(70 days)
K070908, 011219
KINSA RC, TWINFIX AB
No
The 510(k) summary describes a mechanical suture anchor and does not mention any AI or ML components or functionalities.
Yes
The device is described as "suture anchors" intended for reattachment of soft tissue to bone for various indications like Bankhart Repair, SLAP lesion repairs, and Rotator Cuff tear repairs. These are therapeutic uses, as they are used to treat a medical condition or injury.
No
The device description and intended use clearly state that it is a suture anchor used for reattaching soft tissue to bone, which is a therapeutic or reconstructive function, not a diagnostic one.
No
The device description clearly states it is a suture anchor manufactured from PEEK with suture on a stainless steel inserter, indicating it is a physical medical device, 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 perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The provided information clearly describes a surgical implant (suture anchor) used to physically reattach soft tissue to bone during surgical procedures. It is used in vivo (within the body), not in vitro (outside the body).
- Lack of IVD Characteristics: The description does not mention any testing of biological samples, analysis of bodily fluids, or diagnostic purposes.
Therefore, based on the provided information, the Smith & Nephew TWINFIX FT PK suture anchor is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Smith & Nephew TWINFIX FT PK suture anchors are intended for use for the reattachment of soft tissue to bone for the following indications:
Shoulder:
Bankhart Repair
SLAP lesion repairs
Capsular Shift or capsulolabral Reconstructions
Acromioclavicular separation repairs
Deltoid Repairs
Rotator Cuff tear repairs
Biceps tenodesis
Foot and Ankle:
Hallux valgus repairs
Medial or lateral instablility 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
Patellar realignment and tendon repairs:
vastus medialis obliquous advancement
Iliotibial band tenodesis
Product codes
HWC, MBI, JDR
Device Description
Preloaded 5.5/6.5 mm suture anchor manufactured from PEEK (polyaryletherkeone) incorporating ultra high molecular weight polyethelene suture on 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, Elbow, Knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
The performance testing conducted includes bench testing that demonstrates substantial equivalence to KINSA RC and TWINFIX AB.
Key Metrics
Not Found
Predicate Device(s)
K070908, 011219
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
K.72785 page 42
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.
TWINFIX FT PK
Date Prepared: September 28, 2007
A. Submitter's Name:
Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road
Andover MA, 01810
DEC 1 0 2007
15
B. Company Contact
Deana Boushell
Principle Regulatory Affairs Specialist
(508) 337-4036 Phone:
FAX: (508) 261-3620
C. Device Name
.
| Trade Name: | TWINFIX FT PK |
|---|---|
| Common Name: | Suture Anchor |
| Classification Name: | Fastener, Fixation, |
Non-degradable, soft tissue
D. Predicate Devices
The TWINFIX FT PK Suture Anchor is substantially equivalent to the Smith & Nephew KINSA RC (K070908) and TWINFIX AB (011219).
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page 2/2
E. Description of Device
Preloaded 5.5/6.5 mm suture anchor manufactured from PEEK (polyaryletherkeone) incorporating ultra high molecular weight polyethelene suture on a stainless steel inserter.
F. Intended Use
The suture anchors are intended for the fixation of soft tissue to bone.
G. Comparison of Technological Characteristics
| Device
| Characteristics | Predicate Devices | Proposed Devices | |
|---|---|---|---|
| TWINFIX AB | KINSA RC | TWINFIX FT PK | |
| Device Design/Principles of | |||
| Operation | Screw in Suture | ||
| Anchor | Tap and Twist | ||
| Suture Anchor | Tap and Twist Suture Anchor | ||
| Materials | PLLA with | ||
| Polyethelene | |||
| Suture | PEEK with | ||
| Polyethelene | |||
| Suture | PEEK with Polyethelene | ||
| Suture | |||
| Sterilization Method | EO | EO | EO |
| Intended Use | Attachment of soft | ||
| tissue to bone | Attachment of soft | ||
| tissue to bone | Attachment of soft tissue to | ||
| bone | |||
| Indications for Use | Reattachment of | ||
| soft tissue to bone | |||
| in the Shoulder, | |||
| Foot, Ankle, Elbow, | |||
| Knee | Reattachment of | ||
| soft tissue to bone | |||
| in the rotator cuff. | Reattachment of soft tissue to | ||
| bone in the Shoulder, Foot, | |||
| Ankle, Elbow, Knee |
H. Summary Performance Data
The performance testing conducted includes bench testing that demonstrates substantial equivalence to KINSA RC and TWINFIX AB.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an abstract design that resembles a bird or a person with outstretched arms.
DEC 1 0 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Smith & Nephew, Inc., Endoscopy Division % Ms. Deana Boushell 150 Minuteman Road Andover MA 01810
Re: K072785
Trade/Device Name: TwinFix FT PK Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, MBI, JDR Dated: September 28, 2007 Received: October 1, 2007
Dear Ms. Boushell:
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 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.
3
Page 2 - Ms. Deana Boushell
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Millison
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: TWINFIX FT PK
Indications For Use:
The Smith & Nephew TWINFIX FT PK suture anchors are intended for use for the reattachment of soft tissue to bone for the following indications:
| Shoulder | Elbow | |
|---|---|---|
| Bankhart Repair | Ulnar or radial collateral ligament | |
| reconstructions | ||
| SLAP lesion repairs | Lateral epicondylitis repair | |
| Capsular Shift or capsulolabral Reconstructions | Biceps tendon reattachment | |
| Acromioclavicular separation repairs | ||
| Deltoid Repairs | Knee | |
| Rotator Cuff tear repairs | Extra-capsular repairs: | |
| Biceps tenodesis | medial collateral ligament | |
| lateral collateral ligament | ||
| Foot and Ankle | posterior oblique ligament | |
| Hallux valgus repairs | Patellar realignment and tendon repairs: | |
| Medial or lateral instablility | ||
| repairs/reconstructions | vastus medialis obliquous advancement | |
| Achilles tendon repairs/reconstructions | Iliotibial band tenodesis | |
| Midfoot reconstructions | ||
| Metatarsal ligament/tendon | ||
| repairs/reconstructions | ||
| Prescription Use | ||
| X | AND/OR | Over-The-Counter Use No |
iption Use
(21 CFR 807 Subpart C)
ter Use No
(Per 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
barbare Bneun
-
Restoraci E Division of Gener and Neurological Devices
510(k) Number K072288
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