(92 days)
Not Found
No
The description focuses on the mechanical components and materials of the suture system and anchors. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies are mechanical tests, not evaluations of algorithmic performance.
No
The device is described as a system of soft tissue fixation devices and sutures intended for various orthopedic repairs, such as ligament reconstruction and tendon repair, which are used to fix tissues rather than provide therapy.
No
The device is described as a system for suture or tissue fixation in various parts of the body, including soft tissue fixation devices and suture anchors. Its purpose is to repair or reconstruct tissues, not to diagnose medical conditions.
No
The device description clearly outlines physical components including suture anchors, sutures, needles, and instrumentation made of materials like UHMWPE, stainless steel, and ABS. It describes a physical implantation process. There is no mention of software as a component or function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description and Intended Use: The Extremity All Suture System is a surgical implant and associated instrumentation used to fix suture or tissue within the body during surgical procedures. It is used for repairing ligaments, tendons, and other soft tissues in various joints. This is an in vivo application, not in vitro.
The description clearly outlines a device used for surgical repair and fixation within the body, which is the opposite of an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Extremity All Suture System is intended to be used for suture or tissue fixation in the foot/ankle, knee, hand/wrist, elbow, and shoulder. 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, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction
Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Product codes (comma separated list FDA assigned to the subject device)
MBI, HTY, HWC
Device Description
The Extremity All Suture System (EASS) includes the Griplasty™ System – Base of Thumb and Griplasty™ System – Micro, Mini and Small Suture Anchor. The system incorporates soft tissue fixation devices; 'all suture' anchors with an expandable push-in design, provided preloaded in an inserter handle with associated single-use instruments, and supplied sterile (ethylene oxide) for single use. The EASS anchors are constructed from a hollow braid with a suture component assembled through the hollow braid. All sutures, inclusive of suture line and anchor, are made with non-absorbable Ultra High Polyethylene (UHMWPE) per ASTM F2848. All needles are made with Stainless Steel per ASTM F899. The instrumentation is made stainless steel and medical grade Acrylonitrile Butadiene Styrene (ABS). The anchor and impacted into a pilot hole. The sutures are manually tensioned to set the anchor by bunching the suture sleeve. Griplasty" System – Base of Thumb: Comprises a suture anchor implant (with or without needles) and associated instrumentation for use in carpometacarpal (CMC) joint arthroplasty. Griplasty" System – Micro, Mini and Suture Anchor: Comprises a range of all suture anchor implants (with or without needles) and associated instrumentation for use in securing soft tissue to bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot/ankle, knee, hand/wrist, elbow, shoulder
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)
Mechanical testing of the worst-case size anchors of the EASS was performed per the FDA Guidance Document for Suture Anchors, ASTM F543-17, and ASTM F1839-08. Engineering analysis indicated that the smallest anchor was worst-case (least resistance to pull-out force). Acceptance criteria were based on similar sized predicate suture anchor devices. The results of mechanical testing, which included statistical analysis and comparison of subject and predicate device pull-out loads, showed the subject device to have noninferior (i.e. similar / 'substantially equivalent') pull-out load and performance as the predicate devices.
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.
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.
Not Found
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the letters "FDA" followed by "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font size.
September 12, 2024
Field Orthopaedics % Robert Poggie President of BioVera, Inc., Regulatory Consultant to Field Orthopaedics BioVera, Inc. 65 Promenade Saint Louis Notre-Dame-de-L'Ile-Perrot, QC J7W3J6 Canada
Re: K241695
Trade/Device Name: Extremity All Suture System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI, HTY, HWC Dated: August 23, 2024 Received: August 23, 2024
Dear Robert Poggie:
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
2
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,
Thomas Mcnamara -S
For: Christopher Ferreira, MS 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
Submission Number (if known)
Device Name
Extremity All Suture System
Indications for Use (Describe)
The Extremity All Suture System is intended to be used for suture or tissue fixation in the foot/ankle, knee, hand/wrist, elbow, and shoulder. 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 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 Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
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) #: K241695
510(k) Summary
Prepared on: 2024-09-10
Contact Details
21 CFR 807.92(a)(1)
| Applicant Name | Field Orthopaedics |
|---|---|
| Applicant Address | Suite 5, 30 Florence St Teneriffe QLD 4005 Australia |
| Applicant Contact Telephone | +617478188591 |
| Applicant Contact | Jillianne McKenzie |
| Applicant Contact Email | jillianne@fieldorthopaedics.com |
| Correspondent Name | BioVera, Inc. |
| Correspondent Address | 65 Promenade Saint Louis, Notre-Dame-de-L'lle-Perrot, QC, J7W3J6 Canada |
| Correspondent Contact Telephone | 5143497226 |
| Correspondent Contact | Robert A Poggie, PhD |
| Correspondent Contact Email | orthobob@biovera.ca |
| Device Name 21 CFR 807.92(a)(2) | |
| Device Trade Name | Extremity All Suture System |
| Common Name | Smooth or threaded metallic bone fixation fastener |
| Classification Name | Fastener, Fixation, Nondegradable, Soft Tissue |
| Regulation Number | 888.3040 |
| Product Code(s) | MBI, HTY, HWC |
| Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) | |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) Product Code |
| K151230 | Arthrex FiberTak Anchors MBI |
| K112237 | MicroSuture Anchors HWC |
| K180348 | Field Orthopaedics Micro Screw System - FO Pin and Wire Kit HTY |
| Device Description Summary 21 CFR 807.92(a)(4) | |
| The Extremity All Suture System (EASS) includes the Griplasty™ System – Base of Thumb and Griplasty™ System – Micro, Mini and Small | |
| Suture Anchor. The system incorporates soft tissue fixation devices; 'all suture' anchors with an expandable push-in design, provided |
preloaded in an inserter handle with associated single-use instruments, and supplied sterile (ethylene oxide) for single use. The EASS anchors are constructed from a hollow braid with a suture component assembled through the hollow braid.
All sutures, inclusive of suture line and anchor, are made with non-absorbable Ultra High Polyethylene (UHMWPE) per
5
ASTM F2848. All needles are made with Stainless Steel per ASTM F899. The instrumentation is made stainless steel and medical grade Acrylonitrile Butadiene Styrene (ABS). The anchor and impacted into a pilot hole. The sutures are manually tensioned to set the anchor by bunching the suture sleeve.
Griplasty" System – Base of Thumb: Comprises a suture anchor implant (with or without needles) and associated instrumentation for use in carpometacarpal (CMC) joint arthroplasty.
Griplasty" System – Micro, Mini and Suture Anchor: Comprises a range of all suture anchor implants (with or without needles) and associated instrumentation for use in securing soft tissue to bone.
Intended Use/Indications for Use
The Extremity All Suture System is intended to be used for suture or tissue fixation in the foot/ankle, knee, hand/wrist, elbow, and shoulder. 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, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction
Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Indications for Use Comparison
The Extremity All Suture System (EASS) indications for use are the same as the predicate device.
Technological Comparison
The Extremity All Suture System (EASS) has the same intended use, basic technological and design characteristics and materials as the predicate device. Any differences between the EASS and the predicate are considered minor and do not raise questions concerning safety and effectiveness.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Mechanical testing of the worst-case size anchors of the EASS was performed per the FDA Guidance Document for Suture Anchors, ASTM F543-17, and ASTM F1839-08. Engineering analysis indicated that the smallest anchor was worst-case (least resistance to pull-out force). Acceptance criteria were based on similar sized predicate suture anchor devices. The results of mechanical testing, which included statistical analysis and comparison of subject and predicate device pull-out loads, showed the subject device to have noninferior (i.e. similar / 'substantially equivalent') pull-out load and performance as the predicate devices.
Based on the intended use, technological characteristics, and data submitted, Field Orthopaedics, Pty. Ltd. has determined that its Extremity All Suture System is substantially equivalent to currently marketed predicate devices.
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)