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)

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.

AI/ML Overview

The provided document is a 510(k) summary for the TWINFIX FT PK Suture Anchor. It primarily focuses on demonstrating substantial equivalence to predicate devices through a comparison of technological characteristics and performance data. The document does not contain the specific information requested in the prompt regarding acceptance criteria, a study proving the device meets those criteria, sample sizes for test/training sets, ground truth establishment, expert qualifications, or MRMC studies for AI devices.

Instead, the document describes a traditional medical device (suture anchor) and its regulatory approval process, which relies on bench testing and comparison to existing similar devices.

Therefore, I cannot extract the requested information from the provided text because it is not an AI/ML device and the document does not discuss those evaluation metrics.

Summary

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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

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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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

DeviceCharacteristics	Predicate Devices	Proposed Devices
	TWINFIX AB	KINSA RC	TWINFIX FT PK
Device Design/Principles ofOperation	Screw in SutureAnchor	Tap and TwistSuture Anchor	Tap and Twist Suture Anchor
Materials	PLLA withPolyetheleneSuture	PEEK withPolyetheleneSuture	PEEK with PolyetheleneSuture
Sterilization Method	EO	EO	EO
Intended Use	Attachment of softtissue to bone	Attachment of softtissue to bone	Attachment of soft tissue tobone
Indications for Use	Reattachment ofsoft tissue to bonein the Shoulder,Foot, Ankle, Elbow,Knee	Reattachment ofsoft tissue to bonein the rotator cuff.	Reattachment of soft tissue tobone 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.

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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 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.

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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

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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 ligamentreconstructions
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 instablilityrepairs/reconstructions		vastus medialis obliquous advancement
Achilles tendon repairs/reconstructions		Iliotibial band tenodesis
Midfoot reconstructions
Metatarsal ligament/tendonrepairs/reconstructions


Prescription UseX	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

ğı.D

Regulation Number and Section

§ 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.