(193 days)
Not Found
No
The provided text describes a mechanical bone screw system made of titanium alloy for fracture fixation and stabilization. There is no mention of software, algorithms, image processing, AI, ML, or any related concepts.
No.
The device is described as screws for fracture fixation and reconstruction/stabilization of bones, which are structural and mechanical functions rather than a direct therapeutic action on a disease process.
No
The device is a medical implant (screws) used for fracture fixation, reconstruction, and stabilization of bones, which are therapeutic actions, not diagnostic ones.
No
The device description explicitly states the device is a bone screw made of Titanium alloy, which is a physical hardware component, not software.
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. These tests are performed outside of the body.
- Device Description and Intended Use: The description clearly states that the Leforte System Screws are intended for fracture fixation, reconstruction, and stabilization of bones within the body. This is a surgical implant, not a device used for testing samples.
The information provided about the device's material, types of screws, and anatomical sites all point to it being a surgical device used in vivo (within the living body), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
"The Leforte System Screws are intended for fracture fixation as well as reconstruction and stabilization of small bones (i.e. toe, foot, finger, hand, etc) and the mandibulofacial (i.e. mandible and maxilla) bones."
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
Leforte system bone screw is made of Titanium alloy (ASTM F136) and consists of common bone screw, self-drilling screw (auto screw) and dual head screw. The common bone screws are classified to 4 classes; Micro screw, Mid screw, Mini screw, Maxi screw. This device is manufactured and intended for small bone (toe, foot, finger, hand etc.) and mandibulofacial (mandible & Maxilla) fracture fixation. Also This device is intended for reconstruction & stabilization of small bone and mandibulofacial (mandible & Maxilla) Jeil Medical Corporation utilizes the state of the art technology and apply the essential requirement of MDD (93/42/EEC) and ISO 14630, 1997 from the device design to manufacturing and QC
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Small bones (i.e. toe, foot, finger, hand, etc) and the mandibulofacial (i.e. mandible and maxilla) bones.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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KC23365 Page V3
EXHIBIT 2. 510(K) SUMMARY
APR 1 8 2003
Jeil Medical Corporation 808, ACE Techno-Tower, 3rd 197-48, Kuro 3Dong Kuro-ku, Seoul, KOREA Telephone : 82-2-2109-6781~9 Fax: 82-2-2109-6791 January 30, 2002 Contact: N.K.Kim, R&D Director 510(k) Summary
-
- Identification of the Device: Proprietary-Trade Name: Leforte System Bone Screw Classification Name: Screw, Fixation, Bone, Product Code HWC Common/Usual Name: Bone Screw
-
- Indications for Use (intended use) . The Leforte System Screws are intended for fracture fixation as well as reconstruction and stabilization of small bones (i.e. toe, foot, finger, hand, etc) and the mandibulofacial (i.e. mandible and maxilla) bones
-
- Description of the Device: Leforte system bone screw is made of Titanium alloy (ASTM F136) and consists of common bone screw, self-drilling screw (auto screw) and dual head screw. The common bone screws are classified to 4 classes; Micro screw, Mid screw, Mini screw, Maxi screw. This device is manufactured and intended for small bone (toe, foot, finger, hand etc.) and mandibulofacial (mandible & Maxilla) fracture fixation. Also This device is intended for reconstruction & stabilization of small bone and mandibulofacial (mandible & Maxilla) Jeil Medical Corporation utilizes the state of the art technology and apply the essential requirement of MDD (93/42/EEC) and ISO 14630, 1997 from the device design to manufacturing and QC ...
-
- Potential Adverse Affects and Complications: (Common to all devices of this type)
1
- Poor bone formation, Osteoporosis, Osteomyelitis, inhibited revascularization, . or infection can cause loosening, bending, cracking or fracture of the device or premature loss of fixation with the bone, leading to nonunion.
- 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, or abnormal sensation due to the presence of the device. .
- Increased fibrous tissue response around the fracture site and/or the implan". ●
- Necrosis of bone. ●
- 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
| Device Name | Twist off™
Screw | Aesculap
Titanium
Alloy Bone
Screws | K3 Bone Screw
System | Le forte System
(Bone Screw) |
|----------------------------------|----------------------------------------------------------|----------------------------------------------|-----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| Device
Classification
Name | No Comment | Screw, Fixation,
Bone
888.3030 | Smooth or Threaded
Bone Fixation
Fastener | Screw, Fixation, Bone
888.3040 |
| Applicant | Medinov-AMP | Aesculp, Inc. | KMI
(Kinetikos Medical
Inc.) | Jeil Medical
Corporation |
| 510(K) Number | K971069 | K970549 | K960533 | (This submission) |
| Material | Titanium Alloy | Titanium Alloy | Titanium Alloy
(Ti-6Al-4V ELI
Alloy
: ASTM F136-84) | Titanium Alloy
(ASTM F 136-98) |
| Intended use | Fixation of
fracture, fusion
of a joint or
Bone | Long & small
bone fracture
fixation | Fixation/stabilization
of small bones in
hand or small bones
in mid & forefoot | Small bone and
mandibulofacial
(mandible & Maxilla)
fracture fixation |
-
- Comparisons to predicate devices:
2
| | reconstruction of
the carpals,
metacarpals &
phalanges of the
hand | | fractures | reconstruction &
stabilization of small
bone and
mandibulofacial
(mandible & Maxilla) |
|-------------------|--------------------------------------------------------------------------------|------------|------------|---------------------------------------------------------------------------------------------------|
| Supplied Sterile? | No Comment | No Comment | No comment | Non sterile, steam
sterilize before use |
-
- Conclusion: In all respects, the Leforte System Bone Screws are the equivalent of currently marked devices. They are made of the same materials and have similar dimensions and characteristics. Potential adverse effects are identical to those of predicate devices. This device is manufactured from material of titanium alloy (ASTM 136-97) that is used generally in this kind of bone screw. Similar devices made from titanium alloy (ASTM 136-97) to this device are manufactured and sold around the world. This device, Le forte system bone screw is substantially equivalent in design, material, intended use and function to the products on the table above. These devices are certificated by notified body for CE.
3
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it and a pair of wings at the top.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20:350
APR 1 8 2003
Jeil Medical Corporation c/o Mr. Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates P.O. Box 7007 Deerfield, Illinois 60015
Re: K023365
Trade Name: LeForte System Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: February 3, 2003 Received: February 4, 2003
Dear Mr. Kamm:
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 forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2 - Mr. Daniel Kamm, P.E.
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,
Sincerely yours,
Mark N Millman
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
5
j) Indications for Use
K023365 510(k) Number_
Device Name: LeForte System Screws (various models)
"The Leforte System Screws are intended for fracture fixation as well as reconstruction and stabilization of small bones (i.e. toe, foot, finger, hand, etc) and the mandibulofacial (i.e. mandible and maxilla) bones."
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use × OR (Per 21 CFR 801.109)
Over the Counter Use _________________________________________________________________________________________________________________________________________________________
Mark N Mlkern
for Division Sign Off
(Division Sign-Off) Division of General, Restorative and Neurological Devices
10(k) Number K023365