(121 days)
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.
The Arthrex Bio-Composite Suture Anchors Family is identical to the predicate devices.
This document is a 510(k) summary for the Arthrex Bio-Composite Suture Anchors, specifically for the expansion of indications to include the hip. It does not describe a study involving performance criteria for a device that relies on data analysis or AI/ML.
Instead, it is a submission to the FDA demonstrating substantial equivalence of a medical device (suture anchors) to a previously cleared predicate device. Substantial equivalence means the new device is as safe and effective as a legally marketed device. This is typically based on comparing the design, materials, manufacturing, and intended use, rather than a clinical study with acceptance criteria and performance metrics in the way one might expect for a diagnostic or AI-driven device.
Therefore, I cannot provide the requested information for acceptance criteria and a study proving device performance in the context of data analysis or AI/ML, as that kind of information is not present in the provided text.
Here's a breakdown of what is in the document, relating to your request where possible, and highlighting what is absent:
1. A table of acceptance criteria and the reported device performance
- Not Applicable. This document does not describe performance metrics in terms of sensitivity, specificity, accuracy, or similar measures that would be used for a diagnostic device or AI/ML system. The basis for clearance is "substantial equivalence" to a predicate device. This typically involves comparison of materials, design specifications, and intended use rather than numerical performance criteria against a specific benchmark.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. No test set or data provenance in the context of clinical performance evaluation (like for an imaging AI) is mentioned. The submission is based on engineering and material comparisons to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. No ground truth establishment for a test set is discussed. The FDA's review for substantial equivalence primarily relies on the manufacturer's documentation and comparison to the predicate device, not on expert consensus for clinical interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. There is no test set or adjudication method described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This type of study is completely irrelevant to the clearance of a suture anchor. The device is a surgical implant, not a diagnostic tool or an AI-assisted system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. The device is a physical suture anchor, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. No quantifiable ground truth is mentioned in this type of submission for a physical implant. The "ground truth" for substantial equivalence would broadly be a demonstration that the new device shares the same fundamental scientific technology, materials, and intended use as the predicate device, and any differences do not raise new questions of safety or effectiveness.
8. The sample size for the training set
- Not Applicable. No training set for an algorithm is involved.
9. How the ground truth for the training set was established
- Not Applicable. No training set is involved.
Summary of the provided document:
The document is a 510(k) Premarket Notification from Arthrex, Inc. for their Bio-Composite Suture Anchors. The purpose of this submission (K082810) is to expand the indications for use of these anchors to include the hip, in addition to previously cleared indications.
The key information provided is:
- Manufacturer: Arthrex, Inc.
- Trade Name: Arthrex Bio-Composite Suture Anchors (including PushLock, Tak, and Corkscrew)
- Common Name: Suture Anchor
- Predicate Device: Arthrex Bio-Composite Suture Anchors (K071177)
- Basis for Clearance: Substantial Equivalence to the predicate device. The document explicitly states: "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."
- New Indications for Use (Hip): Capsular Repair, acetabular labral repair.
The FDA's letter confirms that the device is substantially equivalent and can be marketed for the stated indications.
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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.
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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 AssociateArthrex, Inc1370 Creekside BoulevardNaples, FL 34108-1945 USATelephone 239/643 5553, ext. 1113Fax 239/598 5508Email nancy hoft@arthrex.com | JAN 2 3 2009 | |
| Trade Name | Arthrex Bio-Composite Suture Anchors Arthrex Bio-CompositePushLock, 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 Descriptionand Intended Use | The Arthrex Bio-Composite Suture Anchors Family is identical to thepredicate devices The Arthrex Bio-Composite Suture Anchor Familyis 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 wheresize is appropriate | ||
| See the Indications for Use statements for specific indications | ||
| SubstantialEquivalence Summary | The Arthrex Bio-Composite Suture Anchor Family is substantiallyequivalent to the predicate Arthrex Bio-Composite Suture AnchorFamily in which the basic features and intended uses are the same Anydifferences between the Bio-Composite Suture Anchor Family and thepredicate K071177 are considered minor and do not raise questionsconcerning safety and effectiveness Based on the information submitted,Arthrex, Inc has determined that the new Bio-Composite Suture AnchorFamily is substantially equivalent to the currently marketed predicatedevice |
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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
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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
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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
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Arthres 5 510(k). Hip Indications for Brocomposite Anchors
3 Indications for Use Form
Indications for Use
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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
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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
§ 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.