SURELOCK ALL-SUTURE ANCHOR WITH INSERTER, 1.4MM, SURELOCK ALL-SUTURE ANCHOR WITH INSERTER, 2.2MM

K132867 · Cayenne Medical, Inc. · MBI · Dec 30, 2013 · Orthopedic

Device Facts

• Record ID: K132867
• Device Name: SURELOCK ALL-SUTURE ANCHOR WITH INSERTER, 1.4MM, SURELOCK ALL-SUTURE ANCHOR WITH INSERTER, 2.2MM
• Applicant: Cayenne Medical, Inc.
• Product Code: MBI · Orthopedic
• Decision Date: Dec 30, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Cayenne Medical, Inc. SureLock™ All- Suture Anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures. The system may be used in either arthroscopic or open surgical procedures. After the anchor is deployed in the bone, the floating sutures can be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period. The Cayenne Medical, Inc. SureLock™ All-Suture Anchors are intended to be used for the reattachment of soft tissue to bone for the following indications: Shoulder: Capsular stabilization (Bankart repair, Anterior shoulder instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstructions), Acromioclavicular separation repairs, Deltoid repairs, Rotator cuff repairs, Biceps tenodesis. Foot and Ankle: Hallux valgus repairs, Medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, Mid and forefoot reconstructions, Metatarsal ligament/tendon repairs/reconstructions, Bunionectomy. Elbow: Ulnar or radial collateral ligament reconstruction, Lateral epicondylitis repair, Biceps tendon repair. Hand and Wrist: Collateral ligament repair, Scapholunate ligament reconstruction, Volar plate reconstruction, Tendon transfers in phalanx. Hip: Acetabular labral repair. Knee: Extra-capsular repairs (Medial collateral ligament, Lateral collateral ligament, Posterior oblique ligament), Patellar realignment and tendon repairs, Illiotibial band tenodesis, VMO advancement, Joint capsule closure.

Device Story

SureLock™ All-Suture Anchor is a sterile, manually operated, single-procedure device for reattaching soft tissue to bone. It consists of a preloaded UHMWPE suture anchor and a disposable stainless steel/ABS plastic inserter. During surgery (arthroscopic or open), the surgeon drills a hole in the bone, inserts the anchor, and rotates the inserter knob to tension the floating sutures, causing the anchor to expand and deploy within the bone tunnel. The inserter is then removed, leaving the anchor secured. The device stabilizes damaged tissue during the healing period. It is used by orthopedic surgeons in clinical settings. Benefits include secure soft tissue fixation to bone.

Clinical Evidence

Bench testing only. Mechanical pull-out strength testing was performed comparing the SureLock™ All-Suture Anchor to the predicate device. Results showed the ultimate pull-out strength of the subject device was comparable to the predicate.

Technological Characteristics

Materials: UHMWPE (non-absorbable) for anchors and sutures; stainless steel and ABS plastic for inserter. Principle: Mechanical expansion of suture construct via tensioning. Sizes: 1.4mm and 2.2mm. Sterilization: Ethylene oxide. Connectivity: None (manual device).

Indications for Use

Indicated for reattachment of soft tissue (ligaments, tendons, joint capsules) to bone in shoulder, foot/ankle, elbow, hand/wrist, hip, and knee orthopedic procedures. Suitable for arthroscopic or open surgery.

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

• ConMed Linvatec Y-Knot™ All-Suture Anchor (K111779)
• Riverpoint Medical HS Fiber Polyblend nonabsorbable surgical suture (K100006)
• Teleflex Medical ForceFiber® sutures (K040472, K070673, K092533, and K100506)

Submission Summary (Full Text)

{0}------------------------------------------------

# 510(k) Summary

DEC 30 2013

# Cayenne Medical, Inc.

SureLock™ All- Suture Anchor

# ADMINISTRATIVE INFORMATION

| Date of summary: | 10/07/2013 |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer Name: | Cayenne Medical, Inc.<br>16597 N. 92 ^nd St., Suite 101<br>Scottsdale, AZ 85260<br>Telephone [phone]<br>FAX [phone] |
| Official Contact: | Shima Hashemian<br>16597 N. 92 ^nd St., Suite 101<br>Scottsdale, AZ 85260<br>[e-mail]<br>Telephone [phone]<br>FAX [phone] |

#### DEVICE NAME

| Classification Name: | Smooth or threaded metallic bone fixation fastener |
|-------------------------|----------------------------------------------------|
| Trade/Proprietary Name: | SureLock™ All-Suture Anchor |
| Common Name: | Suture Anchor |

# DEVICE CLASSIFICATION

FDA has classified bone screws as Class II devices (21 CFR 888.3040). The product code for Fastener, Fixation, Nondegradable, and Soft Tissue is MBI. These devices are reviewed by the Orthopedic Joint Devices Branch.

#### INTENDED USE

The Cayenne Medical, Inc. SureLock™ All- Suture Anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures. The system may be used in either arthroscopic or open surgical procedures. After the anchor is deployed in the bone, the floating sutures can be used to reattach soft tissue, such as ligaments, tendons, or joint

{1}------------------------------------------------

capsules to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.

The Cayenne Medical, Inc. SureLock™ All-Suture Anchors are intended to be used for the reattachment of soft tissue to bone for the following indications:

### Shoulder

- | Capsular stabilization
- o Bankart repair
- Anterior shoulder instability o
- o SLAP lesion repairs
- o Capsular shift or capsulolabral reconstructions
- -Acromioclavicular separation repairs
- Deltoid repairs l
- -Rotator cuff repairs
- | Biceps tenodesis

# Foot and Ankle

- -Hallux valgus repairs
- Medial or lateral instability repairs/reconstructions --
- Achilles tendon repairs/reconstructions -
- Mid and forefoot reconstructions -
- Metatarsal ligament/tendon repairs/reconstructions -
- Bunionectomy —

#### Elbow

- -Ulnar or radial collateral ligament reconstruction
- -Lateral epicondylitis repair
- --Biceps tendon repair

#### Hand and Wrist

- Collateral ligament repair —
- Scapholunate ligament reconstruction -
- Volar plate reconstruction -
- -Tendon transfers in phalanx

# Hip

- -Acetabular labral repair
#### Knee

- -Extra-capsular repairs
- Medial collateral ligament o
- o Lateral collateral ligament

{2}------------------------------------------------

- o Posterior oblique ligament
- Patellar realignment and tendon repairs l
- Illiotibial band tenodesis ।
- VMO advancement
- -Joint capsule closure

## DEVICE DESCRIPTION

The SureLock™ All-Suture Anchor is a sterile (using ethylene oxide sterilization method), manually operated, single procedure all suture anchor device for reattachment of soft tissue to bone. The all-suture anchor is preloaded with floating suture and loaded on a disposable inserter. SureLock™ All-Suture Anchor incorporates design features that facilitate suture anchor placement under arthroscopic, open, or limited access conditions in soft tissue to bone reattachment procedures.

The SureLock™ All-Suture Anchor is offered in two different sizes, 1.4mm and 2.2mm. The anchors and floating sutures are made out of non-absorbable Ultra High Molecular Weight Polyethylene (UHMWPE) surgical sutures.

The 1.4mm anchor is formed by passing one end of a length of suture perpendicularly back through itself in alternating directions a number of times. This results in a construct resembling a ladder. The four suture tails are cut and trimmed. A floating suture is passed through the loops in the anchor to form the anchor construct.

The 2.2mm anchor is formed by passing the end of a first length of suture through the core of a second length. Then, one end of the second length is passed through the core of the first length, creating a loop with four suture tails. The loop is twisted alternately a number of times with the floating sutures weaved through each twist to form the anchor construct.

The 1.4mm anchor is pre-loaded with one floating suture and the 2.2mm size is preloaded with two floating sutures.

The following table summarizes the two configurations of the All-suture Anchor device.

{3}------------------------------------------------

| Catalog<br>number | All-Suture<br>anchor size | Anchor-<br>suture size<br>and color | Floating<br>suture size | Number of<br>floating<br>sutures | Floating suture<br>type and color |
|-------------------|---------------------------|-------------------------------------|-------------------------|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| CM-9614 | 1.4 mm | USP size 2 -<br>White | USP size 2 | 1 | Co-braid<br>Black/white, or<br>co-braid<br>blue/white, or co-<br>braid<br>green/white, or<br>solid blue |
| CM-9622 | 2.2 mm | USP size 2 -<br>White | USP size 2 | 2 | a combination of<br>any two colors;<br>co-braid<br>Black/white, or<br>co-braid<br>blue/white, or co-<br>braid<br>green/white, or<br>solid blue |

The disposable inserter has a working shaft length of 22,2 cm with an outer shaft diameter of 2.0 mm for the 1.4mm SureLock anchor and 2.4mm for the 2.2mm SureLock anchor. The inserter shaft is made out of surgical grade stainless steel and the handle and knob are made out of ABS plastic. The inserter pushes the suture anchor construct into a hole drilled in the bone. The knob on the inserter handle is rotated to apply tension on the floating suture(s) to expand and deploy the anchor in the bone tunnel. The floating suture limbs are then released from the inserter and the inserter is removed.

# NON-CLINICAL TESTING

Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence is included. Mechanical testing (pull-out strength) was performed on the SureLock™ All-Suture Anchor and the predicate device. Testing showed that the SureLock™ All-Suture Anchor ultimate pull-out strength was comparable to that of the predicate device.

# EQUIVALENCE TO MARKETED PRODUCT

Cayenne Medical, Inc. demonstrated that, for the purposes of FDA's regulation of medical devices, the SureLock™ All-Suture Anchor is substantially equivalent in indication and design principles to predicate devices, each of which has been determined by FDA to be substantially equivalent to preamendment devices: ConMed Linvatec Y-Knot™ All-Suture Anchor (K111779), Riverpoint Medical HS Fiber Polyblend nonabsorbable surgical suture (K100006), and Teleflex Medical ForceFiber® sutures

{4}------------------------------------------------

(K040472, K070673, K092533, and K100506). The substantial equivalence of SureLock™ All-Suture Anchor is based on similarities in indications for use, intended use. design features, technology, and materials to the predicate device.

The subject SureLock device has the same intended use as the predicate device, the ConMed Linvatec Y-Knot™. The predicate device has a broad indication for use stated as "to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone." The subject device is indicated for a subset of the predicate device's indications for use. The subject device has a narrower indication for use than the predicate device. Cayenne Medical tested both predicate and subject devices for the range of the subject device indications using three bone block densities.

This subject device differs from the predicate device, Conmed Linvatec Y-Knot™, in terms of the All-Suture anchor construction, the inserter role during deployment, and the offered sizes.

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in bold, uppercase letters. The text is arranged on a single line and appears to be a header or title. The font is sans-serif and the color is black against a white background.

Public Health Service

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

December 30, 2013

Cavenne Medical, Incorporated Ms. Shima Hashemian Quality Engineering Manager 16597 North 92nd Street, Suite 101 Scottsdale, Arizona 85260

Re: K132867

Trade/Device Name: SureLock™ All- 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 2, 2013 Received: October 3, 2013

Dear Ms. Hashemian:

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 (2 l 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

{6}------------------------------------------------

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] 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" (21 CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Sincerely yours,

# Mark N. Melkerson -S

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

Enclosure

{7}------------------------------------------------

# Indications for Use

Device Name: Surchock™ All- Suture Anchor

Indications for Use:

The Cayenne Medical, Inc. SureLock™ All- Suture Anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures. The system may be used in either arthroscopic or open surgical procedures. After the anchor is deployed in the bone, the floating sutures can be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.

The Cayenne Medical, Inc. Surchock™ All-Suture Anchors are intended to be used for the reattachment of soft tissue to bone for the following indications:

#### Shoulder

- । Capsular stabilization
- o Bankart repair
- o Anterior shoulder instability
- O SLAP lesion repairs
- Capsular shift or capsulolabral reconstructions
- Acromioclavicular separation repairs ।
- । Deltoid repairs
- Rotator cuff repairs l
- । Biceps tenodesis

#### Foot and Ankle

- । Hallux valgus repairs
- Medial or lateral instability repairs/reconstructions -
- Achilles tendon repairs/reconstructions l
- Mid and forefoot reconstructions -
- Metatarsal ligament/tendon repairs/reconstructions -
- Bunionectomy ー

#### Elbow

- l Ulnar or radial collateral ligament reconstruction
- -Lateral epicondylitis repair
- Biceps tendon repair ।

#### Hand and Wrist

- । Collateral ligament repair
- Scapholunate ligament reconstruction l

{8}------------------------------------------------

# 510(k) Premarket Notification

- -Volar plate reconstruction
- Tendon transfers in phalanx --

#### Hip

- Acctabular labral repair -
#### Knee

- Extra-capsular repairs
- 0 Medial collateral ligament
- o Latcral collateral ligament
- o Posterior oblique ligament
- Patellar realignment and tendon repairs -
- Illiotibial band tenodesis -
- VMO advancement ﺖ
- Joint capsule closure -

Prescription Use X (Part 21 CFR 801 Subpart D)

... ..........................................................................................................................................................................

- -- ··

:

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

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

## Concurrence of CDRH, Office of Device Evaluation (ODE)

Image /page/8/Picture/19 description: The image shows a logo with the text "Casey L. Hanley Ph.D." on the top line and "Division of Orthopedic Devices" on the second line. There is a horizontal line separating the two lines of text. The text is surrounded by a geometric design that resembles the letters "FDA".

Page 16 of 216