(119 days)
The 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: Bankart lesion repairs Slap lesion repairs Capsular shift or capsulolabral reconstructions Acromioclavicular separation repairs Deltoid repairs Rotator cuff tear repairs Biceps tenodesis Foot & Ankle: Hallux valgus repairs Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstruction Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions 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. Elbow: Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Biceps tendon reattachment Hip: Gluteal tendon repairs - Gluteus medius and gluteus minimus repair
The Next Generation Fully Threaded PEEK Suture Anchor is manufactured from PEEK (polyetheretherketone) and is offered in diameters of 4.5mm and 5.5mm sizes. The screw-in anchor is pre-assembled onto a stainless steel inserter and pre-loaded with up to three strands of suture.
The provided text is a 510(k) Summary for a medical device called the "Smith & Nephew Next Generation Fully Threaded PEEK Suture Anchor." It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, the document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the way you've outlined for performance studies involving AI or diagnostic accuracy.
Instead, the submission focuses on demonstrating substantial equivalence to already legally marketed predicate devices, meaning it has the same intended use and similar technological characteristics, and does not raise new questions of safety or effectiveness. The performance data mentioned is related to insertion and fixation properties of the suture anchor, which are biomechanical characteristics, not diagnostic accuracy.
Therefore, I cannot populate your requested table and information points as they pertain to clinical or diagnostic performance studies. The document states:
"The performance testing conducted demonstrates that the insertion and fixation properties of the Smith & Nephew Next Generation Fully Threaded PEEK Suture Anchor is substantially equivalent to the predicate TWINFIX AB 5.0 suture anchor, cleared via 510(k) K011299. The testing demonstrates that the differences between the new device and the predicate device do not raise any new issues of safety and efficacy."
This indicates that the "study" was likely a series of mechanical tests to compare the new anchor's physical performance (e.g., pull-out strength, insertion torque) to that of the predicate device. The acceptance criteria would have been that these properties are comparable or equivalent to the predicate. The document doesn't provide the detailed numerical results, specific acceptance thresholds, or the methodology of these mechanical tests.
The questions you've asked (about sample size for test set, data provenance, number of experts, adjudication, MRMC studies, standalone performance, ground truth types, and training set details) are highly relevant for AI/diagnostic device performance studies, but they are not applicable to the type of 510(k) submission for a surgical implant like a suture anchor, which relies on demonstrating biomechanical equivalence rather than diagnostic accuracy.
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Endoscopy Smith & Nephew, Inc. 150 Minuteman Road Andover, MA 01810
0001 072 878 978 749 1599 Fax www.smlth-nephew.com
- We are smith&nephew
JUN 2 4 2011
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 Next Generation Fully Threaded PEEK Suture Anchor
Date Prepared: June 13, 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 Fax: (508) 261-3620
C. Device Name
Smith & Nephew Next Generation Fully Threaded PEEK Suture Trade Name: Anchor Suture Anchor Common Name: Fastener, fixation, non-degradable, soft tissue Classification Name:
D. Predicate Devices
The Smith & Nephew Next Generation Fully Threaded PEEK Suture Anchor is substantially equivalent in intended use and fundamental scientific technology to the following legally marketed suture anchors: Smith & Nephew TWINFIX FT PK (K072785), Smith & Nephew TWINFIX AB 5.0 (K011299) and Arthrex SwiveLock (K101823).
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Description of Device E.
The Next Generation Fully Threaded PEEK Suture Anchor is manufactured from PEEK (polyetheretherketone) and is offered in diameters of 4.5mm and 5.5mm sizes. The screw-in anchor is pre-assembled onto a stainless steel inserter and pre-loaded with up to three strands of suture.
F. Intended Use
The 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:
Knee:
Shoulder:
-Bankart lesion repairs -Slap lesion repairs -Capsular shift or capsulolabral reconstructions . -Acromioclavicular separation repairs -Deltoid repairs -Rotator cuff tear repairs -Biceps tenodesis
Foot & Ankle:
-Hallux valgus repairs -Medial or lateral instability
repairs/reconstructions
-Achilles tendon repairs/reconstruction
- -Midfoot reconstructions
-Metatarsal ligament/tendon repairs/reconstructions
-Extra-capsular repairs: -Medial collateral ligament -Lateral collateral ligament -Posterior oblique ligament -Patellar realignment and tendon repairs: -Vastus medialis obliquous
advancement -Iliotibial band tenodesis.
Elbow:
-Ulnar or radial collateral ligament reconstructions -Lateral epicondvlitis repair -Biceps tendon reattachment
Hip:
-Gluteal tendon repairs -Gluteus medius and gluteus minimus repair
G. Comparison of Technological Characteristics
The Smith & Nephew Next Generation Fully Threaded PEEK Suture Anchor is substantially equivalent in intended use, technological characteristics, and is as safe and effective as its currently marketed predicate devices, the Smith & Nephew TWINFIX FT PK (K072785), the Smith & Nephew TWINFIX AB 5.0 (K011299), and the Arthrex SwiveLock (K101823) suture anchors.
H. Summary Performance Data
The performance testing conducted demonstrates that the insertion and fixation properties of the Smith & Nephew Next Generation Fully Threaded PEEK Suture Anchor is substantially equivalent to the predicate TWINFIX AB 5.0 suture anchor, cleared via 510(k) K011299. The testing demonstrates that the differences between the new device and the predicate device do not raise any new issues of safety and efficacy.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the central emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Smith & Nephew, Inc. % Ms. Elizabeth Lavelle Sr. Regulatory Affairs Specialist 1 50 Minuteman Road Andover, Massachusetts 01810
JUN 2 4 2011
Re: K110545
Trade/Device Name: Smith & Nephew Next Generation Fully Threaded PEEK 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: May 5, 2011 Received: May 6, 2011
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.
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Page 2 - Ms. Elizabeth Lavelle
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.
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/default.htm.
Sincerely vours.
Sincerely, yours,
Eriel Keith
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: Smith & Nephew Next Generation Fully Threaded PEEK Suture Anchor
Indications For Use:
The 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:
Bankart lesion repairs Slap lesion repairs Capsular shift or capsulolabral reconstructions Acromioclavicular separation repairs Deltoid repairs Rotator cuff tear repairs Biceps tenodesis
Foot & Ankle: Hallux valgus repairs Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstruction Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions
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.
Elbow: Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Biceps tendon reattachment
Hip: Gluteal tendon repairs - Gluteus medius and gluteus minimus repair
Prescription Use AND/OR
(Per 21 CFR 801 Subpart D)
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)
Jr M. Adkerson
(Division Sign Oft) (Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K110545
23
§ 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.