MICRO/MINI N-PK(F) BONE ANCHOR

K121354 · Anulex Technologies, Inc. · MBI · Nov 9, 2012 · Orthopedic

Device Facts

• Record ID: K121354
• Device Name: MICRO/MINI N-PK(F) BONE ANCHOR
• Applicant: Anulex Technologies, Inc.
• Product Code: MBI · Orthopedic
• Decision Date: Nov 9, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Micro/Mini N-PK Bone Anchor is intended for the reattachment of soft tissue to bone for the following indications: Foot and Ankle • Hallux valgus repairs • Medial or lateral instability repairs/reconstructions • Achilles tendon repairs/reconstructions • Midfoot reconstructions • Metatarsal ligament/tendon repairs/reconstructions • Bunionectomy

Device Story

Bone anchor system for reattaching soft tissue to bone in foot and ankle orthopedic procedures. Device consists of adjustable non-absorbable suture loop with one or two anchors; anchor comprises nitinol sleeve and PEEK core. Nitinol sleeve expands upon delivery to provide pullout resistance. Provided sterile, preloaded on disposable delivery instrument. Operated by surgeons in clinical/OR settings. Surgeon delivers anchor to bone site; expansion secures construct; suture used to reattach soft tissue. Provides mechanical fixation to facilitate healing.

Clinical Evidence

Bench testing only. Included biocompatibility (ISO 10993-1), corrosion testing (ASTM F2129), tensile testing (USP suture requirements), and mechanical performance testing (fixation/static disassembly strength and cyclic fatigue).

Technological Characteristics

Materials: Nitinol (sleeve) and PEEK (core). Non-absorbable suture (sizes 2, 0, 2-0). Mechanical fixation via nitinol expansion. Corrosion testing per ASTM F2129. Biocompatibility per ISO 10993-1. Sterile, single-use, preloaded on disposable delivery instrument.

Indications for Use

Indicated for reattachment of soft tissue to bone in foot and ankle procedures, including hallux valgus repairs, medial/lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, midfoot reconstructions, metatarsal ligament/tendon repairs/reconstructions, and bunionectomy.

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

• Smith & Nephew, Inc., Bioraptor PK Suture Anchor (K071586)
• DePuy Mitek Mini QuickAnchor Plus (K071257)

Submission Summary (Full Text)

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# Appendix 5: 510(k) Summary

大121354

As Required by 21 CFR 807.92

| Submitter: | Anulex Technologies, Inc.<br>5600 Rowland Road, Suite 280<br>Minnetonka, MN 55343 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Rachel Kennedy<br>Director, Regulatory Affairs and Quality Systems<br>Anulex Technologies, Inc.<br>Direct: 952.224.4034<br>Fax: [phone]<br>E-Mail: [e-mail] |
| Date Prepared: | October 25, 2012 |
| | NOV 9 2012 |
| Trade Name: | Micro/Mini N-PK(F) Bone Anchor |
| Classification: | II |
| Product Code: | MBI |
| | 21 CFR 888.3040 |
| Predicate Device(s): | The subject device is substantially equivalent to the<br>following predicate devices:<br>• Smith & Nephew, Inc., Bioraptor PK Suture Anchor<br>(K071586 cleared August 17, 2007)<br>• DePuy Mitek Mini QuickAnchor Plus (K071257<br>cleared June 29, 2007) |
| Device Description: | The Micro/Mini N-PK(F) Bone Anchor consists of an<br>adjustable loop of non-absorbable suture (Sizes 2, 0 and 2-0)<br>with one (1) or two (2) attached anchors. The bone anchor<br>is a two part system, one part nickel-titanium (nitinol) and<br>the second part polyetheretherketone (PEEK). The PEEK<br>part resides within the nitinol sleeve and retains the suture.<br>The nitinol part expands upon delivery providing resistance<br>to pullout.<br>The construct is provided sterile and preloaded on a<br>disposable delivery instrument. |
| Indications for Use: | The Micro/Mini N-PK Bone Anchor is intended for the<br>reattachment of soft tissue to bone for the following<br>indications:<br>Foot and Ankle<br>• Hallux valgus repairs |

Anulex Technologies, Inc.

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- Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstructions � Midfoot reconstructions ● Metatarsal ligament/tendon ● repairs/reconstructions . Bunionectomy Functional and Safety Biocompatibility testing was conducted in accordance with ISO 10993-1 standards. Corrosion testing was conducted in Testing: accordance with ASTM F2129. Tensile testing was performed to verify compliance with USP suture requirements and comparison testing to support the safety and effectiveness of the Micro/Mini N-PK(F) Bone Anchor included evaluation of fixation/static disassembly strength and cyclic fatigue performance. The Micro/Mini N-PK(F) Bone Anchor that is the subject of Comparison to Predicate: this submission has the same materials and similar technological characteristics in comparison to the predicate suture anchors. The intended use is the same as the predicates, fixation of soft tissue to bone for a variety of orthopedic procedures in the foot and ankle while the predicate anchors include procedures in additional anatomical locations. Substantial equivalence is demonstrated through the detailed device description, performance testing and conformance Conclusion: with voluntary performance standards.
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K121354A2

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

### Letter Dated: November 9, 2012

Anulex Technologies, Incorporated % Ms. Rachel Kennedy Director, Regulatory Affairs and Quality Systems 5600 Rowland Road, Suite 280 Minnetonka, Minnesota 55343

Re: K121354

Trade/Device Name: Micro/Mini N-(PK)(F) Bone Anchor Regulation Number: 21 CFR 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener. Regulatory Class: Class II Product Code: MBI Dated: October 26, 2012 Received: October 31, 2012

### Dear Ms. Kennedy,

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 connisted pror to 1125 2011-11-11 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. Troumly, therefere, maxisions of the Act include requirements for annual registration, listing of I ho general vont ons proving practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability addition. Trease noter u, 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 may be subject to additions, 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 i Tease of advised that I Dris issuants over device complies with other requirements of the Act that I Dr Has made a word regulations administered by other Federal agencies. You must of any I color statutes and registements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical CI it Fart 607); aboning (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Rachel Kennedy

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quand of ovisions (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/ucm 115809.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 note and regalations regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/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/ResourcesforYou/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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K121354

### Appendix 4: Indications for Use Form

Device Name: Micro/Mini N-PK(F) Bone Anchor

### Indications for Use:

The Micro/Mini N-PK Bone Anchor is intended for the reattachment of soft tissue to bone for the following indications:

### Foot and Ankle

- . Hallux valgus repairs
- Medial or lateral instability repairs/reconstructions .
- Achilles tendon repairs/reconstructions
- . Midfoot reconstructions
- Metatarsa} ligament/tendon repairs/reconstructions .
- . Bunionectomy

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)

Asto

(Division Sign-Oft) Division of Surgical, Ort- Spedic, and Restorative Devices

510(k) Number K121354

Micro/Mini N-PK(F) Bone Anchor Anulex Technologies, Inc. Confidential

" .

Traditional 510(k) Premarket Notification

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