(111 days)
The Arthrex Corkscrew Family of Suture Anchors has been previously cleared in 510(k) K003817, K003227, K043337, and K050358. These suture anchors are intended for fixation of suture(soft tissue) to bone in the shoulder, foot/ankle, hip, knee, hand/wrist, elbow, and pelvis in, but not limited to, 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, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament /Tendon Repair, Bunionectomy . .
Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Iliotibial Band Tenodesis.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar 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 of intrinsic sphincter deficiency.
Hip: Capsular repair, acetabular labral repair.
The Arthrex PushLock™, previously cleared under 510(k) K051219, 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:
Rotator Cuff Repair, 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, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar 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 Tak™ Family, previously cleared under 510(k)s K971723, K000506, and K050749, is intended to be used for suture or tissue fixation in the foot, ankle, knee, hip, hand, wrist, elbow, shoulder, 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 Joint (TMJ) reconstruction. soft tissue 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 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, Illiotibial Band Tenodesis
Bladder Neck Suspension for female urinary incontinence due to Pelvis: urethral hypermobility or intrinsic sphincter deficiency.
Hip: Capsular repair, acetabular labral repair.
The Arthrex Families which are part of this expanded indications submission are as follows: Arthrex Bio-Corkscrew and Corkscrew Arthrex Bio-Corkscrew FT and Corkscrew FT Arthrex PushLock Arthrex Tak Family
These implants are comprised of titanium alloy, poly (L-lactide) or PLLA, poly (Llactide-Co-D, L-lactide) or PLDLA, and Polyaryletherketone or (PEEK). They are offered in several different shapes and sizes. They are offered sterile.
This 510(k) premarket notification is for an expanded indication for the Arthrex PushLock, Tak, and Corkscrew products. Therefore, the information provided focuses on demonstrating substantial equivalence to predicate devices for the new indications rather than establishing new acceptance criteria and conducting studies against them.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
There is no table of acceptance criteria or reported device performance for the Arthrex PushLock, Tak, and Corkscrew products in the provided 510(k) summary (K061863). This submission is for an expanded indication for already cleared devices. The acceptance criteria for these devices would have been established during their original 510(k) clearances (K003817, K003227, K043337, K050358 for Corkscrew; K051219 for PushLock; K971723, K000506, K050749 for Tak Family).
The current submission hinges on demonstrating substantial equivalence to existing predicate devices for the new indications of hip capsular repair and acetabular labral repair. The performance criteria for these new indications are implicitly met by showing equivalence to the predicate devices, which are already deemed safe and effective for similar uses.
The predicate device for the hip labral repair indication is identified as K053344, Smith & Nephew BioRaptor 2.9 mm and TwinFix Ti 2.8 & 3.5 mm implants. The performance of the Arthrex devices for these new indications would be considered acceptable if they are deemed substantially equivalent to the Smith & Nephew devices.
2. Sample Size Used for the Test Set and Data Provenance:
The provided document does not mention any sample sizes used for a test set or data provenance because this is a 510(k) submission for new indications based on substantial equivalence to predicate devices, not a de novo submission requiring extensive new clinical trial data. Instead, the focus is on comparing the characteristics of the Arthrex devices to the predicate devices, particularly for the new hip indications. This typically involves:
- Dimensional comparisons: Ensuring the sizes and designs are comparable.
- Material comparisons: Confirming the materials (titanium alloy, PLLA, PLDLA, PEEK) are acceptable and similar to the predicate.
- Mechanical testing data (if any was submitted): To demonstrate comparable strength, pull-out strength, or other relevant biomechanical properties for the intended use, although the document does not explicitly detail such testing for this particular submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. As this is a substantial equivalence submission, there is no "test set" in the context of clinical studies requiring expert ground truth establishment for performance evaluation. The "ground truth" for the predicate devices' safety and effectiveness has already been established through their prior clearances and clinical use.
4. Adjudication Method for the Test Set:
Not applicable. No test set requiring adjudication is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is not a study involving human readers or AI assistance. It's a regulatory submission for expanded indications of medical devices based on substantial equivalence.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:
Not applicable. This is not a study of an algorithm or AI.
7. Type of Ground Truth Used:
The "ground truth" for this submission is the established safety and effectiveness of the predicate devices (Smith & Nephew BioRaptor and TwinFix Ti implants for hip labral repair), as determined by their previous 510(k) clearances and accepted clinical performance. The Arthrex devices are being presented as having sufficiently similar characteristics and intended use to the predicates for the new indications.
8. Sample Size for the Training Set:
Not applicable. This is not an AI/ML device, so there is no training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As there is no training set.
In summary, the provided document K061863 is a 510(k) premarket notification seeking clearance for expanded indications for existing Arthrex medical devices (suture anchors). It operates on the principle of "substantial equivalence" to predicate devices already on the market. Therefore, it does not involve the type of acceptance criteria, clinical studies, or data provenance usually associated with proving performance for novel devices or AI algorithms. The "proof" is the detailed comparison of the new indications' intended use and the device characteristics to those of the legally marketed predicate devices.
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K 061863 page 141
510(k) Summary
OCT 1 9 2006
| 510(k) Number: | |
|---|---|
| Company: | Arthrex, Inc. |
| Address: | 1370 Creekside Blvd., Naples, FL 34108-1945 |
| Telephone: | (239) 643-5553 |
| Facsimile: | (239) 598-5508 |
| Contact: | Ann Waterhouse, RAC |
| Device Name: | Arthrex PushLock, Tak, and Corkscrew products |
| Classification: | Screw, Fixation, Bone, degradable and non-degradable |
| Product Code: | HWC (21 CFR 888.3040) |
| MBI (21 CFR 888.3040) | |
| MAI (21 CFR 888.3030) |
Description:
The Arthrex Families which are part of this expanded indications submission are as follows: Arthrex Bio-Corkscrew and Corkscrew Arthrex Bio-Corkscrew FT and Corkscrew FT Arthrex PushLock Arthrex Tak Family
These implants are comprised of titanium alloy, poly (L-lactide) or PLLA, poly (Llactide-Co-D, L-lactide) or PLDLA, and Polyaryletherketone or (PEEK). They are offered in several different shapes and sizes. They are offered sterile.
Predicate Devices;
The indication of hip labral repair is substantially equivalent to K053344, Smith & Nephew BioRaptor 2.9 mm and TwinFix Ti 2.8 & 3.5 mm implants.
Indications for Use:
Please see individual indications for use statements, additional indications include Capsular repair and Acetabular labral repair.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 9 2006
Arthrex, Inc. % Ann Waterhouse, RAC Regulatory Affairs Project Manager 1370 Creekside Boulevard Naples, Florida 34108
Re: K061863
Trade/Device Name: Arthrex Corkscrew, Corkscrew FT, Bio-Corkscrew, and Bio Corkscrew FT Suture Anchor(s) Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, MBI, JDR, MAI Dated: September 6, 2006 Received: September 7, 2006
Dear Ms. Waterhouse:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrobars) to regists the Medical Device Amendments, or to eonimores that have been reclassified in accordance with the provisions of the Federal Food, Drug, do noos that have been that do not require approval of a premarket approval application (PMA). and Cosmeter For (110) that be nevice, subject to the general controls provisions of the Act. The r ou may) arones provisions of the Act include requirements for annual registration, listing of general controls provision 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 or anv Federal statutes and regulations administered by other Federal agencies. You must or any i with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 301); good manufacturing practice requirements as set Orth 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 - Ann Waterhouse, RAC
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" (21 CFR 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/cdrb/industry/support/index.html.
Sincerely yours,
R.A. Riffon
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) Number (if known):
Device Name: Arthrex Corkscrew, Corkscrew FT, Bio-Corkscrew, and Bio-Corkscrew FT Suture Anchor(s)
Indications for Use:
The Arthrex Corkscrew Family of Suture Anchors has been previously cleared in 510(k) K003817, K003227, K043337, and K050358. These suture anchors are intended for fixation of suture(soft tissue) to bone in the shoulder, foot/ankle, hip, knee, hand/wrist, elbow, and pelvis in, but not limited to, 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, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament /Tendon Repair, Bunionectomy . .
Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Iliotibial Band Tenodesis.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar 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 of intrinsic sphincter deficiency.
Hip: Capsular repair, acetabular labral repair.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) | |
| AND/OR | |
| Over-The-Counter Use | No |
| (21 CFR 807 Subpart C) |
Concurrence of CDRH, Office of Device Evaluation (ODE)
page 1 of ____________________________________________________________________________________________________________________________________________________________________
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510(k) Number (if known):
Device Name: Arthrex PushLock™
Indications for Use:
The Arthrex PushLock™, previously cleared under 510(k) K051219, 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:
Rotator Cuff Repair, 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, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
3 page 2 of
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K061663
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510(k) Number (if known):
Device Name: Arthrex Tak Family
Indications for Use: The Arthrex Tak™ Family, previously cleared under 510(k)s K971723, K000506, and K050749, is intended to be used for suture or tissue fixation in the foot, ankle, knee, hip, hand, wrist, elbow, shoulder, 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 Joint (TMJ) reconstruction. soft tissue 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 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, Illiotibial Band Tenodesis
Bladder Neck Suspension for female urinary incontinence due to Pelvis: urethral hypermobility or intrinsic sphincter deficiency.
Hip: Capsular repair, acetabular labral repair.
(PLEASE DO NOT WRITE BELOW THIS LINE—CONTINUE ON ANOTHER PAGE IF NEEDED)
Prescription Use x AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 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.