Cleared Traditional

K161840 - LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip System PoroLink® (microporous) and HX® (CaP) coated

K161840 is an FDA 510(k) clearance for LINK SP-CL Hip System PoroLink (micropo..., manufactured by Waldemar Link GmbH & Co. KG. The device is a Class 2 Orthopedic device with product code LZO cleared through the Traditional 510(k) pathway after a 254-day FDA review.

K161840 · Waldemar Link GmbH & Co. KG · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2017
Decision
254d
Days
Class 2
Risk

K161840 is an FDA 510(k) clearance for the LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® .... 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 March 16, 2017 after a review of 254 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Waldemar Link GmbH & Co. KG devices

FDA 510(k) Submission Details - K161840

510(k) Number K161840 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2016
Decision Date March 16, 2017
Days to Decision 254 days
Submission Type Traditional
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
132d slower than avg
Panel avg: 122d · This submission: 254d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 509
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K161840.
Corin MetaFix Hip Stem
K162942 · Corin U.S.A. Limited · Jun 2017
Responsive Orthopedics Total Hip Arthroplasty System
K163585 · Responsive Orthopedics, LLC · Jun 2017
AMIStem-H Proximal Coating
K161635 · Medacta International S.A. · Mar 2017
Revision Femoral Stem
K161226 · Lima Corporate S.P.A. · Feb 2017
Initia Total Hip System & BIOCERAM AZUL(R) HEAD
K160895 · Kyocera Medical Corporation · Nov 2016
Zimmer M/L Taper Hip Prosthesis
K161830 · Zimmer, Inc. · Oct 2016