(90 days)
Not Found
No
The device description and intended use clearly describe simple mechanical components (washers) used in conjunction with bone screws. There is no mention of any computational or analytical capabilities, let alone AI or ML.
No
The device, bone screw washers, is intended to provide mechanical support and surface area contact, not to treat or diagnose a disease or condition.
No
The device is described as a surgical implant (bone screw washers) intended to provide additional surface area contact, not to diagnose a condition.
No
The device description clearly states that the device consists of physical bone screw washers, which are 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, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided text clearly describes the device as bone screw washers intended for use in surgical procedures to provide additional surface area contact between a screw head and bone. This is a surgical implant/accessory, not a device that analyzes biological specimens.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, chemical reactions, or diagnostic purposes related to bodily fluids or tissues.
Therefore, based on the provided information, this device falls under the category of a surgical implant or accessory, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The washers are intended to be used to provide additional surface area contact between the screw head and bone surface, when used in combination with bone screws for small bone reconstruction of the mandible, hand, foot and the midfacial skeleton where there exists a condition of a thin cortex or osteoporotic bone.
Product codes
HWC
Device Description
The Howmedica® and Howmedica® Leibinger Bone Screw Washers consist of sizes ranging from .8 mm internal diameter to 3.5 mm internal diameter. The washers are used in conjunction with screws, of like or similar material, currently available in Luhr® and Leibinger®-Luhr® plating systems, which were cleared under various 510(k) notifications (K761228, K854886, K862482, K862534, K882454, K901941, K913355, K923861, K935448, K950595, K951415, K961485, K961497, K963739, K963740, K970912,) and any future styles of Howmedica® and Howmedica Leibinger® screws found substantially equivalent.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandible, hand, foot and the midfacial 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
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)
Not Found
Reference Device(s)
K761228, K854886, K862482, K862534, K882454, K901941, K913355, K923861, K935448, K950595, K951415, K961485, K961497, K963739, K963740, K970912
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
APR 2 9 1998
510(k) Summarv
Proprietary Name:
Common Name: Classification Name & Reference: Proposed Requlatory Class: Device Product Code:
Howmedica® and Howmedica® Leibinger Bone Screw Washers Washers Smooth or threaded metallic bone fixation fastener 21 CFR 888.3040 ﺍﻟﻤ HWC
For information contact:
Sean Luland Regulatory Affairs Associate Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 Phone: (201) 507-7437 Fax: (201) 507-6870
The Howmedica® and Howmedica® Leibinger Bone Screw Washers consist of sizes ranging from .8 mm internal diameter to 3.5 mm internal diameter. The washers are used in conjunction with screws, of like or similar material, currently available in Luhr® and Leibinger®-Luhr® plating systems, which were cleared under various 510(k) notifications (K761228, K854886, K862482, K862534, K882454, K901941, K913355, K923861, K935448, K950595, K951415, K961485, K961497, K963739, K963740, K970912,) and any future styles of Howmedica® and Howmedica Leibinger® screws found substantially equivalent.
The washers are intended to be used to provide additional surface area contact between the screw head and bone surface, when used in combination with bone screws for small bone reconstruction of the mandible, hand, foot and the midfacial skeleton where there exists a condition of a thin cortex or osteoporotic bone.
The substantial equivalence of these components is based on an equivalence in intended use, materials, design, and operational principles to Howmedica's Large Cancellous Washer, Vitallium Washer, ICS Mini and Small Fregment Set Washer and Synthes® Mini Fragment Implant Set Washer and Schuhli Washer.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 9 1998
Mr. Sean Luland Requlatory Affairs Associate Howmedica Inc. Pfizer Hospital Products Group 359 Veterans Boulevard Rutherford, New Jersey 07070-2584
K980364 Re : Bone Screw Washers Trade Name: Requlatory Class : II Product Code: HWC Dated: January 28, 1998 Received: January 29,1998
Dear Mr. Luland:
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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਜੋ 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 Failure to Administration (FDA) will verify such assumptions. 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.
2
Page 2 - Mr. Sean Luland
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 general 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
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Indications for Use
510(k) Number (if known):
Device Name: The Howmedica® and Howmedica® Leibinger Bone Screw Washers
Indications for Use:
The washers are intended to be used to provide additional surface area contact between the screw head and bone surface, when used in combination with bone screws between the occord froution of the mandible, hand, foot and the midfacial skeleton where there exists a condition of a thin cortex or osteoporotic bone.
(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) | X |
| OR | |
| Over-The-Counter Use |
| (Division Sign-Off) | |
|---|---|
| --------------------- | -- |
| Division of General Restorative Devices | |
|---|---|
| ----------------------------------------- | -- |
| 510(k) Number | 4980364 |
|---|---|
| --------------- | --------- |
(Optional Format 1-2-96)