(73 days)
Smith & Nephew Next Generation Fully Threaded PK Suture Anchor (K110545)
No
The document describes a mechanical suture anchor and its intended uses and performance in an animal study. There is no mention of AI or ML technology.
Yes
The device is described as a 'Suture Anchor' intended for the 'reattachment of soft tissue to bone' for various indications like 'Bankart lesion repairs' and 'Rotator cuff tear repairs', which directly treat conditions.
No
This device is a surgical implant (suture anchor) used for reattaching soft tissue to bone, not for diagnosing conditions. Its intended use is therapeutic, not diagnostic.
No
The device description explicitly states it is manufactured from PEEK and preassembled onto a stainless steel inserter, indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical device used for the reattachment of soft tissue to bone in various anatomical locations. This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The device is a suture anchor made of PEEK, designed to be implanted into bone. This is consistent with a surgical implant, not a device used to test samples from the body.
- Performance Studies: The performance study described involves an animal study evaluating bone growth into the anchor. This type of study is relevant to the mechanical and biological integration of a surgical implant, not the performance of a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Smith & Nephew HEALICOIL PK Suture Anchor is intended for use for the reattachment of soft tissue to bone for the following indications:
Shoulder:
Bankart lesion repairs
Slap lesion repairs
Capsular shift or capsulolabral reconstructions
Acromioclavicular separation repairs
Deltoid repairs
Rotator cuff tear repairs
Biceps tenodesis
Knee:
Extra-capsular repairs:
Medial collateral ligament
Lateral collateral ligament
Posterior oblique ligament
Patellar realignment and tendon repairs:
Vastus medialis obliquous advancement
Iliotibial band tenodesis.
Foot & Ankle:
Hallux valgus repairs
Medial or lateral instability repairs/reconstructions
Achilles tendon repairs/reconstruction
Midfoot reconstructions
Metatarsal ligament/tendon repairs/reconstructions
Elbow:
Ulnar or radial collateral ligament reconstructions
Lateral epicondylitis repair
Biceps tendon reattachment
Hip:
Gluteal tendon repairs - Gluteus medius and gluteus minimus repair
Product codes
MBI
Device Description
The HEALICOIL PK Suture Anchor is manufactured from PEEK (polyetheretherketone) and is offered in diameters of 4.5mm and 5.5mm sizes. The screw-in anchor is preassembled onto a stainless steel inserter and pre-loaded with up to three strands of suture.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Knee, Foot & Ankle, Elbow, Hip
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)
The purpose of this submission was to update the labeling to include results from an animal study. The animal study evaluated bone growth into the HEALICOIL PK Suture Anchor and a control suture anchor via micro computed tomography (micro CT) and histology.
Study 1: The open architecture of the HEALICOIL PK Suture Anchor allows for new bone to fill the fenestrations between threads and into the central channel.
HEALICOIL PK suture anchors (5.5 x 20mm) were implanted into 4.5 x 20mm sites created in ovine cancellous bone (n=12) of the medial distal femur and evaluated by micro-CT and histology analysis 12 weeks post implantation. Micro-CT and histology analysis demonstrated that new bone formed within the HEALICOIL PK suture anchor in the fenestrations between the threads and into the central channel in all specimens.
Note: Animal data is not necessarily indicative of human clinical outcomes. These results have not been demonstrated in humans having a variety of bone quality based on specific disease states such as osteoporosis. The effect of formation of new bone on pullout strength was not shown.
Study 2: The Smith and Nephew HEALICOIL PK Suture Anchor contained 63% of the bone volume of control bone by 12 weeks post-implantation in sheep.
HEALICOIL PK suture anchors (5.5 x 20mm) were implanted into 4.5 x 20mm sites created in ovine cancellous bone of the medial distal femur and compared to control intact bone of the same anatomical site at 12 weeks post implantation. Micro-CT analysis of new bone formed within the HEALICOIL PK Suture Anchor demonstrated that 21.9% of the implant volume was new bone by 12 weeks post-implantation (n=12). Micro-CT analysis of a 4.5 x 20mm volume of control bone from the same anatomical site demonstrates that intact bone has an average bone volume of 34.5% (n=12).
Note: Animal data is not necessarily indicative of human clinical outcomes. These results have not been demonstrated in humans having a variety of bone quality based on specific disease states such as osteoporosis. The effect of formation of new bone on pullout strength was not shown.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Smith & Nephew Next Generation Fully Threaded PK Suture Anchor (K110545)
Reference Device(s)
Not Found
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
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SECTION IV
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
As required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which the substantial equivalence is based.
Smith & Nephew HEALICOIL PK Suture Anchor
Date Prepared: November 7, 2011
A. Submitter's Name:
Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road, Andover, MA 01810
B. Company Contact
Elizabeth Lavelle Senior Regulatory Affairs Specialist Phone: (508) 261-3607
C. Device Name
| Trade Name: | HEALICOIL PK Suture Anchor |
|---|---|
| Common Name: | Suture Anchor |
| Classification Name: | Fastener. fixation, non-degradable, soft tissue |
D. Predicate Devices
The Smith & Nephew HEALICOIL PK Suture Anchor is substantially equivalent in intended use and fundamental scientific technology to the following legally marketed device in commercial distribution: Smith & Nephew Next Generation Fully Threaded PK Suture Anchor (K110545).
Description of Device E.
The HEALICOIL PK Suture Anchor is manufactured from PEEK (polyetheretherketone) and is offered in diameters of 4.5mm and 5.5mm sizes. The screw-in anchor is preassembled onto a stainless steel inserter and pre-loaded with up to three strands of suture.
F. Intended Use
The Smith & Nephew HEALICOIL PK Suture Anchor is intended for use for the reattachment of soft tissue to bone for the following indications:
1
Kff3294
| Shoulder: | Knee: |
|---|---|
| Bankart lesion repairs | Extra-capsular repairs: |
| Slap lesion repairs | Medial collateral ligament |
| Capsular shift or capsulolabral | |
| reconstructions | Lateral collateral ligament |
| Acromioclavicular separation repairs | Posterior oblique ligament |
| Deltoid repairs | Patellar realignment and tendon repairs: |
| Rotator cuff tear repairs | Vastus medialis obliquous advancement |
| Biceps tenodesis | Iliotibial band tenodesis. |
| Foot & Ankle: | Elbow: |
| Hallux valgus repairs | Ulnar or radial collateral ligament reconstructions |
| Medial or lateral instability | |
| repairs/reconstructions | Lateral epicondylitis repair |
| Achilles tendon repairs/reconstruction | Biceps tendon reattachment |
| Midfoot reconstructions | Hip: |
| Metatarsal ligament/tendon | |
| repairs/reconstructions | Gluteal tendon repairs |
- Gluteus medius and gluteus minimus repair |
G. Comparison of Technological Characteristics
The Smith & Nephew HEALICOIL PK Suture Anchor is substantially equivalent in design, materials, technological characteristics, intended use, and indications for use to its currently marketed predicate device, the Smith & Nephew Next Generation Fully Threaded PEEK Suture Anchor.
H. Summary Performance Data
There have been no design modifications that required additional mechanical testing. Performance characteristics of the anchors have not changed from those described in K110545.
The purpose of this submission was to update the labeling to include results from an animal study. The animal study evaluated bone growth into the HEALICOIL PK Suture Anchor and a control suture anchor via micro computed tomography (micro CT) and histology. The labeling updates are as follows:
(1) The open architecture of the HEALICOIL PK Suture Anchor allows for new bone to fill the fenestrations between threads and into the central channel.
HEALICOIL PK suture anchors (5.5 x 20mm) were implanted into 4.5 x 20mm sites created in ovine cancellous bone (n=12) of the medial distal femur and evaluated by micro-CT and histology analysis 12 weeks post implantation. Micro-CT and histology analysis demonstrated that new bone formed within the HEALICOIL PK suture anchor in the fenestrations between the threads and into the central channel in all specimens.
Note: Animal data is not necessarily indicative of human clinical outcomes. These results have not been demonstrated in humans having a variety of bone quality based on specific disease states such as osteoporosis. The effect of formation of new bone on pullout strength was not shown.
2
(2) The Smith and Nephew HEALICOIL PK Suture Anchor contained 63% of the bone volume of control bone by 12 weeks post-implantation in sheep.
HEALICOIL PK suture anchors (5.5 x 20mm) were implanted into 4.5 x 20mm sites created in ovine cancellous bone of the medial distal femur and compared to control intact bone of the same anatomical site at 12 weeks post implantation. Micro-CT analysis of new bone formed within the HEALICOIL PK suture anchor demonstrated that 21.9% of the implant volume was new bone by 12 weeks post-implantation (n=12). Micro-CT analysis of a 4.5 x 20mm volume of control bone from the same anatomical site demonstrates that intact bone has an average bone volume of 34.5% (n=12).
Note: Animal data is not necessarily indicative of human clinical outcomes. These results have not been demonstrated in humans having a variety of bone quality based on specific disease states such as osteoporosis. The effect of formation of new bone on pullout strength was not shown.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, depicted with stylized lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Smith & Nephew Incorporated % Ms. Elizabeth Lavelle Senior Regulatory Affairs Specialist 150 Minuteman Road Andover. Massachusetts 01810
JAN 2 0 2012
K113294 Re:
Trade/Device Name: Smith & Nephew HealiCoil PK Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: January 5, 2012 Received: January 6, 2012
Dear Ms. Lavelle:
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. 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2 - Ms. Elizabeth Lavelle
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/defaulthtm.
Sincerely yours,
Mark N. Melkerson
Director
Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name: HEALICOIL PK Suture Anchor (formerly Next Generation Fully Threaded Suture Anchor)
Indications For Use:
.
The HEALICOIL PK Suture Anchor (formerly Smith & Nephew Next Generation Fully Threaded PEEK Suture Anchor) is intended for use for the reattachment of soft tissue to bone for the following indications:
| Shoulder: | Knee: |
|---|---|
| Bankart lesion repairs | Extra-capsular repairs: |
| Slap lesion repairs | Medial collateral ligament |
| Capsular shift or capsulolabral reconstructions | Lateral collateral ligament |
| Acromioclavicular separation repairs | Posterior oblique ligament |
| Deltoid repairs | Patellar realignment and tendon repairs: |
| Rotator cuff tear repairs | Vastus medialis obliquous advancement |
| Biceps tenodesis | Iliotibial band tenodesis. |
Foot & Ankle: Hallux valgus repairs Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstruction Midfoot reconstructions · Metatarsal ligament/tendon repairs/reconstructions
Elbow: Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Biceps tendon reattachment
Hip: Glutea! tendon repairs - Gluteus medius and gluteus minimus repair
Prescription Use x (Per 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use_ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K113294