Cleared Abbreviated

K991026 - REFLECTION CROSSLINKED UHMWPE ACETABULA...

K991026 is the FDA 510(k) clearance for REFLECTION CROSSLINKED UHMWPE ACETABULA... by Smith & Nephew, Inc.. It is a Class 2 Orthopedic device (product code LPH) cleared through the Abbreviated 510(k) pathway after a 207-day FDA review.

K991026 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1999
Decision
207d
Days
Class 2
Risk

K991026 is an FDA 510(k) clearance for the REFLECTION CROSSLINKED UHMWPE ACETABULAR COMPONENTS. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on October 22, 1999 after a review of 207 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - the FDA orthopedic device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Smith & Nephew, Inc. devices

Submission Details

510(k) Number K991026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1999
Decision Date October 22, 1999
Days to Decision 207 days
Submission Type Abbreviated
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
85d slower than avg
Panel avg: 122d · This submission: 207d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3358
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 - LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

All 443
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K991026.
EXACTECH ACUMATCH INTEGRATED HIP SYSTEM A-SERIES POROUS COATED ACETABULAR COMPONENT
K993082 · Exactech, Inc. · Nov 1999
CROSSFIRE SYSTEM 12 ACETABULAR INSERTS
K993352 · Howmedica Osteonics Corp. · Nov 1999
ZMR HIP SYSTEM-REVISION TAPER
K992667 · Zimmer, Inc. · Oct 1999
ENCORE FULLY COATED HIP
K992109 · Encore Orthopedics, Inc. · Aug 1999
TRILOGY ACETABULAR SYSTEM LONGEVITY CROSSLINKED POLYETHYLENE
K990135 · Zimmer, Inc. · Jul 1999
SYNERGY POROUS SIZE 8 HIP STEM
K991485 · Smith & Nephew, Inc. · Jul 1999