(95 days)
Not Found
No
The device description and intended use are purely mechanical, describing a screw and washers for fixation. There is no mention of any software, algorithms, or data processing that would indicate AI/ML.
No.
The device is described as an "anchor device for suture or to secure soft tissue directly to bone" and for "maintenance of alignment, reduction, and fixation of fractures, osteotomies or arthrodesis." These functions are structural and mechanical, not therapeutic.
No
The device is described as an anchor device for suture or to secure soft tissue directly to bone, used for various repair and reconstruction procedures, and for the maintenance of alignment, reduction, and fixation of fractures, osteotomies or arthrodesis. It is a physical implant (a post screw with washers) rather than a tool for diagnosis.
No
The device description clearly states it is a physical implantable device made of PLLA, including a post screw and washers. It is intended for surgical fixation and reconstruction, which are hardware-based procedures.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as an anchor for suture or soft tissue to bone, and for maintaining alignment, reduction, and fixation of fractures, osteotomies, or arthrodesis. These are all surgical procedures performed directly on the patient's body.
- Device Description: The device is described as a post screw and washers, which are physical implants used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
- The Arthrex Bi-Cortical Bio-Post™ and Washers device is intended as an anchor device for suture or to secure soft tissue directly to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow in the following procedures:
Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Reconstruction, Midfoot Reconstruction.
Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Illiotibial Band Tenodesis.
Hand/Wrist: Scaphaolunate Ligament Reconstruction, Ulnar Collateral Ligament Radial Collateral Ligament Reconstruction.
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction,
- The Arthrex Bi-Cortical Bio-Post™ and Washers device is intended for the maintenance of alignment, reduction, and fixation of fractures, osteotomies or arthrodesis of the upper extremity, ankle and foot.
Fusions/fracture of Phalangeal, Metacarpal, and Carpal Wrist arthrodesis Fractures of Distal radius, Olecranon, Radial head, Humeral condylar, Cancellous Osteotomies Malleolus, Ankle fractures, Metatarsal Correction of hallux valgus
Product codes
HTN, HWC
Device Description
The Arthrex Bi-Cortical Bio-Post™ and Washers device is a PLLA 6.5 mm diameter x 70 mm length post screw with a hybrid thread and two 16mm washers in two configurations, smooth and spiked.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, foot/ankle, knee, hand/wrist, and elbow, upper extremity, ankle and foot, Phalangeal, Metacarpal, and Carpal Wrist, Distal radius, Olecranon, Radial head, Humeral condylar, Malleolus
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)
K023119, K011495, K021932, K012001, K030900
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
FEB 1 8 2005
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Arthrex Bi-Cortical Bio-Post™ and Washers
MANUFACTURER / SPONSOR Arthrex. Inc. 1370 Creekside Boulevard Naples, Florida 34108-1945
510(K) CONTACT:
Sally Foust, RAC Sr. Regulatory Affairs Specialist Telephone: (239) 643-5553 ext. 1251 FAX: (239) 598-5539
Bi-Cortical Bio-Post™ and Washers
TRADE NAME:
COMMON NAME:
Fastener Washer, Bolt, Nut Screw, Fixation, Bone
PRODUCT CODE / CLASSIFICATION NAME
Fastener, Fixation, Biodegradable, Soft Tissue
21 CFR 888.3030 / HTN Single/multiple component metallic bone fixation appliances and accessories
21 CFR 888.3040 / HWC Fastener, Fixation, Nondegradable, Soft Tissue Smooth or threaded metallic bone fixation fastener
PREDICATE DEVICES:
K023119, Bi-Cortical Bio-Post™ and Washers K011495, Bio-Post™ and Washers K021932, 6.5 mm Cannulated Screw K012001, SmartScrew™ K030900, OTPS™ Biodegradable Fixation System
DEVICE DESCRIPTION AND INTENDED USE:
The Arthrex Bi-Cortical Bio-Post™ and Washers device is a PLLA 6.5 mm diameter x 70 mm length post screw with a hybrid thread and two 16mm washers in two configurations, smooth and spiked.
1
page 2/2
The Arthrex Bi-Cortical Bio-Post™ and Washers device is intended as an anchor device for suture or to secure soft tissue directly to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow.
The Arthrex Bi-Cortical Bio-Post™ and Washers device is intended for the maintenance of alignment, reduction, and fixation of fractures, osteotomies or arthrodesis of the upper extremity, ankle and foot, or condylar grafts.
SUBSTANTIAL EQUIVALENCE SUMMARY
The Arthrex Bi-Cortical Bio-Post™ and Washers device is substantially equivalent to the predicate devices where basic features and intended uses are the same. Any differ ances between the Arthrex Bi-Cortical Bio-Post™ and Washers and the predicate devices are considered minor and do not raise questions concerning safety and effectiveness. Based on the information submitted, Arthrex, Inc. has determined that the Bi-Cortical Bio-Post™ and Washers are substantially equivalent to the currently marketed predicated no r os cleared for the expanded indications.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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" around the perimeter. Inside the circle is a stylized symbol that resembles three wavy lines or stripes, which is a common element in the department's branding.
Public Health Service
FEB 1 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Sally Foust, RAC Sr. Regulatory Affairs Specialist Arthrex, Inc. 1370 Creekside Boulevard Naples, Florida 34108
K043145 Re:
K049145
Trade/Device Name: Arthrex Bi-Cortical Bio-Post™ and Washers Trade/Dorios rumber: 21 CFR 888.3030, 21 CFR 888.3040 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories, Smooth or threaded metallic bone fixation fastener Regulatory Class: II
Product Code: HTN, HWC Dated: February 7, 2005 Received: February 9, 2005
Dear Ms. Foust:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your Section 9 ro(x) premained in substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosure) to regally attent date of the Medical Device Amendments, or to commerce proof to May 26, 1978, the enaturance with the provisions of the Federal Food. Drug. devices that have been recuired in acceranted who a premarket approval application (PMA). and Cosment Act (Act) that to not require appent of the general controls provisions of the Act. The You may, therefore, market the act include requirements for annual registration, listing of general Controls provisions of the rice 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 If your device is classified (sec above) into exist on regulations affecting your device can
may be subject to such additional controls. Existing major regulations of the co may be subject to such additional controlls. Existing time of the 21, Parts 800 to 898. In addition, FDA may be found in the Code of Peacharing your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA 3 issuation of a backsnice of the requirements of the Act that 117A has made a decemination administered by other Federal agencies. You must or any Federal statures and regulations canamisms, but not limited to: registration and listing (21 comply with an the Act 31equirements, mercaing, entreading, entice requirements as set and CFR Part 807), labeling (21 CFR Part 801), good in and 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 -- Ms. Sally Foust, RAC
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin hanketing your antial equivalence of your device to a legally premarket notheadon: "The PDA miding of basification 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 If you desire specific advice for Jour as 1040) 276-0120. Also, please note the regulation entitled, contact the Office of Comphanes as (= %) = f Ecation" (21CFR Part 807.97) you may obtain.
"Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obt Milsolanding by reference to promasionsibilities under the Act may be obtained from the Other general information on your responsional 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/industry/support/index.html
Sincerely yours,
Mark McMahon
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
4
Indications for Use
510(k) Number (if known): K043145
Device Name: Arthrex Bi-Cortical Bio-Post™ and Washers
Indications for Use:
- The Arthrex Bi-Cortical Bio-Post™ and Washers device is intended as an anchor device for suture or to secure soft tissue directly to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow in the following procedures:
Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Reconstruction, Midfoot Reconstruction.
Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Illiotibial Band Tenodesis.
Hand/Wrist: Scaphaolunate Ligament Reconstruction, Ulnar Collateral Ligament Radial Collateral Ligament Reconstruction.
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction,
- The Arthrex Bi-Cortical Bio-Post™ and Washers device is intended for the maintenance of alignment, reduction, and fixation of fractures, osteotomies or arthrodesis of the upper extremity, ankle and foot.
Fusions/fracture of Phalangeal, Metacarpal, and Carpal Wrist arthrodesis Fractures of Distal radius, Olecranon, Radial head, Humeral condylar, Cancellous Osteotomies Malleolus, Ankle fractures, Metatarsal Correction of hallux valgus
Prescription Use
(Per 21 CFR 801 Subpart D)
AND/OR Over-The-Counter Use
(21 CFR 801 Subpart C)
(Division Sign-Off)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
NEEDED)
Division of General, Restorative,
and Neurological Devices
Concurrence of CDRH, Office of Device Evaluation (ODE)
510(k) Number V043145 Page 1 of 1