(153 days)
The Smith & Nephew TWINFIX Ultra Ti, PK, HA suture anchor families are intended for use for the reattachment of soft tissue to bone for the following indications:
Shoulder
Bankart lesion repairs SLAP lesion repairs Acromioclavicular separation repairs Rotator cuff tear repairs Capsular shift or capsulolabral reconstructions Biceps tenodesis Deltoid repairs
Foot and Ankle Hallux valgus repairs Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstructions Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions
Elbow
Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Biceps tendon reattachment
Knee
Extra-capsular repairs: Medial collateral ligament Lateral collateral ligament Posterior oblique ligament Iliotibial band tenodesis Patellar realignment and tendon repairs: Vastus medialis obliquous advancement
Hip Abductor tendon repair
The TWINFIX Ultra Ti suture anchor is manufactured from titanium, the TWINFIX Ultra PK suture anchor manufactured from polyetheretherketone grade LT3 and the TWINFIX Ultra HA suture anchor is manufactured from poly 1lactide/hydroxylapatite. All anchors are offered in diameters of 4.5, 5.5, and 6.5 mm sizes. The screw-in anchor is preloaded with suture, preassembled onto a stainless steel inserter and offered with and without needles.
The provided text describes an Indication Expansion for a medical device (TWINFIX Ultra Ti, PK, and HA suture anchors), seeking to add "Abductor tendon repair" to its intended uses. The submission focuses on demonstrating substantial equivalence to predicate devices and does not describe a study to establish new acceptance criteria or device performance for the new indication alone.
Instead, the submission states that:
- "The performance testing conducted includes static loading, dynamic loading and in vitro degradation properties that are substantially equivalent to the indicated predicates." (Section H)
- "Testing also demonstrates that the differences in the TWINFIX Ultra Ti, PK and HA families and the predicate devices do not raise any new issues of safety and efficacy." (Section H)
- "Since there are no changes to the design the technological characteristics remain the same." (Section G)
Therefore, the acceptance criteria are implicitly those established for the predicate devices and for general suture anchors, with the new indication being supported by demonstrating that the device's performance characteristics (static loading, dynamic loading, degradation properties) are equivalent to those already accepted for similar devices with similar indications. No new, specific acceptance criteria for "Abductor tendon repair" or a dedicated study for it are detailed.
Given this, I cannot fill the requested table or answer most of the questions about a new study proving devices meet acceptance criteria as such a study is not described in the provided text. The document is a 510(k) summary focused on demonstrating substantial equivalence rather than presenting new performance study data for novel acceptance criteria.
However, I can extract the following relevant information based on the premise of substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Static loading properties (of predicate devices/suture anchors) | Substantially equivalent to indicated predicates |
| Dynamic loading properties (of predicate devices/suture anchors) | Substantially equivalent to indicated predicates |
| In vitro degradation properties (of predicate HA devices) | Substantially equivalent to indicated predicates (for HA anchors) |
| No new issues of safety and efficacy | Differences in device families and predicates do not raise new safety/efficacy issues |
The rest of the questions relate to a specific study demonstrating device performance against new acceptance criteria. Since this document focuses on substantial equivalence to existing devices and does not describe such a study for the indication expansion, I cannot answer them from the given text.
To reiterate, the provided text is a 510(k) summary for an indication expansion, which relies on demonstrating that the performance of the device (TWINFIX Ultra Ti, PK, and HA suture anchors) for the new indication (Abductor tendon repair) is substantially equivalent to that of already legally marketed predicate devices. It does not describe a de novo study to establish new performance criteria or a new study with the details requested in points 2-9 for the expanded indication.
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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.
Indication Expansion - TWINFIX Ultra Ti, PK and HA suture anchors
Date Prepared: August 26, 2011
A. Submitter's Name:
.
Smith & Nephew, Inc., Endoscopy Division
150 Minuteman Road
Andover MA, 01810
B. Company Contact
Melissa Egan, M.Sc. Regulatory Affairs Specialist II Phone: (508) 261-3645 FAX: (508) 261-3620
C. Device Name
| Trade Name | TWINFIX Ultra HA | TWINFIX Ultra Ti, PK |
|---|---|---|
| Common Name | Suture Anchor | Suture Anchor |
| Classification | Fastener, fixation,biodegradable, softtissue | Fastener, fixation,nondegradable, soft tissue |
D. Predicate Devices
The indication of abductor tendon repair is substantially equivalent to the currently marketed indications for use of the following legally marketed device in commercial distribution: The Smith & Nephew Next Generation Fully Threaded Suture Anchor (NGFTSA) (K110545), Smith & Nephew TWINFIX Ultra Ti Suture Anchor (K100159), Smith & Nephew TWINFIX Ultra PK Suture Anchor (K093228), Smith & Nephew TWINFIX Ultra HA Suture Anchor (K093844) and Arthrex Corkscrew Suture Anchor (K061665).
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E. Description of Device
The TWINFIX Ultra Ti suture anchor is manufactured from titanium, the TWINFIX Ultra PK suture anchor manufactured from polyetheretherketone grade LT3 and the TWINFIX Ultra HA suture anchor is manufactured from poly 1lactide/hydroxylapatite. All anchors are offered in diameters of 4.5, 5.5, and 6.5 mm sizes. The screw-in anchor is preloaded with suture, preassembled onto a stainless steel inserter and offered with and without needles.
F. Intended Use
The intended use of the currently available suture anchors remains unchanged with the addition of abductor repair. The suture anchors are intended for the reattachment of soft tissue to bone for the following indications.
Shoulder
Bankart lesion repairs SLAP lesion repairs Acromioclavicular separation repairs Rotator cuff tear repairs Capsular shift or capsulolabral reconstructions Biceps tenodesis Deltoid repairs
Foot and Ankle
Hallux valgus repairs
Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstructions Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions
- Elbow
Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Biceps tendon reattachment
Knee
Extra-capsular repairs: Medial collateral ligament Lateral collateral ligament Posterior oblique ligament
Iliotibial band tenodesis
Patellar realignment and tendon repairs:
Vastus medialis obliquous advancement
Hip
Abductor tendon repair
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G. Comparison of Technological Characteristics
Since there are no changes to the design the technological characteristics remain the same.
H. Summary Performance Data
The performance testing conducted includes static loading, dynamic loading and in vitro degradation properties that are substantially equivalent to the indicated predicates. Testing also demonstrates that the differences in the TWINFIX Ultra Ti, PK and HA families and the predicate devices do not raise any new issues of safety and efficacy.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and 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, composed of three curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Smith & Nephew, Incorporated, Endoscopy Division % Melissa Egan, M.Sc. Regulatory Affairs Specialist II 150 Minuteman Road Andover, Massachusetts 01810
JAN 3 1 2012
Re: K112526
Trade/Device Name: TWINFIX Ultra Ti, PK and HA suture anchors Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: January 19, 2012 Received: January 20, 2012
Dear Ms. Egan:
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.
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Page 2 - Melissa Egan, M.Sc.
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 yours,
Mark N. Melkerson
Director
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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KII2526 (11)
$I.D
Indications for Use
510(k) Number (if known):
Device Name: TWINFIX Ultra Ti, PK, HA suture anchor
Indications for Use:
The Smith & Nephew TWINFIX Ultra Ti, PK, HA suture anchor families are intended for use for the reattachment of soft tissue to bone for the following indications:
Shoulder
Bankart lesion repairs SLAP lesion repairs Acromioclavicular separation repairs Rotator cuff tear repairs Capsular shift or capsulolabral reconstructions Biceps tenodesis Deltoid repairs
Foot and Ankle Hallux valgus repairs Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstructions Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions
Elbow
Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Biceps tendon reattachment
Knee
Extra-capsular repairs: Medial collateral ligament Lateral collateral ligament Posterior oblique ligament Iliotibial band tenodesis Patellar realignment and tendon repairs: Vastus medialis obliquous advancement
Hip Abductor tendon 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)
D. B. Neal
(Division Sien-Off) Divis on of Surges), Orthopedic, and Restorative Devices
510(k) Number K112526
§ 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.