(179 days)
Not Found
Not Found
No
The device description and performance studies focus on the mechanical properties of the screw and washer system, with no mention of AI or ML technology.
Yes
The device is used for the attachment of ligaments, tendons, and soft tissue to bone, which implies it directly treats or manages an injury or condition.
No
The device is described as an implantable system for attaching soft tissue to bone, which is a therapeutic function, not a diagnostic one. Its description and performance studies focus on material and structural properties for surgical use.
No
The device description clearly states it consists of physical components (screws and washers) made of titanium, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "in the attachment of ligaments, tendons and other soft tissue to bone." This describes a surgical implant used directly on a patient's body.
- Device Description: The description details a screw and washer system made of titanium, designed for physical attachment within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis. IVDs are used in vitro (outside the body) to diagnose or provide information about a disease or condition.
This device is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Implex Screw and Washer System is indicated for use in the attachment of ligaments, tendons and other soft tissue to bone.
Product codes (comma separated list FDA assigned to the subject device)
MBI, HWC
Device Description
The Implex Screw and Washer System consists of the Implex Continuum Bone Screw configured with a Hedrocel®/CP titanium Washer. The Implex Continuum Bone Screw has a 5 mm diameter and is offered in lengths from 15 to 65 mm, in 5 mm increments. The Washer is offered in two versions. Washer-A and Washer-A has a flat tissue-contacting Washer-B. surface and Washer-B has a flat tissue-contacting surface with recessed grooves. Both versions are round, and offered in three outer diameters, 14 mm, 17 mm, and 20 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone
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)
Performance data provided in MAF#920 demonstrates that material and structural properties of the washer component of the Implex Screw and Washer System are suitable for the intended use of the device. The screw is a currently legally marketed bone screw. Mechanical testing demonstrating the strength of the CP Titanium/Hedrocel® interface is included in this 510(k) Premarket Notification.
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.
Not Found
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.
0
FEB
510(k) SUMMARY Implex Screw and Washer System
Submitter Name: | Implex Corp. |
---|---|
Submitter Address: | 80 Commerce Drive |
Allendale, New Jersey 07401-1600 | |
Contact Person: | John Schalago, RAC or Robert Poggie, Ph.D. |
Phone Number: | (201) 818-1800 |
Fax Number: | (201) 818-0567 |
Date Prepared: | January 27, 1999 |
Device Trade Name: | Implex Screw and Washer System |
Device Common Name: | Washer, bolt, nut |
Classification Number | 21 CFR § 878.3030 |
| Substantial
Equivalence: | The term "substantial equivalence" as used in this
510(k) notification is limited to the definition of
substantial equivalence found in the Federal Food,
Drug and Cosmetic Act, as amended and as applied
under 21 CFR 807, Subpart E under which a device
can be marketed without premarket approval or
reclassification. A determination of substantial
equivalency under this notification is not intended
to have any bearing whatsoever on the resolution of
patent infringement suits or any other patent
matters. No statements related to, or in support of
substantial equivalence herein shall be construed
as an admission against interest under the US
Patent Laws or their application by the courts. |
----------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
---|
- Device Description: The Implex Screw and Washer System consists of the Implex Continuum Bone Screw configured with a Hedrocel®/CP titanium Washer. The Implex Continuum Bone Screw has a 5 mm diameter and is offered in lengths from 15 to 65 mm, in 5 mm increments. The Washer is offered in two versions. Washer-A and Washer-A has a flat tissue-contacting Washer-B. surface and Washer-B has a flat tissue-contacting surface with recessed grooves. Both versions are round, and offered in three outer diameters, 14 mm, 17 mm, and 20 mm.
1
510(k) Summary of Safety and Effectiveness (continued)
,
| Indications for Use: | The Implex Screw and Washer System is indicated
for use in the attachment of ligaments, tendons and
other soft tissue to bone. |
|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Technological
Characteristics and
Comparison to
Predicate Device: | The Hedrocel® Screw and Washer System has the
same intended use and indications for use, and is
offered in equivalent geometries and sizes as the
predicate devices. |
| Performance Data: | Performance data provided in MAF#920
demonstrates that material and structural properties
of the washer component of the Implex Screw and
Washer System are suitable for the intended use of
the device. The screw is a currently legally marketed
bone screw. Mechanical testing demonstrating the
strength of the CP Titanium/Hedrocel® interface is
included in this 510(k) Premarket Notification. |
| Predicate Device
Information: | The predicate device cited in this premarket
notification to support a determination of substantial
equivalence are the Implex Continuum® Bone Screw,
the MDLI Soft Tissue Screw and Washer System, and
the Mitek Screw and Washer System. |
| Conclusion: | The Implex Screw and Washer System is
substantially equivalent to the identified predicate
devices. |
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three stylized human profiles incorporated into the design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB | 1 1999
John A. Schalago, RAC Requlatory Affairs Manager Implex Corporation 80 Commerce Drive 07401-1600 Allendale, New Jersey
Re: K982751 Implex Corporation Screw and Washer System Trade Name: Regulatory Class: II Product Codes: MBI and HWC Dated: November 3, 1998 November 4, 1998 Received:
Dear Mr. Schalago:
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, Druq, 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 against 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. A 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 action. In addition, FDA may publish further announcements 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 requlations.
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Page 2 - John A. Schalago, RAC
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,
Neil R.P. Ogden for
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
4
510(k) Number (if known): 2 1 5 1
Implex Screw and Washer System Device Name:
Indications For Use:
The Implex Screw and Washer System is indicated for use in the ligaments, tendons and other soft tissue to attachment of bone .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of Device Evaluation (ODE)
X Prescription Use (Per 21 CFR 801.109)
OR...
Over-The-Counter Use
(Optional Format 1-2-96)
fo
(Division Sign-Off) Division of Ceneral Restorative Devices 982 510(k) Number_ ﮨﮯ۔ 5