Shoulder: Rotator Cuff, Bankart and SLAP lesion repair, Biceps tenodesis, Acromio-Clavicular separation and Deltoid repair, Capsular shift and Capsulolabral reconstruction.
Foot/Ankle: Lateral and Medial stabilization. Achilles tendon and Metatarsal ligament repair, Hallux Valgus and Midfoot reconstruction.
Knee: Medial collateral and Lateral ligament repair, Patellar tendon and Posterior oblique ligament repair.
Hand/Wrist: Scapholunate ligament, Radial collateral ligament and Ulnar collateral ligament reconstruction.
Elbow: Biceps tendon reattachment, Tennis elbow repair, Ulnar and Radial collateral ligament reconstruction.

Device Description

The In2Bones Hercules™ Suture Anchor System is a bone implant device intended for the fixation of soft tissue to bone. This system consists of two anchor styles manufactured from ASTM F 2026 Poly Ether Ether Ketone (PEEK) - Fully threaded anchor and Knotless anchor - that are available in five sizes ranging from 2.0mm to 5.5mm and 4 sizes ranging from 2.5mm to 5.5mm respectively, for use in a range of fixation applications.

AI/ML Overview

This document is a 510(k) summary for the Hercules™ Suture Anchor System. It details the device's indications for use, comparison to predicate devices, and performance testing conducted to demonstrate substantial equivalence.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" for the mechanical performance tests in an easily digestible table format with reported performance. Instead, it states that "mechanical testing was done in accordance with ASTM F543-07 to evaluate the anchors and establish substantial equivalence." This implies that the acceptance criteria are met if the device's performance is comparable to or better than previously cleared predicate devices, as assessed against the standards of ASTM F543-07.

To extract acceptance criteria and reported performance, we infer from what is mentioned:

Test	Acceptance Criteria (Inferred)	Reported Device Performance
Anchor Insertion Torque and Torque to Failure	Performance comparable to or better than predicate devices, as per ASTM F543-07.	"mechanical testing was done in accordance with ASTM F543-07 to evaluate the anchors and establish substantial equivalence." (Implies satisfactory performance relative to predicates via this standard).
Tensile Pullout	Performance comparable to or better than predicate devices, as per ASTM F543-07.	"mechanical testing was done in accordance with ASTM F543-07 to evaluate the anchors and establish substantial equivalence." (Implies satisfactory performance relative to predicates via this standard).
Cyclic Load	Performance comparable to or better than predicate devices, as per ASTM F543-07.	"mechanical testing was done in accordance with ASTM F543-07 to evaluate the anchors and establish substantial equivalence." (Implies satisfactory performance relative to predicates via this standard).
Post-Fatigue Pullout	Performance comparable to or better than predicate devices, as per ASTM F543-07.	"mechanical testing was done in accordance with ASTM F543-07 to evaluate the anchors and establish substantial equivalence." (Implies satisfactory performance relative to predicates via this standard).
Bacterial Endotoxin Testing (LAL)	Meet requirements of ANSI/AAMI ST72.	"Bacterial endotoxin testing (LAL) was done per ANSI/AAMI ST72." (Implies successful completion and meeting the standard).
Sterility Validations (EO sterilization)	Meet requirements of ISO 11135.	"Sterility validations for EO sterilization per ISO 11135 for the implants... were conducted and shelf-life validations were completed and determined to be 5 years." (Implies successful validation for sterility and shelf-life).
Sterility Validations (gamma sterilization)	Meet requirements of ISO 11137-2.	"Sterility validations... for gamma sterilization per ISO 11137-2 for the instruments were conducted and shelf-life validations were completed and determined to be 5 years." (Implies successful validation for sterility and shelf-life).
Biocompatibility Assessment	Meet requirements of ISO 10993-1, with all required testing done per ISO 10993 standard.	"A biocompatibility assessment was done per ISO 10993-1 and any required testing was done per the ISO 10993 standard." (Implies successful assessment and testing).
Packaging Validations	Meet requirements of ISO 11607-1.	"Packaging validations were completed in accordance with ISO 11607-1." (Implies successful validation).

Note: The document focuses on demonstrating substantial equivalence rather than defining specific acceptance criteria for a new, novel product. Therefore, the "reported device performance" is often a statement that the relevant standard was met, implying that the performance was acceptable relative to the predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not specify the exact sample size (number of anchors) used for each mechanical test (Anchor Insertion Torque, Torque to Failure, Tensile Pullout, Cyclic Load, Post-Fatigue Pullout). It only mentions that "mechanical testing was done."
Data Provenance: The studies were bench tests (non-clinical performance mechanical testing). This means the data is not from human subjects. The location where the tests were performed is not specified, but it would have been in a laboratory or testing facility. The data is prospective in the sense that these tests were conducted specifically for this submission, although they are based on established standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This section is not applicable as the studies are mechanical bench tests, not involving human interpretation or expert evaluation of data to establish a ground truth. The "ground truth" for these tests is defined by the physical properties and performance characteristics measured against industry standards (ASTM, ISO).

4. Adjudication Method for the Test Set

This section is not applicable as the studies are mechanical bench tests. Adjudication methods (like 2+1, 3+1) are typically used for studies involving multiple human readers assessing medical images or patient data where disagreements may arise.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study involves human readers, and the provided information pertains to the mechanical performance of a medical device (suture anchors), not an AI algorithm for diagnostic purposes.

6. Standalone (Algorithm Only Without Human-in-the Loop Performance) Study

Not applicable. The device is a physical medical implant (suture anchor system), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. Type of Ground Truth Used

The "ground truth" for the mechanical performance tests is based on established engineering standards and specifications (e.g., ASTM F543-07, ANSI/AAMI ST72, ISO 11135, ISO 11137-2, ISO 10993-1, ISO 11607-1). The device's performance is compared against these objective, quantifiable standards and against the performance of predicate devices as measured under these standards.

8. Sample Size for the Training Set

Not applicable. This submission is for a physical medical device, not an AI or machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As stated above, there is no training set for a physical medical device.

Summary

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August 20, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

In2Bones USA, LLC Christine Scifert VP of Quality and Regulatory 6000 Poplar Ave. Suite 115 Memphis, Tennessee 38119

Re: K201636

Trade/Device Name: Hercules™ Suture Anchor System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: August 6, 2020 Received: August 7, 2020

Dear Ms. Scifert:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 misleading.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Laura C. Rose, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201636

Device Name Hercules™ Suture Anchor System

Indications for Use (Describe)

The In2Bones Hercules™ Suture Anchors are intended for use in the following applications:

Shoulder: Rotator Cuff, Bankart and SLAP lesion repair, Biceps tenodesis, Acromio-Clavicular separation and Deltoid repair, Capsular shift and Capsulolabral reconstruction.
Foot/Ankle: Lateral and Medial stabilization. Achilles tendon and Metatarsal ligament repair, Hallux Valgus and Midfoot reconstruction.
Knee: Medial collateral and Lateral ligament repair, Patellar tendon and Posterior oblique ligament repair.
Hand/Wrist: Scapholunate ligament, Radial collateral ligament and Ulnar collateral ligament reconstruction.
Elbow: Biceps tendon reattachment, Tennis elbow repair, Ulnar and Radial collateral ligament reconstruction.

Type of Use (Select one or both, as applicable)

☑ Reporting Use (Part 21 CFR 601 Subpart D)
☐ Safety Reporting Use (21 CFR 601 Subpart C)

Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Hercules™ Suture Anchor System August 14, 2020

Company:	In2Bones USA, LLC6000 Poplar Ave, Suite 115Memphis, TN 38119901-260-7931
Primary Contact:	Christine Scifert
Company Contact:	Rebecca Wahl
Trade Name:	Hercules™ Suture Anchor System
Common Name:	Fastener, Fixation, Non-Degradable, Soft Tissue
Classification:	II
Regulation Number:	21 CFR 888.3040, Smooth or threaded metallic bone fixation fastener
Panel:	87-Orthopedic
Product Code(s):	MBI

The In2Bones Hercules™ Suture Anchor System is a bone implant device intended Device Description: for the fixation of soft tissue to bone. This system consists of two anchor styles manufactured from ASTM F 2026 Poly Ether Ether Ketone (PEEK) - Fully threaded anchor and Knotless anchor - that are available in five sizes ranging from 2.0mm to 5.5mm and 4 sizes ranging from 2.5mm to 5.5mm respectively, for use in a range of fixation applications.

Indications for Use:

The In2Bones Hercules™ Suture Anchors are intended for use in the following applications:

1. Shoulder: Rotator Cuff, Bankart and SLAP lesion repair, Biceps tenodesis, Acromio-Clavicular separation and Deltoid repair, Capsular shift and Capsulolabral reconstruction.
1. Foot/Ankle: Lateral and Medial stabilization, Achilles tendon and Metatarsal ligament repair, Hallux Valgus and Midfoot reconstruction.

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1. Knee: Medial collateral and Lateral collateral ligament repair, Patellar tendon and Posterior oblique ligament repair.
1. Hand/Wrist: Scapholunate ligament, Radial collateral ligament and Ulnar collateral ligament reconstruction.
1. Elbow: Biceps tendon reattachment, Tennis elbow repair, Ulnar and Radial collateral ligament reconstruction.

Substantial Equivalence: The subject components were demonstrated to be substantially equivalent to the following systems previously cleared by the FDA:

Primary Predicate:

K110773 and K150715- Tornier Insite FT PEEK Knotless Suture Anchors .
Additional Predicates:
K112237 Arthrex MicroSuture Anchors ●
K071257 and K992487 Depuy Mitek Mini QUICKANCHOR .

Device	In2Bones Hercules™ SutureAnchor System(Subject Device)	Arthrex MicroSutureAnchors(FT Predicate Device)	Depuy MitekMINI QuickAnchor Plus(Knotless Predicate Device)	Tornier Insite FT Suture Anchor,2.5mm & 3.5mm; 4.5, 5.5mm, 6.5mm(Predicate Device)
510K #	Subject	K112237	K071257, 992487	K150715, K110773
IntendedUse	Secure soft tissue to bone	Secure soft tissue to bone	Secure soft tissue to bone	Secure soft tissue to bone
Indicationsfor Use	Foot/Ankle:Lateral and Medialstabilization, Achillestendon and Metatarsalligament repair, HalluxValgus and Midfootreconstruction.Shoulder:Rotator Cuff, Bankart andSLAP lesion repair, Bicepstenodesis, Acromio-Clavicular separation andDeltoid repair, Capsularshift and Capsulolabralreconstruction.Knee:Medial collateral andLateral collateral ligamentrepair, Patellar tendon andPosterior oblique ligamentrepairHand and Wrist:Scapholunate ligament,Radial collateral ligamentand Ulnar collateralreconstruction.Elbow:Biceps tendonreattachment, Tennis elbowrepair, Ulnar and Radialcollateral ligamentreconstruction.	Foot/Ankle:Lateral Stabilization, MedialStabilization, AchillesTendon Repair, Hallux ValgusReconstruction, digitaltendon transfers, MidfootreconstructionShoulder:Rotator Cuff Repairs,Bankart Repair, SLAP LesionRepair, Biceps Tenodesis,Acromio-ClavicularSeparation Repair, DeltoidRepair, Capsular Shift orCapsulolabralReconstructionKnee:Medial Collateral LigamentRepair, Lateral CollateralLigament Repair,Patellar Tendon Repair,Posterior Oblique LigamentRepair, Iliotibial BandTenodesis.Elbow, Wrist, Hand:Scapholunate LigamentReconstruction, Ulnar orRadial Collateral LigamentReconstruction, BicepsTendon Reattachment,repair/reconstruction of	Foot/Ankle:Hallux Valgus reconstructionMidfoot reconstructionShoulder:Bankart RepairWrist, Hand:Scapholunate ligamentreconstructionThumb ulnar or radial collateralligamentPubis:Fixation in the pubis for bladderneck suspension to resolvestress urinary incontinence	Foot/Ankle:Lateral and Medial stabilization,Achilles tendon and Metatarsalligament repair, Hallux Valgus andMidfoot reconstruction.Shoulder:Rotator Cuff, Bankart and SLAP lesionrepair, Biceps tenodesis, Acromio-Clavicular separation and Deltoidrepair, Capsular shift andCapsulolabral reconstruction.KneeMedial collateral and Lateral collateralligament repair, Patellar tendon andPosterior oblique ligament repair,Hallux Valgus and Midfootreconstruction.Hand/WristScapholunate ligament, Radialcollateral ligament and Ulnar collateralligament reconstruction.ElbowBiceps tendon reattachment, Tenniselbow repair, Ulnar and Radialcollateral ligament reconstruction.Extra Capsular Repairs: Medial, Lateraland Posterior Oblique Ligaments

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K201636 Page 3 of 3

		collateral ligaments, repairof flexor and extensortendons at the PIP, DIP andMCP joints for all digits,digital tendon transfers,Carpal ligamentreconstruction and		Patellar Tendon Repair
		Carpometacarpal jointarthroplasty (basal thumbjoint arthroplasty)
ClassificationName	Screw, Fastener, Fixation,Nonabsorbable, Bone, SoftTissue	Screw, Fastener, Fixation,Biodegradable, Soft Tissue	Smooth or threaded metallicbone fixation fastener	Fastener, Fixation, Non-degradable,Soft Tissue, Smooth or ThreadedMetallic bone fixation fastener
ProductCode	MBI	HWC, MAI, MBI	HWC	MBI
Material	PEEK	Ti, PLA/βTCP	NiTi, Ti6Al4V	PEEK and Titanium
Sizes	2.0mm - 5.5mm	2.2mm-2.7mm	1.8 w/5.5mm arc	2.5mm - 6.5mm
Sutures	Fully Threaded:Pre-threaded Non-absorbable braidedpolyethylene sutureKnotless:Provided separate Non-absorbable braidedpolyethylene suture	Pre-threaded Non-absorbable polyethylene /polyester suture	Pre-threaded Non-absorbablebraided polyethylene suture	Pre-Threaded Non-absorbable braidedpolyethylene suture

The subject Hercules™ Suture Anchor System made of PEEK is different in some design features compared to the predicates, but have been demonstrated to be substantially equivalent to the previously cleared devices cleared under K150715, K110773 K112237, K071257 and K992487 as the products are similar in indications, materials, sterilization and geometry.

Reference Devices:

K063778, K092533, K181774 – Teleflex Force Fiber
K182402 CoLink View Plating System ●

Performance Testing:

Non-clinical performance bench testing (mechanical testing) was performed to demonstrate substantial equivalence to the predicate devices per draft Guidance for Premarket Notification (510(k)) for Bone Anchors issued on January 3, 2017, mechanical testing was done in accordance with ASTM F543-07 to evaluate the anchors and establish substantial equivalence. Testing included Anchor Insertion Torque and Torque to Failure, Tensile Pullout, Cyclic Load, and Post-Fatigue Pullout. Bacterial endotoxin testing (LAL) was done per ANSI/AAMI ST72. Sterility validations for EO sterilization per ISO 11135 for the implants and for gamma sterilization per ISO 11137-2 for the instruments were conducted and shelf-life validations were completed and determined to be 5 years. A biocompatibility assessment was done per ISO 10993-1 and any required testing was done per the ISO 10993 standard. Packaging validations were completed in accordance with ISO 11607-1.

Conclusion

Based on the test results and the comparison to the predicate devices, the subject device is determined to be substantially equivalent to the predicate devices.

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.