(21 days)
Not Found
No
The summary describes a mechanical device (self-drilling screws) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is an internal fixation device (screws) used for stabilizing bones after fractures, osteotomies, or other reconstructive procedures, which is a structural support device rather than a device that provides therapy.
No
The device is an internal fixation device used for stabilization of bones and fixation of fractures, osteotomies, and other procedures, not for diagnosing medical conditions.
No
The device description clearly describes physical hardware (self-drilling screws) and their intended use in surgical procedures, indicating it is not a software-only device.
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, tissue) to provide information about a person's health.
- Device Description and Intended Use: The provided information clearly describes a device used for internal fixation of bones during surgical procedures. It is a physical implant used directly on the patient's skeletal structure.
- Lack of IVD Characteristics: There is no mention of analyzing samples, performing tests on bodily fluids or tissues, or providing diagnostic information based on laboratory analysis.
This device falls under the category of surgical implants or orthopedic devices, not IVDs.
N/A
Intended Use / Indications for Use
Internal fixation devices to aid the surgeon in the stabilization of oral cranio-maxillofacial skeletal bone, small bones of the hand, feet, wrist, ankles, for the fixation of fractures, osteotomies, revision procedures, joint fusion and reconstructive procedures.
Product codes
87HWC
Device Description
The self drilling screws are 2.4 mm in diameter and the lengths may range up to 12mm. The tip of the screw is designed so that a predrilled hole is not required, but may be used.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral cranio-maxillofacial 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 (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
§ 888.3040 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
AUG 1 1 2003
032228
page 1 of 1
Summary of Safety and Effectiveness
| Device Name: | Lorenz 2.4 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 cranio-maxillofacial skeletal bone, small bones of the hand, feet, wrist, ankles, for the fixation of fractures, osteotomies, revision procedures, joint fusion and reconstructive procedures.
Description:
The self drilling screws are 2.4 mm in diameter and the lengths may range up to 12mm. The tip of the screw is designed so that a predrilled hole is not required, but may be used.
Sterility Information:
The Lorenz Self Drilling Screws will be marketed as non-sterile, single use devices. Steam Sterilization recommendations are included in the package insert and can be seen in Attachment I.
Substantial Equivalence:
Walter Lorenz considers the Lorenz 2.4 Self Drilling Screws equivalent Lorenz Self Drilling Screw (K013954) TAB 3 includes a substantial equivalence comparison table. TAB 4 includes Premarket clearance (510K) for Lorenz Self Drilling Screw (K013954)
Possible risks:
- .1. Poor bone formation, Osteoporosis, Osteolysis, Osteomyelitis, inhibited revascularization, or infection can cause loosening, bending, cracking or fracture 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. 4.
-
- Decrease in bone density due to stress shielding.
- Pain, discomfort, abnormal sensation, or palpability due to the presence of the device. 6.
- Increased fibrous tissue response around the fracture site and/or the implant. 7.
- Necrosis of bone. 8.
-
- Inadequate healing.
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.
1
Image /page/1/Picture/1 description: The image shows a circular seal with text around the perimeter and a symbol in the center. The text reads "U.S. Department of Health & Human Services - USA". The symbol in the center consists of three parallel lines curving upwards, with a smaller, wavy line beneath them.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 1 2003
Ms. Kim Reed Senior Regulatory Specialist Walter Lorenz Surgical, Inc. 1520 Tradeport Drive Jacksonville, Florida 32218
Re: K032228
Trade/Device Name: Lorenz 2.4 Self Drilling Screw Regulation Numbers: 21 CFR 888.3040 Regulation Names: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Codes: HWC Dated: July 18, 2003 Received: July 21, 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 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
2
Page 2 - Ms. Kim Reed
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.
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,
Oliver M. Wittel, Ph.D.
Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
STATEMENT OF INDICATIONS FOR USE
K0322228 510(k) Number:
Device Name: Lorenz 2.4 Self Drilling Screw
Indications For Use:
Internal fixation devices to aid the surgeon in the stabilization and fixation of oral cranio-maxillofacial 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.
Lilly Witt
(Division Sign-Off) (Division Sign=ch)
Division of General, Restorative
Division of General Devices Division of encological Devices and Neurological
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ﺎ Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter-Use (Optional Format 1-2-96)