(303 days)
K180118 - Arthrex NanoSuture Anchor - Arthrex, Inc.
No
The device description and performance studies focus on the mechanical properties and biocompatibility of the suture anchors, with no mention of AI or ML.
Yes
The device is described as an "anchor-type implant" used for "suture or tissue fixation" in various parts of the body to repair ligaments and tendons. This directly indicates a treatment or restorative function, which is therapeutic.
No
The device description clearly states that the device consists of "anchor-type implants" used for "suture or tissue fixation," which are surgically invasive, non-absorbable, and non-active implantable medical devices. These are used for treatment (fixation) rather than for diagnosing a condition.
No
The device description clearly states that the device is an anchor-type implant made of Titanium Alloy and UHMWPE, and includes a disposable inserter device. These are physical components, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "suture or tissue fixation in the elbow, shoulder, hand, wrist, foot, ankle, knee, and hip." This describes a surgical procedure performed on the body, not a test performed on samples taken from the body.
- Device Description: The device is described as "anchor-type implants" that are "surgically invasive, non-absorbable, and non-active implantable medical devices." This clearly indicates a device that is placed within the body during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
Therefore, the Suture Anchors - HTA Headless Titanium Anchor and ZIP Anchors are medical devices, specifically implantable surgical devices, but they do not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Suture Anchors - HTA Headless Titanium Anchor and ZIP Anchors are indicated to be used for suture or tissue fixation in the elbow, shoulder, hand, wrist, foot, ankle, knee, and hip. Specific indications are listed below:
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, Repair/Reconstruction of 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 Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)
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 Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hip: Capsular repair, acetabular labral repair.
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The Suture Anchors, manufactured by GM dos Reis Indústria e Comércio Ltda, are anchor-type implants, and are composed of two groups of anchors, manufactured in Titanium Alloy (ASTM F136) and Ultra High Molecular Weight Polyethylene – UHMWPE (which are called ZIP Anchor), that is the same raw material of the suture. The anchors are made available preloaded in a disposable inserter device, composed of a metal rod and a polymeric cable. The implant and disposable inserter devices are unique products and cannot be sold separately.
Implants of the Suture Anchors - GM Reis are classified as surgically invasive, non-absorbable, and non-active implantable medical devices. In addition, the implants, as well as, the inserter device, are for single-use and sold in sterile form - supplied as a sterile kit for ethylene oxide (ETO) according to ISO 11135 - "Preview Sterilization of health-care products -- Ethylene oxide -- Requirements for the development, validation and routine control of a sterilization process for medical devices".
The Suture Anchors - GM Reis is composed of two different groups of anchors:
- HTA – Headless Titanium Anchor.
- Anchor Diameters: ø1,7 mm; ø2,2 mm; ø2,7 mm; ø3,5 mm and ø5,0 mm
- -ZIP Anchor.
- Ø0.9mm; Ø1.2mm; Ø1.5mm; Ø1.8mm; Ø1.9mm; Ø2.6mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
elbow, shoulder, hand, wrist, foot, ankle, knee, and hip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified surgeons mastering the surgical technique, having been trained and qualified in orthopedic surgeries.
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)
The insertion torque and the pullout strength were selected for comparing the anchors performance. Statistical analysis was applied to demonstrate that the performance measured for the GM Reis anchors are equivalent to the predicate performance. The procedure for evaluating the compatibility with the magnetic resonance (MR) environment of the suture anchors were tested following current standards. To select the appropriate endpoints for biological evaluation, the chemical characteristics of the nature, frequency, and duration of exposure to the body (i.e., intended use), were considered according to ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K180118 - Arthrex NanoSuture Anchor - Arthrex, Inc.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K112237 - MicroSuture Anchors - Arthrex, Inc., K003816 - Titanium Fixation System - Arthrex, Inc., K061863 – Arthrex PushLock, Tak, and Corkscrew products Arthrex, Inc., K110879 – JuggerKnotTM Mini Soft Anchors – Biomet Sports Medicine, K172612 – FiberTak DX - Arthrex, Inc., K151230 – Arthrex FiberTak Anchors – Arthrex, Inc., K181769 - Arthrex FiberTak Suture Anchor - Arthrex, Inc., K200332 – Expert - Joint Fixation System – GM Dos Reis Industria E Comercio Ltda, K100006 – HS Fiber (Polyblend); RiverBond (Polyester); RiverSilk (silk); RiverPro (PP); RiverLon (Nylon) — Riverpoint Medical
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image contains 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.
August 2, 2023
Gm Dos Reis Industria E Comerico Ltda % Homero Antunes Regulatory Affairs Specialist PR Servicos Regulatorios Administrativos Ltda Rua Alice Alem Saadi, 855/2402 Ribeirao Preto, Sao Paulo 14096570 Brazil
Re: K223114
Trade/Device Name: Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: July 7, 2023 Received: July 7, 2023
Dear Homero Antunes:
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
1
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 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 medical devices and radiation-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,
Sara S. Thompson -S
For
Jesse Muir, 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) K223114
Device Name
Suture Anchors - HTA Headless Titanium Anchor and ZIP Anchors
Indications for Use (Describe)
The Suture Anchors - HTA Headless Titanium Anchor and ZIP Anchors are indicated to be used for suture or tissue fixation in the elbow, shoulder, hand, wrist, foot, ankle, knee, and hip. Specific indications are listed below:
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Hand Wrist: Scapholunate Ligament Reconstruction of 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 Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)
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 Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hip: Capsular repair, acetabular labral repair.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| -------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------- |
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510(k) Summary ADMINISTRATIVE INFORMATION Sponsor/Manufacturer Name GM dos Reis Indústria e Comércio Ltda Avenida Pierre Simon de La Place 600 Campinas, São Paulo, Brazil 13069-320 Telephone: +55 (19) 3765-9900 Contact Person and Preparer Homero Santiago Antunes Regulatory Affairs Specialist Passarini Regulatory Affairs PR Serviços Regulatórios Administrativos Ltda E-Mail: homero@passarini.com.br Telephone +55 (47) 3804 0075 August, 1 2023 Date Prepared
DEVICE NAME AND CLASSIFICATION
| Trade/ Proprietary Name | Suture Anchors - HTA Headless Titanium Anchor and
ZIP Anchors |
|------------------------------|-----------------------------------------------------------------------------------------------------|
| Common Name | Fastener, Fixation, Nondegradable, Soft Tissue |
| Classification Name | Single/multiple component metallic bone fixation
appliances and accessories |
| Product Code | MBI |
| Classification Regulation | 21 CFR 888.3040, Class II |
| Review Panel | Orthopedic |
| PREDICATE DEVICE INFORMATION | |
| Predicate Devices | K180118 - Arthrex NanoSuture Anchor - Arthrex, Inc. |
| Reference Devices | K112237 - MicroSuture Anchors - Arthrex, Inc.
K003816 - Titanium Fixation System - Arthrex, Inc. |
| Predicate Devices | K180118 – Arthrex NanoSuture Anchor - Arthrex, Inc. |
|---|---|
| Reference Devices | K112237 – MicroSuture Anchors - Arthrex, Inc. |
| K003816 - Titanium Fixation System - Arthrex, Inc. | |
| K061863 – Arthrex PushLock, Tak, and Corkscrew products Arthrex, Inc. | |
| K110879 – JuggerKnotTM Mini Soft Anchors – Biomet Sports Medicine |
4
K172612 – FiberTak DX - Arthrex, Inc. K151230 – Arthrex FiberTak Anchors – Arthrex, Inc. K181769 - Arthrex FiberTak Suture Anchor - Arthrex, Inc. K200332 – Expert - Joint Fixation System – GM Dos Reis Industria E Comercio Ltda K100006 – HS Fiber (Polyblend); RiverBond (Polyester); RiverSilk (silk); RiverPro (PP); RiverLon (Nylon) — Riverpoint Medical
INDICATIONS FOR USE
The Suture Anchors - HTA Headless Titanium Anchor and ZIP Anchors are indicated to be used for suture or tissue fixation in the elbow, shoulder, hand, wrist, foot, ankle, knee, and hip. Specific indications are listed below:
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, Repair/Reconstruction of 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 Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)
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 Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hip: Capsular repair, acetabular labral repair.
DEVICE DESCRIPTION
The Suture Anchors, manufactured by GM dos Reis Indústria e Comércio Ltda, are anchor-type implants, and are composed of two groups of anchors, manufactured in Titanium Alloy (ASTM F136) and Ultra High Molecular Weight Polyethylene – UHMWPE (which are called ZIP Anchor), that is the same raw material of the suture. The anchors are made available preloaded in a disposable inserter device, composed of a metal rod and a polymeric cable. The implant and disposable inserter devices are unique products and cannot be sold separately.
Implants of the Suture Anchors - GM Reis are classified as surgically invasive, non-absorbable, and non-active implantable medical devices. In addition, the implants, as well as, the inserter device, are for single-use and sold in sterile form - supplied as a sterile kit for ethylene oxide (ETO) according to ISO 11135 - "Preview Sterilization of health-care products -- Ethylene oxide -- Requirements for the development, validation and routine control of a sterilization process for medical devices".
The Suture Anchors - GM Reis is composed of two different groups of anchors:
- । HTA – Headless Titanium Anchor.
- o Anchor Diameters: ø1,7 mm; ø2,2 mm; ø2,7 mm; ø3,5 mm and ø5,0 mm
5
- -ZIP Anchor.
- Ø0.9mm; Ø1.2mm; Ø1.5mm; Ø1.8mm; Ø1.9mm; Ø2.6mm. o
The devices must only be used by qualified surgeons mastering the surgical technique, having been trained and qualified in orthopedic surgeries.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE:
The subject device is substantially equivalent in indications and design principles to the predicates identified before.
The subject and predicate devices have equivalent intended use and equivalent technological characteristics. The subject and predicate devices are all manufactured from identical materials and share equivalent design characteristics. The subject and predicate devices encompass equivalent physical dimensions. Any difference in the technological characteristics do not raise new issues of safety or efficacy. No clinical data were included in this submission.
NON-CLINICAL PERFORMANCE DATA:
The insertion torque and the pullout strength were selected for comparing the anchors performance. Statistical analysis was applied to demonstrate that the performance measured for the GM Reis anchors are equivalent to the predicate performance. The procedure for evaluating the compatibility with the magnetic resonance (MR) environment of the suture anchors were tested following current standards. To select the appropriate endpoints for biological evaluation, the chemical characteristics of the nature, frequency, and duration of exposure to the body (i.e., intended use), were considered according to ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
CONCLUSION
The documentation submitted in this premarket notification demonstrates that the subject devices have comparable features and performance and, therefore, are substantially equivalent to the identified predicate devices.