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EndoPearl

by Linvatec Corp.

510(k) K984171

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK984171 Date29 Apr 1999ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MAI
Device Class
Class II
Regulation
21 CFR Part 888.3030
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The EndoPearl is a biodegradable, cannulated fixation device designed for soft tissue applications. It features a spherical shape with a 2 mm central hole and is intended for use as a fastener in orthopedic procedures, providing secure fixation during surgical interventions.

This single-use, sterile device is composed of Poly (L-lactic acid) (PLLA), a bioabsorbable material that metabolizes within the body. Available in sizes 7 mm, 8 mm, and 9 mm, it is used in conjunction with interference screws during procedures such as ACL/PCL reconstruction. The device is classified under product code MAI and adheres to FDA 510(k) clearance (K984171) with a regulatory classification of Class II under special controls.

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