K Number
K163034
Device Name
SUTUREFIX Curved Suture Anchor
Date Cleared
2016-12-07

(37 days)

Product Code
Regulation Number
888.3040
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Smith & Nephew SUTUREFIX Curved Suture Anchors are intended for the secure fixation of soft tissue to bone for the following indications: Hip • Acetabular labrum repair/reconstruction Shoulder - · Capsular stabilization - Bankart repair - Anterior shoulder instability - SLAP lesion repairs - Capsular shift or capsulolabral reconstructions - Rotator cuff tear repairs - Bicepts tenodesis
Device Description
The Smith & Nephew SUTUREFIX Curved suture anchor system consists of an all suture based implant, hole preparation, and curved insertion accessory instruments. The implant will be offered in multiple suture configurations including single and double loaded suture options. The instruments will include sterile flexible drills and reusable curved drill guides and obturators.
More Information

No
The summary describes a mechanical suture anchor system and its intended use, with no mention of AI or ML technology in the device description, intended use, or performance studies.

No
The device is described as an all-suture-based implant intended for secure fixation of soft tissue to bone, which functions as a surgical anchor rather than directly providing therapy.

No
The device is a surgical anchor used for the fixation of soft tissue to bone, not for diagnosing medical conditions.

No

The device description explicitly details physical components including an all-suture based implant, drills, drill guides, and obturators, indicating it is a hardware 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 states the device is for "secure fixation of soft tissue to bone" for specific surgical procedures in the hip and shoulder. This is a therapeutic/surgical intervention, not a diagnostic test performed on samples from the body.
  • Device Description: The description details a surgical implant (suture anchor) and associated instruments for insertion. This aligns with a surgical device, not a diagnostic one.
  • Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.

IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.

N/A

Intended Use / Indications for Use

The Smith & Nephew SUTUREFIX Curved Suture Anchors are intended for the secure fixation of soft tissue to bone for the following indications:

Hip
• Acetabular labrum repair/reconstruction

Shoulder

  • Capsular stabilization
  • Bankart repair
  • Anterior shoulder instability
  • SLAP lesion repairs
  • Capsular shift or capsulolabral reconstructions
  • Rotator cuff tear repairs
  • Bicepts tenodesis

Product codes

MBI

Device Description

The Smith & Nephew SUTUREFIX Curved suture anchor system consists of an all suture based implant, hole preparation, and curved insertion accessory instruments. The implant will be offered in multiple suture configurations including single and double loaded suture options. The instruments will include sterile flexible drills and reusable curved drill guides and obturators.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Hip, Shoulder

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)

Bacterial endotoxin testing was completed and met acceptable endotoxin limits per ANSI/AAMI ST72:2011. Performance data demonstrates that the SUTUREFIX Curved Suture Anchor has met performance specifications for insertion strength and pull-out strength and therefore, is considered substantially equivalent to the currently marketed predicate devices.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K122059, K102660

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.

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other, with a flowing ribbon-like element extending from the bottom profile.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 7, 2016

Smith and Nephew, Inc. Ms. Anne-Marie Keefe Senior Regulatory Affairs Specialist 150 Minuteman Road Andover, Massachusetts 01810

Re: K163034

Trade/Device Name: SUTUREFIX Curved Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: October 28, 2016 Received: October 31, 2016

Dear Ms. Keefe:

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 and 8091); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

1

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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.

Mark N. Melkerson -S

Mark N. Melkerson Division Director Division of Orthopaedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K163034

Device Name

SUTUREFIX Curved Suture Anchor

Indications for Use (Describe)

The Smith & Nephew SUTUREFIX Curved Suture Anchors are intended for the secure fixation of soft tissue to bone for the following indications:

Hip

• Acetabular labrum repair/reconstruction

Shoulder

  • Capsular stabilization
  • Bankart repair
  • Anterior shoulder instability
  • SLAP lesion repairs
  • Capsular shift or capsulolabral reconstructions
  • Rotator cuff tear repairs
  • Bicepts tenodesis

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)Over-The-Counter Use (21 CFR 801 Subpart C)

Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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T 978-749-1000 978-749-1443 www.smith-nephew.com

Image /page/3/Picture/2 description: The image shows the Smith & Nephew logo. The logo consists of an orange flower-like symbol on the left, followed by the text "We are smith&nephew" in a combination of gray and orange colors. The words "We are" are in gray, while "smith&nephew" is in orange.

510(k) Summary

Prepared: 29 November 2016

Submitter InformationContact Information
Smith & Nephew, Inc.
Endoscopy Division
150 Minuteman Road
Andover, MA 01810Anne-Marie Keefe
Senior Regulatory Affairs Specialist
Phone: (508) 261-3713
Fax: (978) 749-1443
Device Name & Classification
Proprietary NameSUTUREFIX Curved Suture Anchor
Common NameSoft Tissue Fixation Device
Classification NameFastener, fixation, nondegradable, soft tissue
Classification Regulation21 CFR 888.3040
ClassII
Product Code(s)MBI
PanelOrthopedic

Legally Marketed Predicate Devices

The Smith & Nephew SUTUREFIX Curved Suture Anchor is substantially equivalent in intended use and Fundamental Scientific Technology to the following legally marketed devices in commercial distribution:

| Description | Submission
Number | Clearance Date |
|--------------------------------|----------------------|-------------------|
| SUTUREFIX All Suture Anchor | K122059 | March 18, 2013 |
| BIORAPTOR 2.3 PK Suture Anchor | K102660 | December 13, 2010 |

Device Description

The Smith & Nephew SUTUREFIX Curved suture anchor system consists of an all suture based implant, hole preparation, and curved insertion accessory instruments. The implant will be offered in multiple suture configurations including single and double loaded suture options. The instruments will include sterile flexible drills and reusable curved drill guides and obturators.

4

Intended Use

The Smith & Nephew SUTUREFIX Curved Suture Anchors are intended for the secure fixation of soft tissue to bone for the following indications:

Hip

• Acetabular labrum repair/reconstruction

Shoulder

  • · Capsular stabilization
  • Bankart repair
  • Anterior shoulder instability
  • SLAP lesion repairs
  • Capsular shift or capsulolabral reconstructions
  • Rotator cuff tear repairs
  • Bicepts tenodesis

Technological Characteristics

The Smith & Nephew SUTUREFIX Curved Suture Anchor is substantially equivalent in intended use and fundamental scientific technology to the legally marketed predicate devices - Smith and Nephew SUTUREFIX Ultra Suture Anchor (K122059), and the BIORAPTOR 2.3 PK Suture Anchor (K102660), and raises no new issues of safety and efficacy. The Smith & Nephew SUTUREFIX Curved Suture Anchor and the predicate SUTUREFIX Ultra Suture Anchor use the identical component materials, and all-suture based implant configurations. The Smith & Nephew SUTUREFIX Curved Suture Anchor and the predicate BIORAPTOR 2.3 PK Suture Anchor share the same curved, anchor delivery system.

Summary Performance Data

Bacterial endotoxin testing was completed and met acceptable endotoxin limits per ANSI/AAMI ST72:2011. Performance data demonstrates that the SUTUREFIX Curved Suture Anchor has met performance specifications for insertion strength and pull-out strength and therefore, is considered substantially equivalent to the currently marketed predicate devices.

Substantial Equivalence Information

The substantial equivalence of the SUTUREFIX Curved Suture Anchor is based on similarities in indications for use, design features, operational principles, material biocompatibility and composition, and performance to the predicate devices listed above. Based on the similarities to the predicates, the SUTUREFIX Curved Suture Anchor is substantially equivalent to its predicates.