(121 days)
Not Found
No
The summary describes a suture anchor family, a mechanical device for tissue fixation to bone. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The device is stated to be identical to the predicate device, which is also a suture anchor.
No.
The device is used for fixation of soft tissue to bone, which is a structural or supportive function, not a therapeutic treatment of a disease or condition.
No
Explanation: The device is a suture anchor used for fixation of soft tissue to bone, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a "Suture Anchor Family," which are physical implants used for fixation. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description: The description clearly states the device is a "Suture Anchor Family" intended for "Fixation of suture (soft tissue) to bone". This is a surgical implant used within the body to attach soft tissue to bone.
- Intended Use: The intended use describes a surgical procedure, not a diagnostic test performed on a sample.
- Anatomical Site: The anatomical sites listed are locations within the body where the device is implanted.
This device is a surgical implant, not a diagnostic device.
N/A
Intended Use / Indications for Use
The Arthrex Bio-Composite Suture Anchors Family is identical to the predicate devices The Arthrex Bio-Composite Suture Anchor Family is intended to be used for Fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, hip, knee, hand/wrist, elbow, and pelvis for suture or tissue fixation in the foot, ankle, hip, hand, wrist, elbow, shoulder, and in select maxillofacial applications where size is appropriate.
The Arthrex Bio-Composite PushLock™ is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, hip, and pelvis in the following procedures: Shoulder: Rotator Cuff Repars, Bankart Repar, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction. Foot/Ankler Lateral Stabilization, Medial Stabulization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bumonectomy Medial Collateral Ligament Repair, Lateral Collateral Ligament Repar, Knee: Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illotibial Band Tenodesis Hand/Wrist Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction. Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Elbow. Collateral Ligament Reconstruction, Lateral Epicondylitis Repair Pelvis Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency Hip Capsular Repair, acetabular labral repair
The Arthrex BIO-Composite Corkscrew is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, hip, knee, hand/wrist, elbow, and pelvis in, but not lumited to, the following procedures: Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesson Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repar, Hallux Valgus Reconstruction, Mid-foot reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Knee: Lateral Collateral Ligament Repair. Patellar Tendon Repair. Posternor Oblique Ligament Repair, Iliotibial Band Tenodesis Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Hand/Wrist Reconstruction, Radial Collateral Ligament Reconstruction. Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Elbow: collateral Ligament Reconstruction, Lateral Epicondylitis Repair Bladder Neck Suspension for female unmary incontinence due to urethral Petvis: hypermobility or intrinsic sphincter deficiency Hip: Capsular Repair, acetabular labral repair
The Arthrex B10-Composite Takma is intended to be used for suture or tissue fixation in the foot, ankle, knee, hip, hand, wrist, shoulder, elbow, and in select maxillofacial applications. Specific indications are listed below and are size appropriate per patient needs: Skull: Stabilization and fixation of oral cranio-maxillofacial skeletal bone, mandible and maxillofacial bones, Lateral Canthoplasty, Repair of Nasal Vestibular Stenosis, Brow Lift, Temporomandibular Jount (TMJ) reconstruction, Soft tussue attachment to the parietal temporal ridge, frontal, zygoma, and perioorbital bones of the skull. Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Elbow: Reconstruction. Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction. Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Hand/Wrist. 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 Repar, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-foot reconstruction. Medial Collateral Ligament Repair, Lateral Collateral Ligament Repar, Knee: Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis Bladder Neck Suspension for female urmary incontinence due to urethral Petvis: hypermobility or intrinsic sphincter deficiency Hyp: Capsular Repair, acetabular labral repair.
Product codes
HWC, MBI, JDR, MAI
Device Description
The Arthrex Bio-Composite Suture Anchors Family is identical to the predicate devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, foot/ankle, hip, knee, hand/wrist, elbow, pelvis, skull, oral cranio-maxillofacial skeletal bone, mandible and maxillofacial 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
KOPZSIO
Image /page/0/Picture/1 description: The image shows a logo with the word "Arthrex" in a stylized font. To the right of the logo, there is the text "510(k) Hbp II". The text is smaller than the logo and is in a simple font.
7
ﺎ
Arthress 510(k) Hip Indications for Biocomposite Anchars
4 510(k) Summary of Safety and Effectiveness
| Manufacturer/Sponsor | Arthrex, Inc | |
|---|---|---|
| 1370 Creekside Boulevard | ||
| Naples, FL 34108-1945 USA | ||
| 510(k) Contact | Nancy Hoft | |
| Regulatory Affairs Associate | ||
| Arthrex, Inc | ||
| 1370 Creekside Boulevard | ||
| Naples, FL 34108-1945 USA | ||
| Telephone 239/643 5553, ext. 1113 | ||
| Fax 239/598 5508 | ||
| Email nancy hoft@arthrex.com | JAN 2 3 2009 | |
| Trade Name | Arthrex Bio-Composite Suture Anchors Arthrex Bio-Composite | |
| PushLock, Bio-Composite Tak and Bio-Composite Corkscrew | ||
| Common Name | Suture Anchor | |
| Product Code - | HWC -Screw, Fixation, Bone | |
| Classification Name | MBI - Fastener, Fixation, Nondegradable Soft Tissue | |
| JDR - Staple, fixation, bone | ||
| MAI - Fastener, Fixation, Biodegradable, Soft Tissue | ||
| Predicate Device | Arthrex Bio-Composite Suture Anchors K071177 | |
| Device Description | ||
| and Intended Use | The Arthrex Bio-Composite Suture Anchors Family is identical to the | |
| predicate devices The Arthrex Bio-Composite Suture Anchor Family | ||
| is intended to be used for | ||
| Fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, | ||
| hip, knee, hand/wrist, elbow, and pelvis | ||
| For suture or tissue fixation in the foot, ankle, hip, hand, wrist, | ||
| elbow, shoulder, and in select maxillofacial applications where | ||
| size is appropriate | ||
| See the Indications for Use statements for specific indications | ||
| Substantial | ||
| Equivalence Summary | The Arthrex Bio-Composite Suture Anchor Family is substantially | |
| equivalent to the predicate Arthrex Bio-Composite Suture Anchor | ||
| Family in which the basic features and intended uses are the same Any | ||
| differences between the Bio-Composite Suture Anchor Family and the | ||
| predicate K071177 are considered minor and do not raise questions | ||
| concerning safety and effectiveness Based on the information submitted, | ||
| Arthrex, Inc has determined that the new Bio-Composite Suture Anchor | ||
| Family is substantially equivalent to the currently marketed predicate | ||
| device |
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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight. The logo is rendered in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Arthrex Inc % Ms Nancy Hoft Regulatory Affairs Associate 1370 Creekside Boulevard Naples, Florida 34108
JAN 2 3 2009
Re K082810
Trade/Device Name Bro-Composite Suture Anchors, Expansion of Indications to include Hip Regulation Number 21 CFR 888 3040 Regulation Name Smooth or threaded metallic bone fixation fastener Regulatory Class II Product Code MAI, HWC Dated January 20, 2009 Received January 21, 2009
Dear Ms Hoft
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 etther 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 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
2
Page 2 - Ms Nancy Hoft
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807 97) For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Brometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474 For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464 You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http //www fda gov/cdrh/industry/support/index html
Sincerely yours,
Mark N. Millican
Mark N Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Hip Indications for Blocomposite Anchars
Indications for Use
K082810 510(k) Number Arthrex Bio-Composite PushLock™ Device Name.
The Arthrex Blo-Composite PushLock™ is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, hip, and pelvis in the following procedures
- Shoulder: Rotator Cuff Repars, Bankart Repar, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.
- Foot/Ankler Lateral Stabilization, Medial Stabulization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bumonectomy
- Medial Collateral Ligament Repair, Lateral Collateral Ligament Repar, Knee: Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illotibial Band Tenodesis
- Hand/Wrist Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction.
- Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Elbow. Collateral Ligament Reconstruction, Lateral Epicondylitis Repair
- Pelvis Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency
- Capsular Repair, acetabular labral repair Hup
Prescription Use X AND/OR Over-The-Counter Use __
(Per 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
PAGE 2 of 3
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number L082146
4
Arthres 5 510(k). Hip Indications for Brocomposite Anchors
3 Indications for Use Form
Indications for Use
1 2 5 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4
Image /page/4/Figure/3 description: The image shows the 510(k) number and device name for a medical device. The 510(k) number is K082810. The device name is Arthrex Bio-Composite Corkscrew.
The Arthrex BIO-Composite Corkscrew is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, hip, knee, hand/wrist, elbow, and pelvis in, but not lumited to, the following procedures
Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesson Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repar, Hallux Valgus Reconstruction, Mid-foot reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy
Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Knee: Lateral Collateral Ligament Repair. Patellar Tendon Repair. Posternor Oblique Ligament Repair, Iliotibial Band Tenodesis
- Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Hand/Wrist Reconstruction, Radial Collateral Ligament Reconstruction.
- Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Elbow: collateral Ligament Reconstruction, Lateral Epicondylitis Repair
- Bladder Neck Suspension for female unmary incontinence due to urethral Petvis: hypermobility or intrinsic sphincter deficiency
Hip: Capsular Repair, acetabular labral repair
Prescription Use X AND/OR Over-The-Counter Use
(Per 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
PAGE 1 of 3
5
Arthrest 510(k) Hip Indications for Blocamposite Anchars
Indications for Use
| 510(k) Number | K082810 |
|---|---|
| Device Name: | Arthrex Bio-Composite Tak |
The Arthrex B10-Composite Takma is intended to be used for suture or tissue fixation in the foot, ankle, knee, hip, hand, wrist, shoulder, elbow, and in select maxillofacial applications Specific indications are listed below and are size appropriate per patient needs
- Skull: Stabilization and fixation of oral cranio-maxillofacial skeletal bone, mandible and maxillofacial bones, Lateral Canthoplasty, Repair of Nasal Vestibular Stenosis, Brow Lift, Temporomandibular Jount (TMJ) reconstruction, Soft tussue attachment to the parietal temporal ridge, frontal, zygoma, and perioorbital bones of the skull. Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Elbow: Reconstruction. Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction. Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Hand/Wrist. 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 Repar, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-foot reconstruction. Medial Collateral Ligament Repair, Lateral Collateral Ligament Repar, Knee: Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis Bladder Neck Suspension for female urmary incontinence due to urethral Petvis: hypermobility or intrinsic sphincter deficiency Hyp: Capsular Repair, acetabular labral repair Prescription Use X AND/OR Over-The-Counter Use (Per 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
PAGE 3 of 3