(67 days)
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Not Found
No
The summary describes a system of passive mechanical implants (plates and screws) for bone fixation. There is no mention of software, algorithms, or any technology that would typically incorporate AI/ML.
Yes
The device is used for stabilization and fixation of fractures, which falls under the definition of therapy by treating or alleviating a disease or injury.
No
The device, the Small Fragment System, is described as bone plates and screws for stabilization and fixation of fractures and reconstruction. This indicates a therapeutic or reconstructive function, not a diagnostic one.
No
The device description explicitly states it is comprised of titanium plates and screws, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The provided description clearly states that the device is a system of bone plates and screws used for the stabilization and fixation of bones. This is a surgical implant used directly within the body.
- Intended Use: The intended use is for treating fractures, fusions, and reconstructions of small bones. This is a therapeutic intervention, not a diagnostic test performed on a specimen.
Therefore, based on the provided information, the Lorenz Small Fragment System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Small Fragment System consists of bone plates and screws to be used for stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist, ankles, fingers, toes, and craniomaxillofacial skeleton.
Product codes
87 HRS
Device Description
The Lorenz Small Fragment System is comprised of a variety of titanium plates and screws with shapes and sizes designed for internal fixation of small bones. The screws will have both cross drive and center drive head features and be 1.2mm - 2.7mm in diameter. The plates will include straight, rectangle, parallelogram, trapezoid, T, L, Y, Z, and condylar pin options with various lengths and thicknesses.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
small bones of the hand, feet, wrist, ankles, fingers, toes, and craniomaxillofacial skeleton
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Not Found
Key Metrics
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Predicate Device(s)
Not Found
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
510(k) Summary
Diana Preston Regulatory Affairs Specialist Walter Lorenz Surgical, Inc. 1520 Tradeport Drive Jacksonville, FL 32218-2480
Device Name: Lorenz Small Fragment System
Common or Usual Name: Small Bone Plating System
Classification Name: Single / Multiple Component Metallic Bone Fixation Appliances and Accessories
Device Classification: Class II
Device Product Code: 87 HRS (21 CFR - 888.3030)
Device Description: The Lorenz Small Fragment System is comprised of a variety of titanium plates and screws with shapes and sizes designed for internal fixation of small bones. The screws will have both cross drive and center drive head features and be 1.2mm - 2.7mm in diameter. The plates will include straight, rectangle, parallelogram, trapezoid, T, L, Y, Z, and condylar pin options with various lengths and thicknesses.
Intended Use: The Small Fragment System consists of bone plates and screws to be used for stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist, ankles, fingers, toes, and craniomaxillofacial skeleton.
Potential Adverse Affects and Complications:
- 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 implant.
- 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
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three stripes representing the feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 8 1999
Ms. Diana Preston Requlatory Affairs Specialist Walter Lorenz Surgical, Inc. 1520 Tradeport Drive 32218 Jacksonville, Florida
K992961 Re : Lorenz Small Fragment System Trade Name: Regulatory Class: II Product Code: HRS September 1, 1999 Dated: Received: "September 2, 1999
Dear Ms. Preston:
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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਰੋ 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.
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Page 2 - Ms. Diana Preston
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 qeneral 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) Number (if known): unknown
'
Device Name: Lorenz Small Fragment System
- Indications For Use: The Small Fragment System consists of bone plates and screws to be used for stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist, ankles, fingers, toes, and craniomaxillofacial skeleton.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General Restorative 510(k) Number
Prescription Use_X (Per 21 CFR 801.109) OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)