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Fixed-bearing designs lock the polyethylene component into the baseplate, which provides greater stability, but increases constraint and edge-loading stress at the bone implant interface, potentially increasing risk of early loosening and failure. The first fixed-bearing devices were implanted with cement fixation (cement fixation requires more removal of bone). In 2002, the U.S. Food and Drug Administration (FDA) approved the Agility Ankle Revision Prosthesis (DePuy Orthopaedics), which is intended for cemented use only in patients with a failed previous ankle surgery. In 2005, the FDA reviewed a 510(k) marketing clearance application for the Topez Total Ankle Replacement (Topez Orthopedics, Inc., Boulder, Colorado) and determined that it was substantially equivalent to the existing DePuy Agility device. The Topez Ankle is now called the Inbone™ Total Ankle (INBONE Technologies) and is also intended for cemented use only. The Agility™ LP (DePuy Orthopaedics) and the Eclipse (Kinetikos Medical) received 510(k) marketing clearance in 2006. The Salto Talaris™ (Tornier) received 510(k) marketing clearance in 2006 and 2009. These semi-constrained cemented prostheses are indicated in patients with end-stage ankle disorders (e.g., affected with severe rheumatoid, post-traumatic, or degenerative arthritis) as an alternative to ankle fusion.

Mobile-bearing systems have a polyethelene component that is unattached and articulates independently with both the tibial and talar components. The 3-piece mobile-bearing prostheses are designed to reduce constraint and edge loading, but are less stable than fixed-bearing designs and have the potential for dislocation and increased wear of the polyethylene component. Mobile-bearing designs are intended for uncemented implantation and have a porous coating on the components to encourage osseo-integration. They include the Scandinavian Total Ankle Replacement (STAR®, Small Bone Innovations) the TNK ankle (Kyocera Corporation) and the Buechel-Pappas™ system. Three-component mobile-bearing systems are Class III devices, and are considered under a different regulatory pathway (pre-market approval) than the fixed component devices described above, which were cleared for marketing under the 510(k) regulatory pathway. Pre-market approval (PMA) requires demonstration of clinical efficacy in FDA-regulated trials conducted under an investigational device exemption (IDE). In May 2009, the FDA approved the STAR® ankle as an alternative to fusion for replacing an ankle joint deformed by rheumatoid arthritis, primary arthritis or post-traumatic arthritis. As a condition of the approval, the device maker must evaluate the safety and effectiveness of the device over the next eight years. The TNK and Buechel-Pappas™ systems are not currently used in the U.S.

Total ankle replacement has been performed in patients with severe rheumatoid arthritis, severe osteoarthritis, or post-traumatic osteoarthrosis.

• Arthritis in adjacent joints (i.e., subtalar or midfoot), or
• Severe arthritis of the contralateral ankle, or
• Arthrodesis of the contralateral ankle, or
• Inflammatory (e.g., rheumatoid) arthritis

The following Guideline may be used for Patient Selection Criteria:

Contraindications to Ankle Arthroplasty include:

Total ankle replacement is considered investigational for all other indications.

Investigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

2/7/2002: Investigational definition added

5/8/2002: Type of Service and Place of Service deleted

5/29/2002: Code Reference section updated, ICD-9 procedure code 81.56 added, ICD-9 diagnosis codes 4th and 5th digit added 

3/14/2005: Policy reviewed, Description section revised to be consistent with BCBSA policy # 7.01.77 and Agility FDA marketing approval documents, Sources updated

8/25/2005: Code Reference section updated, CPT code 01486 added, ICD-9 procedure code 81.49 deleted, ICD-9 procedure code 81.59 added, ICD-9 diagnosis code 711.07, 711.17, 711.27, 711.37, 711.47, 711.57, 711.67, 711.77, 711.87, 711.97, 714.0-714.89, 715.07-715.97 deleted

3/15/2006: Coding updated.  CPT4 2006 revisions added to policy

11/13/2006: Policy reviewed, no changes

9/18/2007: Policy reviewed, no changes

12/09/2009: Policy Description Section revised with new FDA approved devices information and ankle replacement indications. Policy Statement Section revised as follows: Total ankle replacement is now medically necessary for specific indications and only when used with a FDA-approved device. Guideline for Patient Selection Criteria added. Contraindications added. Total ankle replacement is investigational for all other indications added. Policy Exceptions Section revised to add FEP verbiage. Coding Section revised as follows: A Covered Codes Table added. CPT4 codes 27702 and 01486 moved from Non-Covered Codes Table to Covered. CPT4 code 27703 added to Covered Codes Table. ICD9 procedure codes 81.56 and 81.59 moved from Non-Covered Codes Table to Covered Codes Table. ICD9 diagnosis codes 714.0, 715.17, 715.27, 715.37, and 715.97 added to Covered Codes Table. Non-Covered Codes Table removed. Verbiage, "This is not intended to be comprehensive list of covered codes. Some codes may be variable, and coverage will be based on the clinical indication for the service.", "*Some covered procedure codes may have multiple descriptions. Coverage will only be made for covered codes when used for services outlined within the policy statement section." and "*This is not an all inclusive list of non-covered procedure codes." added.

10/21/2010: Policy reviewed; no changes.

10/05/2011: Policy reviewed. Deleted outdated references from the Sources section.

11/30/2012: Policy reviewed; no changes.

The code(s) listed below are ONLY covered if the procedure is performed according to the "Policy" section of this document. 

Covered Codes

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