Cleared Special

K213675 - MP Reconstruction System

K213675 is an FDA 510(k) clearance for MP Reconstruction System, manufactured by Waldemar Link GmbH & Co. KG. The device is a Class 2 Orthopedic device with product code LZO cleared through the Special 510(k) pathway after a 140-day FDA review.

K213675 · Waldemar Link GmbH & Co. KG · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2022
Decision
140d
Days
Class 2
Risk

K213675 is an FDA 510(k) clearance for the MP Reconstruction System. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Waldemar Link GmbH & Co. KG (Norderstedt, DE). The FDA issued a Cleared decision on April 11, 2022 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K213675

510(k) Number K213675 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2021
Decision Date April 11, 2022
Days to Decision 140 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 122d · This submission: 140d
Pathway characteristics
Modification to existing cleared device.

LZO Device Classification - Class 2, Special Controls

Product Code LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3353
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

All 533
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K213675.
BiMobile Instruments (for BiMobile Dual Mobility System)
K211567 · Waldemar Link GmbH & Co. KG · Jun 2022
M-Vizion Monobloc
K212327 · Medacta International S.A. · May 2022
Amis K Long
K220405 · Medacta International S.A. · Apr 2022
Corin MetaFix™ Hip Stem
K212069 · Corin U.S.A. Limited · Apr 2022
DePuy Corail AMT Hip Prosthesis
K213839 · DePuy Orthopaedics, Inc. · Jan 2022
Restoration Modular 115mm Conical Distal Stem
K213129 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Dec 2021
K213675 · MP Reconstruction System
Download PDF FDA Summary Waldemar Link GmbH & …