(63 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, knee, hand/wrist, elbow, and pelvis.
For suture or tissue fixation in the foot, ankle, hand, wrist, elbow, shoulder, and in select maxillofacial applications where size is appropriate.
Please see indications for use statements for specific indications.
The Arthrex Bio-Composite Corkscrew is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, 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, Mid-foot reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy.
Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction.
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial collateral Ligament Reconstruction, Lateral Epicondylitis Repair.
Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency.
The Arthrex Bio-Composite PushLock™ is intended for fixation of suture (soft tissue) to bone in the shoulder, footlankle, knee, hand/wrist, elbow, and pelvis in 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, 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, Iliotibial Band Tenodesis.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction.
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair.
Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency.
The Arthrex Bio-Composite Tak™ is intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, shoulder, elbow, and in select maxillofacial applications. Specific indications are listed below and are size appropriate per patient needs:
Stabilization and fixation of oral cranio-maxillofacial skeletal bone, Skull: 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. Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Shoulder: Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction. Scapholunate Ligament Reconstruction, Carpal Ligament Hand/Wrist: 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.
Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency.
The Arthrex Bio-Composite Suture Anchors Family is very similar to the predicate devices in diameter, length, and eyelet design. The difference lies in the bio-degradable material used to construct the new model. The implants will use PLLA or PLDLA combined with TCP.
The provided text describes a 510(k) submission for the Arthrex Bio-Composite Suture Anchors. This submission aims to demonstrate substantial equivalence to a previously cleared predicate device (K061863), rather than proving the device meets specific acceptance criteria through a clinical study with performance metrics in the typical sense.
Here's an analysis based on the information provided, addressing your requested sections where applicable:
Acceptance Criteria and Device Performance (as interpreted from a 510(k) context)
For a 510(k) submission, "acceptance criteria" are generally met by demonstrating substantial equivalence to a predicate device. This means showing that the new device is as safe and effective as a legally marketed device. The "device performance" is therefore described in terms of its similarities and any minor differences to the predicate, and how those differences do not raise new questions of safety or effectiveness.
| Acceptance Criterion (for Substantial Equivalence in 510(k)) | Reported Device Performance (Comparison to Predicate K061863) |
|---|---|
| Similar Intended Use | Met: The intended uses are "Identical" as stated in the comparison table. The Arthrex Bio-Composite Suture Anchor Family is intended for "Fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and pelvis." |
| Similar Indications for Use | Largely Met, with a specified exclusion: "Identical except for the exclusion of the hip indications." The Bio-Composite Suture Anchors are not indicated for capsular and acetabular labral repair in the hip. Otherwise, specific indications (e.g., Rotator Cuff Repairs, Achilles Tendon Repair) for shoulder, foot/ankle, knee, hand/wrist, elbow, and pelvis are consistent with the predicate across the different product types (Corkscrew, PushLock, Tak). |
| Similar Technological Characteristics (Design) | Largely Met: "Screw-In, push-In Anchors: Full threaded, cannulated/non-cannulated, partially cannulated, with or without suture eyelet." This is identical to the predicate. |
| Similar Technological Characteristics (Materials) | Difference, but deemed safe: The new device uses "PLLA/TCP or PLDLA/TCP." The predicate uses "PLLA, PLDLA, PEEK, Titanium." The bio-composite materials (PLLA, PLDLA, TCP) used in the new device are stated to have "a long history of implantable use in the medical field and have been shown to be biocompatible" and are currently used in other Arthrex marketed bioabsorbable devices. This difference is considered minor and does not raise new questions of safety or effectiveness. |
| Similar Technological Characteristics (Dimensions) | Minor Differences, but within acceptable range: |
- Diameter: New device: "3-5.5 mm". Predicate: "2.4 - 6.5 mm". The new device falls within the predicate's range, albeit with a narrower overall range.
- Length: New device: "14-14.7 mm". Predicate: "5-18.5 mm". The new device also falls within the predicate's range, with a narrower specific range.
These differences are not presented as raising safety/effectiveness concerns. |
| Similar Performance Characteristics (e.g., Strength, Biocompatibility) | Implied to be met through materials and design comparison: The document states "Any differences between the Bio-Composite Suture Anchor Family and the predicate K061863 are considered minor and do not raise questions concerning safety and effectiveness." This implies that the performance (e.g., mechanical strength, degradation profile, biocompatibility) is considered equivalent despite the material change, likely supported by non-clinical testing or existing data for the composite materials, though specific test results are not detailed in this summary. The mention that the biodegradable materials have a "long history of implantable use" supports the biocompatibility aspect. |
| Similar Sterile, Single Use, Packaging, Shelf Life | Met: All are listed as "Identical" for Packaging, Sterile, and Single Use. Shelf life for PLLA/PLDLA is 2 years for both new and predicate, ensuring equivalence for relevant material types. |
Study Information
The provided document describes a 510(k) Premarket Notification which primarily relies on demonstrating substantial equivalence to a predicate device. It does not present a study (e.g., clinical trial) in the traditional sense with acceptance criteria, sample sizes, experts, or ground truth as would be the case for a novel device or a device requiring a PMA.
Therefore, for most of the requested points, the answer is "Not Applicable" or "Not provided in this 510(k) summary."
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This is a 510(k) substantial equivalence submission, not a study with a test set of patient data. The "test set" here refers to a comparison of the new device's specifications against the predicate device's specifications and existing knowledge/data about the materials.
- 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. There is no "ground truth" established by experts for a test set in this context. The determination of substantial equivalence is made by the FDA reviewer based on the information provided by the manufacturer.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set requiring adjudication in this format.
- 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
- Not Applicable. This is a physical medical device (suture anchors), not an AI/software device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable. The "ground truth" for a 510(k) substantial equivalence is the safety and effectiveness profile of the predicate device, as established by its clearance and general market use, and the scientific/clinical knowledge underpinning the materials and design. The new device is evaluated against this established standard.
- The sample size for the training set
- Not Applicable. There is no "training set" in the context of this 510(k) submission for a physical device.
- How the ground truth for the training set was established
- Not Applicable. No training set.
Summary of the 510(k) Process:
The key to this submission is demonstrating that the Arthrex Bio-Composite Suture Anchors are substantially equivalent to the predicate Arthrex PushLock, Tak, and Corkscrew Suture Anchors (K061863). The manufacturer achieves this by:
- Highlighting identical intended uses.
- Acknowledging minor differences in indications for use (exclusion of hip).
- Acknowledging differences in materials (new bio-composite), but justifying their safety and effectiveness due to their history of use in medical implants and other Arthrex devices.
- Showing similar design and dimensions that fall within the predicate's range or are presented as minor and not impacting safety/effectiveness.
The FDA's letter (Section 4, 5) confirms that based on the submitted information, the device is found substantially equivalent to legally marketed predicate devices. This means the device meets the "acceptance criteria" for demonstrating substantial equivalence for the purpose of market clearance via the 510(k) pathway.
§ 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.