(97 days)
Not Found
No
The device description and intended use are for mechanical fixation screws, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is used for fixation of tissue (ligaments, tendons, and bone) to bone, which implies it directly treats injuries or conditions.
No
The description states that the device is an "Interference Screw" used for "fixation of tissue including ligament or tendon to bone and bone tendon bone," indicating it is a surgical implant, not a diagnostic tool.
No
The device description explicitly states that the device is "Arthrex Interference Screws" made of "PEEK, Titanium, or Bioabsorbable Polymer," which are physical materials used for surgical fixation. This indicates a hardware device, not software.
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 being used for the fixation of tissue (ligament, tendon, bone) during surgical procedures. This is a direct surgical intervention on the patient's body.
- Device Description: The description reinforces the surgical application of the screws for fixation.
- 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) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used outside the body to analyze biological samples. This device is used inside the body during surgery.
N/A
Intended Use / Indications for Use
The Arthrex Interference Screws are intended to be used for fixation of tissue including ligament or tendon to bone and bone tendon bone. Interference fixation with PEEK, Titanium, or Bioabsorbable Polymer Interference Screws is appropriate for surgeries of the knee, shoulder, elbow, ankle, foot, and hand/wrist where the sizes offered are patient appropriate. Specifically;
- Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Shoulder: Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
- Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Foot/Ankle: Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle
- Anterior Cruciate Ligament Repair, Medial Collateral Ligament Knee: Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis
- Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
- Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, tendon transfer in the hand/ wrist
Product codes
HWC, MAI, MBI
Device Description
The Arthrex Interference Screws are intended to be used for fixation of tissue including ligament or tendon to bone and bone tendon bone. Interference fixation with PEEK, Titanium, or Bioabsorbable Polymer Interference Screws is appropriate for surgeries of the knee, shoulder, elbow, ankle, foot, and hand/wrist where the sizes offered are patient appropriate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee, shoulder, elbow, ankle, foot, and hand/wrist
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)
Arthrex Interference Screw, K052607
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
NOV 2 9 2006
VIII. 510(k) Summary of Safety and Effectiveness
Arthrex Interference Screw
| Manufacturer / Sponsor | Arthrex, Inc.
1370 Creekside Boulevard
Naples, Florida 34108-1945 |
|------------------------|-------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Ann Waterhouse, RAC
Regulatory Affairs Project Manager
Telephone: (239) 643-5553 ext. 1179
FAX: (239) 598-5508 |
| Trade Name: | Arthrex Interference Screw |
| Common Name: | Fastener, Fixation, bone, degradable and
nondegradable |
| Product Code / | HWC, 21 CFR 888.3040
MAI, 21 CFR 888.3030
MBI, 21 CFR 888.3040 |
| Classification Name: | Fixation, Fastener, bone |
| Predicate Device: | Arthrex Interference Screw, K052607 |
Device Description and Intended Use:
The Arthrex Interference Screws are intended to be used for fixation of tissue including ligament or tendon to bone and bone tendon bone. Interference fixation with PEEK, Titanium, or Bioabsorbable Polymer Interference Screws is appropriate for surgeries of the knee, shoulder, elbow, ankle, foot, and hand/wrist where the sizes offered are patient appropriate. Specifically;
- Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Shoulder: Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
- Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Foot/Ankle: Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle
1
- Anterior Cruciate Ligament Repair, Medial Collateral Ligament Knee: Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis
- Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
- Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, tendon transfer in the hand/ wrist
Substantial Equivalence:
The Arthrex Interference Screw is substantially equivalent to the predicate Arthrex Interference Screw in which the basic features and intended uses are the Any differences between the Arthrex Interference Screw and the same. predicate are considered minor and do not raise questions concerning safety and effectiveness. Based on the information submitted, Arthrex, Inc. has determined that the PEEK, PLLA, and Titanium Interference Screw are substantially equivalent to the currently marketed predicate device.
2
Image /page/2/Picture/12 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or other bird-like figure.
NOV 2 9 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Arthrex, Inc. % Ann Waterhouse, RAC Project Manager, Regulatory Affairs 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K062466
Trade/Device Name: Interference Screws Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Codes: MAI, MBI, HWC Dated: November 6, 2006 Received: November 8, 2006
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 may 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
3
Page 2 - Ann Waterhouse, RAC
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) 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 (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Вашава Внешир
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Form ==============================================================================================================================================================================
KOG 2466 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Arthrex Interference Screw
Indications for Use:
The Arthrex Interference Screws are intended to be used for fixation of tissue including ligament or tendon to bone and bone tendon bone. Interference fixation with PEEK, Titanium, or Bioabsorbable Polymer Interference Screws is appropriate for surgeries of the knee, shoulder, elbow, ankle, foot, and hand/wrist where the sizes offered are patient appropriate. Specifically;
- Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Shoulder. Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
- Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Foot/Ankle: Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle
- Anterior Cruciate Ligament Repair, Medial Collateral Ligament Knee: Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis
- Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Elbow: Reconstruction
- Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Radial Collateral Ligament Reconstruction, Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, tendon transfer in the hand/ wrist
AND/OR Over-The-Counter Use Prescription Use X (21 CFR 801 Subpart C) (Per 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
============================================================================================================================================================================== Concurrence of CDRH, Office of Device Evaluation (Open vision
Division of General, Restoracya. and Neurological Devices
510(k) Number /