ANCHORMAN Tibial Ligament Fixation Device

K170388 · Summit Medical , Ltd. · MBI · Jul 25, 2017 · Orthopedic

Device Facts

• Record ID: K170388
• Device Name: ANCHORMAN Tibial Ligament Fixation Device
• Applicant: Summit Medical , Ltd.
• Product Code: MBI · Orthopedic
• Decision Date: Jul 25, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Tibial fixation of biological ligament during orthopaedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) reconstruction

Device Story

ANCHORMAN is a PEEK cortical tibial suspensory fixation device; used in orthopedic reconstruction (e.g., ACL). Device functions by looping biological or artificial tendon graft through device loop component; graft pulled through tibial and femoral tunnels. Wing components rest on tibial cortex; facilitates tensioning; provides tibial suspensory fixation supporting graft until aperture healing/integration. Used by surgeons in clinical/OR settings. Device is redundant once graft integrates with bone. Benefits patient by securing graft during healing process.

Clinical Evidence

No clinical data. Substantial equivalence established via comparative in-vitro bench testing on human cadaveric tibiae, evaluating mechanical characteristics (UTS, initial and cyclic displacement, stiffness) and usability.

Technological Characteristics

Cortical tibial suspensory fixation device; material: PEEK; form factor: includes loop and wing components; principle: mechanical fixation via cortical suspension; non-degradable; standalone implant.

Indications for Use

Indicated for tibial fixation of biological ligament during orthopaedic reconstruction procedures, such as Anterior Cruciate Ligament (ACL) 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

• Arthrex Inc., Retrobutton (K062747)

Submission Summary (Full Text)

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Summit Medical Ltd. Sam Drew RA Manager - Projects Bourton Industrial Park Bourton on the Water, Gloucestershire GL54 2HO United Kingdom

July 25, 2017

Re: K170388

Trade/Device Name: ANCHORMAN Tibial Ligament Fixation Device Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: June 14, 2017 Received: June 14, 2017

Dear Sam Drew:

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

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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 devicerelated adverse events) (21 CFR 803); 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.

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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

## Mark N. Melkerson -S

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

Enclosure

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Page 1 of 1

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

510(k) Number (if known) K170388

Device Name

ANCHORMAN Tibial ligament fixation device

Indications for Use (Describe)

Tibial fixation of biological ligament during orthopaedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) reconstruction

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| <div> <span> ☒ Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> □ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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#### 510(k) Summary – K170388 Summit Medical Ltd ANCHORMAN

# SUMMIT MEDICAL
SURGICAL PRODUCTS

SURGICAL PRODUCTS

Head office OrthoD Group Ltd Industrial Park Bourton on the Water Gloucestershire GL54 2HQ United Kingdom

[phone] tel. [e-mail] email website www.orthod.com

| Date prepared | 31/May/2017 |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Summit Medical Ltd |
| Contact person | Sam Drew<br>RA Manager - Projects<br>Summit Medical<br>Industrial Park<br>Bourton-on-the-Water<br>Gloucestershire<br>GL54 2HQ<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Name of device | ANCHORMAN cortical tibial fixation device |
| Classification | Classification - II<br>Product Code - MBI<br>Classification name - Fastener, Fixation, Nondegradable, Soft Tissue<br>Classification Rule - 888.3040<br>Device Panel – 87 - "Orthopedic surgery" |
| Predicate device(s) | Arthrex Inc., Retrobutton cleared under K062747 |
| Indications for use | Tibial fixation of biological ligament during orthopaedic reconstruction<br>procedures such as Anterior Cruciate Ligament (ACL) reconstruction |
| Device description | ANCHORMAN is a PEEK cortical tibial suspensory fixation device, and<br>functions via the looping of a biological or artificial tendon graft through the<br>loop component of the device. The tendon graft is then pulled through the<br>tibial and femoral tunnels. The wing components of the device rest on the<br>tibial cortex, facilitating tensioning on the femoral side (if required). The<br>device then provides tibial suspensory fixation, supporting the graft until<br>aperture healing occurs and the graft integrates with the bone, at which point<br>the device does not bear load and is redundant. |

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#### 510(k) Summary Summit Medical Ltd ANCHORMAN

### MMIT MEDICAL

SURGICAL PRODUCTS

| Non-clinical testing | Comparative in-vitro testing on human cadaveric tibiae was performed and<br>the results for ANCHORMAN were compared to that of the predicate. The<br>results showed that ANCHORMAN possesses mechanical, chemical, physical<br>and handling characteristics necessary to demonstrate that it is substantially<br>equivalent to Retrobutton. |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical testing | Clinical data was not required to establish substantial equivalence between<br>the ANCHORMAN and the predicate device. |
| Chemical differences | Although ANCHORMAN and the predicate are composed of different<br>materials, and therefore have chemical differences, both PEEK<br>(ANCHORMAN), UHMWPE and Titanium Ti6Al4V (RetroButton) are long<br>established implant materials, with confirmatory biocompatibility testing<br>verifying this. Comparative in-vitro testing on human cadaveric tibiae was<br>performed and the results for ANCHORMAN were compared to that of the<br>predicate, and showed that the chemical differences between ANCHORMAN<br>and the predicate do not raise any new questions of safety and effectiveness |
| Physical differences | Although ANCHORMAN and the predicate have different designs and<br>materials, direct comparative performance testing in cadaveric tibiae<br>comparing ANCHORMAN and the predicate device has confirmed that, when<br>the relevant performance/ clinical characteristics which may be affected by<br>size (UTS, initial and cyclic displacement and stiffness) are equivalent with<br>reference to the clinically identified failure levels. |
| Handling differences | Direct comparative performance testing in human cadaveric tibiae comparing<br>ANCHORMAN and the predicate device has confirmed that, when implanted<br>properly, the relevant performance/ clinical characteristics which may be<br>affected by size (UTS, initial and cyclic displacement and stiffness) are<br>equivalent with reference to the clinically identified failure levels. The<br>cadaveric usability study for ANCHORMAN has demonstrated the<br>appropriateness of this technique for users, even in worst case insertion and<br>removal circumstances. These differences do not raise any new questions of<br>safety and effectiveness |
| Substantial equivalence | Based on the similarities in design, function, indications for use and<br>fundamental scientific technology, the devices that are the subject of this<br>submission are similar to the predicate devices and do not introduce any new<br>risks of safety or efficacy. Therefore, Summit Medical concludes that the<br>subject device is substantially equivalent to the predicate device. |