwires and a caddy/tray.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Small bones, interfragmentary indications including specific long bone indications, Scaphoid, Capitate, Metacarpal, Phalangeal, Ulnar Styloid, Small Joint, Humeral head, Intercarpal, Tarsal, Patellar, Forefoot, Lunate, Trapezial, Metatarsal, Radial Head, Glenoid, Interphalangeal, Malleolar, Metaphyseal, Radius, Distal Metatarsal, Midfoot. Not intended for use in the spine.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hand Surgery, Orthopedic Surgery, Plastic Surgery and Podiatric Surgery.
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)
Osteomed K063298, Osteomed K010783, Koby Surgical K060026, BioPro K101030, Memometal K070039, Vilex K973309, Vilex K991197, Vilex K991151, Vilex K014154, Instratek K960537, Instratek K960533, Instratek K950704
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
:
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
Vice President |
| Date summary prepared: | February 15, 2012 |
| Device trade name: | Mini Cannulated Titanium Headed and Headless Screw Set |
| Device common name: | Bone Screw |
| Device classification name: | Screw, Fixation, Bone.
HWC at 21 CFR Part 888.3040 |
| Legally marketed device to
which the device is
substantially equivalent: | Osteomed K063298
Osteomed K010783
Koby Surgical K060026
BioPro K101030
Memometal K070039
Vilex K973309, K991197, K991151
Vilex K014154
Instratek K960537, K960533, K950704 |
| Description of the device: | The Instratek Mini Cannulated Titanium Headed and Headless
Screw Set is comprised of screws in diameters 2.5mm through
4.0mm. The screws are all cannulated and constructed of anodized
titanium alloy. The screws have Torx heads. Instruments provided
in the set include drivers (fixed and rotating) and blades,
countersink/depth gauge, screw pickup, drill bits, threaded and |
unthreaded kwires and a caddy/tray.
.
·
Traditional 510(k)
MAY 1 7 2012
1
| Intended use of the device: | The Instratek Cannulated Titanium (Ti6AL4V) Headed & Headless
Mini 2.5 mm, 3.0 mm and 4.0mm bone screws are indicated for use
in the treatment of bone fractures, osteotomies, arthrodesis,
osteochrondritis, and tendon reattachment in small bones and
interfragmentary indications including specific long bone indications.
The device is intended for, but not limited to, Hand Surgery,
Orthopedic Surgery, Plastic Surgery and Podiatric Surgery. These
devices are not intended for use in the spine.
The Instratek Cannulated Titanium Headed & Headless Mini Screw
Set is intended for the following surgical indications:
• Scaphoid Fractures
• Capitate
• Metacarpal Fractures
• Phalangeal Fractures
• Ulnar Styloid Fractures
• Small Joint Fusion
• Humeral head Fractures
• Intercarpal Fractures
• Tarsal Fusions
• Patellar Fractures
• Interfragmentary Ulnar Fractures
• Small Hand and Wrist Bone Fractures
• Forefoot Interfragmentary Fractures
• Lunate Fractures
• Trapezial Fractures
• Metatarsal Fractures
• Radial Head Fractures
• Osteo-Chondral
• Ostero-Chondral Fractures
• Glenoid Fractures
• Interphalangeal Fractures
• Malleolar Fractures
• Metaphyseal Fractures
• Interfragmentary Radius Fractures
• Distal Metatarsal Osteotomies
• Midfoot Interfragmentary Fractures |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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
technological characteristics demonstrate that the device is as safe
and effective as the legally marketed predicate devices. |
.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Instratek, Inc. % Mr. Jeff Seavey Vice President 4141 Directors Row, Suite H Houston, Texas 77092
MAY 1 7 2012
Re: K120493
Trade/Device Name: Mini Cannulated Titanium Headed and Headless Screw. Set Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: February 15, 2012 Received: February 17, 2012
Dear Mr. Seavey:
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 r ou may, aroner or visions of the Act include requirements for annual registration, listing of general controle proficturing practice, labeling, and prohibitions against misbranding and ac vious, good manarating processor of 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 may be subject to additions, 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 I lease of advisou that i Drivision that your device complies with other requirements of the Act that I Dr has made a aond regulations administered by other Federal agencies. You must of any I caeral statutes and registments, including, but not limited to: registration and listing (21 compy with an the 1107 21 CFR Part 801); medical device reporting (reporting of medical
3
Page 2 -- Mr. Jeff Seavey
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set de vice-ithated adverse ovents) (21 CER Part 820); and if applicable, the electronic forth in the quality systems (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 11 you desire speerine as roo sortifices/CDRH/CDRHOffices/CDRH/CDRHOffices/ucm115809.htm for go to map.row.winday.com Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part note the regulations 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 Four may 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
For M.H. Davis Cohen
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SECTION 4. INDICATIONS FOR USE STATEMENT
510(k) Number:
Device Name:
Mini Cannulated Titanium Headed and Headless Screw Set
Indications for Use:
The Instratek Cannulated Titanium (Ti6AL4V) Headed & Headless Mini 2.5mm, 3.0mm and 4.0mm bone screws are indicated for use in the treatment of bone fractures, osteotomies, arthrodesis, osteochrondritis, and tendon reattachment in small bones and interfragmentary indications including specific long bone indications. The device is intended for, but not limited to, Hand Surgery, Orthopedic Surgery, Plastic Surgery and Podiatric Surgery. These devices are not intended for use in the spine.
The Instratek Cannulated Titanium Headed & Headless Mini Screw Set is intended for the following surgical indications:
- Scaphoid Fractures .
- Capitate .
- Metacarpal Fractures
- Phalangeal Fractures
- Ulnar Styloid Fractures .
- Small Joint Fusion
- Humeral head Fractures
- Intercarpal Fractures
- Tarsal Fusions
- Patellar Fractures
- Interfragmentary Ulnar Fractures
- Small Hand and Wrist Bone Fractures
- Forefoot Interfragmentary Fractures
- Lunate Fractures
- Trapezial Fractures
- Metatarsal Fractures
- Radial Head Fractures
- Osteo-Chondral
- Ostero-Chondral Fractures
- Glenoid Fractrures
- Interphalangeal Fractures
- Malleolar Fractures
- Metaphyseal Fratures
- Interfragmentary Radius Fractures
- Distal Metatarsal Osteotomies
- Midfoot Interfragmentary Fractures
Prescription Use × (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)
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
| 510(k) Number | K120493 |
|---|---|
| --------------- | --------- |
Instratek, Inc.