Cleared Special

MODIFICATION TO: ACUMATCH L-SERIES BIPOLAR ENDOPROSTHESIS (K013211) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K013211 · Exactech, Inc. · Orthopedic device
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Dec 2001
Decision
70d
Days
Class 2
Risk

K013211 is an FDA 510(k) clearance for the MODIFICATION TO: ACUMATCH L-SERIES BIPOLAR ENDOPROSTHESIS. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented (product code KWY), Class II - Special Controls.

Submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on December 5, 2001 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3390 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Exactech, Inc. devices

Submission Details

510(k) Number K013211 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2001
Decision Date December 05, 2001
Days to Decision 70 days
Submission Type Special
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
52d faster than avg
Panel avg: 122d · This submission: 70d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KWY Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3390
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 - KWY Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented

All 47
Devices cleared under the same product code (KWY) and FDA review panel - the closest regulatory comparables to K013211.
AESCULAP BIPOLAR ACETABULAR CUP
K060707 · Aesculap, Inc. · May 2006
STAGEONE DISPOSABLE CEMENT SPACER MOLD FOR TEMPORARY HIP PROSTHESIS WITH REINFORCEMENT STEM
K052990 · Biomet, Inc. · Dec 2005
SMITH & NEPHEW GLOBAL BIPOLAR SYSTEM
K023743 · Smith & Nephew, Inc. · Jan 2003
ACUMATCH L-SERIES UNIPOLAR ENDOPROSTHESIS
K010081 · Exactech, Inc. · Feb 2001
M2A 32MM TAPER SYSTEM
K003363 · Biomet, Inc. · Dec 2000
TRI-POLAR SYSTEM
K991990 · Biomet, Inc. · Sep 1999