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OmniSpan Meniscal Repair SYSTEM/0 Degree, Model 228140, RapidLoc A2 Meniscal Repair SYSTEM/12 Degree, Model 228141

by Depuy Mitek, A Johnson & Johnson Company

510(k) K092836

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 NumberK092836 Date4 Feb 2010ClearedStatusActive

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  • Withdrawn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
MBI
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 device is an orthopedic meniscal repair system comprising two components: the OmniSpan Meniscal Repair System at 0 degree (Model 228140) and the RapidLoc A2 Meniscal Repair System at 12 degree (Model 228141). It is designed for the repair of meniscal tears in the knee joint.

The system is supplied as a surgical instrument set for use in orthopedic procedures. It is intended for use in a clinical setting by trained healthcare professionals. The device received traditional 510(k) clearance from the FDA under product code MBI, with clearance granted on February 4, 2010, based on substantial equivalence to a predicate device.

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