(90 days)
Not Found
Not Found
No
The device description and intended use are purely mechanical and material-based, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
No
The device is described as an "anchor device for suture" and is used for "suture fixation or securing soft tissue to bone." Its function is structural support and fixation, not to treat a disease or condition therapeutically.
No
Explanation: The device is described as an "anchor device for suture or to secure soft tissue directly to bone," which is a therapeutic or assistive function, not a diagnostic one. It does not gather information for the purpose of identifying a medical condition.
No
The device description clearly states the device is composed of poly(I-lactide) acid (PLLA) and describes its physical dimensions, indicating it is a physical implantable device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "as an anchor device for suture or to secure soft tissue directly to bone." This describes a surgical implant used in vivo (within the body) to physically attach tissues.
- Device Description: The description details a physical implant made of biodegradable material, designed for surgical fixation.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
The information provided clearly indicates this is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Bi-Cortical Bio-Post and Washer is intended as an anchor device for suture or to secure soft tissue directly to bone.
Product codes
HTN, HWC
Device Description
Arthrex, Inc. Bio-Post and Washer is intended for suture fixation or securing soft tissue to bone. The Bio-Post and Washer is composed of poly(I-lactide) acid, PLLA which is biodegradable and biocompatible. It is 35 mm in length and 6.5 mm wide at the head of the Bio-Post. The addition of the washer increases the diameter to 16.5 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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Arthrex, Inc. Bio-Post and Washer System, Synthes(USA), Synthes Bioresorbable Suture Anchor, Bionx Implants, LTD., Smartwedge ACL, Bionx Implants>, LTD., Smart Screw ACL, Bionx Implants, LTD., Biocuff.
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
DEC 1 8 2002
Ko23/119
510(k) Summary
| 510(k) Number: | |
|---|---|
| Contact Person: | Ann Waterhouse, Regulatory Affairs Specialist |
| Date Prepared: | September 11, 2002 |
| Trade/Proprietary Name: | Bi-Cortical Bio-Post and Washer |
| Product Code: | MAT HTN/HWC |
| Classification Name: | Fastener, Fixation, Biodegradable, Soft Tissue |
| Predicate Devices: | Arthrex, Inc. Bio-Post and Washer System, |
| Synthes(USA), Synthes Bioresorbable Suture Anchor, | |
| Bionx Implants, LTD., Smartwedge ACL, Bionx | |
| Implants, LTD>, Smart Screw ACL, Bionx Implants, | |
| LTD., Biocuff. |
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
Intended Use:
The Bi-Cortical Bio-Post and Washer is intended as an anchor device for suture or to secure soft tissue directly to bone.
Description:
Arthrex, Inc. Bio-Post and Washer is intended for suture fixation or securing soft tissue to bone. The Bio-Post and Washer is composed of poly(I-lactide) acid, PLLA which is biodegradable and biocompatible. It is 35 mm in length and 6.5 mm wide at the head of the Bio-Post. The addition of the washer increases the diameter to 16.5 mm.
Substantial Equivalence:
The Arthrex, Inc. Bio-Post and Washer is substantially equivalent to predicate devices where the basic features and intended uses are the same. Minor differences between the Arthrex Bio-Post and Washer and predicate devices do not raise any questions concerning safety and effectiveness and have no apparent effect on the performance, function, or intended use of this device.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Ann Waterhouse Regulatory Affairs Specialist Arthrex, Inc. . 2885 South Horseshoe Drive Naples, Florida 34104
Re: K023119
Trade/Device Name: Bi-Cortical Bio-Post and Washer™ Regulation Number: 21 CFR 888.3030 and 21 CFR 888.3040 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories; and Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HTN and HWC Dated: September 18, 2002 Received: September 19, 2002
Dear Ms. Waterhouse:
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 mav 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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k)
2
Page 2 - Ms. Ann Waterhouse
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. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Muriam C. Provost
fer 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
3
Page 1 of 1
510(k) Number (if known):
Device Name: Arthrex Bio-Post and Washer
Indications for Use:
The Arthrex Bio-Post and Washer is intended as an anchor device for suture or to secure soft tissue directly to bone.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Option Format 3-10-98)
Muriam C. Provost
on of General, Restorative and Neurological Devices
Number K 023/19
.
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