(107 days)
The Smith & Nephew TWINFIX Ultra HA Suture Anchor is intended for use for the reattachment of soft tissue to bone for the following indications: Shoulder: Bankart 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/reconstructions Metatarsal ligament/tendon repairs/reconstructions Midfoot reconstructions Knee: Extra-capsular repairs: Medial collateral ligament Lateral collateral ligament Posterior oblique ligament Patellar realignment and tendon repairs: Vastus medialis obliquous advancement Illiotibial band tenodesis. Elbow: Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Biceps tendon reattachment
The TWINFIX Ultra HA is a suture anchor manufactured from PLLA-HA and is offered in diameters of 4.5, 5.5, and 6.5 mm sizes. The screw-in anchor is preloaded with ultra high molecular weight polyethylene suture preassembled onto a stainless steel inserter.
The provided document is a 510(k) summary for the Smith & Nephew TWINFIX Ultra HA Suture Anchor. It details the device's intended use and a comparison to predicate devices, but it does not contain the specific information required to answer the prompt regarding acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
The document states: "The performance testing conducted demonstrates that the insertion and fixation properties of the Smith & Nephew TWINFIX Ultra HA suture anchors are substantially equivalent to the predicates; Twinfix AB 5.0 cleared via K011299 and the Twinfix AB 6.5 cleared via K032197."
However, it does not provide the actual acceptance criteria or the reported device performance metrics from these tests. It only makes a general statement about substantial equivalence.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or other detailed study information as requested.
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K0938414.
SECTION IV 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
As required by the Safe Medical Devices Act of 1990 and codified in 21 CEER 80722 பர upon which the substantial equivalence is based.
Smith & Nephew TWINFIX Ultra HA Suture Anchor
APR -1 2010
Date Prepared: December 14, 2009
A. Submitter's Name:
Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road Andover MA, 01810
B. Company Contact
Christina Flores Regulatory Affairs Specialist II (508) 261-3705 Phone: (508) 261-3620 FAX:
C. Device Name
| Trade Name: | TWINFIX Ultra HA Suture Anchor |
|---|---|
| Common Name: | Suture Anchor |
| Classification Name: | Fastener, fixation, bioabsorbable, soft tissue |
D. Predicate Devices
The Smith & Nephew TWINFIX Ultra HA Anchor is substantially equivalent in Intended Use and fundamental scientific technology to the following legally marketed Smith & Nephew anchors: Twinfix AB 5.0 (K011299), Twinfix AB 6.5 (K032197), Twinfix FT PK (072785), and Osteoraptor (K082215).
Description of Device E.
The TWINFIX Ultra HA is a suture anchor manufactured from PLLA-HA and is offered in diameters of 4.5, 5.5, and 6.5 mm sizes. The screw-in anchor is preloaded with ultra high molecular weight polyethylene suture preassembled onto a stainless steel inserter.
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F. Intended Use
The Smith & Nephew TWINFIX Ultra HA Suture Anchor is intended for use for the reattachment of soft tissue to bone for the following indications: Shoulder:
shoulder.
Bankart 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/reconstructions Metatarsal ligament/tendon repairs/reconstructions Midfoot reconstructions
Knee:
Extra-capsular repairs: Medial collateral ligament Lateral collateral ligament Posterior oblique ligament Patellar realignment and tendon repairs:
Vastus medialis obliquous advancement Illiotibial band tenodesis.
Elbow:
Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Biceps tendon reattachment
G. Comparison of Technological Characteristics
The Smith & Nephew TWINFIX Ultra PK suture anchor is substantially equivalent in intended use, technological characteristics, and are as safe and as effective as their currently marketed predicate devices, the Smith & Nephew Twinfix AB 5.0 (K011299), the Twinfix AB 6.5 (K032197), the Twinfix FT PK (072785), and the Osteoraptor anchors (K082215).
H. Summary Performance Data
The performance testing conducted demonstrates that the insertion and fixation properties of the Smith & Nephew TWINFIX Ultra HA suture anchors are substantially equivalent to the predicates; Twinfix AB 5.0 cleared via K011299and the Twinfix AB 6.5 cleared via K032197. The testing also demonstrates that the differences in the new device and the predicate devices do not raise any new issues of safety and efficacy.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol of medicine, with three lines forming a stylized bird-like shape. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Smith & Nephew, Inc. c/o Ms. Christina Flores Regulatory Affairs Specialist II 130 Forbes Boulevard Mansfield, Massachusetts 02048
APR 0 1 2010
. Re: K093844
Trade/Device Name: TWINFIX Ultra HA Suture Anchor Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: MAI Dated: March 17, 2010 Received: March 18, 2010
Dear Ms. Flores:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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
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Page 2 - Ms. Christina Flores
CFR Part 807); labeling (21 CFR Part 801); 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 note the 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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Sincerely yours,
Mark H. Milliken
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
KO938414 510(k) Number (if known):
Device Name: Smith & Nephew TWINFIX Ultra HA Suture Anchor
Indications For Use:
The Smith & Nephew TWINFIX Ultra HA Suture Anchor is intended for use for the reattachment of soft tissue to bone for the following indications:
Shoulder:
- Bankart 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:
Knee:
Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Biceps tendon reattachment
Prescription Use _____________________________________________________________________________________________________________________________________________________________
(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
FOR M. MELKERSIN
(Division Sign-Off)/
Division of Surgical, Orthopedic,
and Restorative Devices
510(k) Number K093844
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.