Q-FIX SUTURE ANCHOR, 1.8MM Q-FIX ACCESS TOOLS (DRILL GUIDE W/OBTURATOR, DRILL BIT) 1.8MM

K122336 · Eleven Blade Solutions, Inc. · MBI · Jan 9, 2013 · Orthopedic

Device Facts

• Record ID: K122336
• Device Name: Q-FIX SUTURE ANCHOR, 1.8MM Q-FIX ACCESS TOOLS (DRILL GUIDE W/OBTURATOR, DRILL BIT) 1.8MM
• Applicant: Eleven Blade Solutions, Inc.
• Product Code: MBI · Orthopedic
• Decision Date: Jan 9, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Eleven Blade Solutions, Inc. Q-Fix™ Suture Anchor System is intended to be used for soft tissue to bone fixation for: Shoulder: Bankart lesion repair, SLAP lesion repair, Acromio-clavicular repair, Capsular shift/capsulolabral reconstruction. Deltoid repair, Rotator cuff tear repair, Biceps tenodesis; Foot and Ankle: Medial/lateral repair and reconstruction, Mid and forefoot repair, Hallux valgus reconstruction, Metatarsal ligament/tendon repair or reconstruction. Achilles tendon repair; Elbow: Ulnar or radial collateral ligament reconstruction, Lateral epicondylitis repair, Biceps tendon reattachment; Knee: Extra-capsular repair: MCL, LCL, and posterior oblique ligament, Illiotibial band tenodesis, Patellar tendon repair, VMO advancement, Joint capsule closure; Hand and Wrist: Collateral ligament repair, Sacpholunate ligament reconstruction, Tendon transfers in phalanx, Volar plate reconstruction; Hip: Acetabular labral repair.

Device Story

Q-Fix™ Suture Anchor System is an all-suture anchor for soft tissue-to-bone fixation. Device consists of a polyester sleeve-type structure with UHMWPE suture strands, provided preloaded on a disposable inserter. During orthopedic surgery, the inserter deploys the anchor into bone; the anchor expands against the bone upon deployment. Suture remains slideable within the anchor to facilitate soft tissue attachment. Accessory instruments (drill bit, drill guide, obturator) are provided sterile for single use. Used by surgeons in clinical settings to secure tendons/ligaments to bone, potentially improving fixation strength and patient recovery outcomes.

Clinical Evidence

Bench testing only. Studies included anchor pull-out strength, cyclic displacement, and device insertion testing to evaluate performance characteristics against predicate devices.

Technological Characteristics

All-suture anchor system; polyester sleeve-type structure; UHMWPE suture; disposable inserter; provided sterile; single-use. Mechanical fixation via expansion against bone.

Indications for Use

Indicated for soft tissue to bone fixation in shoulder, foot/ankle, elbow, knee, hand/wrist, and hip orthopedic procedures. Applicable to patients requiring ligament, tendon, or capsular repair/reconstruction.

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

• Juggerknot Soft Anchor (K110145)
• ForceFiber (K063778)

Submission Summary (Full Text)

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K122336
Q-Fix™ Suture Anchor System
January 7, 2013

JAN 9 2013

## 510(k) Summary

な

| General Company Information | | | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|---------------|--|
| Name: | Eleven Blade Solutions, Inc. | | |
| Contact: | Michael Kolber<br>Regulatory Affairs | | |
| Address: | 147 Hillbrook Dr.<br>Los Gatos, CA 95032 | | |
| Telephone: | 408-505-6626 | | |
| Fax: | 408-402-8361 | | |
| Date Prepared: | January 7, 2013 | | |
| General Device Information | | | |
| Product Name: | Q-Fix™ Suture Anchor System | | |
| Common Name: | Suture Anchor | | |
| Classification: | 21CFR888.3040; Smooth or threaded metallic<br>bone fixation fastener | | |
| Device Class: | Class II | | |
| Product Code: | MBI | | |
| Predicate Devices | | | |
| Manufacturer | Device Name | 510(k) Number | |
| Biomet Sports Medicine | Juggerknot Soft Anchor | K110145 | |
| Teleflex Medical | ForceFiber | K063778 | |
| Description | | | |
| The Q-Fix™ Suture Anchor is an all-suture anchor device designed for soft tissue to<br>bone fixation by expanding against bone when deployed. Made of a polyester sleeve-<br>type structure with one or more strands of UHMWPE suture threaded through it, the<br>anchor is provided preloaded on a disposable inserter. The inserter is used to deploy<br>the anchor into the bone, with the suture remaining slideable within the anchor to<br>facilitate attachment of the soft tissue.<br>The one-time use anchor is provided sterile, preloaded on the inserter. Additional<br>accessory instruments, including a drill bit and drill guide with obturator are single<br>use devices provided sterile for use during the orthopedic procedure. | | | |
| Intended Use (Indications) | | | |
| The Eleven Blade Solutions, Inc. Q-Fix™ Suture Anchor System is intended for soft<br>tissue to bone fixation for: | | | |
| Shoulder | | | |
| Bankart lesion repair, SLAP lesion repair, Acromio-clavicular repair, Capsular<br>shift/capsulolabral reconstruction, Deltoid repair, Rotator cuff repair, Biceps<br>tenodesis | | | |
| Foot and Ankle | | | |
| Medial/lateral repair and reconstruction, Mid and forefoot repair, Hallux valgus | | | |

.

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122336

Image /page/1/Picture/1 description: The image shows the logo for "ELEVEN BLADE SOLUTIONS". The word "ELEVEN" is in large, bold, sans-serif font, with a stylized image of two blades forming a "V" in the middle. Below "ELEVEN", in a smaller, bold, sans-serif font, is the text "BLADE SOLUTIONS".

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K122336 Q-Fix™ Suture Anchor System January 7, 2013

reconstruction, Metatarsal ligament/tendon repair or reconstruction, Achilles tendon repair

### Elbow

Ulnar or radial collateral ligament reconstruction, Lateral epicondylitis repair, Biceps tendon reattachment

Knee

Extra-capsular repair: MCL, LCL, and posterior oblique ligament, Illiotibial band tenodesis, Patellar tendon repair, VMO advancement, Joint capsule closure

### Hand and Wrist

Collateral ligament repair, Sacpholunate ligament reconstruction, Tendon transfers in phalanx, Volar plate reconstruction

Hip

Acetabular labral repair

### Substantial Equivalence

This submission supports the position that the Eleven Blade Solutions, Inc. O-Fix™ Suture Anchor System is substantially equivalent to the Biomet Juggerknot (K110145) and the Teleflex ForceFiber (K063778). The O-Fix™ Suture Anchor System has the following similarities to the previously cleared predicate device: the same intended use, same operating principle, similar technologies, and similar manufacturing process. Design verification activities were performed as a result of the risk analysis. The 510(k) notice contains summaries of bench studies, which were conducted to evaluate the performance characteristics of the O-Fix™ Suture Anchor System. Anchor Pull-out Strength, Cyclic Displacement, and Device Insertion Testing were performed. The data presented demonstrate that the performance characteristics of the Q-Fix™ Suture Anchor System are equivalent to the predicate devices and thus provide equivalent fixation strength within their intended use.

### Conclusions

Eleven Blade Solutions, Inc. believes that the information provided demonstrates that the proposed device is substantially equivalent to the predicate devices and does not raise any new issues of safety or efficacy. Based on the indications for use, technological characteristics, and comparison to predicated devices, the Q-Fix™ Suture Anchor System has been shown to be substantially equivalent to predicate devices as described under the Federal Food, Drug and Cosmetic Act.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Eleven Blade Solutions, Incorporated % Mr. Michael Kolber Regulatory Affairs 147 Hillbrook Drive Los Gatos, California 95032

Letter dated: January 9, 2013

Re: K122336

Trade/Device Name: Eleven Blade Solutions, Incorporated. Q-Fix™ Suture 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: November 23, 2012

Received: November 26, 2012

Dear Mr. Kolber:

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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### Page 2 – Mr. Michael Kolber

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 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

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

Enclosure

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### Indications for Use

510(k) Number (if known): K122336

Device Name: Eleven Blade Solutions, Inc. Q-Fix™ Suture Anchor System

Indications for Use: The Eleven Blade Solutions, Inc., Q-Fix™ Suture Anchor System is intended to be used for soft tissue to bone fixation for:

### Shoulder

Bankart lesion repair, SLAP lesion repair, Acromio-clavicular repair, Capsular shift/capsulolabral reconstruction. Deltoid repair, Rotator cuff tear repair, Biceps tenodesis

### Foot and Ankle

Medial/lateral repair and reconstruction, Mid and forefoot repair, Hallux valgus reconstruction, Metatarsal ligament/tendon repair or reconstruction. Achilles tendon repair

### Elbow

Ulnar or radial collateral ligament reconstruction, Lateral epicondylitis repair, Biceps tendon reattachment

### Knee

Extra-capsular repair: MCL, LCL, and posterior oblique ligament, Illiotibial band tenodesis, Patellar tendon repair, VMO advancement, Joint capsule closure

### Hand and Wrist

Collateral ligament repair, Sacpholunate ligament reconstruction, Tendon transfers in phalanx, Volar plate reconstruction

### Hip

Acetabular labral repair

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

Anton E. Dmitriev, PhD 2013.01.09 14:50:59 -05'00' Division of Orthopedic Devices