Cleared Traditional

SPACER G TEMPORARY HIP PROSTHESIS (K031841) - FDA 510(k) Clearance

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

K031841 · Exactech, Inc. · Orthopedic device
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Jan 2004
Decision
220d
Days
Class 2
Risk

K031841 is an FDA 510(k) clearance for the SPACER G TEMPORARY HIP PROSTHESIS. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal (product code KWL), Class II - Special Controls.

Submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on January 22, 2004 after a review of 220 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3360 - 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 Exactech, Inc. devices

Submission Details

510(k) Number K031841 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2003
Decision Date January 22, 2004
Days to Decision 220 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
98d slower than avg
Panel avg: 122d · This submission: 220d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWL Prosthesis, Hip, Hemi-, Femoral, Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3360
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 - KWL Prosthesis, Hip, Hemi-, Femoral, Metal

All 49
Devices cleared under the same product code (KWL) and FDA review panel - the closest regulatory comparables to K031841.
CORIN ADAPTOR SLEEVE
K071471 · Howmedica Osteonics Corp. · Sep 2007
SMITH & NEPHEW MODULAR FEMORAL (HEMI) HEAD
K062408 · Smith & Nephew, Inc. · Sep 2006
SMITH & NEPHEW MODULAR FEMORAL HEAD
K061243 · Smith & Nephew, Inc. · Jul 2006
UNITRAX MODULAR UNIPOLAR SYSTEM
K014226 · Howmedica Osteonics Corp. · Jan 2002
UNITRAX C-TAPER NECK ADJUSTMENT SLEEVE
K992570 · Howmedica Osteonics Corp. · Sep 1999
OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVE
K984585 · Osteonics Corp. · Feb 1999