(74 days)
Not Found
No
The device description and intended use are purely mechanical components for orthopedic fixation, with no mention of software, data processing, or AI/ML terms.
No
The device, Acufex® Washer Systems, is indicated for fixation of soft tissue to bone in orthopedic procedures. It is a mechanical implant used to secure tissues, not to treat a disease or condition, which would make it a therapeutic device. Its function is structural support.
No
Explanation: The device is described as a system for fixation of soft tissue to bone in orthopedic procedures, which is a therapeutic function, not diagnostic.
No
The device description explicitly states that the system includes physical components such as washers and screws made of polyacetal and titanium, which are hardware.
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, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The Acufex® Washer Systems are used for the physical fixation of soft tissue to bone during orthopedic surgical procedures. They are implanted devices that provide structural support.
- Lack of Specimen Analysis: The description does not mention the device being used to analyze any biological specimens. Its function is purely mechanical and structural within the body.
Therefore, based on the provided information, the Acufex® Washer Systems fall under the category of surgical implants or fixation devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Acufex® Washer Systems are used for fixation of soft tissue, such as to hono quinno orthonodio provodio provoditor tondana and linamonto
and and the same of the same of the same of the same of the same of
The Acufex® Washer Systems are indicated for fixation of soft tissue, such as tendons and ligaments to bone in orthopedic procedures.
Product codes (comma separated list FDA assigned to the subject device)
HWC, HTN
Device Description
The Acufex® Washer Systems are used in fixation of soft tissue to bone. The systems include various style polyacetal (with a titanium ring) or titanium washers and titanium screws. The screws are available with a diameter range from 4.5 to 9 mm and 18 to 70 mm in length. Various washers have spikes to engage to bone. Suture spiked washers are designed with spikes for engagement to bone and suture holes to secure suture tendon construct. Also, suture washers are used to secure suture tendon construct to bone.
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)
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.
0
K994202 1
VI. 510K Summary and Truthful and Accurate Statement
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is :
This summary was prepared on December 10, 1999.
A. Submitter
Smith & Nephew, Inc., Endoscopy Division 130 Forbes Boulevard Mansfield, MA 02048
B. Company Contact
Nicholas Condakes Regulatory Affairs Specialist
C. Device Name
| Proprietary Name: | Acufex® Spiked Washer System
Acufex® Suture Washer System
Acufex® Cancellous Screw and Spiked Suture Washer
System |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Soft Tissue Fixation Screw and Washer |
| Classification Name: | Single/multiple component metallic bone fixation
appliances and accessories |
| Product Code: | Screw: HWC
Washer: HTN |
| Regulatory Class: | The Orthopedic Device Panel has classified Screws and
Washers as a Class II device (21 CFR § 888.3030) |
1
D. Predicate/Legally Marketed Devices
Acufex® Tibial Anchor Screw and Spiked Washer (K961649): Smith + Nephew Inc., Endoscopy Division 130 FORBES BLVD MANSFIELD, MA 02048
DePuy OrthoTech Soft Tissue Fixation Washer (K910229) DePuy OrthoTech, Inc.
20F 3
700 Orthopaedic Drive Warsaw, IN 46581
and and the Mark of the Promoted
Device Description E.
VI.
The Acufex® Washer Systems are used in fixation of soft tissue to bone. The systems include various style polyacetal (with a titanium ring) or titanium washers and titanium screws. The screws are available with a diameter range from 4.5 to 9 mm and 18 to 70 mm in length. Various washers have spikes to engage to bone. Suture spiked washers are designed with spikes for engagement to bone and suture holes to secure suture tendon construct. Also, suture washers are used to secure suture tendon construct to bone.
F. Indications for Use
The Acufex® Washer Systems are used for fixation of soft tissue, such as to hono quinno orthonodio provodio provoditor tondana and linamonto
and and the same of the same of the same of the same of the same of
| ი სახელმწიფო სახლების სამხრეთ და მოსახლეობა მას არამა სხვა სხვა სხვა სხვა სამართვე | |
|---|---|
| 、 | . . |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |
| ﺍﻟﺴﻴﺎﺣﺔ ﺍﻟﻤﺘﻮﻗﻴﺔ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺴﺘﻤﺮﺍﺕ ﺍﻟﻤﺴﺘﻌﻤﻠﻴﺔ ﺍﻟﻤﺴﺘﻌﻤﻠﻴﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺴﺘﻌﻤﻞ ﺍﻟﻤﺴﺘﻌﻤﻞ ﺍﻟﻤﺴﺘﻌﻤﻞ ﺍﻟﻤﺴﺘﻌﻤﻞ ﺍﻟﻤﺴﺘﻌﻤﻞ ﺍﻟﻤﺴﺘﻌﻤﻞ ﺍﻟﻤﺴﺘﻌﻤﻞ ﺍﻟﻤﺴﺘﻌﻤﻞ ﺍﻟﻤﺴﺘﻌﻤﻞ ﺍﻟﻤﺴﺘﻌﻤﻞ ﺍﻟﻤﺴﺘﻌﻤﻞ ﺍﻟﻤﺴﺘﻌﻤﻞ | |
| ் குறிக்கு விட்ட விட்ட பாட்டப் பக்கம் கல்லூரியில் இருந்து இந்து இருக்கும் இந்து இருக்கும் இருக்கும் இருக்கும் இருக்கும் இருக்கும் இருக்கும் இருக்கும் இருக்கும் இருக்கும் இரு | |
| commended to the country | |
| -------------------------------------------- | |
| PRESERT CONSULACIONAL CARACTOR CONSULTION CONSULTION CONTRACTOR CONTRACTOR CONTRACTOR CONTRACTOR CONTRACTOR CONTRACTOR CONTRACTOR CONTRACTOR CONTRACTOR CONTRACTOR CONTRACTOR | the first to the state of the successful and the sub- |
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| | ートーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーー |
| ン・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ | |
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2
510K Summary and Truthful and Accurate Statement
G. Substantial Equivalence
VI.
| | Subject Device
Acufex® Washer
Systems | Predicate Device
Acufex® Tibial
Anchor Screw &
Spiked Washer
(K961649) | Predicate Device
DePuy OrthoTech Soft
Tissue Fixation
Washer
(K910229) |
|------------------------|-----------------------------------------------------------|------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| DESIGN | | | |
| Screw
Configuration | Cancellous | Cancellous | Cancellous |
| Screw size | Screw length
18 - 70 mm | Screw length
18 - 30 mm | Screw length 25-65 mm |
| | Screw diameter 4.5 - 9 mm | Screw diameter
7 - 9 mm | Screw diameter 6.5 mm |
| Washer size | Outer diameter 13 - 22 mm | Outer diameter
14 - 20 mm | Outer diameter
14 - 20 mm |
| INDICATIONS
FOR USE | | | |
| | Soft tissue fixation | Soft tissue fixation | Soft tissue fixation |
| MATERIALS | | | |
| Screw | Titanium | Titanium | Titanium |
| Washer | Titanium reinforced,
Polyacetal polymer
Or Titanium | Titanium reinforced,
Polyacetal polymer | Titanium |
| LABELING | | | |
| Screw | Sterile, Single Use Only/
Non-Sterile, Single Use | Sterile, Single Use Only/
Non-Sterile, Single Use | Sterile, Single Use Only |
| Washer | Sterile, Single Use Only /
Non-Sterile, Single Use | Sterile, Single Use Only | Sterile, Single Use Only |
199 Applicant ____________________________________________________________________________________________________________________________________________________________________ Date / 2 ousliker
3
Image /page/3/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" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, with three wavy lines representing snakes or streams.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 5 2000
Mr. Nicholas Condakes Regulatory Affairs Specialist SMITH & NEPHEW, INC. 130 Forbes Boulevard Mansfield, Massachusetts 02048
Re: K994202 Trade Name: Acufex® Washer System Regulatory Class: II Product Code: HWC and HTN Dated: December 10, 1999 Received: December 13, 1999
Dear Mr. Condakes:
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 control provisions of the Act. The general control 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 (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 regulations.
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.
4
Page 2 - Mr. Nicholas Condakes
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 at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours.
Ronald Reagan
Sor James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known) Device Name Indications For Use:
Acufex® Washer Systems
The Acufex® Washer Systems are indicated for fixation of soft tissue, such as tendons and ligaments to bone in orthopedic procedures.
(Please do not write below this line - Continue on another page if necessary) 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)
Darrell Payne
i
Division Sian-C
(Optional Format 1-2-90)