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PediPlates

by Orthopediatrics Corp.

510(k) K090666

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 NumberK090666 Date24 Apr 2009ClearedStatusActive

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  • Withdrawn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
HRS
Device class
Class II
Regulation
21 CFR Part 888.3030
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 PediPlates is a physeal tethering growth control plating system designed for orthopedic applications. It is engineered to manage skeletal growth in pediatric and adult patients by providing controlled stabilization at the physis, or growth plate, to regulate limb length or alignment.

Available in O (2-hole) and I (4-hole) configurations, the system is supplied in stainless steel and titanium alloys. The device is intended for surgical use under sterile conditions and is classified under FDA 510K clearance (K090666) as substantially equivalent to a predicate device. It is reusable and must be handled according to standard orthopedic surgical protocols.

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