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

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°.

AI/ML Overview

The provided 510(k) summary (K053338) for Arthrex Titanium and Bio-Degradable (polymer) Implants does not contain details directly related to acceptance criteria and performance of an AI/ML powered device, nor does it describe a study like those typically conducted for such devices (e.g., comparative effectiveness, standalone performance).

Instead, this submission focuses on demonstrating substantial equivalence to predicate devices for sterilization processing of existing implants. The "device" in this context is the physical implants themselves, and the "study" described is verification testing related to the change in sterilization method.

Therefore, many of the requested categories for AI/ML device studies are not applicable to this 510(k) submission. Below, I will address the relevant information from the provided document and explicitly state where information is not available or not applicable.

Acceptance Criteria and Device Performance (for sterilization method)

Acceptance Criteria	Reported Device Performance
Sterility Assurance Level (SAL) 10⁻⁶ achieved	The method of VHP sterilization has been validated to an SAL 10⁻⁶
Sterilization does not compromise integrity of materials	"This method of sterilization does not compromise the integrity of the materials used in the construction of the Arthrex implants."
Continued satisfactory performance of implants after VHP sterilization	Non-Clinical Testing: Pull testing, shelf life, and microbiological testing were performed on the implants (implies satisfactory performance after sterilization).

Study Details (for sterilization method as described in the 510(k))

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the provided document.
- Data Provenance: Not explicitly stated. The testing activities (Pull testing, shelf life, sterilization validation, microbiological testing) would have been conducted by Arthrex, Inc. or a contracted lab. The document does not specify country of origin for the data or if it was retrospective or prospective, though sterilization validation is inherently prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For a sterilization validation and material integrity assessment, "ground truth" is typically established through standardized physical, chemical, and microbiological testing protocols rather than expert consensus on interpretation. The qualification of individuals conducting these tests would be in areas like microbiology, materials science, and engineering, but specific numbers and qualifications are not provided.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used for human interpretation of medical images or data where there might be disagreement. For sterilization validation and non-clinical material testing, the results are typically quantitative and objective, following predefined pass/fail criteria.
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 type of study is specifically for AI/ML devices involving human readers and interpretation. The current submission is for physical implants with a new sterilization method.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an AI/ML algorithm. The "device performance" refers to the physical implants and the effectiveness of their sterilization.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For sterilization validation: The ground truth is objective, typically defined by established standards for sterility (e.g., SAL 10⁻⁶) and material integrity (e.g., meeting predefined physical and chemical specifications post-sterilization).
- For non-clinical testing (pull testing, shelf life, microbiological testing): Ground truth is based on quantitative measurements against pre-established specifications and industry standards (e.g., ASTM F136 for titanium alloy).
The sample size for the training set:
- Not Applicable. This submission does not involve an AI/ML model that requires a training set.
How the ground truth for the training set was established:
- Not Applicable. No training set for an AI/ML model is involved.

Summary of the K053338 Submission:

The K053338 submission is concerned with a change in the sterilization method (from previous methods to Vaporized Hydrogen Peroxide - VHP) for existing Arthrex titanium and bio-degradable implants. The acceptance criteria and "study" are focused on demonstrating that this new sterilization method renders the devices sterile to an acceptable level (SAL 10⁻⁶) and does not negatively impact the material integrity or performance of the implants.

The submission claims substantial equivalence to predicate devices (Smith & Nephew products) that also utilize VHP sterilization for their implants, further supporting the safety and effectiveness of the proposed sterilization method for these types of materials. The non-clinical testing performed includes pull testing, shelf life testing, sterilization validation, and microbiological testing to verify these aspects.

Summary

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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 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).

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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 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

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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

Mark N. Melkerson Acting 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): 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

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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

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number (Co s 3338

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510(k) Number (if known): K053338

Device Name: __Arthrex_Bio-FASTak and FASTak, Bio-Corkscrew and Titanium Corkscrew Suture Anchor

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

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510(k) Number (if known): K053338

Device Name: _ Arthrex Tissue Tak Anchors

Indications for Use:

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

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number Kos 3338

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510(k) Number (if known):

Device Name: Arthrex Tak Family

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

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510(k) Number (if known): _ K053338

Device Name: Arthrex Tenodesis Family

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
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

Regulation Number and Section

§ 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.