HemiCAP MTP Resurfacing Hemi-Arthroplasty Implant

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K131377 ↗

FDA Product Code

KWD

Device Class

Class II

Regulation

21 CFR Part 888.3730

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Wrist Hemiarthroplasty System

  Class II

  FDA 510(k) K141920 Active Cleared 23 Dec 2014

• Patello-Femoral Wave (Kahuna) Arthroplasty System Open recall

  Class II

  FDA 510(k) K181280 Active Cleared 14 Jun 2018

• HemiCAP Patello-Femoral Resurfacing Prosthesis

  Class II

  FDA 510(k) K060127 Active Cleared 16 Mar 2006

• Cap 7.0mm Mtp Resurfacing Hemi-Arthroplasty

  Class II

  FDA 510(k) K063370 Active Cleared 12 Jan 2007

• Arthrosurface Bone Screws

  Class II

  FDA 510(k) K161539 Active Cleared 30 Jun 2016

• BOSS Toe Fixation System

  Class II

  FDA 510(k) K190261 Active Cleared 14 Aug 2019

See all devices from Arthrosurface, Inc. →

• What is the HemiCAP MTP Resurfacing Hemi-Arthroplasty Implant used for in clinical practice?

  The HemiCAP MTP Resurfacing Hemi-Arthroplasty Implant is designed to resurface and replace the damaged articular surface of the metatarsophalangeal (MTP) joint in the toe. It is specifically intended to restore joint function and alleviate pain caused by degenerative conditions like hallux rigidus, helping patients regain mobility and comfort in their affected toe.

• Is the HemiCAP MTP Resurfacing Implant reusable or intended for single-use, and how is it supplied?

  The HemiCAP MTP Resurfacing Implant is supplied sterile and intended for single-use only. This ensures patient safety and reduces the risk of cross-contamination, as it is not designed for reuse. Each implant is packaged individually for surgical use.

• What material is the HemiCAP MTP Resurfacing Implant made from, and why does that matter?

  The implant is manufactured from a silicone elastomer, a durable yet flexible material chosen for its biocompatibility and ability to mimic natural joint movement. This material helps reduce wear over time while maintaining structural integrity, which is critical for long-term performance in the toe joint.

• How many sizes are available for the HemiCAP MTP Resurfacing Implant, and how does this accommodate different patients?

  The implant comes in multiple sizes, as indicated by the extensive list of registration numbers (e.g., 3009423112, 3016851379, etc.). These variations allow surgeons to select the best-fitting size for each patient’s anatomy, ensuring proper joint coverage and function restoration during surgery.

• What regulatory pathway was followed for FDA clearance of the HemiCAP MTP Resurfacing Implant, and what does that mean for its use?

  The device received FDA 510(k) clearance under the Traditional pathway, classified as a Class II medical device (regulation number 888.3730). This means it was determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets established safety and effectiveness standards for orthopedic toe prosthetics.