(21 days)
Not Found
No
The description focuses on the mechanical design and intended use of self-drilling screws for bone fixation, with no mention of AI or ML capabilities.
No
The device is used for internal fixation to stabilize skeletal bones and fix fractures, osteotomies, revision procedures, joint fusion and reconstructive procedures. While these procedures improve patient health, the device itself is an implantable mechanical support, not a device that administers therapy or has a direct therapeutic effect on a disease or condition in the way that, for example, a drug or radiation therapy would.
No.
The device description clearly states its purpose is for "internal fixation" and "stabilization of oral craniomaxillofacial skeletal bone, small bones of the hand, feet, wrist, ankles, fingers and toes, for the fixation of fractures, osteotomies, revision procedures, joint fusion and reconstructive procedures." These are all therapeutic or implant-related functions, not diagnostic ones. There is no mention of the device being used to identify or analyze a medical condition.
No
The device description clearly describes physical hardware components (self-drilling screws, disposable cartridge, disposable screwdriver blade, driver blade system) and their intended use in surgical procedures. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The provided description clearly states that this device is an "Internal fixation device" used for stabilizing bone fractures and other skeletal procedures. It is a physical implant used directly on the patient's bone.
- Intended Use: The intended use is for surgical procedures involving bone fixation, not for analyzing biological samples.
The device is a surgical implant, not a diagnostic tool that analyzes samples outside the body.
N/A
Intended Use / Indications for Use
Internal fixation devices to aid the surgeon in the stabilization of oral craniomaxillofacial skeletal bone, small bones of the hand, feet, wrist, ankles, fingers and toes, for the fixation of fractures, osteotomies, revision procedures, joint fusion and reconstructive procedures.
Product codes
87HWC
Device Description
The self drilling screws are 1.5 mm to 2.0 mm in diameter and the thread lengths may range up to 7mm. The head may be center drive or cross drive. The screw is designed so that a predrilled hole is not required, but may be used. Five screws are placed within a disposable cartridge A disposable screwdriver blade is loaded between each screw. The cartridges are delivered to the user sterile. The cartridge is loaded into a driver blade system for delivery to the patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral craniomaxillofacial skeletal bone, small bones of the hand, feet, wrist, ankles, fingers and toes
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
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
Not Found
Key Metrics
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
JUN 26 2003
031751
page 1 of 2
Summary of Safety and Effectiveness
| Device Name: | Lorenz Self Drilling Screw |
|---|---|
| Classification Name: | Screw, Fixation, Bone |
| Device Product Code: | 87HWC (21 CFR 888.3040) |
Intended Use:
Internal fixation devices to aid the surgeon in the stabilization of oral craniomaxillofacial skeletal bone, small bones of the hand, feet, wrist, ankles, fingers and toes, for the fixation of fractures, osteotomies, revision procedures, joint fusion and reconstructive procedures.
Description:
The self drilling screws are 1.5 mm to 2.0 mm in diameter and the thread lengths may range up to 7mm. The head may be center drive or cross drive. The screw is designed so that a predrilled hole is not required, but may be used. Five screws are placed within a disposable cartridge A disposable screwdriver blade is loaded between each screw. The cartridges are delivered to the user sterile. The cartridge is loaded into a driver blade system for delivery to the patient.
Sterility Information:
The Rapidfire Self Drilling Screws will be marketed as sterile, single use devices.
Substantial Equivalence:
Walter Lorenz considers the Rapidfire Self Drilling Screws equivalent to Lorenz Self Drilling Screws (K013954).
Possible risks:
-
- Poor bone formation, Osteoporosis, Osteomyelitis, inhibited revascularization, or infection can cause loosening of the device.
-
- Nonunion or delayed union which may lead to breakage of the implant.
-
- Migration, bending, fracture or loosening of the implant
-
- Metal sensitivity, or allergic reaction to a foreign body.
-
- Decrease in bone density due to stress shielding.
-
- Pain, discomfort, abnormal sensation, or palpability due to the presence of the device.
-
- Increased fibrous tissue response around the fracture site and/or the implant.
-
- Necrosis of bone.
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- Inadequate healing.
31751
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Apart from these adverse effects there are always possible complications of any surgical procedure such as, but not limited to, infection, nerve damage, and pain which may not be related to the implant.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a symbol of three stylized human figures, represented by curved lines, facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 6 2003
Ms. Kim Reed Senior Regulatory Specialist Walter Lorenz Surgical, Inc. 1520 Tradeport Drive Jacksonville, Florida 32218
Re: K031751
Trade/Device Name: Rapidfire Self Drilling Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: June 4, 2003 Received: June 6, 2003
Dear Ms. Reed:
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 many:facturing 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 - Ms. Kim Reed
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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
R. Mark N. Milliken
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure ·
4
STATEMENT OF INDICATIONS FOR USE
510(k) Number: K031751
Device Name: Rapidfire self drilling screws
Indications For Use:
Internal fixation devices to aid the surgeon in the stabilization of oral craniomaxillofacial skeletal bone, small bones of the hand, feet, wrist, ankles, fingers and toes, for the fixation of fractures, osteotomies, revision procedures, joint fusion and reconstructive procedures.
(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) OR
Over-The-Counter-Use (Optional Format 1-2-96)
Mark A. Milliman
Division of General, Restorative and Neurological Devices
510(k) Number -