(61 days)
Not Found
No
The summary describes a mechanical suture anchor made of PEEK and preloaded with suture. There is no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is described as a 'suture anchor' intended for the 'reattachment of soft tissue to bone' for various indications related to musculoskeletal repairs, which directly aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No.
The document describes a suture anchor used for reattaching soft tissue to bone, which is a therapeutic device, not a diagnostic one.
No
The device description clearly states the device is a suture anchor manufactured from PEEK and includes physical components like suture and a stainless steel inserter. This indicates it is a physical medical device, not software-only.
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 reattaching soft tissue to bone in various anatomical locations (Shoulder, Foot/Ankle, Knee, Elbow). This is a direct surgical intervention on the body.
- Device Description: The device is a suture anchor made of PEEK with preloaded suture. This is a physical implantable device used during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) during a surgical procedure.
N/A
Intended Use / Indications for Use
The Smith & Nephew TWINFIX Ultra 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
Foot/Ankle:
Hallux valgus repairs repairs/reconstructions Medial or lateral instability Achilles tendon repairs/reconstructions Knee: Extra-capsular repairs: Medial collateral ligament Lateral collateral ligament Posterior oblique ligament Patellar realignment and tendon repairs: Vastus medialis obliquious advancement Illiotibial band tenodesis.
Elbow:
Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Biceps tendon reattachment Metatarsal ligament/tendon repairs/reconstruction Midfoot reconstructions
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The TWINFIX Ultra PK is a suture anchor manufactured from PEEK (polyetheretherketone) 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Foot/Ankle, Knee, Elbow
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 demonstrates that the insertion and fixation properties of the Smith & Nephew TWINFIX Ultra PK suture anchor is substantially equivalent to the predicate TWINFIX FT PK suture anchor, cleared via K072875. The testing also demonstrates that the differences in the new device and the predicate device do not raise any new issues of safety and efficacy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Traditional 510(k) Section IV
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 TWINFIX Ultra PK Suture Anchor
Date Prepared: October 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: FAX: (508) 261-3620
C. Device Name
| Trade Name: | TWINFIX Ultra PK Suture Anchor |
|---|---|
| Common Name: | Suture Anchor |
| Classification Name: | Fastener, fixation, non-degradable, soft tissue |
D. Predicate Devices
The Smith & Nephew TWINFIX Ultra PK Anchor is substantially equivalent in Intended Use and fundamental scientific technology to the legally marketed Smith & Nephew TWINFIX PK FT Suture Anchor cleared via K072875.
E. Description of Device
The TWINFIX Ultra PK is a suture anchor manufactured from PEEK (polyetheretherketone) 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.
Image /page/0/Picture/18 description: The image contains the word "MATION" in large, bold, black font. The text is simple and isolated against a white background. The word appears to be a fragment, possibly part of a larger word or phrase.
1093228
DEC 1 5 2009
1
F. Intended Use
The Smith & Nephew TWINFIX Ultra 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
Foot/Ankle:
Hallux valgus repairs repairs/reconstructions Medial or lateral instability Achilles tendon repairs/reconstructions Knee: Extra-capsular repairs: Medial collateral ligament Lateral collateral ligament Posterior oblique ligament Patellar realignment and tendon repairs: Vastus medialis obliquious advancement Illiotibial band tenodesis.
Elbow:
Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Biceps tendon reattachment Metatarsal ligament/tendon repairs/reconstruction Midfoot reconstructions
G. Comparison of Technological Characteristics
| Device Characteristics | TWINFIX FT PK
Predicate Device | TWINFIX Ultra PK
Proposed Device |
|------------------------------------------|-----------------------------------|-------------------------------------|
| Device Design/Principles of
Operation | Tap-in/Screw-in anchor | Screw-in suture anchor |
| Materials | PEEK with polyethylene
suture | PEEK with polyethylene
suture |
2
| Sterilization Method | EO | EO |
|---|---|---|
| Intended Use | Attachment of soft tissue to bone | Attachment of soft tissue to bone |
| Indications for Use | Reattachment of soft tissue to bone in | |
| 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/reconstructions | ||
| Midfoot reconstructions | ||
| Metatarsal ligament/tendon | ||
| repairs/reconstruction | ||
| Knee: | ||
| Extra-capsular repairs: | ||
| Medial collateral ligament | ||
| Lateral collateral ligament | ||
| Posterior oblique ligament | ||
| Patellar realignment and tendon | ||
| repairs: | ||
| Vastus medialis obliquious | ||
| advancement | ||
| Illiotibial band tenodesis. | ||
| Elbow: | ||
| Ulnar or radial collateral ligament | ||
| reconstructions | ||
| Lateral epicondylitis repair | ||
| Biceps tendon reattachment | Reattachment of soft tissue to bone in | |
| 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/reconstructions | ||
| Midfoot reconstructions | ||
| Metatarsal ligament/tendon | ||
| repairs/reconstruction | ||
| Knee: | ||
| Extra-capsular repairs: | ||
| Medial collateral ligament | ||
| Lateral collateral ligament | ||
| Posterior oblique ligament | ||
| Patellar realignment and tendon | ||
| repairs: | ||
| Vastus medialis obliquious | ||
| advancement | ||
| Illiotibial band tenodesis. | ||
| Elbow: | ||
| Ulnar or radial collateral ligament | ||
| reconstructions | ||
| Lateral epicondylitis repair | ||
| Biceps tendon reattachment |
H. Summary Performance Data
The performance testing conducted demonstrates that the insertion and fixation properties of the Smith & Nephew TWINFIX Ultra PK suture anchor is substantially equivalent to the predicate TWINFIX FT PK suture anchor, cleared via K072875. The testing also demonstrates that the differences in the new device and the predicate device do not raise any new issues of safety and efficacy.
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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" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right. The eagle is depicted in a simple, abstract manner with flowing lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Smith & Nephew Inc., Endoscopy Division % Ms. Christina Flores Regulatory Affairs Specialist II 150 Minuteman Road Andover, Massachusetts 01810
DEC 1 5 2009
Re: K093228
Trade/Device Name: Smith & Nephew TWINFIX Ultra PK Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded bone fixation fasteners Regulatory Class: Class II Product Code: MBI Dated: October 14, 2009 Received: October 15, 2009
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 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
4
Page 2 - Ms. Christina Flores
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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Joxutii 3
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
Ko9 3228 510(k) Number (if known):
Device Name: Smith & Nephew TWINFIX Ultra PK Suture Anchor
Indications For Use:
The Smith & Nephew TWINFIX Ultra 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
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 obliquious advancement Illiotibial band tenodesis.
Elbow: Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Biceps tendon reattachment
Prescription Use _ x_
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) | ||
|---|---|---|
| Division sign-off) | MXM | |
| Division of Surgical, Orthopedic, |
and Restorative Devices
510(k) Number K093228
P, lot 1