Web Content Viewer - Fixed Context

Policy title: Subtalar Arthroereisis

Policy number: MA 1.114

Clinical benefit

  • Minimize safety risk or concern.
  • Minimize harmful or ineffective interventions.
  • Assure appropriate level of care.
  • Assure appropriate duration of service for interventions.
  • Assure that recommended medical prerequisites have been met.
  • Assure appropriate site of treatment or service.

Effective date: 8/1/2026

Policy

Subtalar arthroereisis is considered investigational as there is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure.

This medical policy applies to Medicare Advantage plans offered by Capital Blue Cross and its subsidiaries.

Description/Background

Arthroereisis is a surgical procedure that purposely limits movement across a joint. Subtalar arthroereisis or extraosseous talotarsal stabilization is designed to correct excessive talar displacement and calcaneal eversion by reducing pronation across the subtalar joint. Extraosseous talotarsal stabilization is also being evaluated as a treatment of talotarsal joint dislocation. It is performed by placing an implant in the sinus tarsi, which is a canal located between the talus and the calcaneus.

Subtalar arthroereisis has been performed for more than 50 years, with a variety of implant designs and compositions. The Maxwell-Brancheau Arthroereisis implant is the most frequently used, although other devices such as the HyProCure® subtalar arthroereisis implant, and Kalix® devices are also available. The Maxwell-Brancheau Arthroereisis implant is designed to be reversible and easy to insert, while the additional advantage is that it does not require bone cement. In children, insertion of the Maxwell-Brancheau Arthroereisis implant may be offered as a standalone procedure, although often used in combination with other procedures to correct additional deformities.

Regulatory Status

A number of implants have been cleared for marketing by the U.S. Food and Drug Administration through the 510(k) process, and are summarized in Table 1. In general, these devices are indicated for insertion into the sinus tarsi of the foot, allowing normal subtalar joint motion while blocking excessive pronation. FDA Product Code: HWC.

Table 1. Representative Subtalar Implant Devices Cleared by FDA

Device
Manufacturer
Date
510(k)

Subtalar MBA®

Integra LifeSciences

07/96

K960692

OsteoMed Subtalar Implant System

OsteoMed

08/03

K031155

BioPro Subtalar Implant

BioPro

09/04

K041936

HyProCure Subtalar Implant System

Graham Medical Technologies

09/04

K042030

MBA Resorb Implant

Kinetikos Medical

09/05

K051611

Metasurg Subtalar Implant

Metasurg

05/07

K070441

Subtalar Implant

Biomet Sports Medicine

07/07

K071498

Arthrex ProStop Plus Arthroereisis Subtalar Implant

Arthrex

01/08

K071456

Trilliant Surgical Subtalar Implant

Trilliant Surgical

02/11

K103183

Metasurg Subtalar Implant

Metasurg

08/11

K111265

NuGait™ Subtalar Implant System

Ascension Orthopedic

08/11

K111799

Disco Subtalar Implant

Trilliant Surgical

12/11

K111834

OsteoSpring FootJack Subtalar Implant System

OsteoSpring Medical

12/11

K112658

IFS Subtalar Implant

Internal Fixation Systems

12/11

K113399

The Life Spine Subtalar Implant System

Life Spine

06/16

K160169

Incore Subtalar System

Nextremity Solutions, Inc.

12/21

K213301

Bioplan subtalar implant

BRM Extremities

12/22

K222820

FDA 510(k) database search product code HWC (03/08/18).

Rationale

Summary of Evidence

For individuals who have flatfoot who receive STA, the evidence includes single-arm observational studies, systematic reviews of observational data, and a small nonrandomized controlled trial comparing subtalar arthroereisis with lateral column calcaneal lengthening. Relevant outcomes are symptoms, functional outcomes, and quality of life. The small nonrandomized comparative trial (N=24 feet) is considered preliminary, and interpretation of the observational evidence is limited by the use of adjunctive procedures in addition to subtalar arthroereisis, creating difficulties in determining the extent to which each modality contributed to the outcomes. Another limitation of the published data is the lack of long-term outcomes, which is of particular importance because the procedure is often performed in growing children. Also, some studies have reported high rates of complications and implant removal. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have talar subluxation joint dislocation who receive subtalar arthroereisis, the evidence consists of 1 prospective, single-arm study of talocalcaneal stabilization using HyProCure®. Relevant outcomes are symptoms, functional outcomes, and quality of life. Although improvements in pain and function were observed, the current evidence on the use of subtalar arthroereisis for treatment of talar subluxation joint dislocation is insufficient to draw conclusions about treatment effectiveness. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Definitions

Calcaneus is the largest of the tarsal bones situated at the lower and back part of the foot forming the heel.

Talus is the ankle bone; the bone of the tarsus which articulates with the tibia at the ankle.

Disclaimer

Capital Blue Cross’ medical policies are used to determine coverage for specific medical technologies, procedures, equipment, and services. These medical policies do not constitute medical advice and are subject to change as permitted by law or applicable clinical evidence from independent treatment guidelines. Treating providers are solely responsible for medical advice and treatment of members. These policies are not a guarantee of coverage or payment. Payment of claims is subject to a determination regarding the member’s benefit program and eligibility on the date of service, and a determination that the services are medically necessary and appropriate. Final processing of a claim is based upon the terms of contract that applies to the members’ benefit program, including benefit limitations and exclusions. If a provider or a member has a question concerning this medical policy, please contact Capital Blue Cross’ Provider Services or Member Services.

Coding Information

Note: This list of codes is not exhaustive and may change from time to time as permitted by law or applicable clinical guidelines. The inclusion of a code in this section is not a guarantee of coverage or payment. In addition, not all covered services are eligible for separate reimbursement.

Investigational; therefore, not covered:

Procedure Codes

0335T

0510T

0511T

28899

 

References

  1. Galán-Olleros M, Del Baño Barragán L, Figueroa MJ, et al. Outcomes of the "Calcaneo-stop" procedure for treating symptomatic flexible flatfoot in children: A systematic review and meta-analysis of 2394 feet. Foot Ankle Surg. Oct 2024; 30(7): 535-545. PMID 38714453
  2. Metcalfe SA, Bowling FL, Reeves ND. Subtalar joint arthroereisis in the management of pediatric flexible flatfoot: a critical review of the literature. Foot Ankle Int. Dec 2011;32(12):1127-1139. PMID 22381197
  3. Chong DY, Macwilliams BA, Hennessey TA, et al. Prospective comparison of subtalar arthroereisis with lateral column lengthening for painful flatfeet. J Pediatr Orthop B. Jul 2015;24(4):345-353. PMID 25856275
  4. Khury F, Danto E, Taurman R, et al. Clinical and radiographic efficacy of subtalar screw arthroereisis in the treatment of pediatric flexible flatfoot. Eur J Orthop Surg Traumatol. Feb 19 2026; 36(1): 106. PMID 41711996Metcalfe
  5. Silva S, Tavernini T, Bruschi A, et al. Calcaneo-stop for paediatric idiopathic flexible flatfoot: High functional results and return to sport in 644 feet at mid-term follow-up. J Exp Orthop. Jan 2025; 12(1): e70182. PMID 39980608
  6. Graham ME, Jawrani NT, Chikka A. Extraosseous talotarsal stabilization using HyProCure(R) in adults: a 5-year retrospective follow-up. J Foot Ankle Surg. Jan-Feb 2012;51(1):23-29. PMID 22196455
  7. Moraca G, Martinelli N, Bianchi A, et al. Subtalar arthroereisis with metallic implant is a safe and effective treatment for pediatric patients with symptomatic flexible flatfeet. A 10-year clinical and radiographic follow-up. Foot Ankle Surg. Jan 2025; 31(1): 31-37. PMID 38972783
  8. Vedantam R, Capelli AM, Schoenecker PL. Subtalar arthroereisis for the correction of planovalgus foot in children with neuromuscular disorders. J Pediatr Orthop. May-Jun 1998;18(3):294-298. PMID 9600551
  9. Nelson SC, Haycock DM, Little ER. Flexible flatfoot treatment with arthroereisis: radiographic improvement and child health survey analysis. J Foot Ankle Surg. May-Jun 2004;43(3):144-155. PMID 15181430
  10. Needleman RL. A surgical approach for flexible flatfeet in adults including a subtalar arthroereisis with the MBA sinus tarsi implant. Foot Ankle Int. Jan 2006;27(1):9-18. PMID 16442023
  11. Cicchinelli LD, Pascual Huerta J, Garcia Carmona FJ, et al. Analysis of gastrocnemius recession and medial column procedures as adjuncts in arthroereisis for the correction of pediatric pes planovalgus: a radiographic retrospective study. J Foot Ankle Surg. Sep-Oct 2008;47(5):385-391. PMID 18725117
  12. Lucaccini C, Zambianchi N, Zanotti G. Distal osteotomy of the first metatarsal bone in association with sub-talar arthroerisis, for hallux valgus correction in abnormal pronation syndrome. Chir Organi Mov. Dec 2008;92(3):145- 148. PMID 19082522
  13. Scharer BM, Black BE, Sockrider N. Treatment of painful pediatric flatfoot with Maxwell-Brancheau subtalar arthroereisis implant a retrospective radiographic review. Foot Ankle Spec. Apr 2010;3(2):67-72. PMID 20400415
  14. Brancheau SP, Walker KM, Northcutt DR. An analysis of outcomes after use of the Maxwell-Brancheau Arthroereisis implant. J Foot Ankle Surg. Jan-Feb 2012;51(1):3-8. PMID 22196453
  15. Bresnahan PJ, Chariton JT, Vedpathak A. Extraosseous talotarsal stabilization using HyProCure(R): preliminary clinical outcomes of a prospective case series. J Foot Ankle Surg. Mar-Apr 2013;52(2):195-202. PMID 23313499
  16. Scher DM, Bansal M, Handler-Matasar S, et al. Extensive implant reaction in failed subtalar joint arthroereisis: report of two cases. HSS J. Sep 2007;3(2):177-181. PMID 18751791
  17. Saxena A, Nguyen A. Preliminary radiographic findings and sizing implications on patients undergoing bioabsorbable subtalar arthroereisis. J Foot Ankle Surg. May-Jun 2007;46(3):175-180. PMID 17466243
  18. Cook EA, Cook JJ, Basile P. Identifying risk factors in subtalar arthroereisis explantation: a propensity-matched analysis. J Foot Ankle Surg. Jul-Aug 2011;50(4):395-401. PMID 21708340
  19. Piraino JA, Theodoulou MH, Ortiz J, et al. American College of Foot and Ankle Surgeons Clinical Consensus Statement: Appropriate Clinical Management of Adult-Acquired Flatfoot Deformity. J Foot Ankle Surg. 2020; 59(2): 347-355. PMID 32131002
  20. National Institute for Health and Care Excellence (NICE). Sinus Tarsi Implant Insertion for Mobile Flatfoot [HTG196]. 2009

Policy History

  • MA 1.114
    • 8/5/2025 Creation of policy.
    • 05/05/2026 Consensus review. No change to policy statement. Background, Rationale and References updated.

Plans issued by Capital Blue Cross and it’s subsidiaries are independent licensees of the Blue Cross Blue Shield Association. Communications issued by Capital Blue Cross in its capacity as administrator of programs and provider relations for all companies.

Health care benefit programs issued or administered by Capital Blue Cross and/or its subsidiaries, Capital Advantage Insurance Company®, Capital Advantage Assurance Company® and Keystone Health Plan® Central. Independent licensees of the Blue Cross BlueShield Association. Communications issued by Capital Blue Cross in its capacity as administrator of programs and provider relations for all companies.

Web Content Viewer - Fixed Context

Updated January 1, 2026

Y0016_26WBST_M