(56 days)
No
The document describes surgical implants and their sterilization method, with no mention of AI or ML technology.
Yes.
The device is used to fix tissue and grafts in reconstruction and repair procedures, which are therapeutic interventions.
No
The device is an implantable medical device (screws, anchors, suture taks, and buttons) used for fixation of soft tissue to bone in orthopedic procedures, not for diagnosing conditions.
No
The device description explicitly states it is comprised of metal and polymer implants, which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended uses described are all related to surgical procedures for fixing tissue to bone in various parts of the body (ACL reconstruction, rotator cuff repair, ligament reconstruction, etc.). These are all in vivo procedures, meaning they are performed within a living organism.
- Device Description: The device is described as metal and polymer implants (screws, anchors, suture taks, buttons) used for fixation. This aligns with surgical implants, not devices used to examine specimens in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological specimens (blood, urine, tissue samples, etc.) to provide information about a patient's health status.
IVD devices are specifically designed to be used in vitro for the examination of specimens derived from the human body. The device described here is clearly intended for surgical implantation in vivo.
N/A
Intended Use / Indications for Use
The products found in the original 510(k) K971358 Bio-Interference Screw, will use the following indications for use:
- To provide interference fixation of bone-tendon-bone and soft tissue grafts in ACL reconstruction through arthroscopy or arthrotomy.
The products found in the original 510(k) K011172 Bio-Transfix, will use the following indications for use:
- To provide ACL graft fixation in the femur in orthopedic procedures.
The products found in the original 510(k) Arthrex FASTak Suture Anchor, K971723, K000506 Arthrex Bio-FASTak, K003227 Bio-Corkscrew Suture Anchor, and K003816 Titanium Corkscrew Suture Anchor are intended to fix suture to bone, and depending on size, will use the following indications for use:
- 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
- Medial Collateral Ligament Repair, Lateral Collateral Ligament Knee: Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis
- Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Elbow: Radial Collateral Ligament Reconstruction
- Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
- Bladder Neck suspension for female urinary incontinence due to Pelvis: urethral hyper mobility or intrinsic sphincter deficiency
The products found in the original 510(k) K990340 Arthrex Tissue Tak, are intended for fixation of soft tissue to bone for reattachment of the glenoid labrum or inferior glenohumeral ligament in patients with primary or recurrent anterior dislocation or subluxation of the shoulder in association with adequate post operative immobilization.
The products found in the original 510(k) K050749 Arthrex Tak Family are intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and in select maxillofacial applications and will use the following indications for use:
Skull: Stabilization and fixation of oral cranio-maxillofacial skeletal bone, mandible and maxillofacial bones, Lateral Canthoplasty, Repair of Nasal Vestibular Stenosis, Brow Lift, Temporomandibular Joint (TMJ) reconstruction, soft tissue attachment to the parietal temporal ridge, frontal, zygoma, and perioorbital bones of the skull
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Hand/Wrist: Scapholunate Ligament Reconstruction. Carpal Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
The products found in the original 510(k), K051726 are intended to provide soft tissue reattachment, i.e. fixation of ligament and tendon graft tissue in surgeries of the shoulder, elbow, knee, foot/ankle, and hand/wrist. This product is intended for the following indications:
- Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Shoulder. Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
- Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair. Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle
- Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament 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, MBI, MAI
Device Description
The Arthrex metal and polymer implants are manufactured from titanium alloy conforming to ASTM F136, and medical grade polymers (PLLA and PLDLA). These implant families are made up of previous cleared devices. The screws, anchors, suture taks, and buttons are threaded or smooth, fully cannulated, partially cannulated, or non-cannulated, and offered with or without suture. Most of these implants are offered for sale with specific instruments and accessories.
The Arthrex implants described above will now be sold sterile by VHP or Vaporized Hydrogen Peroxide. This method of sterilization does not compromise the integrity of the materials used in the construction of the Arthrex implants. The method of VHP sterilization has been validated to an SAL 10°.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ACL, femur, bone, Shoulder (Rotator Cuff, Bankart, SLAP Lesion, Biceps Tenodesis, Acromio-Clavicular Separation, Deltoid, Capsular Shift or Capsulolabral), Foot/Ankle (Lateral Stabilization, Medial Stabilization, Achilles Tendon, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament, Flexor Hallucis Longus), Knee (Medial Collateral Ligament, Lateral Collateral Ligament, Patellar Tendon, Posterior Oblique Ligament, Iliotibial Band, Anterior Cruciate Ligament), Elbow (Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament), Hand/Wrist (Scapholunate Ligament, Ulnar Collateral Ligament, Radial Collateral Ligament, Carpal Ligament, Flexor and Extensor Tendons at PIP, DIP and MCP joints, Carpometacarpal joint), Pelvis (Bladder Neck), glenoid labrum, inferior glenohumeral ligament, Skull (oral cranio-maxillofacial skeletal bone, mandible and maxillofacial bones, Lateral Canthoplasty, Nasal Vestibular Stenosis, Brow Lift, Temporomandibular Joint (TMJ), parietal temporal ridge, frontal, zygoma, and perioorbital bones).
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
Non-Clinical Testing: The following verification activities were performed on the implants which are the subject of this submission; Pull testing, shelf life, sterilization validation and microbiological testing.
Key Metrics
Not Found
Predicate Device(s)
K971358, K011172, K971723, K000506, K003227, K003816, K990340, K050749, K051726
Reference Device(s)
Smith & Nephew hip (K012787), shoulder (K012788), and knee (K012778)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K053338 pge41
JAN 26 2006
510(k) Summary
| Company: | Arthrex, Inc.
1370 Creekside Blvd., Naples, FL 34108-194 |
|------------|-------------------------------------------------------------|
| Telephone: | (239) 643-5553 |
| Facsimile: | (239) 598-5508 |
| Contact: | Ann Waterhouse |
Arthrex Titanium and Bio-Degradable (polymer) Implants Trade Name: Classification Name:Fastener, Fixation, non-degradable and degradable Regulation Number: 21 CFR 888.3040 and 888.3030
Device Description:
The Arthrex metal and polymer implants are manufactured from titanium alloy conforming to ASTM F136, and medical grade polymers (PLLA and PLDLA). These implant families are made up of previous cleared devices. The screws, anchors, suture taks, and buttons are threaded or smooth, fully cannulated, partially cannulated, or non-cannulated, and offered with or without suture. Most of these implants are offered for sale with specific instruments and accessories.
The Arthrex implants described above will now be sold sterile by VHP or Vaporized Hydrogen Peroxide. This method of sterilization does not compromise the integrity of the materials used in the construction of the Arthrex implants. The method of VHP sterilization has been validated to an SAL 10°
Indications for Use:
Please reference the indications for use pages.
Summary of Technologies:
The devices technological characteristics (materials, design, size ranges, and indications) are identical to those of the previously cleared products, and use similar or identical materials and packaging as that of the predicate devices.
Non-Clinical Testing:
The following verification activities were performed on the implants which are the subject of this submission; Pull testing, shelf life, sterilization validation and microbiological testing,
Substantially Equivalent Devices:
Arthrex is claiming substantial equivalence to sterilization processing of a competitor's products; Smith & Nephew hip (K012787), shoulder (K012788), and knee (K012778).
1
Image /page/1/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or bird in flight, with three curved lines representing the wings and a wavy line representing the body.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 6 2006
Ms. Ann Waterhouse Project Manager, Regulatory Affairs Arthrex, Inc. 1370 Creekside Blvd. Naples, Florida 34108-1945
K053338 Re:
Trade/Device Name: Arthrex Titanium and Bio-degradable (Polymer) Implants Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, MBI, MAI Dated: November 30, 2005 Received: December 1, 2005
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 mcan 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
2
Page 2 - Ms. Ann Waterhouse
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 (301) 594-4639. 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 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 vours,
్ట్స్
2
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): K0533338
Device Name: Arthrex Bio-Interference Screw
Indications for Use:
The products found in the original 510(k) K971358 Bio-Interference Screw, will use the following indications for use:
- To provide interference fixation of bone-tendon-bone and soft tissue grafts ● in ACL reconstruction through arthroscopy or arthrotomy.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1_ of 6
signature
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number
4
510(k) Number (if known): K053338
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The products found in the original 510(k) K011172 Bio-Transfix, will use the following indications for use:
. To provide ACL graft fixation in the femur in orthopedic procedures.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 2_ of _6
25
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number (Co s 3338
5
510(k) Number (if known): K053338
Device Name: __Arthrex_Bio-FASTak and FASTak, Bio-Corkscrew and Titanium Corkscrew Suture Anchor
Indications for Use:
The products found in the original 510(k) Arthrex FASTak Suture Anchor, K971723, K000506 Arthrex Bio-FASTak, K003227 Bio-Corkscrew Suture Anchor, and K003816 Titanium Corkscrew Suture Anchor are intended to fix suture to bone, and depending on size, will use the following indications for use:
- 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
- Medial Collateral Ligament Repair, Lateral Collateral Ligament Knee: Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis
- Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Elbow: Radial Collateral Ligament Reconstruction
- Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
- Bladder Neck suspension for female urinary incontinence due to Pelvis: urethral hyper mobility or intrinsic sphincter deficiency
Prescription Use Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of C
Consurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page _3 of _6
1053338 510(k) Number
6
510(k) Number (if known): K053338
Device Name: _ Arthrex Tissue Tak Anchors
Indications for Use:
The products found in the original 510(k) K990340 Arthrex Tissue Tak, are intended for fixation of soft tissue to bone for reattachment of the glenoid labrum or inferior glenohumeral ligament in patients with primary or recurrent anterior dislocation or subluxation of the shoulder in association with adequate post operative immobilization.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page _ 4 of _ 6
Z
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number Kos 3338
7
510(k) Number (if known):
Device Name: Arthrex Tak Family
Indications for Use:
The products found in the original 510(k) K050749 Arthrex Tak Family are intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and in select maxillofacial applications and will use the following indications for use:
Skull: Stabilization and fixation of oral cranio-maxillofacial skeletal bone, mandible and maxillofacial bones, Lateral Canthoplasty, Repair of Nasal Vestibular Stenosis, Brow Lift, Temporomandibular Joint (TMJ) reconstruction, soft tissue attachment to the parietal temporal ridge, frontal, zygoma, and perioorbital bones of the skull
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Hand/Wrist: Scapholunate Ligament Reconstruction. Carpal Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative. and Neurological Devices
Page 5_ of 6
510(k) Number Kos 3333
8
510(k) Number (if known): _ K053338
Device Name: Arthrex Tenodesis Family
Indications for Use:
The products found in the original 510(k), K051726 are intended to provide soft tissue reattachment, i.e. fixation of ligament and tendon graft tissue in surgeries of the shoulder, elbow, knee, foot/ankle, and hand/wrist. This product is intended for the following indications:
- Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Shoulder. Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
- Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair. Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle
- Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament 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
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEFDED)
(Division Sign-Off) Concurrence of CDRH, Office of Device Evaluation (ODE) Division of General, Restorative, Page 6 of 6 and Neurological Devices
510(k) Number K053338