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Taper Set Hip System RDP Stem

by Consensus Orthopedics, Inc.

510(k) K121263

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 · Special NumberK121263 Date22 May 2012ClearedStatusActive

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  • Withdrawn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
LPH
Device Class
Class II
Regulation
21 CFR Part 888.3358
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 Taper Set Hip System RDP Stem is a monolithic titanium alloy femoral hip stem intended for total or partial hip arthroplasty. It features a dual wedge geometry, a 135° neck-shaft angle, a 12/14 Morse taper trunnion, and a proximal plasma-sprayed porous CPTi coating for cementless fixation.

This device is used by orthopedic surgeons in clinical settings for hip replacement procedures. It is supplied as a reusable medical device and is compatible with the Consensus Hip System. The device holds an FDA 510(k) clearance under the product code LPH, with a special review designation under the Orthopedic Advisory Committee.

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