Cleared Traditional

ESKA MODULAR HIP SYSTEM (K993027) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K993027 · Specs USA, Inc. · Orthopedic device
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Apr 2000
Decision
210d
Days
Class 2
Risk

K993027 is an FDA 510(k) clearance for the ESKA MODULAR HIP SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Specs USA, Inc. (Sarasota, US). The FDA issued a Cleared decision on April 6, 2000 after a review of 210 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 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 Specs USA, Inc. devices

Submission Details

510(k) Number K993027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1999
Decision Date April 06, 2000
Days to Decision 210 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d slower than avg
Panel avg: 122d · This submission: 210d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 325
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K993027.
PINNACLE ACETABULAR SYSTEM
K001534 · DePuy Orthopaedics, Inc. · Jun 2000
REACH FEMORAL COMPONENT
K000760 · Biomet, Inc. · May 2000
MALLORY/HEAD CALCAR REPLACEMENT WITH INTERLOCKING SLOTS BI-METRIC POROUS COLLARED STEM WITH INTERLOCKING SLOTS
K990830 · Biomet, Inc. · Apr 2000
PINNACLE ACETABULAR SYSTEM
K000306 · DePuy Orthopaedics, Inc. · Mar 2000
MALLORY/HEAD LATERALIZED PRESS-FIT FEMORAL
K000538 · Biomet, Inc. · Mar 2000
ZMR HIP SYSTEM-POROUS REVISION
K994286 · Zimmer, Inc. · Mar 2000