(67 days)
CONCISE Compression Hip Screw System (Non-Sterile)
Not Found
No
The summary describes a mechanical implant system for hip fractures and makes no mention of AI or ML.
No.
The device is a surgical implant designed to provide stability for bone fractures, which is a structural function, not a therapeutic treatment of a disease or condition itself.
No
The device description indicates it is a system of screws and plates used for fracture fixation, not for diagnosing medical conditions.
No
The device description explicitly lists hardware components (lag screws, cortical bone screws, compression screws, and compression bone plates).
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples 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 and intended use clearly state that the CONCISE™ Compression Hip Screw System is a system of implants (screws and plates) used to fix fractures in the proximal femur. This is a surgical implant, not a device used for testing samples outside the body.
The information provided describes a device used in vivo (within the body) for surgical repair, not in vitro (in glass/outside the body) for diagnostic testing.
N/A
Intended Use / Indications for Use
The CONCISE™ Compression Hip Screw System (Sterile) is indicated for use in stable and unstable fractures in which a stable medial buttress can be reconstructed for fractures of the proximal femur including:
- intertrochanteric fractures .
- subtrochanteric fractures .
- basilar neck fractures .
- . selected non-unions
Product codes
KTW
Device Description
The CONCISE™ Compression Hip Screw System (Sterile) consists of lag screws, cortical bone screws, compression screws, and compression bone plates. Each component is available in a range of sizes to fit varying anatomical requirements.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Proximal femur
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
CONCISE Compression Hip Screw System (Non-Sterile)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
1 / 1998
Image /page/0/Picture/1 description: The image shows a stylized letter "W" logo. The "W" is formed by three thick, diagonal bars that converge at the bottom and extend upwards, creating a triangular shape. The logo is black and is set against a white background. There is a registered trademark symbol to the right of the logo.
Image /page/0/Picture/2 description: The image shows the logo and contact information for Wright Medical Technology, Inc. The address is 5677 Airline Road, Arlington, TN 38002. The phone number is 901-867-9971.
Image /page/0/Picture/3 description: The image shows a handwritten string of characters, "K98 2390". The characters are written in a cursive style, with varying stroke thicknesses. The characters are all connected, and the overall appearance is somewhat stylized.
Lynne Witkowski Contact Person: Date Prepared: July 7, 1998
CONCISE™ Compression Hip Screw System (Sterile) Trade Name: Metallic Bone Fixation Device Common Name: Classification: II CONCISE Compression Hip Screw System (Non-Sterile) Predicate Device:
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.
Description/Intended Use
The CONCISE™ Compression Hip Screw System (Sterile) consists of lag screws, cortical bone screws, compression screws, and compression bone plates. Each component is available in a range of sizes to fit varying anatomical requirements.
The CONCISE™ Compression Hip Screw System (Sterile) is indicated for use in stable and unstable fractures in which a stable medial buttress can be reconstructed for fractures of the proximal femur including:
- intertrochanteric fractures .
- subtrochanteric fractures .
- basilar neck fractures .
- . selected non-unions
Materials
All component are manufactured from 316 LVM stainless steel conforming to ASTM F 138.
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SFP 1 1998
Ms. Lynne Witkowski Requlatory Affairs Associate Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002
Re : K982390 CONCISE™ Compression Hip Trade Name: Screw System (Sterile) II Regulatory Class: Product Code: KTW Dated: July 7, 1998 Received: July 9, 1998
Dear Ms. Witkowski:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Ms. Lynne Witkowski
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain-html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(K) SUBMISSION WRIGHT MEDICAL TECHNOLOGY, INC. CONCISE™ Compression Hip Screw System (Sterile)
C. Indications for Use of the Device
1982390 510(k) Number (if known):
Device Name: CONCISE™ Compression Hip Screw System (Sterile)
Indications for Use:
The CONCISE™ Compression Hip Screw System is indicated for stable and unstable fractures in which a stable medial buttress can be reconstructed for fractures of the proximal femur including:
- Intertrochanteric fractures .
- Subtrochanteric fractures .
- Basilar neck fractures .
- Selected trochanteric non-unions
(Please do not write below this line-continue on another page if needed) * * 米 * * મ ઋ *
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use X Over-the-Counter Use Or (Per 21 CFR 801.109) (Optional Format 1-2-96)
tcoellea
Sign-Off) (Divisio of General Res Division 510(k) Number
0000000