(56 days)
Not Found
No
The device description and intended use clearly describe a mechanical screw system for bone fixation. There is no mention of software, algorithms, or any functionality that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes.
The device is used for treating fractures and other musculoskeletal issues, which falls under therapeutic indications.
No
The provided text describes the TwinFix® Interfragmentary Compression Screw System as a device used for the treatment of fractures and other bone conditions. Its purpose is to fix and compress bone fragments, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly describes a physical screw system designed for surgical implantation, not a software-only product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes the device as being used for the treatment of fractures and arthrodesis in various anatomical locations (bones and joints). This is a surgical/implantable device used directly on the patient's body.
- Device Description: The description further reinforces this by detailing a screw system designed for bone fixation and compression.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze biological samples. This device is used inside the body for structural support and fixation.
N/A
Intended Use / Indications for Use
The subject device, TwinFix® Interfragmentary Compression Screw System is Indicated for fractures or arthrodesis of carpais and metacarpals, radial styloid fractures, metatarsal fractures and ostectornies of the forefoot and intra-articular arthrodesis in the wrist.
The Stryker Leibinger, TwinFix® Interfragmentary Compression Screw System is intended to be used for fractures or arthrodesis of carpals and metacarpals, radial head and radial styloid fractures, metatarsal fractures and osteotomies of the forefoot and intra-articular arthrodesis in the wrist.
Product codes
HRS, LXH
Device Description
The Stryker Leibinger, TwinFix® Interfragmentary Compression Screw System is indicated for the treatment of fractures, psueudo-arthrosis, degenerative alterations and corrective osteotomies alming to a functionally stable osteosysntheis such as, but not limited to: scaphoid fractures, fractures of other carpal bones, scaphoid pseudo-arthrosis, intercarpal arthrodesis of finger end and metacarpal joints and fractures of ulna head and radius head. The TwinFix® is a double cancellous bone thread screw system that is designed for in situ dynamic adjustable interfragmentary compression purposes. It has a self-tapping screw tip design with varying lengths. It may be placed using an open approach with the use of a target bow device for placement of screws or through percutaneous screw placement using K-virre as a guide to minimize the incision.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Carpals, metacarpals, radial styloid, metatarsals, forefoot, wrist, scaphoid, ulna head, radius head, finger end, intercarpal joints.
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)
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
K∅13775
PG 1 OF 2
Jan 8 2002
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS: TwinFix® Interfragmentary Compression Screw System
| Proprietary Name: | TwinFix® Interfragmentary Compression Screw System |
|---|---|
| Common Name: | Small Bone Screw System |
| Single/Multiple Component Metallic Bone Fixation | |
| Application and Accessories 888.3030 | |
| Target Bow Instrumentation | |
| Orthopedic manual surgical instrument | |
| 21 CFR 888.4540 Class I exempt | |
| Proposed Regulatory Class: | Class II |
| Device Classification: | 87 HRS |
| 87 LXH | |
| Submitter: | Stryker Leibinger |
| 4100 East Milham Avenue | |
| Kalamazoo, MI 49001 | |
| 800-253-7370 | |
| Submitter's Registration #: | 1811755 |
| Manufacturer's Registration #: | 8010177 |
| Contact Person: | Robin L. Rowe |
| Regulatory Affairs Representative | |
| Telephone: 877-534-2464 x3295 | |
| Fax: 616-324-5458 | |
| Summary Preparation Date: | November 01, 2001 |
510(K) Summary of Safety and Effectiveness TwinFix® Interfragmentary Compression Screw System 1
1
013775
Intended Use
The subject device, TwinFix® Interfragmentary Compression Screw System is Indicated for fractures or arthrodesis of carpais and metacarpals, radial styloid fractures, metatarsal fractures and ostectornies of the forefoot and intra-articular arthrodesis in the wrist.
See Appendix C for equivalency.
Device Description
The Stryker Leibinger, TwinFix® Interfragmentary Compression Screw System is indicated for the treatment of fractures, psueudo-arthrosis, degenerative alterations and corrective osteotomies alming to a functionally stable osteosysntheis such as, but not limited to: scaphoid fractures, fractures of other carpal bones, scaphoid pseudo-arthrosis, intercarpal arthrodesis of finger end and metacarpal joints and fractures of ulna head and radius head. The TwinFix® is a double cancellous bone thread screw system that is designed for in situ dynamic adjustable interfragmentary compression purposes. It has a self-tapping screw tip design with varying lengths. It may be placed using an open approach with the use of a target bow device for placement of screws or through percutaneous screw placement using K-virre as a guide to minimize the incision.
Substantial Equivalence
The TwinFix® Interfragmentary Compression Screw is Identical to K961498, Resch Arthroscopic and Percutaneous Screw Fixation System in all respects of fixations of small bones. A table of eguivalency is provided in Appendix C.
Robin L Rowe
Regulatory Affairs Representative December 20, 2001
510(K) Summary of Safety and Effectiveness TwinBix® Interfragmentary Compression Screw System 2
2
Image /page/2/Picture/1 description: The image is a black and white circular logo. The logo contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the circle is a stylized image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 8 2002
Stryker Leibinger Robin L. Rowe Regulatory Affairs Representative 4100 East Milham Avenue Kalamazoo, Michigan 49001
Re: K013775
Trade Name: Twinfix Interfragmentary Compression Screw System Regulation Number: 888.3030 Regulation Name: Compression Screw with accessories Regulatory Class: II Product Code: HRS Dated: December 7, 2001 Received: December 11, 2001
Dear Ms. Rowe:
We have reviewed your Section 510(k) premarket 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) 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 注 Ms. Robin Rowe
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 promated 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
KO13775
510(k) Number (if known):
Page 1 of 1
Device Name: TwinFix® Interfragmentary Compression Screw System
Indication For Use:
The Stryker Leibinger, TwinFix® Interfragmentary Compression Screw System is intended to be used for fractures or arthrodesis of carpals and metacarpals, radial head and radial styloid fractures, metatarsal fractures and osteotomies of the forefoot and intra-articular arthrodesis in the wrist.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH,Office of device Evaluation (ODE)
Prescription Use
(per 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)
2
(Division Sign-Off) Division of General. Pastorative and Neurolegican Bookes
or
510(k) Number K013775