The Arthrex BioComposite TransFix is intended to be used for fixation of tissue including ligament or tendon to bone and bone tendon bone. Fixation with the BioComposite TransFix is appropriate for surgeries of the knee, shoulder, elbow, ankle, foot, and hand/wrist where the sizes offered are patient appropriate. Specifically;

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 Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle
Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Knee: 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: Ligament Scapholunate 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 BioComposite TransFix is very similar to the predicate devices in diameter, and length. The difference lies in the biodegradable material used to manufacture the new model and the addition of a longer device. The implants will be manufactured from PLDLA combined with biphasic calcium phosphate.

AI/ML Overview

The provided text describes the Arthrex BioComposite TransFix device and its substantial equivalence to a predicate device, K062466 (Arthrex Interference Screw): Arthrex Bio-TransFix, rather than a study proving the device meets specific acceptance criteria through clinical performance metrics like accuracy, sensitivity, or specificity.

This submission is a 510(k) Pre-market Notification, a regulatory pathway for medical devices where a new device is shown to be substantially equivalent to a legally marketed predicate device. In such cases, the "acceptance criteria" and "device performance" are typically demonstrated through bench testing (mechanical testing) and biocompatibility testing, to show that the new device is as safe and effective as the predicate, not necessarily through clinical studies with human participants to measure traditional diagnostic performance metrics.

Therefore, many of the requested categories for AI/diagnostic device studies are not applicable to this type of device submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Material Biocompatibility (ISO 10993-1)	Confirmed
Degradation Shear Strength (through 16 weeks)	Meets or exceeds the shear strength of the predicate device.
Technological Characteristics	The "basic features and intended uses are the same" as the predicate device. Differences are "considered minor and do not raise questions concerning safety and effectiveness."

2. Sample size used for the test set and the data provenance

Sample Size: Not applicable. This was a physical device (implant) undergoing mechanical and biocompatibility testing, not a diagnostic algorithm tested on a dataset. The "test set" would refer to the physical samples of the BioComposite TransFix devices. The exact number of samples used for the mechanical and biocompatibility testing is not specified in this summary, but implied to be sufficient for regulatory demonstration.
Data Provenance: Not applicable. Material testing data is generated in a lab setting, not from clinical patient data from a specific country or collected retrospectively/prospectively.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth, in the context of diagnostic devices, refers to an established correct diagnosis. For an orthopedic implant, the "ground truth" would be established by the physical and chemical properties of the material, tested against engineering standards (e.g., ISO for biocompatibility, and mechanical strength specifications). This is typically performed by engineers and analytical chemists.

4. Adjudication method for the test set

Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human readers in interpreting clinical data for diagnostic studies. For material properties, results are typically quantitative and objective, without the need for human adjudication in that sense.

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 is not an AI/diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. This is not an AI/diagnostic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance is based on engineering standards and physical/chemical properties as determined by ISO 10993-1 for biocompatibility and laboratory mechanical testing for shear strength. The comparative element is against the predicate device's known performance.

8. The sample size for the training set

Not applicable. This is not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. Since there is no training set, there is no ground truth establishment for it.

Summary

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Arthrex SPECIAL 510(k): Arthrex BioComposite TransFix

1 510(k) Summary of Safety and Effectiveness

Date Summary Prepared	December 14, 2011
Purpose of Submission	To obtain clearance of new Arthrex BioComposite TransFix devices.
Manufacturer/Distributor/Sponsor	Arthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USA
510(k) Contact	Courtney SmithManager, Regulatory AffairsArthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USATelephone: 239/643.5553, ext. 1270Fax: 239/598.5508Email: courtney.smith@arthrex.com
Trade Name	BioComposite TransFix
Common Name	Pin, Fixation, Bone
Product Code -Classification Name	HWC - Screw, fixation, boneMAI - Fastener, fixation, biodegradable21 CFR 888.3030: Single/multiple component metallic bonefixation appliances and accessories.
Predicate Devices	K062466 (Arthrex Interference Screw): Arthrex Bio-TransFix
Device Description andIntended Use	The Arthrex BioComposite TransFix is very similar to the predicate devices in diameter, and length. The difference lies in the biodegradable material used to manufacture the new model and the addition of a longer device. The implants will be manufactured from PLDLA combined with biphasic calcium phosphate.The Arthrex BioComposite TransFix is intended to be used for fixation of tissue including ligament or tendon to bone and bone tendon bone. Fixation with the BioComposite TransFix is appropriate for surgeries of the knee, shoulder, elbow, ankle, foot, and hand/wrist where the sizes offered are patient appropriate. Specifically:Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral ReconstructionFoot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles
		Tendon Repair, Hallux Valgus Reconstruction,Midfoot Reconstruction, Metatarsal LigamentRepair, Flexor Hallucis Longus for Achilles Tendonreconstruction, tendon transfers in the foot and ankle
	Knee:	Anterior Cruciate Ligament Repair, MedialCollateral Ligament Repair, Lateral CollateralLigament Repair, Patellar Tendon Repair, PosteriorOblique Ligament Repair, Illiotibial Band Tenodesis
	Elbow:	Biceps Tendon Reattachment, Ulnar or RadialCollateral Ligament Reconstruction
	Hand/Wrist:	Scapholunate Ligament Reconstruction, UlnarCollateral Ligament Reconstruction, RadialCollateral Ligament Reconstruction,Carpometacarpal joint arthroplasty (basal thumb jointarthroplasty), Carpal Ligament Reconstructions andrepairs, tendon transfer in the hand/ wrist
Substantial EquivalenceSummary	The Arthrex BioComposite TransFix is substantially equivalentto the Arthrex Bio-TransFix predicates, in which the basicfeatures and intended uses are the same. Any differencesbetween the BioComposite TransFix and the predicates areconsidered minor and do not raise questions concerning safetyand effectiveness.
	The proposed devices are composed of PLDLA/biphasic calciumphosphate and are ISO 10993-1 tested to confirm the material'sbiocompatibility.The submitted mechanical testing data demonstrated that thedegradation shear strength, through 16 weeks, of the proposeddevices meets or exceeds the shear strength of the predicatedevice.
	Based on the indication for use, technological characteristics, andthe comparison to the predicate devices, Arthrex, Inc. hasdetermined that the Arthrex BioComposite TransFix aresubstantially equivalent to currently marketed predicate devices.

Page 1 of 2

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K11 2040

Arthrex SPECIAL 510(k): Arthrex BioComposite TransFix

Page 2 of 2

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized image of an eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is presented in black and white, giving it a formal and official appearance.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Arthrex, Incorporated % Ms. Courtney Smith Manager, Regulatory Affairs 1370 Creekside Boulevard Naples, Florida 34108-1945

DEC 1 5 2011

Re: K112040

Trade/Device Name: Arthrex Biocomposite Transfix Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: MAI, HWC Dated: November 16, 2011 Received: November 17, 2011

Dear Ms. Smith:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misJeading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical

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Page 3 - Ms. Courtney Smith

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

N. Malkerson, oes

Mark N. Melkerson Director Division of Surgical. Orthopedic. and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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KII 2040

Arthrex SPECIAL 510(k): Arthrex BioComposite Tr

Indications for Use

510(k) Number (if known): K112040

Device Name: Arthrex BioComposite TrunsFix

Indications For Use:

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 Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle
Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Knee: 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: Ligament Scapholunate 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_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)

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(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Device

510(k) Number K11204

Regulation Number and Section

§ 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.