CINCH BONE ANCHOR SYSTEM

K062739 · Sapphire Medical, Inc. · MBI · Feb 13, 2007 · Orthopedic

Device Facts

• Record ID: K062739
• Device Name: CINCH BONE ANCHOR SYSTEM
• Applicant: Sapphire Medical, Inc.
• Product Code: MBI · Orthopedic
• Decision Date: Feb 13, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CINCH Bone Anchor System is intended to be used for fixation of soft tissue to bone during rotator cuff repair.

Device Story

The CINCH Bone Anchor System is a surgical fixation device used during arthroscopic shoulder procedures to attach soft tissue to bone. It consists of a pre-loaded delivery instrument containing either a WRC (curved PEEK base) or RRC (cylindrical PEEK base) anchor configuration, featuring nitinol clips, rings, and an anchor pin. Surgeons operate the device to secure sutures without the need for traditional knot-tying. The design allows for direct tactile feedback regarding suture tension and enables individual adjustment of suture ends for precise tissue-to-bone placement. By facilitating fine-tuned tissue positioning and knotless fixation, the device aims to improve the efficiency and accuracy of rotator cuff repairs.

Clinical Evidence

Bench testing only. Results demonstrate the device meets all performance specifications and functions as intended, raising no new issues of safety or effectiveness.

Technological Characteristics

Materials: PEEK base, nitinol clip, nitinol rings, nitinol anchor pin. Principle: Mechanical bone fixation fastener. Form factor: Pre-loaded delivery instrument with two configurations (WRC and RRC). Biocompatible materials consistent with similar predicate devices.

Indications for Use

Indicated for fixation of soft tissue to bone during rotator cuff repair in patients undergoing arthroscopic shoulder procedures.

Regulatory Classification

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.

Predicate Devices

• DePuy/Mitek Products, Rotator Cuff QuickAnchor® Plus
• Linvatec Corporation, UltraFix® RC
• ArthroCare Corporation, Opus® Magnum
• Arthrex, Inc., PEEK Corkscrew FT
• Smith & Nephew, Inc., BioRaptor 2.9 Suture Anchor

Submission Summary (Full Text)

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#### 510(k) SUMMARY

SAPPHIRE MEDICAL, INC. CINCH™ BONE ANCHOR SYSTEM

FEB 1 3 2007

# Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Sapphire Medical, Inc 690 Oak Grove Avenue Menlo Park, CA 94025

Phone: [phone] Facsimile: 650-322-3546

Contact Person: Brooke Campbell

Date Prepared: September 13, 2006

# Name of Device and Name/Address of Sponsor

CINCH Bone Anchor System

Sapphire Medical, Inc 690 Oak Grove Avenue Menlo Park, CA 94025

#### Common or Usual Name

Bone Anchor

## Classification Name

Class II Classification: Classification Name: Fastener, fixation, nondegradable, soft tissue.

### Predicate Devices

- DePuy/Mitek Products, Rotator Cuff QuickAnchor® Plus .
- Linvatec Corporation, UltraFix® RC .
- ArthroCare Corporation, Opus® Magnum .
- Arthrex, Inc., PEEK Corkscrew FT ●
- Smith & Nephew, Inc., BioRaptor 2.9 Suture Anchor .

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#### Intended Use / Indications for Use

The CINCH Bone Anchor System is intended to be used for fixation of soft tissue to bone during rotator cuff repair.

#### Device Description

The CINCH Bone Anchor System provides surgeons with a fixation anchor that can be used during arthroscopic shoulder procedures. The device is available in two configurations, the CINCH WRC Anchor and the CINCH RRC Anchor. Both configurations are provided pre-loaded in a delivery instrument.

The CINCH WRC Anchor configuration is comprised of a curved PEEK base, a flared nitinol clip, two nitinol laser cut rings and a nitinol anchor pin. The device is preloaded in the CINCH Inserter

The CINCH RRC Anchor, is comprised of a machine molded cylindrical PEEK base, two nitinol laser cut rings and a nitinol anchor pin This device is also preloaded in a CINCH Inserter.

The design of the CINCH Bone Anchors is intended to permit surgeons to have direct tactile feedback of the tension in the suture between the tissue and the bone. Additionally, the CINCH Anchors are designed to allow the two ends of a suture to be individually adjusted. This permits the surgeon to fine-tune the placement of the tissue with respect to the bone, and then secure the suture without tying a knot.

#### Performance Data

Results of bench testing demonstrate that the CINCH Bone Anchor System meets its specifications and does not raise new issues of safety or effectiveness. In all instances, the CINCH Bone Anchor functioned as intended.

#### Biocompatibility Data

The materials used in the CINCH Bone Anchor System are biocompatible. The same materials are commonly used in similar medical devices.

#### Substantial Equivalence

The CINCH Bone Anchor System is substantially equivalent to the DePuy/Mitek Products' Rotator Cuff QuickAnchor® Plus, Arthrex, Inc.'s PEEK Corkscrew FT, Smith & Nephew, Inc.'s BioRaptor 2.9 Suture Anchor, and Linvatec Corporation's UltraFix® RC. The CINCH Bone Anchor System has the same intended uses and similar indications, technological characteristics, and principles of operation as the predicate devices. The minor technological differences between the CINCH Bone Anchor System and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the CINCH Bone Anchor System is as safe and effective as the predicate devices. Thus, the CINCH Bone Anchor System is substantially equivalent.

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# Summary

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Based on the intended use, technological characteristics, and performance information Based on this notification, the subject device has been shown to be substantially provided in this nothriouncil, the such predicate devices.

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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 stylized eagle or bird-like figure with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Sapphire Medical, Inc. % Janice M. Hogan, Esq. Partner Hogan & Hartson, L.L.P. 1835 Market Street, 28th Floor Philadelphia, Pennsylvania 19103

FEB 1 3 2007

Re: K062739

> Trade/Device Name: CINCH Bone Anchor System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: January 26, 2007 Received: January 26, 2007

Dear Ms. Hogan:

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.

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## Page 2 - Janice M. Hogan, Esq.

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. 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Budara Muehlus

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 Statement

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: CINCH Bone Anchor System

Indications for Use:

The CINCH Bone Anchor System is intended for the fixation of soft tissue to bone during rotator cuff repair.

Prescription Use X (Part 21 C.F.R. 801 Subpart D) AND/OR

Over-The-Counter Use (21 C.F.R. 807 Subpart C)

## (PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Oalbara Barehn
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number K062739

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