Hercules Suture Anchor System
Device Facts
| Record ID | K201636 |
|---|---|
| Device Name | Hercules Suture Anchor System |
| Applicant | In2bones USA, LLC |
| Product Code | MBI · Orthopedic |
| Decision Date | Aug 20, 2020 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3040 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
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. 2. Foot/Ankle: Lateral and Medial stabilization. Achilles tendon and Metatarsal ligament repair, Hallux Valgus and Midfoot reconstruction. 3. Knee: Medial collateral and Lateral ligament repair, Patellar tendon and Posterior oblique ligament repair. 4. Hand/Wrist: Scapholunate ligament, Radial collateral ligament and Ulnar collateral ligament reconstruction. 5. Elbow: Biceps tendon reattachment, Tennis elbow repair, Ulnar and Radial collateral ligament reconstruction.
Device Story
Hercules™ Suture Anchor System consists of PEEK bone anchors (fully threaded and knotless styles) used for soft tissue-to-bone fixation. Anchors are implanted by surgeons in clinical settings (OR) to secure tendons or ligaments during orthopedic repairs. Device functions as a mechanical fastener; anchors are inserted into bone to provide attachment points for sutures. Benefits include stabilization of soft tissue to facilitate healing. No AI/ML or software components involved.
Clinical Evidence
Bench testing only. Mechanical testing performed per ASTM F543-07 (insertion torque, torque to failure, tensile pullout, cyclic load, post-fatigue pullout). Biocompatibility per ISO 10993-1. Sterility per ISO 11135 (EO) and ISO 11137-2 (gamma). Packaging per ISO 11607-1. Bacterial endotoxin testing per ANSI/AAMI ST72.
Technological Characteristics
Material: ASTM F 2026 PEEK. Anchor types: Fully threaded (2.0-5.5mm) and Knotless (2.5-5.5mm). Mechanical fixation principle. Sterilization: EO (implants) and Gamma (instruments).
Indications for Use
Indicated for soft tissue to bone fixation in shoulder, foot/ankle, knee, hand/wrist, and elbow procedures, including ligament, tendon, and capsular repairs/reconstructions.
Regulatory Classification
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.
Predicate Devices
- Tornier Insite FT PEEK Knotless Suture Anchors (K110773, K150715)
- Arthrex MicroSuture Anchors (K112237)
- Depuy Mitek Mini QUICKANCHOR (K071257, K992487)
Reference Devices
Submission Summary (Full Text)
{0}------------------------------------------------
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
{1}------------------------------------------------
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
{2}------------------------------------------------
# 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:
1. Shoulder: Rotator Cuff, Bankart and SLAP lesion repair, Biceps tenodesis, Acromio-Clavicular separation and Deltoid repair, Capsular shift and Capsulolabral reconstruction.
2. Foot/Ankle: Lateral and Medial stabilization. Achilles tendon and Metatarsal ligament repair, Hallux Valgus and Midfoot reconstruction.
3. Knee: Medial collateral and Lateral ligament repair, Patellar tendon and Posterior oblique ligament repair.
4. Hand/Wrist: Scapholunate ligament, Radial collateral ligament and Ulnar collateral ligament reconstruction.
5. Elbow: Biceps tendon reattachment, Tennis elbow repair, Ulnar and Radial collateral ligament reconstruction.
Type of Use (Select one or both, as applicable)
| <span style="font-size: 20px;">☑</span> 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)
### CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
# 510(k) Summary
Hercules™ Suture Anchor System August 14, 2020
| Company: | In2Bones USA, LLC<br>6000 Poplar Ave, Suite 115<br>Memphis, TN 38119<br>901-260-7931 |
|--------------------|--------------------------------------------------------------------------------------|
| 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.
- 2. Foot/Ankle: Lateral and Medial stabilization, Achilles tendon and Metatarsal ligament repair, Hallux Valgus and Midfoot reconstruction.
{4}------------------------------------------------
- 3. Knee: Medial collateral and Lateral collateral ligament repair, Patellar tendon and Posterior oblique ligament repair.
- 4. Hand/Wrist: Scapholunate ligament, Radial collateral ligament and Ulnar collateral ligament reconstruction.
- 5. 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™ Suture<br>Anchor System<br>(Subject Device) | Arthrex MicroSuture<br>Anchors<br>(FT Predicate Device) | Depuy Mitek<br>MINI QuickAnchor Plus<br>(Knotless Predicate Device) | Tornier Insite FT Suture Anchor,<br>2.5mm & 3.5mm; 4.5, 5.5mm, 6.5mm<br>(Predicate Device) |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510K # | Subject | K112237 | K071257, 992487 | K150715, K110773 |
| Intended<br>Use | Secure soft tissue to bone | Secure soft tissue to bone | Secure soft tissue to bone | Secure soft tissue to bone |
| Indications<br>for Use | Foot/Ankle:<br>Lateral and Medial<br>stabilization, Achilles<br>tendon and Metatarsal<br>ligament repair, Hallux<br>Valgus and Midfoot<br>reconstruction.<br>Shoulder:<br>Rotator Cuff, Bankart and<br>SLAP lesion repair, Biceps<br>tenodesis, Acromio-<br>Clavicular separation and<br>Deltoid repair, Capsular<br>shift and Capsulolabral<br>reconstruction.<br>Knee:<br>Medial collateral and<br>Lateral collateral ligament<br>repair, Patellar tendon and<br>Posterior oblique ligament<br>repair<br>Hand and Wrist:<br>Scapholunate ligament,<br>Radial collateral ligament<br>and Ulnar collateral<br>reconstruction.<br>Elbow:<br>Biceps tendon<br>reattachment, Tennis elbow<br>repair, Ulnar and Radial<br>collateral ligament<br>reconstruction. | Foot/Ankle:<br>Lateral Stabilization, Medial<br>Stabilization, Achilles<br>Tendon Repair, Hallux Valgus<br>Reconstruction, digital<br>tendon transfers, Midfoot<br>reconstruction<br>Shoulder:<br>Rotator Cuff Repairs,<br>Bankart Repair, SLAP Lesion<br>Repair, Biceps Tenodesis,<br>Acromio-Clavicular<br>Separation Repair, Deltoid<br>Repair, Capsular Shift or<br>Capsulolabral<br>Reconstruction<br>Knee:<br>Medial Collateral Ligament<br>Repair, Lateral Collateral<br>Ligament Repair,<br>Patellar Tendon Repair,<br>Posterior Oblique Ligament<br>Repair, Iliotibial Band<br>Tenodesis.<br>Elbow, Wrist, Hand:<br>Scapholunate Ligament<br>Reconstruction, Ulnar or<br>Radial Collateral Ligament<br>Reconstruction, Biceps<br>Tendon Reattachment,<br>repair/reconstruction of | Foot/Ankle:<br>Hallux Valgus reconstruction<br>Midfoot reconstruction<br>Shoulder:<br>Bankart Repair<br>Wrist, Hand:<br>Scapholunate ligament<br>reconstruction<br>Thumb ulnar or radial collateral<br>ligament<br>Pubis:<br>Fixation in the pubis for bladder<br>neck suspension to resolve<br>stress urinary incontinence | Foot/Ankle:<br>Lateral and Medial stabilization,<br>Achilles tendon and Metatarsal<br>ligament repair, Hallux Valgus and<br>Midfoot reconstruction.<br>Shoulder:<br>Rotator Cuff, Bankart and SLAP lesion<br>repair, Biceps tenodesis, Acromio-<br>Clavicular separation and Deltoid<br>repair, Capsular shift and<br>Capsulolabral reconstruction.<br>Knee<br>Medial collateral and Lateral collateral<br>ligament repair, Patellar tendon and<br>Posterior oblique ligament repair,<br>Hallux Valgus and Midfoot<br>reconstruction.<br>Hand/Wrist<br>Scapholunate ligament, Radial<br>collateral ligament and Ulnar collateral<br>ligament reconstruction.<br>Elbow<br>Biceps tendon reattachment, Tennis<br>elbow repair, Ulnar and Radial<br>collateral ligament reconstruction.<br>Extra Capsular Repairs: Medial, Lateral<br>and Posterior Oblique Ligaments |
{5}------------------------------------------------
# K201636 Page 3 of 3
| | | collateral ligaments, repair<br>of flexor and extensor<br>tendons at the PIP, DIP and<br>MCP joints for all digits,<br>digital tendon transfers,<br>Carpal ligament<br>reconstruction and | | Patellar Tendon Repair |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| | | Carpometacarpal joint<br>arthroplasty (basal thumb<br>joint arthroplasty) | | |
| Classification<br>Name | Screw, Fastener, Fixation,<br>Nonabsorbable, Bone, Soft<br>Tissue | Screw, Fastener, Fixation,<br>Biodegradable, Soft Tissue | Smooth or threaded metallic<br>bone fixation fastener | Fastener, Fixation, Non-degradable,<br>Soft Tissue, Smooth or Threaded<br>Metallic bone fixation fastener |
| Product<br>Code | 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:<br>Pre-threaded Non-<br>absorbable braided<br>polyethylene suture<br>Knotless:<br>Provided separate Non-<br>absorbable braided<br>polyethylene suture | Pre-threaded Non-<br>absorbable polyethylene /<br>polyester suture | Pre-threaded Non-absorbable<br>braided polyethylene suture | Pre-Threaded Non-absorbable braided<br>polyethylene 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.
