(153 days)
No
The device description and performance studies focus on the material properties and mechanical performance of suture anchors, with no mention of AI or ML.
Yes
The device is described as a "suture anchor" intended for "reattachment of soft tissue to bone," which directly addresses injuries or conditions and restores function, fitting the definition of a therapeutic device.
No
This device is a surgical implant (suture anchor) used for reattaching soft tissue to bone, not for diagnosing medical conditions.
No
The device description explicitly states the device is manufactured from titanium, polyetheretherketone, or poly 1lactide/hydroxylapatite, and is a screw-in anchor preloaded with suture, preassembled onto a stainless steel inserter. These are all physical components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided text clearly describes a suture anchor, which is a surgical implant used to reattach soft tissue to bone. This is a device used within the body during a surgical procedure, not for testing specimens outside the body.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples, chemical reactions, or diagnostic testing.
Therefore, based on the provided information, the Smith & Nephew TWINFIX Ultra suture anchor families are not IVDs. They are surgical implants.
N/A
Intended Use / Indications for Use
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
Product codes
MBI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Foot and Ankle, Elbow, Knee, 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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K110545, K100159, K093228, K093844, K061665
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
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, soft | ||
| tissue | 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).
1
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
2
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.
3
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.
4
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
5
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