Cleared Traditional

K992109 - ENCORE FULLY COATED HIP

K992109 is an FDA 510(k) clearance for ENCORE FULLY COATED HIP, manufactured by Encore Orthopedics, Inc.. The device is a Class 2 Orthopedic device with product code LPH cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K992109 · Encore Orthopedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1999
Decision
51d
Days
Class 2
Risk

K992109 is an FDA 510(k) clearance for the ENCORE FULLY COATED HIP. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Encore Orthopedics, Inc. (Austin, US). The FDA issued a Cleared decision on August 12, 1999 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Encore Orthopedics, Inc. devices

FDA 510(k) Submission Details - K992109

510(k) Number K992109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1999
Decision Date August 12, 1999
Days to Decision 51 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
71d faster than avg
Panel avg: 122d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LPH Device Classification - Class 2, Special Controls

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 446
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K992109.
CROSSFIRE SYSTEM 12 ACETABULAR INSERTS
K993352 · Howmedica Osteonics Corp. · Nov 1999
ZMR HIP SYSTEM-REVISION TAPER
K992667 · Zimmer, Inc. · Oct 1999
REFLECTION CROSSLINKED UHMWPE ACETABULAR COMPONENTS
K991026 · Smith & Nephew, Inc. · Oct 1999
TRILOGY ACETABULAR SYSTEM LONGEVITY CROSSLINKED POLYETHYLENE
K990135 · Zimmer, Inc. · Jul 1999
SYNERGY POROUS SIZE 8 HIP STEM
K991485 · Smith & Nephew, Inc. · Jul 1999
TITANIUM LOW PROFILE SCREWS
K991807 · Biomet, Inc. · Jul 1999