(65 days)
No
The device description and performance studies focus on the mechanical properties and biocompatibility of a physical implant (suture anchors) and do not mention any software, algorithms, or data processing capabilities that would indicate AI/ML.
Yes
The device is described as a "bone implant device intended for the fixation of soft tissue to bone" for various repairs and reconstructions, which directly describes a therapeutic function.
No
The device is a bone implant intended for fixation of soft tissue to bone, not for diagnosis.
No
The device description clearly states it is a bone implant device consisting of physical components (suture anchors made of PEEK) and mentions mechanical testing, sterilization, and biocompatibility, all indicative of a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description: The In2Bones Hercules™ Suture Anchors are described as a "bone implant device intended for the fixation of soft tissue to bone." This is a surgical implant used within the body to physically attach tissues.
- Intended Use: The intended uses listed are all surgical procedures involving the repair and reconstruction of ligaments, tendons, and other soft tissues in various anatomical locations. These are not diagnostic tests performed on samples.
The information provided clearly indicates that this device is a surgical implant, not a diagnostic tool.
N/A
Intended Use / Indications for Use
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.
Product codes
MBI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Foot/Ankle, Knee, Hand/Wrist, Elbow
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K110773, K150715, K112237, K071257, K992487
Reference Device(s)
K063778, K092533, K181774, K182402
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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:
-
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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3
510(k) Summary
Hercules™ Suture Anchor System August 14, 2020
| Company: | In2Bones USA, LLC
6000 Poplar Ave, Suite 115
Memphis, TN 38119
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:
-
- 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.
4
-
- Knee: Medial collateral and Lateral collateral 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.
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 ●
| Device | In2Bones Hercules™ Suture
Anchor System
(Subject Device) | Arthrex MicroSuture
Anchors
(FT Predicate Device) | Depuy Mitek
MINI 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 |
| Intended
Use | Secure soft tissue to bone | Secure soft tissue to bone | Secure soft tissue to bone | Secure soft tissue to bone |
| Indications
for Use | Foot/Ankle:
Lateral and Medial
stabilization, Achilles
tendon and Metatarsal
ligament repair, Hallux
Valgus and Midfoot
reconstruction.
Shoulder:
Rotator Cuff, Bankart and
SLAP lesion repair, Biceps
tenodesis, Acromio-
Clavicular separation and
Deltoid repair, Capsular
shift and Capsulolabral
reconstruction.
Knee:
Medial collateral and
Lateral collateral ligament
repair, Patellar tendon and
Posterior oblique ligament
repair
Hand and Wrist:
Scapholunate ligament,
Radial collateral ligament
and Ulnar collateral
reconstruction.
Elbow:
Biceps tendon
reattachment, Tennis elbow
repair, Ulnar and Radial
collateral ligament
reconstruction. | Foot/Ankle:
Lateral Stabilization, Medial
Stabilization, Achilles
Tendon Repair, Hallux Valgus
Reconstruction, digital
tendon transfers, Midfoot
reconstruction
Shoulder:
Rotator Cuff Repairs,
Bankart Repair, SLAP Lesion
Repair, Biceps Tenodesis,
Acromio-Clavicular
Separation Repair, Deltoid
Repair, Capsular Shift or
Capsulolabral
Reconstruction
Knee:
Medial Collateral Ligament
Repair, Lateral Collateral
Ligament Repair,
Patellar Tendon Repair,
Posterior Oblique Ligament
Repair, Iliotibial Band
Tenodesis.
Elbow, Wrist, Hand:
Scapholunate Ligament
Reconstruction, Ulnar or
Radial Collateral Ligament
Reconstruction, Biceps
Tendon Reattachment,
repair/reconstruction of | Foot/Ankle:
Hallux Valgus reconstruction
Midfoot reconstruction
Shoulder:
Bankart Repair
Wrist, Hand:
Scapholunate ligament
reconstruction
Thumb ulnar or radial collateral
ligament
Pubis:
Fixation in the pubis for bladder
neck suspension to resolve
stress urinary incontinence | Foot/Ankle:
Lateral and Medial stabilization,
Achilles tendon and Metatarsal
ligament repair, Hallux Valgus and
Midfoot reconstruction.
Shoulder:
Rotator Cuff, Bankart and SLAP lesion
repair, Biceps tenodesis, Acromio-
Clavicular separation and Deltoid
repair, Capsular shift and
Capsulolabral reconstruction.
Knee
Medial collateral and Lateral collateral
ligament repair, Patellar tendon and
Posterior oblique ligament repair,
Hallux Valgus and Midfoot
reconstruction.
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.
Extra Capsular Repairs: Medial, Lateral
and Posterior Oblique Ligaments |
5
K201636 Page 3 of 3
| | | collateral ligaments, repair
of flexor and extensor
tendons at the PIP, DIP and
MCP joints for all digits,
digital tendon transfers,
Carpal ligament
reconstruction and | | Patellar Tendon Repair |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| | | Carpometacarpal joint
arthroplasty (basal thumb
joint arthroplasty) | | |
| Classification
Name | Screw, Fastener, Fixation,
Nonabsorbable, Bone, Soft
Tissue | Screw, Fastener, Fixation,
Biodegradable, Soft Tissue | Smooth or threaded metallic
bone fixation fastener | Fastener, Fixation, Non-degradable,
Soft Tissue, Smooth or Threaded
Metallic bone fixation fastener |
| Product
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:
Pre-threaded Non-
absorbable braided
polyethylene suture
Knotless:
Provided separate Non-
absorbable braided
polyethylene suture | Pre-threaded Non-
absorbable polyethylene /
polyester suture | Pre-threaded Non-absorbable
braided polyethylene suture | Pre-Threaded Non-absorbable braided
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:
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.